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Orthopedic and Dental Industry News Complete Archive »

Spine

Bioventus to Acquire OsteoAMP Product Line from Advanced Biologics BY ANDREW VAHRADIAN, OCTOBER 15, 2014

Bioventus entered into an agreement to acquire the OsteoAMP product line from Advanced Biologics. Under the terms of the agreement, Bioventus will acquire the intellectual property, commercial business, research and development (R&D) and product supply (which could lead to future... more

Medtronic to Utilize External Debt to Finance Its Acquisition of Covidien BY ANDREW VAHRADIAN, OCTOBER 6, 2014

Medtronic disclosed that it intends to use approximately $16 billion in external financing to complete its previously announced $43 billion acquisition of Covidien plc, rather than utilizing a combination of a $13.5 billion intercompany loan from a foreign subsidiary, and... more

Amedica Appoints New President & CEO BY ANDREW VAHRADIAN, OCTOBER 6, 2014

Amedica Corporation announced the appointment of Dr. Sonny Bal as the company's President and Chief Executive Officer. Dr. Bal has served as a member of Amedica's Board since February 2012, and as its Chairman since August 20th, 2014. He succeeds... more

Blackstone to Acquire Stake in Xinrong Best Medical Instrument for a Reported $100M BY ANDREW VAHRADIAN, SEPTEMBER 23, 2014

The Blackstone Group entered into an agreement to acquire an unspecified stake in Xinrong Best Medical Instrument Co., a Chinese-based developer of orthopedic implants with Trauma, Spine and Joint applications, for a reported $100 million. Xinrong is planning to target... more

ReWalk Robotics Prices IPO BY ANDREW VAHRADIAN, SEPTEMBER 22, 2014

ReWalk Robotics priced its initial public offering (IPO) of 3.0 million shares of common stock at a price of $12.00 per share, raising total proceeds of $36 million. This equates to an enterprise value of approximately $155 million. The final... more

Mazor Robotics' Renaissance Guidance System Receives Approval in China BY ANDREW VAHRADIAN, SEPTEMBER 9, 2014

Mazor Robotics received approval from the China Food & Drug Administration (CFDA) for its Renaissance surgical guidance system, an intraoperative 3-D imaging system intended to assist with the use of surgical instruments in a variety of spine and brain... more

ReWalk Robotics Proposes Terms for IPO BY ANDREW VAHRADIAN, SEPTEMBER 5, 2014

ReWalk Robotics filed to raise between $54 million and $60 million through a previously 3634">announced initial public offering (IPO), by offering 3.4 million shares of common stock at a proposed price range of $14-$16 a share. At the midpoint of... more

Integra Lifesciences Expresses Interest to Divest Spine Business BY ANDREW VAHRADIAN, AUGUST 27, 2014

Last week, Glenn Coleman the CFO of Integra Lifesciences, expressed to analysts that the company is interested in exploring strategic alternatives for its Spine business. Integra's management team believes that Integra's Spine unit would need a significant investment in order... more

Humana Sues Medtronic Over Marketing Strategy of INFUSE BY ANDREW VAHRADIAN, JUNE 9, 2014

Last week, Humana filed a lawsuit against Medtronic accusing the defendant of falsely representing its INFUSE Bone Graft product as "safe and effective" in spinal fusion surgeries. INFUSE is Medtronic's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2), which... more

Spinal Kinetics Completes $34M Financing and Settles IP Litigation with Johnson & Johnson BY ANDREW VAHRADIAN, JUNE 5, 2014

Spinal Kinetics completed a $34 million private financing and entered a global settlement of all patent litigation with Synthes and Depuy Synthes (Johnson & Johnson) with respect its M6 Cervical and Lumbar artificial disc implants. The company's M6-C artificial cervical... more

Medtronic Reported to be Considering an Acquisition of Smith & Nephew BY ANDREW VAHRADIAN, JUNE 5, 2014

Medtronic is reported to be considering an acquisition of Smith & Nephew. Presently, no offer is imminent as Medtronic's bid preparations are believed to be at an early stage. The transaction would impart greater leverage to Medtronic with payor and... more

Johnson & Johnson Plans to Launch 30 New Medical Devices by 2016 BY ANDREW VAHRADIAN, MAY 30, 2014

In the 2013 fiscal year, Johnson & Johnson's Pharmaceutical business grew 12% on a constant currency basis, outstripping the company's Medical Device & Diagnostic (MD&D) segment, which grew at 6%. Therefore, in order to bolster growth to its MD&D unit,... more

K2M Prices IPO BY ANDREW VAHRADIAN, MAY 8, 2014

K2M priced its initial public offering (IPO) of 8,825,000 shares of common stock at a price of $15.00 per share, raising total proceeds of $132 million. This equates to an enterprise value of approximately $595 million, or 3.8x LTM revenues.... more

Graphene, a Novel and Promising Biomaterial BY ANDREW VAHRADIAN, MAY 7, 2014

Initially derived from graphite, graphene is a metamaterial (a material artificially engineered to have unique properties not commonly found in nature) composed of a single layer of carbon atoms arranged in a 2-dimensional, regular hexagonal (honeycomb) lattice. Graphene was first... more

K2M Proposes Terms for IPO BY ANDREW VAHRADIAN, APRIL 22, 2014

K2M filed to raise between $141 million and $159 million through a previously announced initial public offering (IPO), by offering 8.8 million shares of common stock at a proposed price range of $16-$18 a share. At the midpoint of the... more

Stem Cell Therapy Halts DDD BY ANDREW VAHRADIAN, MARCH 21, 2014

Meta-analysis of pre-clinical animal studies concluded that stem cell transplant was effective treatment in halting or reversing degenerative disc disease (DDD) of the spine. The study demonstrated that stem cell therapy not only increased intervertebral disc (IVD) height, but also... more

K2M Proposes $100M IPO BY ANDREW VAHRADIAN, MARCH 17, 2014

K2M filed to raise up to $100 million through a previously announced initial public offering (IPO) of common shares. The price range and number of shares to be sold in the offering has not yet been determined. The company plans... more

Amedica Prices IPO BY ANDREW VAHRADIAN, FEBRUARY 19, 2014

Amedica Corporation priced its initial public offering (IPO) of 3,500,000 shares of common stock at a public offering price of $5.75 per share, raising total proceeds of $20 million. This equates to an enterprise value of approximately $97 million, or... more

K2M Files for IPO BY ANDREW VAHRADIAN, JANUARY 27, 2014

Another sign that orthopedics and spine is coming back into favor with the investment community has emerged with K2M Group announcing its filing to do an initial public offering (IPO). K2M has formally submitted its draft registration statement (Form S-1)... more

Globus Medical to Acquire Excelsius Surgical BY ANDREW VAHRADIAN, JANUARY 9, 2014

Globus Medical entered into a definitive agreement to acquire Excelsius Surgical, a company developing a novel surgical robotic positioning platform for the spine, brain and musculoskeletal markets. The financial terms of the deal were not disclosed, however analysts estimate the... more

Drug Device Combination Product Market to Grow to $115B BY ANDREW VAHRADIAN, JANUARY 7, 2014

According to a new report from Transparency Market Research, the global market for drug device combination products is anticipated to grow from $66 billion in 2012 to $115.1 billion by 2019. According to the FDA, drug device combination products are... more

Alphatec Spine Announces Executive Leadership Changes BY EDITOR, JANUARY 2, 2014

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, announced that Mike Plunkett will succeed Pat Ryan as Chief Operating Officer. Mr. Ryan, who has... more

Medtronic Presents 7-year Clinical Data for Artificial Disc Replacement BY ANDREW VAHRADIAN, DECEMBER 12, 2013

Medtronic presented 7-year clinical and radiographic outcomes of artificial disc replacement procedures with its PRESTIGE Cervical Disc, which is a stainless steel device that articulates through a ball and trough mechanism. The study enrolled a total 541 patients and compared... more

Baxano Surgical Secures $22M in Financing Commitments BY ANDREW VAHRADIAN, DECEMBER 6, 2013

Baxano Surgical, a comany that develops minimally invasive products to treat degenerative spinal conditions affecting the lumbar region, secured a comprehensive financing package that entails a credit facility of up to $15.0 million with Hercules Technology Growth Capital, and a... more

FDA Permits Reviews of Wright Medical and FzioMed Biologic Products BY ANDREW VAHRADIAN, NOVEMBER 19, 2013

Wright Medical and FzioMed received notifications from the FDA agreeing to withdraw its not approvable letters and establish Medical Dispute Resolution Panels (DRP) for the companys' Augment Bone Graft and Oxiplex Gel products respectively. Wright's Augment product is intended for... more

Amedica Announces Public Offering BY ANDREW VAHRADIAN, NOVEMBER 18, 2013

Amedica announced plans to launch an initial public offering (IPO) to raise up to $35 million. The Salt Lake City company specializes in silicon nitride-based implants used during joint-replacement and spinal procedures. The company had previously filed for an IPO... more

The FDA Outlines Approach to Personalized Medicine BY ANDREW VAHRADIAN, OCTOBER 31, 2013

It is widely believed that personalized medicine will dramatically change the manner in which medical devices and drugs are developed, tested, and regulated. The FDA believes that with the progression of science, technology and the understanding of the underlying mechanisms... more

LDR Holding Completes IPO BY ANDREW VAHRADIAN, OCTOBER 9, 2013

LDR Holding priced its initial public offering (IPO) and began trading on the NASDAQ Stock Market under the ticker symbol "LDRH" today. The company raised $75 million by offering 5.0 million shares priced at $15 a share, the midpoint of... more

Biomet to Acquire Privately-held Lanx, Inc. BY ANDREW VAHRADIAN, OCTOBER 8, 2013

Biomet announced a definitive agreement to acquire Lanx, Inc., a developer of minimally invasive devices for spinal fusion procedures. Financial details of the transaction were not disclosed. The pending deal increases Biomet's spine market share, grants Biomet greater exposure to... more

European Union Committee Votes in Favor of a Stricter Regulatory Process for Medical Devices BY ANDREW VAHRADIAN, OCTOBER 3, 2013

Members of the European Union parliament's Environment Committee (Committee), voted in favor of a new pre-market authorization (PMA) system that would employ randomized clinical trials for Class III, or high-risk, implantable devices under the oversight of the European Medicines Agency... more

Musculoskeletal News Roundup 26-Sept-13 BY LAUREN UZDIENSKI, SEPTEMBER 26, 2013

SYK to acquire MAKO ... Crosstress Medical receives 510(k) clearance for PVA Pod System ... PlusLife's Allogeneic Bone Gel for sale ... Integra announces first implantation of the Titan Reverse Shoulder System ... RTI Surgical's first implantation of the map3 Cellular Allogeneic Bone Graft ... Mazor Robotics to raise up to $46M in Nasdaq offering and announces new Renaissance installation in Russia more

rhBMP-2 Linked to Higher Rates of Benign Tumor Development BY ANDREW VAHRADIAN, SEPTEMBER 13, 2013

In recent years, the use bone morphogenetic proteins (BMPs) has come under scrutiny. A study published in Spine, found a rise in the prevalence of off-label use of BMPs, determining that between 2003 and 2007, the annual number of procedures... more

Aurora Spine Completes IPO BY ANDREW VAHRADIAN, SEPTEMBER 9, 2013

Aurora Spine Corporation completed its initial public offering (IPO) of 5,150,000 common shares at a price per share of $0.70, for total gross proceeds of $3,605,000. Aurora Spine's common shares are expected to commence trading on the TSX Venture Exchange... more

Gender: An Important Parameter for Personalized Medicine BY ANDREW VAHRADIAN, AUGUST 26, 2013

The FDA’s Center for Devices and Radiological Health (CDRH) has launched its Health of Women Program, an initiative focused on improving women’s access to, and outcomes from, treatments incorporating medical devices. The initiaitive highlights that: 1) Women are less frequently... more

Chinese Research Team Conducting Study on 3D Printed Spinal Implants BY ANDREW VAHRADIAN, AUGUST 15, 2013

At the Peking University Third Hospital in Beijing, Dr. Liu Zhongjun, Chairman of the Department of Orthopedic surgery and the Research Center of Spinal Surgery, Peking University, is leading a team of researchers in the process of conducting human clinical... more

Bioactive Glass Scaffolds Demonstrate Potential as Weight-bearing Implants BY ANDREW VAHRADIAN, AUGUST 1, 2013

Researchers at Missouri University of Science and Technology have developed a type of glass implant that could one day be used to repair injured bones in the arms, legs and other areas of the body that are most subject to... more

Aurora Spine Files Preliminary Prospectus to go Public BY ANDREW VAHRADIAN, JULY 18, 2013

Aurora Spine Corporation announced that it has filed a preliminary prospectus with the securities regulatory authorities in the Canadian provinces of Alberta and Ontario in connection with a proposed initial public offering (IPO) of common shares for total gross proceeds... more

Hospitals to Settle with Federal Government over Fraudulent Billing Scheme BY ANDREW VAHRADIAN, JULY 9, 2013

Fifty-five hospitals in 21 states will be paying a total of $34 million to the federal government in order to settle allegations that they overcharged Medicare and other government healthcare programs for kyphoplasty back procedures. The settlements were the result... more

Medtronic Announces the Publication of the Yale Review of INFUSE BY ANDREW VAHRADIAN, JUNE 19, 2013

Medtronic announced the publication of two highly anticipated independent reviews overseen by Yale University regarding its INFUSE Bone Graft product, the company's proprietary formulation of recombinant human bone morphogenetic protein-2 (rhBMP-2). The results of both analyses, published in the June... more

RTI Biologics to Acquire Pioneer Surgical Technology BY ANDREW VAHRADIAN, JUNE 12, 2013

RTI Biologics announced plans to acquire the outstanding stock of Pioneer Surgical Technology in an all cash transaction valued at $130 million. The deal will expand RTI's current implant portfolio into the metals and synthetics sectors, accelerate gross margin expansion,... more

Musculoskeletal News Roundup 23-May-2013 BY LAUREN UZDIENSKI, MAY 23, 2013

MDT reports earnings ... OsteoGeneX receives SBIR grant ... FDA panel votes to reclassify pedicle screws for the thoracolumbosacral class II ... Depuy Synthes to discontinue ULTAMET Metal-on-Metal Articulation and COMPLETE Ceramic-on-Metal hip systems ... KFx receives new patents ... Benvenue Medical completes follow-up for KAST study ... Globus files suit against Depuy Synthes ... Blue Belt partners with DJO ... EOS announces Asia expansion ... Stryker and OrthoSensor extend co-marketing agreement for VERASENSE more

Alphatec Spine to Host Technology Day on June 6, 2013 in New York City BY EDITOR, MAY 13, 2013

Venue: Convene Conference Center (730 Third Avenue) From 8:30 AM to 11:30 AM Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets physician-inspired solutions for patients with spinal... more

TranS1 to buy Baxano BY JOHN MCCORMICK, MARCH 4, 2013

This morning spinal implant maker TranS1 announced that it was merging with stenosis technology company Baxano. The deal, valued at a total of $23.6 million, is paid for primarily by TranS1 issuing new stock, although TranS1 will pay $500k of... more

Researchers Conclude the "July Effect" is Negligible on Spinal Surgery BY ANDREW VAHRADIAN, FEBRUARY 6, 2013

Researchers concluded that the storied "July Effect", which claims that patients receive a lower standard of care due to the introduction of new residents and fellows at teaching hospitals during the month of July, has an negligible effect on periprocedural... more

SPORT Data Demonstrates Obese Patients Realize Less Clinical Benefit from Treatment of Lumbar Disc Herniation BY ANDREW VAHRADIAN, JANUARY 3, 2013

It has been well documented that obesity exacerbates the strain exerted on and deterioration of a person's musculoskeletal system, and leads to a greater probability of lower back pain, facet arthritis and degenerative disc disease. Though, the link between obesity... more

Alphatec Spine Receives U.S. FDA 510(K) Market Clearance for Two New Products and Receives Japanese Shonin Approval to Begin Marketing Its Novel Peek Lumbar Spinal Spacers BY EDITOR, JANUARY 3, 2013

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine,... more

Musculoskeletal News Roundup 20-Sept-2012 BY LAUREN UZDIENSKI, SEPTEMBER 20, 2012

K2M receives expanded 510(k) clearance for MESA portfolio ... ATEC announces first clinical use of NEXoss ... DJO launches Movation TKA ... KFx announces new patent ... Lanx announces ASPEN MIS results more

Spending Trends in Spine BY LAUREN UZDIENSKI, SEPTEMBER 19, 2012

New data show that back pain trails only upper respiratory complaints as the most-common reason U.S. patients see a physician, with about 6% of U.S. adults reporting a doctor's visit due to back pain in 2008. In terms of costs, the average per-patient expenditure on spine care rose 95% between 1998 and 2008, resulting in a total of $90 billion spent on the diagnosis and management of low back pain annually, and an additional $10 to $20 billion in economic losses in productivity. These trends were all observed by a new article in the journal Spine, published September 1. more

Musculoskeletal News Roundup 13-Sept-12 BY LAUREN UZDIENSKI, SEPTEMBER 12, 2012

FDA clears Iconacy Orthopedic Implants' I-Hip system ... Precision Spine's Slimplicity Solo Anterior Cervical Plate System 510(k)-cleared ... Amedica studies find "superior osseointegration and bacterial-resistant properties" of silicon nitride ... Ascendx Spine begins commercial shipments to Europe ... Osseon launches Osseoflex SN+ ... Smith & Nephew releases LEGION HK Hinge Knee ... NuVasive signs Premier agreement more

Musculoskeletal News Roundup 6-Sept-12 BY LAUREN UZDIENSKI, SEPTEMBER 6, 2012

FDA clears aap's LOQTEQ, LDR's Avenue L Lateral Lumber Cage System ... K2M introduces SERENGETI Complex Spine Minimally Invasive Retractor System ... AmnioClear clinical data ... Biomet to distribute BONESUPPORT's CEREMENT more

Musculoskeletal News Roundup 30-Aug-12 BY LAUREN UZDIENSKI, AUGUST 30, 2012

Axial Biotech sells ScoliScore for $4.4 million ... Nextremity Solutions closes funding round ... FH Orthopedics announces FDA approval ... Osseon appoints COO more

Musculoskeletal News Roundup 16-Aug-12 BY LAUREN UZDIENSKI, AUGUST 16, 2012

aap Implantate, Mazor announce 2Q revenues ... Spinal Elements announces first surgeries with MIS lumbar system ... Lanx receives patent ... K2M partners with Cadwell Laboratories on neuromonitoring ... SpineMark centers implementing spine protocol more

Mazor Raises $15M for U.S. ADR Program BY LAUREN UZDIENSKI, AUGUST 14, 2012

Israeli company Mazor Robotics, which currently trades on the Tel Aviv Stock Exchange under the symbol MZOR, announced a $15 million private placement that the company will use to support an ADR program. ADRs allow non-U.S. companies to trade on U.S. exchanges. The investment, led by Oracle Investment Management, consists of two tranches of $7.5 million each. more

Musculoskeletal News Roundup 9-Aug-12 BY LAUREN UZDIENSKI, AUGUST 8, 2012

ATEC, TRNX announce earnings ... DePuy receives 510(k) for adolescent idiopathic scoliosis products ... ulrich medical launches golden gate Lateral Plate System ... WMGI subpoenaed over Profemur more

Globus Medical Debuts on the New York Stock Exchange BY LAUREN UZDIENSKI, AUGUST 3, 2012

Globus Medical (GMED) began trading on the New York Stock Exchange this morning, opening at $13.10 per share after pricing 8.3 million Class A common shares at $12 per share last night. The stock is up 17% in mid-morning trading. Globus has said they will use proceeds from the offering to expand its sales and for investments in research and development. more

Musculoskeletal News Roundup 2-Aug-12 BY LAUREN UZDIENSKI, AUGUST 2, 2012

ANIK, ARTC, DJO, EXAC, MAKO, RTIX, SNN, SMA, WMGI report 2Q:12 ... Medtronic launches Aquamantys3 BSC 9.1S Bipolar Sealer with Cutting ... NewVert completes biomechanical testing for Octopus Spinal Annular Repair System ... Spinal Elements introduces Lucent Ti-Bond ... Benvenue Medical completes KAST enrollment ... TranS1 announces study results more

Globus Latest IPO Update a Positive for Industry BY JOHN MCCORMICK, JULY 27, 2012

This week, Globus Medical, which is well on its way to going public, made a key amendment to its IPO filing materials that indicate a positive for the challenged spine industry. The amendment also indicates that their IPO is imminent. more

Musculoskeletal News Roundup 26-Jul-12 BY LAUREN UZDIENSKI, JULY 25, 2012

CNMD, Globus, IART, NUVA, OFIX, ZMH report 2Q:12 ... Histogenics raises $49M ... FH Orthopedics receives CE mark ... Discgenics receives stem cell patent ... Exactech, CONMED to collaborate on education program more

Musculoskeletal News Roundup 19-Jul-12 BY LAUREN UZDIENSKI, JULY 19, 2012

Biomet, JNJ, Stryker announce earnings ... Mindray closes Dragonbio acquisition ... K2m debuts Rail 4D Technology ... Globus files amended S-1 ... MTF receives patent covering NovaBone Putty ... Expanding Orthopedics announces data presentation ... SpineGuard reports 6-month data ... Cardinal Health launches Orthopedic Solutions offering more

Musculoskeletal News Roundup 5-Jul-12 BY LAUREN UZDIENSKI, JULY 5, 2012

IlluminOss raises $1.4M ... TSON receives CE mark for its VEO system ... SpineGuard announces milestone ... WMGI launches ORTHOLOC 3Di plating system ... Internal Fixation Systems expands GoDirect sales program more

JBJS: The Latest in Spine Surgery BY LAUREN UZDIENSKI, JULY 5, 2012

JBJS published its annual review of the latest developments in spine surgery this month, covering treatments for the cervical and lumbar spine, deformity and spinal cord injury cases and innovations in biologics. more

Musculoskeletal News Roundup 28-Jun-12 BY LAUREN UZDIENSKI, JUNE 28, 2012

Benvenue raises $25M ... ZMH launches TM Ardis Interbody System for the lumbar spine ... Cartiva completes enrollment for their MOTION trial ... Corin expands LARS distribution agreement ... IART debuts private label version of the aap Implantate stainless headed compression screw system more

Musculoskeletal News Roundup 14-Jun-12 BY LAUREN UZDIENSKI, JUNE 14, 2012

J&J/Synthes transaction closes ... ConforMIS raises $73M ... Mazor announces Korean regulatory approval for Renaissance ... FDA clears TransCorp's SpinePort Spinal Access System ... SANUWAVE announces preclinical osteoarthritis results ... Internal Fixation System launches GoDirect sales program ... Premier awards spine contracts more

Musculoskeletal News Roundup 7-June-12 BY LAUREN UZDIENSKI, JUNE 7, 2012

J&J/Synthes deal may close next week ... Mindray to acquire controlling interest in Chinese orthopedic manufacturer ... FDA clear's Medicrea's LigaPASS ... K2M launches MESA Small Suture implant ... SNN voluntarily withdraws the optional metal liner component of its R3 Acetabular System ... ISTO receives U.S. patent ... SYK close to settling DOJ investigation into OtisKnee ... SANUWAVE comments on preclinical data more

Musculoskeletal News Roundup 31-May-12 BY LAUREN UZDIENSKI, MAY 31, 2012

Globus Medical files amended S-1 ... Medtronic receives CE mark for SHILLA scoliosis system ... Zimmer launches Sidus Stem-Free Shoulder and TM Ardis Interbody System ... House and Senate pass user fee legislation ... Orthofix's Phoenix MIS and Firebird Pedicle Screw Systems to be integrated with Brainlab navigation systems ... TransCorp Spine names President and CEO more

Medtronic Talks Spine on F4Q:12 Earnings Call BY LAUREN UZDIENSKI, MAY 24, 2012

On Tuesday Medtronic announced earnings results from its F4Q:12, which included improving sales in spine. The company reported quarterly spine revenue of $818 million, which declined by 6% overall and 2% after excluding the negative impact U.S. sales of INFUSE. The company benefited from international sales, with OUS spine up 8%, including over 20% growth in the Japanese market. On the call, management added that "business is particularly strong in China, where our joint venture with Weigao is delivering solid results." more

Musculoskeletal News Roundup 24-May-12 BY LAUREN UZDIENSKI, MAY 24, 2012

Medtronic reports earnings ... AxioMed closes Series D round ... Mazor launches C-OnSite ... BlueCross BlueShield of Tennessee announces bundled payments for hip and knee replacements ... Baxano completes enrollment on iO-Flex study ... Benvenue announces Board appointments more

Musculoskeletal News Roundup 17-May-12 BY LAUREN UZDIENSKI, MAY 17, 2012

aap, Corin, Mazor, TiGenix provide 1Q sales ... Regenerative Sciences raises $2M ... Regentis Biomaterials raises $10M ... Zyga raises $25M ... Axiomed receives CE mark for Freedom Cervical Disc ... Orthopaedic Implant Company launches pedicle screw system ... DOJ closes InFuse investigation ... Histogenics, Piramal announce cartilage repair data more

Musculoskeletal News Roundup 10-May-12 BY LAUREN UZDIENSKI, MAY 10, 2012

ATEC, ANIK, BMTI, MAKO, TRNX, TSON report 1Q ... OrthoSensor raises $15M ... Internal Fixation Systems announces distribution agreement with Intelligent Orthopaedics ... Seikagaku announces marketing agreement with Kaken for lumbar disc herniation treatment ... Bioventus officially launched more

Clinical Roundup May 2012 BY LAUREN UZDIENSKI, MAY 10, 2012

Use of fibrin sealant QUIXIL in TKAs ... The accuracy of imaging in spine surgery ... ACL revision data from Denmark ... Ankle surgery and weight loss ... More surgeons working for hospitals more

Musculoskeletal News Roundup 3-May-12 BY LAUREN UZDIENSKI, MAY 3, 2012

ARTC, DJO, EXAC, KNSY, NUVA, SNN, SMA, WMGI report 1Q:12 ... Titan Spine announces publication of data ... VG Innovations awarded new patent ... Solco Biomedical announces U.S. distribution deal more

Musculoskeletal News Roundup 26-Apr-12 BY LAUREN UZDIENSKI, APRIL 26, 2012

CNMD, IART, OFIX, RTIX, Synthes, ZMH report 1Q ... FDA clears LDR's ROI-C Lordotic Cervical Cage ... SNN launches HEALICOIL PK suture anchor ... SNN moving some manufacturing to China ... LDR appoints Robert McNamara CFO more

Musculoskeletal News Roundup 19-Apr-12 BY LAUREN UZDIENSKI, APRIL 19, 2012

JNJ, Stryker announce earnings ... EU approves JNJ's acquisition of Synthes ... DePuy launches VIPER F2 Transfacet Pedicular System ... IART introduces Vu aPOD Prime IBD ... Mesoblast reaches 50% enrollment on phase II study ... OREF announces $3.1 million in grants more

Musculoskeletal News Roundup 12-Apr-12 BY LAUREN UZDIENSKI, APRIL 12, 2012

Biomet kicks off earnings season ... FDA approves phase I Arteriocyte study for Compartment Syndrome ... Piramal receives CE mark for BST-CarGel ... Amedica announces new biologics distribution agreements ... Advanced Biologics inks deal with GPO Premier more

Vexim Plans IPO BY LAUREN UZDIENSKI, APRIL 12, 2012

French spine company Vexim is planning to IPO on the NYSE Alternext next month. Vexim developed the SpineJack procedure for the treatment of vertebral compression fractures and plans to raise as much as EUR 15.9 million ($20.9 million) in the offering, according to reports from Bloomberg. more

Musculoskeletal News Roundup 5-Apr-12 BY LAUREN UZDIENSKI, APRIL 5, 2012

SNN acquires LifeModeler ... Cutting Edge Spine launches E-Vol System of spinal fusion devices ... Medtronic to settle shareholder lawsuit for $85M ... New BONESUPPORT CEO announces 100 Day Plan ... Blue Belt opens new Pittsburgh facility more

Musculoskeletal News Roundup 29-Mar-12 BY LAUREN UZDIENSKI, MARCH 29, 2012

Mazor reports earnings .... Omni Surgical raises $27M ... Relievant Medsystems raises $30M ... FDA warning letters for Lucero Medical, Orthopedic Alliance and Spinal Solutions ... Benvenue Medical launches Blazer Vertebral Augmentation System ... Aperion Biologics completes enrollment in Z-Lig ACL study ... Benvenue Medical announces enrollment of 250th patient in KAST (Kiva System) study ... Ascendx Spine inks distribution deal in Austria, Germany and Switzerland more

Musculoskeletal News Roundup 22-Mar-12 BY LAUREN UZDIENSKI, MARCH 22, 2012

KH reports earnings ... Tepha raises $11M ... Anulex resolves FDA warning letter ... IART launches PyroTITAN Humeral Resurfacing Implant ... Benvenue Medical begins enrollment on Luna Interbody System study more

Musculoskeletal News Roundup 15-Mar-12 BY LAUREN UZDIENSKI, MARCH 15, 2012

BMTI reports 4Q11 ... Interventional Spine to present PerX360 System at ISASS ... DFINE announces first implantation of STAR System ... Simpirica Spine receives FDA approval for pivotal study ... Mazor Robotics signs distribution agreement for China more

Musculoskeletal News Roundup 1-Mar-12 BY LAUREN UZDIENSKI, MARCH 1, 2012

ATEC, ANIK, EXAC announce earnings ... MedShape receives $3M loan ... Globus Medical settles with FDA over NuBone ... FDA clears K2M's SANTORINI Corpectomy Cage ... Wright Medical launches CLAW II Polyaxial Compression Plating System ... TSON opens Raleigh training center more

Clinical Roundup February 2012 BY LAUREN UZDIENSKI, FEBRUARY 27, 2012

Defining conservative treatment in VCF cases ... Obesity and large joint outcomes ... Optimizing TKR rehab ... Navigation in TKR ... A review of PRP data ... Predicting recovery of walking ability in hip fracture patients more

Musculoskeletal News Roundup 23-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 23, 2012

ARTC, IART, MDT, NUVA, OFIX, SMA, TRNX, WMGI announce earnings ... Cerapedics raises debt ... Karolinska Development leads investment in Oss-Q ... FDA clears Ascendx Spine's Acu-Cut Vertebral Augmentation System ... Osseon receives CE mark for Osseoflex SB ... SBi names president and CEO more

Musculoskeletal News Roundup 16-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 16, 2012

co.don, CNMD, DJO and Synthes report ... Baxter closes Synovis acquisition ... Amedica announces $30M debt financing, launches Valeo VBR ... Cayenne Medical raises $10M ... SNN introduces POLARCUP Dual Mobility Hip ... Medtronic seeking royalties, interest relating to NUVA patent case ... Amedica appoints CEO more

Musculoskeletal News Roundup 9-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 9, 2012

Product launches from AAOS ... Nobel Biocare announces 4Q ... Hospitals settle Medicare fraud claims over kyphoplasty billing ... Updates on the American Joint Replacement Registry ... Stryker announces inventory management system rollout more

Musculoskeletal News Roundup 2-Feb-12 BY LAUREN UZDIENSKI, FEBRUARY 2, 2012

EXAC, KNSY, RTIX, SNN announce 4Q:11 ... CartiHeal raises $5M ... ConforMIS raises $89M ... FDA clears Eden Spine's GIZA device ... NLT announces 510(k) clearance for the PROW FUSION TLIF device ... ThermoGenesis announces "encouraging" study results more

Report from the 16th Annual ArgoSpine Symposium BY LAUREN UZDIENSKI, JANUARY 27, 2012

We're in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging). Industry presence is much lighter than is typical at these events, with commercial exhibits limited to single tables from the handful of sponsoring companies. The focus is instead clinical - surgical technique, treatment modalities and optimizing outcomes. more

Musculoskeletal News Roundup 26-Jan-12 BY LAUREN UZDIENSKI, JANUARY 26, 2012

DJO, JNJ, SYK, ZMH report 4Q sales ... FDA clears Interventional Spine's Opticage Expandable device ... Medtronic receives FDA clearance for newest Aquamantys device ... KFx Medical receives new patent ... Judge dismisses motions in MDT/NUVA case ... Pioneer Surgical announces grand opening of new N.C. manufacturing facility more

Musculoskeletal News Roundup 19-Jan-12 BY LAUREN UZDIENSKI, JANUARY 19, 2012

ZMH acquires Synvasive Technology ... Carticept, DiFusion announce funding rounds ... KFx announces ACL study results ... MedShape launches ExoShape Soft Tissue Fastener ... VG Innovations releases VerteLoc v2.5 ... Stryker settles OP-1 charges ... Zyga Technology appoints president and CEO more

Musculoskeletal News Roundup 12-Jan-12 BY LAUREN UZDIENSKI, JANUARY 12, 2012

MAKO, NUVA, OFIX, SYK, TRNX pre-announce ... FDA clears Biomet's E1 humeral bearing and Comprehensive Segmental Revision System ... Ortho Kinematics receives 510(k) clearance ... Lanx announces 100th implantation of Durango ... Mazor receives EU patent ... SNN announces VISIONAIRE study ... Arthrex to market ThermoGenesis PRP, bone marrow concentrate product ... Pioneer Surgical promotes Daniel Webber to CEO more

Musculoskeletal News Roundup 5-Jan-12 BY LAUREN UZDIENSKI, JANUARY 5, 2012

IART pre-announces . . . China Kanghui subsidiary receives FDA clearance for hip and knee systems . . . first procedure performed with Ellipse Technologies device . . . Pioneer Surgical announces first clinical use of nanOss Bioactive 3D . . . Wright Medical launches ORTHOLOC 3Di Ankle Fracture System and the QUICKDRAW Knotless Soft Tissue Fixation System . . . Globus appoints SVP and CFO . . . Vexim appoints CEO more

Musculoskeletal News Roundup 29-12-11 BY LAUREN UZDIENSKI, DECEMBER 29, 2011

KSpine raises $2.5M . . . ICOR provides international device registry update . . . Synthes sues Stryker . . . DePuy to distribute Anika's MONOVISC in the U.S. more

Musculoskeletal News Roundup 22-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 22, 2011

Biomet pre-announces . . . Oregon judge throws out SNN suture anchor ruling . . . Exactech initiates cartilage repair study . . . Spine Wave and MB Innovations announce partnership more

Musculoskeletal News Roundup 15-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 15, 2011

Baxter to acquire Synovis . . . FDA approves DePuy's AOX Antioxidant Polyethylene . . . EXAC launches Gibralt spinal system . . . CMS proposes industry relationships disclosure . . . Spinal Kinetics wins patent suit . . . Amp Orthopedics initiates two new studies . . . Vertiflex completes IDE enrollment . . . K2M names SVP Sales in the Americas more

Musculoskeletal News Roundup 8-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 7, 2011

Mazor reports earnings . . . HealthpointCapital acquires Blue Belt Technologies . . . DFINE receives regulatory clearance in Canada and Mexico . . . LDR approved to market ROC-C cervical cage, ROI-A ALIF cage in China . . . Ranier receives CE mark for Cadisc-C . . . DePuy launches Expedium Neuromuscular System . . . Exactech extends DPA . . . CA sobpoenas MDT over Infuse . . . IART opens China office . . . JNJ names Michel Orsinger worldwide chairman of its Global Orthopedics Group more

Musculoskeletal News Roundup 1-Dec-11 BY LAUREN UZDIENSKI, DECEMBER 1, 2011

IlluminOss raises $4M . . . Nextremity Solutions gets CE mark . . . ArthroSurface announces HemiCAP milestones . . . ARTC to settle class action securities suit . . . Zimmer to establish R&D center in Beijing more

Musculoskeletal News Roundup 23-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 23, 2011

MDT reports F2Q . . . TSON gives reimbursement update . . . Expanding Orthopedics comments on XPED expandable pedicle screw study . . . NREF and OREF to establish Collaborative Spine Research Foundation more

Musculoskeletal News Roundup 17-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 17, 2011

Zimmer acquires ExtraOrtho and XtraFix External Fixation System . . . FDA clears X-spine's Calix PC . . . TranS1 launches lateral access fusion system . . . DFINE initiates post-market study more

EU Begins "In-Depth" Antitrust Review for JNJ, Synthes BY LAUREN UZDIENSKI, NOVEMBER 8, 2011

The European Commission announced on Friday that they would begin an "in-depth" antitrust review of JNJ's proposed acquisition of Synthes. Regulators will determine if the $21B transaction reduces competition in the EU. A particular concern is spine, since the combined companies would have about 30% of the market, just behind Medtronic. more

Musculoskeletal News Roundup 3-Nov-11 BY LAUREN UZDIENSKI, NOVEMBER 3, 2011

ATEC, ARTC, EXAC, IART, WMGI and more announce 3Q . . . FDA clears LDR's ROI-A Oblique ALIF cage . . . ATEC, Custom Spine, Globus, K2M, Medtronic and others debut new products at NASS . . . Relievant MedSystems starts enrolling SMART trial . . . Spine Wave starts EU NuCore study more

Musculoskeletal News Roundup 27-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 27, 2011

Earnings CONMED reported 3Q:11 sales of $172.8 million, down 2% over the year-ago period and missing estimates by $6.8 million. Arthroscopy scales decreased by 1% to $69.4 million. Growth rates exclude the effects of currency. Non-GAAP diluted earnings per share... more

News and Trends at Eurospine BY LAUREN UZDIENSKI, OCTOBER 21, 2011

This week we attended Eurospine in Milan, and we came away noticing a couple of trends. One, VCF technologies are continuing to generate a lot of interest, despite the damper the NEJM studies may have placed on these products in the U.S. Also notable was the increasing prominence of companies based in Asia, who may be playing more of a role in the EU market as cost containment and austerity measures affect hospital budgets. Finally, we observed U.S. companies using Eurospine as an opportunity to highlight their increasing international reach. more

Musculoskeletal News Roundup 20-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 20, 2011

KNSY, JNJ, Medicrea, SYK, SYST announce 3Q . . . BMTI receives Australian approval for Augment . . . FDA clears Medtronic's Aquamantys3 System . . . K2M launches RAVINE Lateral Access System . . . Medicrea highlights six products at Eurospine . . . Globus to fund MIS spine outcomes registry . . . Zimmer to distribute Benvenue's Kiva . . . Lanx creates Surgeon Advisory Board more

Musculoskeletal News Roundup 13-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 13, 2011

aap Implantate pre-announces 3Q:11 ... ISTO receives CE mark for InQu ... Biomet celebrates 35th anniversary of the Oxford partial knee ... TiGenix announces Finnish distribution for ChondroCelect more

Musculoskeletal News Roundup 6-Oct-11 BY LAUREN UZDIENSKI, OCTOBER 6, 2011

Biomet announces earnings . . . OrthoPediatrics raises $20M . . . OsteoGeneX spins off OssiFi . . . Vexim prepares to launch SpineJack in India . . . IART launches new spine products . . . Ranier Technology inks distribution deal for Germany and Switzerland . . . OFIX promotes Bryan McMillan President of the Spine Global Business Unit more

Musculoskeletal News Roundup 25-Aug-11 BY LAUREN UZDIENSKI, AUGUST 25, 2011

Corin, Medtronic announce earnings . . . FDA clears DePuy's TRUMATCH Solutions . . . Ellipse Technologies receives 510(k) clearance . . . FDA expands Zyga's indications for the SImmetry Sacroiliac Joint Fusion System . . . Mesoblast announces first phase II procedure evaluating MPCs for the treatment of low back pain . . . VG Innovations launches modified VerteLoc system . . . Sanuwave and Spinal Restoration receive U.S. patents . . . Zyga Technologies enrolls first EU patients in GLYDER study more

Musculoskeletal News Roundup 18-Aug-11 BY LAUREN UZDIENSKI, AUGUST 18, 2011

KH, DJO and KNSY announce earnings . . . FDA clears ARTC's SpeedLock Knotless Fixation Device . . . NovaBone launches MacroPor-Si+ . . . Pioneer Surgical announces first U.K. case for the nanOss cervical cage . . . Captiva Spine and Crosstrees Medical receive new U.S. patents . . . Misonix announces new distribution agreement for Australia and New Zealand more

Gov. Rick Perry Brings Attention to Stem Cells BY LAUREN UZDIENSKI, AUGUST 10, 2011

Texas governor Rick Perry may be known for his economic conservatism and criticism of President Obama's healthcare overhaul, but lately he's been in the media for a different reason: his support of the use of autologous stem cells in the U.S. Gov. Perry recently underwent a spinal fusion to treat a "recurring back injury", during which he received a dose of his own cultured stem cells. Perry and his surgeon have become public champions for the procedure. more

Musculoskeletal News Roundup 28-Jul-11 BY LAUREN UZDIENSKI, JULY 28, 2011

CNMD, IART, NUVA, OFIX, RTIX, WMGI and ZMH report 2Q . . . FDA releases draft guidance on device modifications . . . Osseon launches in India . . . Carbylan Biosurgery announces results from viscosupplement study . . . Lanx comments on data at IMAST more

Musculoskeletal News Roundup 7-Jul-11 BY LAUREN UZDIENSKI, JULY 7, 2011

Amplitude sold to Apax France . . . ARTC sells vertebroplasty products . . . SpineVision raises $5M . . . Medtronic launches CD HORIZON Fenestrated Screw in Europe . . . RTI Biologics launches BioAdapt DBM Foam . . . DFINE study suggests lower cement leakage rate for Radiofrequency Targeted Vertebral Augmentation . . . MEDICREA to launch pilot study for GRANVIA-C cervical disc more

Musculoskeletal News Roundup 30-Jun-11 BY LAUREN UZDIENSKI, JUNE 30, 2011

Stryker completes Orthovita tender offer . . . ConforMIS to raise $68M . . . FDA clears Corin's highly cross-linked polyethylene liners and large diameter CoCr and BIOLOX Delta Ceramic heads . . . Aesculap launches Hydrolift Vertebral Body Replacement System . . . Cayenne Medical debuts the CrossFix II Meniscal Repair System . . . Mesoblast receives FDA clearance to begin phase II DDD study more

Musculoskeletal News Roundup 16-Jun-11 BY LAUREN UZDIENSKI, JUNE 16, 2011

Altor to acquire Orchid Orthopedic Solutions . . .Spinal Modulation closes $30M in funding . . . FDA approves DePuy's ceramic-on-metal hip . . . TSON announces 10,000th U.S. AxiaLIF implantation . . . Cayenne Medical partners with allograft supplier Parametrics more

Musculoskeletal News Roundup 9-Jun-11 BY LAUREN UZDIENSKI, JUNE 9, 2011

Brainlab to acquire Voyant Health . . . FDA clears ARTC's Spartan 6.5 Needled Anchor . . . Mazor Robotics launches next-gen Renaissance system . . . DFINE comments on VCF study results . . . Senators request investigation of PODs . . . Arteriocyte announces army stem-cell research project more

Musculoskeletal News Roundup 2-Jun-11 BY LAUREN UZDIENSKI, JUNE 2, 2011

BioPoly receives CE mark for knee resurfacing system . . . ConforMIS receives CE mark for the iTotal CR . . . FDA clears Nimbic Systems' Air Barrier System . . Exactech launches the Proliant Polyaxial Pedicle Screw system . . . Zimmer showcases new products at EFORT more

Musculoskeletal News Roundup 12-May-11 BY LAUREN UZDIENSKI, MAY 12, 2011

DJO, Tornier, TSON announce earnings . . . OsteoGeneX receives grant funds . . . BMTI introduces new Augment kit size in Canada . . . Wright Medical commences full commercial launch of the INBONE II Total Ankle . . . Orthovita notes positive vertebroplasty coverage decision . . . RTI Biologics splits Chairman, CEO roles more

Musculoskeletal News Roundup 28-Apr-11 BY LAUREN UZDIENSKI, APRIL 28, 2011

CNMD, IART, SYST, ZMH and more report earnings . . . FDA clears Biomet's Active Articulation E1 Dual Mobility Hip System . . . ORTHOCON receives EU, Canadian clearance to market HEMASORB . . . SI-BONE receives modification to its labeling . . . DJO Global introduces e-plus total knee replacement insert . . . Wright Medical launches FUSIONFLEX Demineralized Moldable Scaffold . . . Kuros regains certain technology rights from Baxter . . . Genzyme files two new HA infringement suits more

Musculoskeletal News Roundup 21-Apr-11 BY LAUREN UZDIENSKI, APRIL 20, 2011

JNJ, SYK report 1Q:11 . . . Benvenue raises $36M . . . FDA clears StelKast's Xp Acetabular Liners . . . Medtronic launches MARROWMAX Bone Marrow Aspiration Needle Kit . . . Genzyme sues Seikagaku for HA patent infringement . . . RTI to supply allograft to Alphatec more

Musculoskeletal News Roundup 14-Apr-11 BY LAUREN UZDIENSKI, APRIL 14, 2011

FDA approves Covidien's DuraSeal Exact . . . IART announces new spine clearances . . . Lanx launches facet screw system and ALIF system . . . Tornier introduces BioFiber Surgical Mesh . . . VITA comments on positive Vitagel data . . . Stryker sues Zimmer for allegedly poaching sales force more

Musculoskeletal News Roundup 7-Apr-11 BY LAUREN UZDIENSKI, APRIL 7, 2011

aap, Medicrea report 1Q sales . . . Orthopaedic Synergy to raise $9.5M . . . FDA clears ATEC's Solus . . . Titan Spine receives CE mark for Endoskeleton lumbar devices . . . Emerge Medical introduces trauma line . . . Life Spine holds surgeon training . . . Mazor announces 2,000th procedure . . . CareFusion's COO resigns more

Total Disc Replacement Offers Benefits, Cost Savings Over Fusion BY LAUREN UZDIENSKI, MARCH 28, 2011

Two new studies on the ProDisc-C and ProDisc-L total discs showed that the cervical discs performed as well as fusion and required fewer secondary procedures than fusion, while a ProDisc-L study showed that replacing a disc is less costly than a fusion. more

Musculoskeletal News Roundup 24-Mar-11 BY LAUREN UZDIENSKI, MARCH 24, 2011

China Kanghui reports earnings, announces acquisition . . . FlexFix to acquire assets from Novalign . . . Newly-formed Rachiotek to acquire Applied Spine Technologies . . . Core Essence raises $11.5M . . . LDR submits PMA for two-level Mobi-C . . . FDA clears TSON's AxiaLIF 1L+ . . . FDA approves Seikagaku's single-injection HA . . . Pioneer Surgical launches the the Streamline TL Spinal Fixation System . . . Spinal Kinetics announces 10,000th implantation of M6 Disc . . . Medtronic of Canada releases data from study on kyphoplasty in cancer patients . . . Zimmer signs Department of Defense contract more

Musculoskeletal News Roundup 17-Mar-11 BY LAUREN UZDIENSKI, MARCH 17, 2011

Biomedical Structures acquires Concordia Medical . . . Neue Magnetodyn IP to go up for auction . . . Wright Medical closes tender offer for convertible senior notes . . . K2M receives CE mark for RAVINE Lateral Access and ALEUTIAN Lateral Interbody Systems . . . Smith & Nephew files suit against former employees . . . OrthAlign comments on new clinical data . . . Misonix, Aesculap sign new distribution agreement . . . Shukla Medical licenses Kytogenics' biopolymer technology . . . Inion resumes operations . . . DePuy Spine appoints worldwide president more

FDA Issues Non-Approvable Letter for Medtronic's Amplify BY SANDER DUNCAN, MARCH 11, 2011

Medtronic disclosed in its 10-Q on Wednesday that the FDA issued a non-approvable letter for Amplify, its new BMP-2 product. Medtronic was seeking a postero-lateral fusion indication for Amplify, for which Infuse, its other BMP product, is already widely-used off-label. more

Musculoskeletal News Roundup 10-Mar-11 BY LAUREN UZDIENSKI, MARCH 10, 2011

ANIK, BMTI, VITA report 4Q . . . Global Biotech to take minority position in BoneGrafix . . . ConforMIS to raise $1.8M . . . Medtronic launches ATLANTIS VISION ELITE cervical plate system . . . Wright Medical launches PRO-TOE VO . . . OFIX receives subpoena . . . Vertos announces mild clinical data . . . GenOsteo and SpineSmith to collaborate on stem cell scaffold . . . RegeneCure licenses synthetic membrane for use with stem cells . . . Bacterin now trading on NYSE Amex more

Musculoskeletal News Roundup 24-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 24, 2011

ATEC, MDT, NUVA report on 4Q spine market . . . IART, SMA report 4Q:10 . . . Mazor Robotics raises $6.3M . . . FDA clears Zimmer's TM-S Trabecular Metal Cervical Interbody Fusion Device . . . Smith & Nephew receives premium reimbursement in Japan for Oxinium hip . . . Intrinsic Therapeutics enrolls first patient in Barricaid study for anular closure . . . Zimmer reports clinical results for DeNovo NT Graft and the MotionLoc Screws more

ArthroCare Rebounds with New Products, Strong Earnings BY LAUREN UZDIENSKI, FEBRUARY 23, 2011

ArthroCare's stock is continuing its upward trend this week with some new product launches in spine and sports medicine. The company is up 22% over the last 30 days, which can be attributed to momentum from new products, a strong 4Q and the conclusion of an SEC investigation into its accounting practices. more

Musculoskeletal News Roundup 17-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 17, 2011

ARTC, DJO, GENZ, OFIX and Synthes report earnings . . . Sonoma raises $22 million . . . Anika provides FDA update . . . AAOS product launches . . . Medtronic announces kyphoplasty data more

Musculoskeletal News Roundup 10-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 10, 2011

EXAC, OSSUR, SNN, WMGI announce 4Q . . . Biomet receives FDA clearance for the Signature patient-specific instrumentation system . . . FDA clears Vitoss BA Bimodal Bone Graft Substitute . . . Integra launces Allograft Cancellous Sponge . . . MedShape Solutions introduces the the ExoShape CL for ACL surgeries . . . ISTO Technologies announces new spine patent . . . InteliFUSE seeks dismissal of patent infringement suit with Biomedical Enterprises . . . Federal appeals court rules against Globus in Medtronic patent dispute . . . SEC concludes ARTC investigation . . . curasan, SYK ink distribution deal more

Musculoskeletal News Roundup 3-Feb-11 BY LAUREN UZDIENSKI, FEBRUARY 3, 2011

CNMD, KNSY, RTIX report 4Q . . . Spine Wave raises $17.5M . . . Vertiflex raises $14M . . . Tornier goes public . . . BioMimetic Therapeutics gets FDA panel hearing date . . . ConforMIS knee system cleared . . . Healthcare reform found unconstitutional in Florida . . . Wright Medical expands supply agreement for GraftJacket . . . Biomet makes a donation to OREF more

Care Fusion Announces New CEO BY JOHN MCCORMICK, FEBRUARY 2, 2011

Yesterday CareFusion announced that Kieran T. Gallahue will assume the role of Chairman and Chief Executive Officer succeeding David L. Schlotterbeck who announced plans to retire last year. CareFusion's core business is selling systems that dispense medication, drug- infusing systems... more

Surgeons Make Some Headway with Blue Cross Blue Shield BY JOHN MCCORMICK, JANUARY 28, 2011

Last month, North Carolina Blue Cross Blue Shield (NC BCBS) made waves when they put out a coverage policy stating that lumbar spinal fusion was not considered medically necessary if the sole indication is degenerative disc disease. Last week, a coalition of surgeon societies met with NC BCBS and made some headway against the new policies. more

Musculoskeletal News Roundup 27-Jan-11 BY LAUREN UZDIENSKI, JANUARY 27, 2011

DJO, JNJ, SYK, ZMH report 4Q;10 . . . Arthrex acquires Cardo Medical's total joint assets . . . Flex Biomedical, OrthoSensor raise funding . . . LDR submits PMA for Mobi-C . . . Medtronic launches CD HORIZON SOLERA . . . Kuros releases one-year data from KUR-111 study . . . Gary Fischetti named group chairman for DePuy subsidiaries more

Genetics a Factor in Lumbar Disc Disease BY LAUREN UZDIENSKI, JANUARY 25, 2011

A new study published this week in JBJS found a genetic component for lumbar disc disease. Reviewing data from more than 2.4 million patients in Utah, the researchers identified familial clusters of disc disease, offering new insight into an ailment that is estimated to cost more than $100 billion annually. more

Musculoskeletal News Roundup 13-Jan-11 BY LAUREN UZDIENSKI, JANUARY 13, 2011

MAKO, NUVA, SYK pre-announce . . . Globus acquires Facet Solutions' assets . . . Doctors Research Group raises $7.7M . . . Wright Medical launches DARCO system in Japan . . . Zimmer introduces NexGen LPS-Flex Mobile Bearing Knee with Prolong Highly Crosslinked Polyethylene . . . FDA approves Wright Medical's IDE for the INBONE Total Ankle Replacement with Calcaneal Stem . . . China Kanghui Holdings and Consensus Orthopedics announce manufacturing and marketing agreement more

Musculoskeletal News Roundup 2-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 2, 2010

Synovis reports F4Q:10 . . . MiMedx receives $0.2 million in grant funding . . . Ortho Kinematics raises $1.0 million . . . Medtronic's CD HORIZON pedicle screw system cleared for adolescent idiopathic scoliosis . . . Smith & Nephew receives expanded CE mark clearance for DUROLANE . . . DePuy Spine launches the MOUNTAINEER Laminoplasty System . . . Spine publishes SCOLISCORE AIS data . . . Australian large joint registry data shows 98% success rate for ceramicized metal technology more

Musculoskeletal News Roundup 24-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 24, 2010

MDT reports F2Q:11 . . . Bacterin, Sonoma Orthopedics announce financing rounds . . . curasan AG receives Health Canada approval for Cerasorb M ORTHO . . . Medtronic launches SOVEREIGN Spinal System in Europe . . . Blue Cross Blue Shield of North Carolina releases new lumbar spinal fusion guidelines . . . Stryker supports South Carolina medtech development consortium more

Medtronic CEO Speaks Out on the Spine Market BY LAUREN UZDIENSKI, NOVEMBER 18, 2010

At the Wall Street Journal CEO Council event this week, Medtronic CEO Bill Hawkins addressed some of the challenges in the spine market. more

Musculoskeletal News Roundup 18-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 18, 2010

MDT closes OSTE acquisition . . . Replication Medical receives grant for GelStix development . . . RepRegen raises $1.6M . . . SI-BONE receives CE mark for iFuse . . . FDA clears Titan Spine's Endoskeleton TO . . . Mazor announces clinical results . . . Amedica/US Spine to distribute BioDlogics stem cell products more

Musculoskeletal News Roundup 28-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 28, 2010

IART, NUVA, OFIX, WMGI, ZMH report 3Q . . . Wright Medical acquires EZ Frame external fixator for the foot . . . ArthroCare cleared to market the Spartan PEEK Suture Implant system . . . FDA clears Medtronic's Kyphon Xpander II Inflatable Bone Tamp . . . Wright Medical launches PRO-STIM Injectable Inductive Graft . . . NUVA to appeal NeuroVision brand name verdict more

Musculoskeletal News Roundup 21-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 21, 2010

EXAC, GENZ, JNJ, VITA, SYK, SYST announce 3Q . . . Biostructures receives FDA warning letter . . . curasan receives CE mark for bone graft substitute . . . Salient Surgical announces first human cases with AQUAMANTYS 3 in Europe . . . Mesoblast announces interim clinical results . . . Merlot OrthopediX and ATEC to collaborate on bone anchorage technology . . . Symmetry division to distribute Cannuflow arthroscopy products more

Musculoskeletal News Roundup 14-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 14, 2010

Biomet announces FQ1:11 . . . Core Essence Orthopaedics raises $1.5M . . . Medical Tracking Solutions launches iTraycer . . . 1,000th Zimmer Natural Nail Cephalomedullary Nail implanted . . . Vertiflex enrolls 200 patients in its Superion IDE study . . . Pioneer Surgical to manufacture and distribute SpineSmith's Cequence anterior cervical plate . . . Cardo Medical seeks capital . . . Pioneer Surgical to open manufacturing and distribution facility in Scotland more

Musculoskeletal News Roundup 30-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 29, 2010

InVivo Therapeutics planning a reverse merger . . . MiMedx to raise $5.0 million . . . FDA clears ArthroCare's Parallax device to treat VCFs . . . Osseon Therapeutics announces 1,000-patient milestone . . . AAOS releases clinical guidelines for vertebroplasty and kyphoplasty . . . ProChon reports BioCart Autologous Cartilage System outcomes . . . RepRegen releases in vivo StronBone data more

Musculoskeletal News Roundup 23-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 23, 2010

M&A Amedica acquired US Spine for an undisclosed amount. The target company manufactures a range of fusion products as well as the Facet Fixation System, which features the Facet Gun to lock the facet joint. Amedica says that with the... more

Amedica Acquires US Spine BY LAUREN UZDIENSKI, SEPTEMBER 21, 2010

Amedica has broadened its spinal portfolio, acquiring US Spine for an undisclosed amount. more

Musculoskeletal News Roundup 9-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 9, 2010

Amedica raises $30M . . . BioMimetic affirms Augment PMA timeline . . . Aesculap, K2M announce 510(k) clearances . . . BMTI and Eden Spine announce U.S. and EU patents . . . Tornier announces early clinical results more

BMPs Used Off-Label in 85% of Cases BY LAUREN UZDIENSKI, SEPTEMBER 8, 2010

A new study in Spine documents the rise of BMPs and the prevalence of off-label use, demonstrating that between 2003 and 2007, the annual number of procedures utilizing BMPs increased 4.3-fold from 23,900 to 103,194. Of those, 85% were identified as off-label uses of the material. more

Musculoskeletal News Roundup 2-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 2, 2010

Sanofi-aventis makes bid for Genzyme . . . Orthofix obtains new credit facility . . . Mazor Surgical adds 3D imaging to SpineAssist . . . CDRH's 510(k) director to retire . . . Amedica, TiGenix announce new U.S. patents . . . U.S. News and World Report names top orthopedic hospitals more

Mazor to Market Combined SpineAssist, 3D Imaging System BY LAUREN UZDIENSKI, SEPTEMBER 1, 2010

Mazor Surgical received FDA clearance to market the SpineAssist robotic surgical system and the C-Insight 3D imaging system as one unit. more

Exactech to Buy VertiFlex's MIS Fusion Portfolio BY LAUREN UZDIENSKI, AUGUST 30, 2010

VertiFlex announced plans to divest an MIS fusion portfolio and related assets to Exactech. Terms of the deal were not disclosed. more

Musculoskeletal News Roundup 26-Aug-10 BY LAUREN UZDIENSKI, AUGUST 26, 2010

Corin, Medtronic, TiGenix report . . . DePuy warned over TruMatch Personalized Solutions System and Corail Hip System . . . FDA clears Medyssey's Zenius Thoracolumbar Spinal System . . . Binder Biomedical launches NEWTON Intervertebral Body Spacer System . . . CareFusion launches AVAmax Vertebral Balloon . . . DePuy recalls ASR system . . . Benvenue Medical enrolls first patient in VCF study . . . MAKO Surgical appoints Director more

Musculoskeletal News Roundup 19-Aug-10 BY LAUREN UZDIENSKI, AUGUST 19, 2010

Medtronic to acquire Osteotech . . . Stryker may buy Boston Scientific's neuromodulation unit . . . SI-Bone raises $11M . . . Aesculap received 510(k) clearance for the A-Fix Spinal System . . . Biomet responds to FDA warning letter . . . Benvenue Medical announces first U.S. use of the Blazer system for treating VCFs . . . Cytori receives patent for stem cell use in musculoskeletal applications . . . NuOrtho Surgical announces pre-clinical results . . . RTI Biologics reports "no change" to Medtronic supply agreement more

New Study Shows Efficacy of Vertebroplasty BY LAUREN UZDIENSKI, AUGUST 10, 2010

A year after two New England Journal of Medicine studies shook up perspectives on vertebroplasty, new data has been released showing the efficacy of the procedure and emphasizing some of the shortcomings of the NEJM papers. more

Musculoskeletal News Roundup 5-Aug-10 BY LAUREN UZDIENSKI, AUGUST 5, 2010

ATEC, ARTC, BMTI, DJO, EXAC, MAKO, VITA, RTIX, SNN, SMA, TSON, WMGI report 2Q:10 . . . Bacterin closes private placement . . . Wright Medical launches the EVOLUTION Medial-Pivot Knee . . . VertiFlex enrolls 150th patient in their IDE study more

Musculoskeletal News Roundup 29-Jul-10 BY LAUREN UZDIENSKI, JULY 29, 2010

CNMD, IART, NUVA, OFIX, Synthes report 2Q:10 sales . . . Axiomed raises $14.5M . . . China Kanghui Holdings to go public . . . FDA panel votes in favor of Medtronic's Amplify . . . FDA approves Orthovita's new collagen processing facility . . . curasan seeking distribution partners for ATR . . . TranS1 launches next-gen AxiaLIF 2L+ system . . . Ortho Kinematics enrolling study more

FDA Panel Recommends Medtronic's Amplify BY LAUREN UZDIENSKI, JULY 28, 2010

An FDA panel voted 6-5 yesterday in favor of approving Medtronic's Amplify, a BMP-2 with a different formulation and carrier than InFuse. Heading into the meeting, concerns circulated over a higher incidence of cancer in patients treated with Amplify, though the panel ultimately voted 9-4 in support of safety (with 1 abstention) and 10-3 (with 1 abstention) on efficacy. more

Relief for Low Back Pain Continues to be Elusive in Glucosamine Study BY LAUREN UZDIENSKI, JULY 7, 2010

A new study on glucosamine shows that the supplement has no effect on low back pain with degenerative lumbar osteoarthritis. more

Musculoskeletal News Roundup 1-Jul-10 BY LAUREN UZDIENSKI, JULY 1, 2010

Biomet and RSB Spine announce revenues . . . Bacterin announces reverse merger, private placement . . . FDA begins review of BioMimetic's Augment . . . Cerapedics receives CE mark for iFactor bone graft . . . DFine signs distribution agreements for Italy and Morocco . . . Michael DeMane declines CEO, Chairman role at Lanx more

Musculoskeletal News Roundup 24-Jun-10 BY LAUREN UZDIENSKI, JUNE 24, 2010

Baxano closes $30M series C . . . SpineForm, Lanx, OrthoHelix receive $1M Ohio Third Frontier Commission awards . . . Aesculap launches S4 MIS Cannulated Pedicle Screw Spine Fusion System . . . Medtronic launches KYPHON ActivOs 10 Bone Cement with Hydroxyapatite . . . SNN granted injunction against Arthrex . . . Senate passes Medicare pay patch . . . Kensey Nash, Arthrex sign agreement over KNSY's ECM . . . Therapure, ProChon Biotech ink manufacturing deal . . . NuVasive leases NJ office space . . . BioTime creates new stem cell subsidiary more

Musculoskeletal News Roundup 17-Jun-10 BY LAUREN UZDIENSKI, JUNE 17, 2010

Orthopaedic Synergy closes acquisition of PRAXIM . . . Trauson reveals IPO details . . . HyperBranch Medical Technology receives CE mark for a spine sealant . . . TriMed and Stryker back in court over wrist fixation device . . . Bacterin signs deal with hospital purchasing group Broadlane . . . Inion files for bankruptcy . . . BONESUPPORT and TSON announce Board appointments more

Musculoskeletal News Roundup 10-June-10 BY LAUREN UZDIENSKI, JUNE 10, 2010

M&A The Quebec Superior Court authorized the sale of BioSyntech's assets to Piramal Healthcare. Piramal will acquire assets and assume certain BioSyntech liabilities for CAN $3.9 million ($3.7 million). The sale should close within 15 business days. Funding According to... more

Musculoskeletal News Roundup 3-Jun-10 BY LAUREN UZDIENSKI, JUNE 3, 2010

Mazor announces first German GO-LIF sales . . . OrthoDynamix launches the ArthroSteer Biter . . . Osprey Biomedical introduces the Eagle Cervical Allograft Series . . . DOJ settles with Idaho orthopedists . . . Stryker and Wright Medical settle knee infringement suit . . . Amedica awarded patent . . . AOFAS releases position paper on total ankle replacement . . . Pioneer Surgical announces NuBac data . . . RepRegen reports StronBone data . . . Medtronic to report physician payments greater than $5,000, and Steve La Neve steps down from spine & biologics more

Musculoskeletal News Roundup 27-May-10 BY LAUREN UZDIENSKI, MAY 27, 2010

Medtronic announces FQ4 . . . Exactech acquires Brighton Partners, supplier of Optetrak knee material . . . VentureMD closes funding round . . . KFx cleared to market AppianFx knee products . . . X-spine receives FDA clearance for Fixcet Spinal Facet Screw System . . . Applied Spine awarded patents . . . DFine, Vertos release clinical data . . . curasan collaborates with Matricel on bone graft substitute . . . SpineGuard appoints Alan Olsen Chairman of the Board more

Musculoskeletal News Roundup 20-May-10 BY LAUREN UZDIENSKI, MAY 20, 2010

ANIK, SYK resolve FDA warning letters . . . FDA clears Mesoblast Phase II study . . . DePuy Mitek to launch Bristow-Latarjet Instability Shoulder System . . . OrthoX developing new bone cement . . . DOJ recovers $20 million in allegedly fraudulent kyphoplasty billings . . . SpineGuard signs European distributor . . . B1 collaborating with Invibio more

Musculoskeletal News Roundup 13-May-2010 BY LAUREN UZDIENSKI, MAY 13, 2010

aap Implantate, ATEC, ANIK, BMTI, OSTE report Q1 earnings . . . SBi announces Olympus investment . . . Aesculap launches pedicle screw system . . . data on B Braun's Targon screw . . . BioSyntech files for bankruptcy more

Musculoskeletal News Roundup 6-May-2010 BY EDITOR, MAY 6, 2010

Earnings ArthroCare reported 1Q:10 revenues of $90.6 million, up 15% over the year-ago period and beating estimates by $5.0 million. Among the company's orthopedics division, sports medicine sales were $60.4 million and spine sales were $4.4 million. Net income for... more

Musculoskeletal News Roundup 29-Apr-10 BY LAUREN UZDIENSKI, APRIL 29, 2010

CNMD, EXAC, OFIX, RTIX, Synthes announce Q1 results . . . Facet Solutions, IMPLANET announce funding rounds . . . Aesculap launches DBM-D . . . Applied Spine Technologies, Facet Solutions release study data . . . Flexuspine cleared to start IDE . . . Federal judge dismisses liability claim against Stryker . . . Cayenne Medical appoints CFO more

Musculoskeletal News Roundup 22-Apr-10 BY LAUREN UZDIENSKI, APRIL 22, 2010

GENZ, DePuy, NUVA, VITA, SYK, ZMH report 1Q:10 . . . Internal Fixation Systems, Soft Tissue Regeneration announce funding rounds . . . Smith & Nephew wins 510(k) clearance for additional VERILAST claims . . . First commercial use of Interventional Spine's RENEW interspinous process device . . . NUVA files legal dispute against OFIX over Osteocel IP . . . LDR completes follow-up on two-level Mobi-C study more

Musculoskeletal News Roundup 15-Apr-10 BY LAUREN UZDIENSKI, APRIL 15, 2010

Biomet kicks off earnings seasons . . . ATEC preannounces . . . Articulinx, biospace med, Osseon close funding rounds . . . ConforMIS G2 Uni receives CE mark clearance . . . EXAC's Novation hip approved for sale in Japan . . . Stryker Interventional Spine launches iVAS for VCFs . . . Cayenne Medical announces clinical results for the AperFix System more

Musculoskeletal News Roundup 8-Apr-10 BY LAUREN UZDIENSKI, APRIL 7, 2010

Earnings RSB Spine announced that 1Q:10 sales increased 25% over 4Q09. M&A Stryker closed its acquisition of assets related to Synergetics' Sonopet/Omni product line, an ultrasonic aspirator that has applications in neurosurgery. Synergetics will receive $2.5 to $3.0 million in... more

JAMA Study Demonstrates Higher Costs and Complications for Older Fusion Patients BY LAUREN UZDIENSKI, APRIL 7, 2010

logo.225x76.gifA study published in the Journal of the American Medical Association this week suggested higher rates of complications and higher costs for Medicare patients who undergo complex spinal fusions (defined as more than two disc levels or combined anterior and posterior approach) compared to decompression procedures. While the study confirmed questions about complications and resource use in elderly patients, it did not consider outcomes measures, such as improvement in function or reduction in pain. more

Musculoskeletal News Roundup 1-Apr-10 BY LAUREN UZDIENSKI, APRIL 1, 2010

xray_small.jpgATEC closes Scient'x acquisition . . . Anulex and Carticept Medical close funding rounds . . . OrthAlign receives 510(k) clearance for its latest KneeAlign design . . . Eden Spine receive a European patent . . . Medicare cuts loom as Congress departs for Easter recess . . . ArthroCare reports data on their Plasma Disc Decompression products more

Alphatec Spine Completes Acquisition of Scient'x Groupe SAS BY EDITOR, MARCH 29, 2010

atec%20logo.gifAlphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., announced today the closing of its previously announced acquisition of Scient'x Groupe SAS, a spinal implant company headquartered in France. The combined company will be the third-largest independent spinal company with a global span of product distribution. more

CareFusion Sues Medtronic BY JOHN MCCORMICK, MARCH 25, 2010

logo_care_fusion.gifYesterday the news circulated that CareFusion, an upstart in the vertebral compression fracture market, has sued Medtronic for violating antitrust laws. With a 619-page complaint in a Federal Court no less. Antitrust? A newcomer suing the incumbent right out of the box? Talk about going against a time-honored tradition! more

Musculoskeletal News Roundup 25-Mar-10 BY LAUREN UZDIENSKI, MARCH 25, 2010

Bovie Medical, Custom Spine receive FDA clearances . . . Stryker resolves an FDA warning letter . . . Aesculap launches Spyder MIS retractor system . . . RTI Biologics opens reimbursement hotline . . . NASS surveys spine physicians about Medicare cuts . . . ConMed, Smith & Nephew and Stryker ink deals with Premier Purchasing Partners more

Musculoskeletal News Roundup 18-Mar-10 BY LAUREN UZDIENSKI, MARCH 18, 2010

doc_xray_small.jpgANIK, ATEC report 4Q:09 . . . ATEC shareholders approve Scient'x Acquisition . . . Non Linear Technologies, Spinal Restoration close funding rounds . . . CareFusion launches kyphoplasty balloon . . . Integra launches new products for spine . . . New vertebroplasty data released more

Musculoskeletal News Roundup: AAOS Edition BY LAUREN UZDIENSKI, MARCH 11, 2010

OR_small.jpg The latest news from AAOS! VITA and MAKO report 4Q09 . . . ETEX receives 510(k) . . . DePuy, Integra, Medtronic, Smith & Nephew and more announce product launches . . . SEC Drops Wright Medical Investigation . . . BioMimetic Therapeutics shares study results . . . Long-term use of bisphosphonates may increase fracture risk . . . NeoStem wins research grant more

Musculoskeletal News Roundup 4-Mar-10 BY LAUREN UZDIENSKI, MARCH 4, 2010

knee.jpg Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more

Musculoskeletal News Roundup 25-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 25, 2010

xray_small.jpgAlphatec Spine reported 4Q:09 revenues of $36.6 million, an increase of 29% from the $28.4 million reported in 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. U.S. revenues for the quarter were $28.3 million, an increase of 29% from the $22.0 million reported for 4Q:08. Asian revenues were $6.6 million, an increase of 38% from the $4.8 million reported for 4Q:08. European revenues in 4Q:09 were $1.7 million. more

Musculoskeletal News Roundup 18-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 18, 2010

Earnings DJO reported 4Q:09 revenues of $257.2 million, up 5% over 4Q:08, with domestic rehab sales up 3% and domestic surgical implant sales up 8%. The company attributed the latter largely to "strong sales of our Reverse Shoulder Prosthesis." Net... more

Blue Cross and Blue Shield Names Spine, Large Joint Centers to its Blue Distinction Program BY LAUREN UZDIENSKI, FEBRUARY 16, 2010

Blue Cross and Blue Shield announced that they would broaden their "Blue Distinction" designation granted to high-performing hospitals to include spine and hip and knee centers. Blue Distinction hospitals have met objective, "evidence-based thresholds for clinical quality and safety" and... more

Musculoskeletal News Roundup 11-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 11, 2010

Earnings Nobel Biocare reported 4Q:09 revenues of EUR 156.0 million ($213.6 million), flat over the year-ago period and missing estimates by EUR 5.0 million ($6.9 million.) EPS of EUR 0.21 ($0.29) missed estimates by EUR 0.05 ($0.07). The company called... more

Musculoskeletal News Roundup 4-Feb-10 BY LAUREN UZDIENSKI, FEBRUARY 4, 2010

Earnings CONMED reported 4Q:09 sales of $190.6 million, up 3% over the year-ago period and beating estimates by $6.0 million. Arthroscopy sales rose 3% to $75.7 million. All growth rates exclude the effects of currency. 4Q:09 EPS of $0.37 beat... more

Musculoskeletal News Roundup 28-Jan-10 BY LAUREN UZDIENSKI, JANUARY 29, 2010

Earnings Johnson & Johnson reported 4Q:09 revenues of $16.5 billion, representing a 9% increase over the year-ago period and beating estimates by $0.8 billion. DePuy reported $1.5 billion in sales, up 10% over the year-ago period, with hip up 12%,... more

Musculoskeletal News Roundup 21-Jan-10 BY LAUREN UZDIENSKI, JANUARY 21, 2010

Earnings MEDICREA reported 4Q:09 sales of EUR 3.9 million ($5.6 million) and 2009 sales of EUR 13.1 million ($18.8 million), representing a 45% increase over 2008. The company said their sales development in the U.S. has been "successful" and a... more

Musculoskeletal News Roundup 14-Jan-10 BY LAUREN UZDIENSKI, JANUARY 14, 2010

Earnings aap Implantate reported preliminary sales of EUR 7.4 million ($10.6 million) in 4Q:09, down 4% from the year-ago period. Full year sales were up 3% to EUR 33.0 million ($47.3 million). Company highlights for the year include "optimizing its... more

TranS1 Pre-Announces as Reimbursement Issues Continue BY LAUREN UZDIENSKI, JANUARY 8, 2010

TranS1 Inc. pre-announced 4Q:09 revenue yesterday, stating that sales for the quarter are expected to be in the range of $6.2 to $6.3 million, off about 15% from 4Q:08 and below prior guidance of $6.7 to $7.2 million and analyst... more

Musculoskeletal News Roundup 7-Jan-10 BY LAUREN UZDIENSKI, JANUARY 7, 2010

Earnings Biomet reported FQ2:10 (ended November 30, 2009) revenues of $696.0 million, up 5% over the year-ago period. Recon sales increased 6% to $528.4 million, with hip up 4%, knee up 8%, dental down 8% and extremity up 27%. Additionally,... more

ArgoSpine: Cervical Disc Replacement BY EDITOR, DECEMBER 22, 2009

As part of our partnership with ArgoSpine, we're republishing select content from the ArgoSpine News and Journal for our audience. The article below, excerpted from a lecture by Robert P. Melcher, M.D. of the Klinikum Karlsbad-Langensteinbach Spine Centre in Germany,... more

Alphatec Spine Agrees to Acquire Scient'x Groupe SAS BY EDITOR, DECEMBER 17, 2009

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions affecting the aging spine, announced... more

Musculoskeletal News Roundup 17-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 17, 2009

M&A Alphatec Holdings, Inc. announced that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France. The transaction is structured as an all-stock transaction such that 100% of outstanding Scient'x stock... more

Musculoskeletal News Roundup 3-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 3, 2009

M&A Stryker entered into a definitive agreement to acquire Ascent Healthcare Solutions, a medical device reprocessing company, for $525.0 million in cash. Ascent describes its operations as including the "cleaning, testing/verifying, packaging and sterilizing" or devices, as well as "remanufacturing,"... more

HealthpointCapital Interviews Adam Deitz, Founder and CEO of Ortho Kinematics, Part Two BY EDITOR, DECEMBER 1, 2009

This is part two of our interview with Adam Deitz, Founder and CEO of Ortho Kinematics. It is continued from here. How have surgeons responded to the KineGraph VMA technology? Adam Deitz: Surgeons love this technology because it gives them... more

HealthpointCapital Interviews Adam Deitz, Founder and CEO of Ortho Kinematics BY EDITOR, NOVEMBER 30, 2009

Recently we sat down with Adam Deitz, Founder and CEO of Ortho Kinematics to talk about his company's technology, unmet needs in spine surgery and advancing diagnostic capabilities for surgeons. This interview will be published in two parts. Adam, why... more

Musculoskeletal News Roundup 25-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 25, 2009

Earnings ArthroCare reported 3Q:09 sales of $76.4 million, representing an increase of 8% over 3Q:08. Analysts had forecast total revenues of $84.3 million. Sports medicine contributed $50.6 million in sales, up 11% over the year-ago period, and spine contributed $4.5... more

Kyphoplasty Safe and Effective for VCFs BY LAUREN UZDIENSKI, NOVEMBER 24, 2009

This month JBJS reprinted data from the Fracture Reduction Evaluation (FREE) study that had been published in the Lancet earlier this year (and discussed at NASS two weeks ago.) FREE researchers found that patients randomized to undergo kyphoplasty for the... more

NASS 2009 Trip Report BY JOHN MCCORMICK, NOVEMBER 16, 2009

For us, North American Spine Society annual meeting remains the best forum to gauge broad scientific and commercial trends in spine surgery technologies. Our trip report this year highlights the findings of our team and the key themes garnered from... more

Musculoskeletal News Roundup 12-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 12, 2009

Earnings Alphatec Holdings, Inc. announced record consolidated revenue of $32.7 million in 3Q:09, which represents 27% growth over 3Q:08. U.S. revenue increased 21% over the prior-year third quarter and 28% over the first nine months of 2008. International revenue was... more

Musculoskeletal News Roundup 5-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 5, 2009

Earnings aap Implantate reported nine-month revenue of EUR 25.6 million ($37.4 million), which represents a 6% increase over the year-ago period. The company said third-quarter highlights included the signing of several IP agreements that emphasize orthopedics, trauma ad spine. Artimplant... more

Musculoskeletal News Roundup 29-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 30, 2009

Earnings Anika Therapeutics reported 3Q:09 revenues of $10.1 million, representing an 18% increase over the year-ago period and missing estimates by $0.3 million. Joint Health sales, including the Orthovisc and Monovisc products, were up 31% to $6.1 million. Anika noted... more

Mazor Surgical Technologies Raises $13M in Public Offering BY LAUREN UZDIENSKI, OCTOBER 26, 2009

Israel-based Mazor Surgical Technologies has raised NIS 48 million ($13 million) in shares and warrants in a public offering that closed this week. Total proceeds include funding from an institutional offering to Yorkville Advisors LLC, which was announced last week... more

Musculoskeletal News Roundup 22-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 22, 2009

Earnings CONMED reported 3Q:09 sales of $175.5 million, down 2% from the year-ago period and beating estimates by $1.4 million. Arthroscopy sales were up 2% and powered instrument sales were flat. Non-GAAP diluted EPS of $0.28 beat estimates by $0.12.... more

NASS Responds to NEJM Vertebroplasty Studies BY LAUREN UZDIENSKI, OCTOBER 16, 2009

In August, the New England Journal of Medicine published two studies challenging the efficacy of vertebroplasty, results that came much to the surprise of both physicians and the industry. These studies were unique in that they were randomized, controlled and... more

Musculoskeletal News Roundup 15-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 15, 2009

Earnings Biomet reported FQ1:10 revenues of $630.0 million, a 7% increase over the year-ago period. Excluding dental, recon sales increased by 9%, with knee up 10%, hip up 6% and extremity up 23%. Dental decreased by 5%. All rates exclude... more

Musculoskeletal News Roundup 8-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 8, 2009

Earnings TranS1 pre-announced 3Q:09 revenues, saying sales for the quarter would be in the range of $6.8 to $6.9 million. This represents a 15% increase over year-ago sales, though it is below 3Q:09 guidance of $7.4 to $7.9 million. Analysts... more

Vertebron Assets Auctioned Off BY JOHN MCCORMICK, OCTOBER 7, 2009

Yesterday, Beverly Hills based Cardo Medical, Inc. announced that it had acquired the assets of Vertebron out of bankruptcy. Cardo Medical is a small, bulletin-board-traded orthopedics company that focuses on reconstructive (e.g. Align 360 Unicompartmental Knee System) and a several... more

Musculoskeletal News Roundup 1-Oct-09 BY LAUREN UZDIENSKI, OCTOBER 1, 2009

Earnings MEDICREA reported revenues of EUR 6.1 million ($8.6 million) in 1H:09, representing a 32% increase over 1H:08, which the company attributed to growth in sales from direct subsidiaries, primarily in the United States. Net loss was EUR 1.5 million... more

Musculoskeletal News Roundup 24-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 24, 2009

Funding MedShape Solutions closed a $10 million round of equity funding from unnamed private investors. The company will use the funds to develop its portfolio of PEEK-based shape-memory devices. An Indianapolis foundation granted $7.0 million for the creation of OrthoWorx,... more

Musculoskeletal News Roundup 17-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 17, 2009

M&A Integra LifeSciences acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Last year the company recorded $2.2 million in revenues, though they ceased operations in January and went into liquidation in May. This transaction... more

Integra Acquries IST BY JOHN MCCORMICK, SEPTEMBER 14, 2009

Early this morning, Integra LifeSciences anounced that it is has acquired the assets of Innovative Spinal Technologies, Inc. (IST) for $9.25 million in cash. Although IST had a little over $2 million of revenue last year, the Company shut its... more

Musculoskeletal News Roundup 10-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 10, 2009

M&A Kapstone Medical acquired exclusive rights to Spherofix's screw-locking technology, which the company plans to incorporate into a line of spinal implants. Terms of the deal were not disclosed. Regulatory Covidien received FDA approval to market its DuraSeal spine sealant,... more

Archus Orthopedics to Dissolve BY LAUREN UZDIENSKI, SEPTEMBER 3, 2009

XConomy reported that Archus Orthopedics is shutting its doors after running out of funds to bring their facet replacement system to market. As of this morning, Archus' website is down, and the company has formally filed with the state of... more

Musculoskeletal News Roundup 3-Sept-09 BY LAUREN UZDIENSKI, SEPTEMBER 3, 2009

Regulatory Active Implants Corporation received a CE Class III Certificate for its TriboFit Hip System. The system is made from a low-wear polycarbonate-urethane material that the company says shares some of the characteristics of human cartilage. MEDICREA received 510(k) clearance... more

Musculoskeletal News Roundup Aug-27-09 BY LAUREN UZDIENSKI, AUGUST 27, 2009

Earnings Corin reported 1H:09 sales of GBP 20.1 million ($33.0 million), down 25% over 1H:08 after adjusting for currency and beating estimates by GBP 2.1 million ($3.5 million). Outside the U.S., revenues increased by 10%, which the company attributed to... more

Medtronic's FQ1:10 Shows Stability in Spine BY LAUREN UZDIENSKI, AUGUST 26, 2009

Medtronic announced their FQ1:10 results on Tuesday, which included $915 million in spine revenues. This reflects an 8% (constant currency) increase over the year-ago period, though it should be noted that Medtronic had about an extra week of selling days... more

Musculoskeletal News Roundup 20-Aug-09 BY LAUREN UZDIENSKI, AUGUST 20, 2009

Earnings aap Implantate reported 1H:09 sales of EUR 14.7 million ($20.7 million), representing a 10% decreased from 1H:08. Adjusting for one-time income, sales were down 3%, and in the second half of 2009, the company "anticipates a recovery in demand... more

Vertebral and Hip Fractures Associated with Increased Mortality Risk BY LAUREN UZDIENSKI, AUGUST 17, 2009

According to a study published in the Canadian Medical Association Journal, patients 50 and older who suffer vertebral and hip fractures may also have an increased risk of mortality. Results showed that 16% of people who develop a vertebral fracture... more

Cervical Fusion, Cervical Disc Arthroplasty Relieve Headaches BY LAUREN UZDIENSKI, AUGUST 10, 2009

Patients who receive cervical fusion or disc arthroplasty to treat radiculopathy or myelopathy may also experience a reduction in associated headaches, according to a new study published in JBJS. Researchers analyzed data from roughly 1,000 patients participating in the Prestige... more

NEJM Studies Challenge the Efficacy of Vertebroplasty BY LAUREN UZDIENSKI, AUGUST 7, 2009

Two studies published this week in the New England Journal of Medicine cast doubts over the efficacy of vertebroplasty. The first study, conducted in Australia, randomized 78 patients in a multicenter, double-blind, placebo-controlled trial in which participants with one or... more

Musculoskeletal News Roundup 30-Jul-09 BY LAUREN UZDIENSKI, JULY 30, 2009

Earnings Exactech reported 2Q:09 revenues of $43.3 million, representing a 1% decrease from the year-ago period and beating estimates by $0.3 million. The company reported net income of $2.6 million, or $0.20 per share, representing a 14% decrease from 2Q:08... more

Musculoskeletal News Roundup 23-Jul-09 BY LAUREN UZDIENSKI, JULY 23, 2009

Earnings Anika Therapeutics reported 2Q:09 revenue of $9.5 million, representing a 5% increase over 2Q:08 and missing estimates by $0.4 million. The company attributed revenue growth to both the ORTHOVISC and MONOVISC product lines, which contributed $5.6 million to total... more

JBJS Reports on the Latest in Spine BY LAUREN UZDIENSKI, JULY 22, 2009

This month JBJS published a review entitled "What's New in Spine Surgery." We've summarized some of the highlights below. Positive Outcomes for Cervical Disc Arthroplasty In two recent studies, arthroplasty was associated with equal or greater pain relief and functional... more

Muscloskeletal News Roundup 16-Jul-09 BY LAUREN UZDIENSKI, JULY 16, 2009

Earnings Biomet reported FQ4:09 sales of $639.3 million, representing a 7% increase over the year-ago period. Among segments, hip increased 9%; knee increased 11%; extremity increased 18%; dental decreased 13%; fixation increased 5%; and spine increase 18%. All growth rates... more

Trans1 Pre-Announces Q2 Amid Reimbursement Changes BY LAUREN UZDIENSKI, JULY 13, 2009

Trans1 pre-announced 2Q:09 sales in the range of $7.9 to $8.0 million, below guidance of $8.7 to $9.0 million and missing analyst projections of $8.8 million. 2Q is also down sequentially from 1Q:09's $8.7 million. Second quarter sales increased 33%... more

Musculoskeletal News Roundup 9-Jul-09 BY LAUREN UZDIENSKI, JULY 9, 2009

Earnings Exactech announced that 2Q:09 revenues would be approximately $43.0 million, below earlier guidance and analyst expectations of approximately $45.0 million. The range for full-year 2009 revenue guidance has also been lowered to $167-$173 million. The company attributed 2Q's sales... more

Musculoskeletal News Roundup 2-Jul-09 BY LAUREN UZDIENSKI, JULY 2, 2009

Earnings Biomet reported net sales of $639.0 million for FQ4:09, which represents an increase of 1% as reported and 7% when adjusting for currency. Among segments, recon, excluding dental, increased 3% as reported and 11% constant currency. Dental decreased by... more

BMPs Increase Complications for Cervical Fusion Patients BY LAUREN UZDIENSKI, JULY 1, 2009

A study published in JAMA reviewed use of BMPs in spinal fusion surgeries, and outcomes included higher complication rates for off-label use in cervical fusions and increased charges for all procedures. Researchers at Brigham and Women's Hospital in Boston conducted... more

Teriparatide and Raloxifene May Reduce Vertebral Fracture Risk BY LAUREN UZDIENSKI, JUNE 29, 2009

We reported back in April that teriparatide, a recombinant form of parathyroid hormone marketed by Eli Lilly as Forteo, may help bones to heal following a fracture. Now a new study published in JBJS reports on an additional application for... more

Musculoskeletal News Roundup 25-Jun-09 BY LAUREN UZDIENSKI, JUNE 25, 2009

Funding BioMimetic Therapeutics raised approximately $17.0 million in a rights offering that closed on Wednesday. The company offered 2,000,000 shares at $8.50 per share in May. The company plans to use the funds for general corporate purposes, including to product... more

Musculoskeletal News Roundup 18-Jun-09 BY LAUREN UZDIENSKI, JUNE 19, 2009

M&A The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT... more

Musculoskeletal News Roundup 11-Jun-09 BY LAUREN UZDIENSKI, JUNE 11, 2009

Funding Alphatec Spine, Inc. has successfully completed a private placement of $10.0 million of shares of its common stock to one of its existing shareholders, HealthpointCapital Partners II, L.P. Alphatec plans to use the net proceeds of the private placement... more

Cortoss Receives FDA Clearance BY LAUREN UZDIENSKI, JUNE 9, 2009

Orthovita has received 510(k) clearance to market Cortoss Bone Augmentation Material for the treatment of vertebral compression fractures, and it's the first cement other than PMMA to be cleared for this use. The product was under review by the FDA... more

Musculoskeletal News Roundup 4-Jun-2009 BY LAUREN UZDIENSKI, JUNE 4, 2009

Funding Active Implants raised $10.0 million in a Series C preferred stock offering. The company is developing the TriboFit Hip and NUsurface implant systems based on its polycarbonate urethane technology. In conjunction with the financing round, the company appointed Charles... more

New SPORT Data Favors Surgery for the Treatment of Spondylolisthesis with Stenosis BY LAUREN UZDIENSKI, JUNE 2, 2009

JBJS published data from the ongoing SPORT trial in this month's edition of the journal, and, like prior results from the study, patients who undergo spine surgery fare better than patients who don't. This arm of the analysis focused on... more

FDA Approves Medtronic's Bryan Cervical Disc BY JOHN MCCORMICK, MAY 29, 2009

Medtronic received long-awaited FDA approval for its Bryan cervical disc on May 12. The device received a favorable FDA panel recommendation in July of 2007, just a day after Medtronic's Prestige disc was approved for market launch. Under the conditions... more

Musculoskeletal News Roundup 28-May-09 BY LAUREN UZDIENSKI, MAY 28, 2009

Regulatory Blackstone Medical received an FDA warning letter relating to the ICON Modular Spinal Fixation System, which the company voluntarily recalled in December of 2005. The FDA said Blackstone failed to adhere to its own risk management procedures and failed... more

FDA Panel Recommends Approval for Duraseal in Spinal Surgery BY LAUREN UZDIENSKI, MAY 22, 2009

Last week an FDA panel voted 4-0 in favor of broadening the approved applications for Covidien's Duraseal sealant to include spinal surgery. Duraseal is a resorbable polymer gel designed, along with sutures, to close small gaps in the dura mater... more

Musculoskeletal News Roundup 14-May-09 BY LAUREN UZDIENSKI, MAY 14, 2009

Earnings aap Implantate reported 1Q:09 revenues of EUR 8.4 million ($11.1 million), representing a 5% increase over the year-ago period. EBITDA for the quarter declined 47% to EUR 0.05 million ($1.1 million). The company says that for the full-year 2009,... more

Spine Arthroplasty 9: London Calling BY JOHN MCCORMICK, MAY 7, 2009

If any spine surgeon congress serves as a litmus test on sentiment concerning new surgical technology, the Spine Arthroplatsy Society ("SAS") meeting is the one. SAS was founded nearly 10 years ago by forward thinking surgeons and technology developers seeking... more

Musculoskeletal News Roundup 7-May-09 BY LAUREN UZDIENSKI, MAY 7, 2009

Earnings Alphatec Spine reported record consolidated revenue of $30.6 million reported in 1Q:09, which represents 32% growth over 1Q:08 and 8% sequential growth over revenues reported in 4Q:08. U.S. revenue growth of 28% over prior year was approximately three times... more

Musculoskeletal News Roundup 30-Apr-09 BY LAUREN UZDIENSKI, APRIL 30, 2009

Earnings aap Implantate reported 2008 revenues of EUR 31.9 million ($45.0 million), a 14% increase over 2007 sales. Sales in the Trauma & Orthopedics division grew by 35%. Biomaterials sales increased by 4%, with the company attributing slower growth to... more

Musculoskeletal News Roundup 23-Apr-09 BY LAUREN UZDIENSKI, APRIL 23, 2009

Earnings CONMED reported 1Q:09 revenues of $164.1 million, representing a 7% decrease over 1Q:08 and missing estimates by $9.5 million. Arthroscopic devices contributed $63.9 million in revenue, down 8% over 1Q:08, with the decline due largely to a 24% decrease... more

NuVasive to Acquire Cervitech for Up to $80 million BY LAUREN UZDIENSKI, APRIL 23, 2009

NuVasive announced yesterday afternoon that they would acquire NJ-based Cervitech for $47 million and up to $33 million upon the achievement of certain regulatory milestones. Up to half of these payments can be made in stock. Cervitech is developing the... more

Musculoskeletal News Roundup 16-Apr-09 BY LAUREN UZDIENSKI, APRIL 16, 2009

Earnings JNJ reported 1Q:09 sales of $15.0 billion, missing estimates by $0.4 billion and representing a 7% decline over 1Q:08, which the company attributed mostly to unfavorable exchange rates. Net income was $3.5 billion, or $1.26 per diluted share, beating... more

Early Earnings Reports Show Growth Despite Economy BY LAUREN UZDIENSKI, APRIL 16, 2009

DePuy and Biomet have kicked off 1Q earnings season on a positive note, offering a view of industry growth that may be outpacing expectations. These two companies, which together comprise more than a third of the ortho market, reported 7%... more

Medtronic Talks "Disappointing" Kyphon Acqusition and Future Growth BY LAUREN UZDIENSKI, APRIL 15, 2009

In recent interviews, Medtronic CEO Bill Hawkins discussed some of the challenges associated with the company's $4.2 billion acquisition of Kyphon in 2007 as well as plans for future acquisitions. Kyphon brought innovative products and an entree into new markets,... more

Musculoskeletal News Roundup 9-Apr-09 BY LAUREN UZDIENSKI, APRIL 9, 2009

Earnings Biomet reported FQ3:09 revenues of $615 million, a 7% (constant currency) increase over FQ3:08. Among segments, recon reported growth of 7%, with hip up 10%, knee up 9%, fixation up 4% and dental down 10%, which the company attributed... more

With Applications Beyond Vertebroplasty, Bone Cement Offers Pain Relief for Cancer Patients BY LAUREN UZDIENSKI, APRIL 6, 2009

Patients suffering crippling pain from metastatic cancer or even "benign" conditions like rheumatoid arthritis may find relief in a minimally-invasive treatment called osteoplasty. Similar to vertebroplasty, osteoplasty is the injection of bone cement into cancerous lesions in the skeleton, and... more

Orthofix Shareholders Vote Down Ramius Proposals BY LAUREN UZDIENSKI, APRIL 2, 2009

Orthofix announced some preliminary results from their Special General Meeting of Shareholders spurred by Ramius LLC's criticism of the company. Ramius, which owns 5.1% of Orthofix, was seeking to remove four members of the Board of Directors and replace them... more

Musculoskeletal News Roundup 2-Apr-09 BY LAUREN UZDIENSKI, APRIL 2, 2009

Earnings Corin reported 2008 revenues of GBP 39.8 million ($57.6 million), an 8% increase over 2007 sales. The company also reported a pretax loss of GBP 3.9 million ($5.6 million), which reflected a GBP 5.2 million ($7.2 million) inventory write-down... more

Stryker's OP-1 Putty Not Approvable According to FDA Panel BY ARIELLA P. GOLOMB, MD, APRIL 1, 2009

Yesterday an FDA advisory panel voted 6-1 that Stryker's PMA for its OP-1 Putty for uninstrumented posterolateral fusion for the treatment of lumbar spondylolisthesis was "not approvable." Stryker was seeking this approval based on 24 months of clinical outcome data... more

Ozone Injections Could Reduce Back Pain BY LAUREN UZDIENSKI, MARCH 25, 2009

Yes, that ozone. The molecule that filters UV rays in the atmosphere and is a pollutant on the ground could have applications for reducing back pain, according to new studies out of Europe. Over the past five years, it is... more

Musculoskeletal News Roundup 26-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 26, 2009

Earnings Artimplant reported 4Q:08 revenues of SEK 4.6 million ($0.6 million), down from SEK 5.0 million ($0.8 million) in 4Q:07. During the quarter, the company reported sales of 900 Artelon Spacers (down from 1,100 in 4Q:07) and 300 units of... more

Musculoskeletal News Roundup 19-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 20, 2009

Earnings Exactech reported 4Q:08 revenues of $40.3 million, representing a 22% increase over 4Q:07 and beating estimates by $0.4 million. Net income was $3.1 million, or $0.24 per share, representing a 15% increase over 4Q:07 and beating estimates by $0.04.... more

Musculoskeletal News Roundup 12-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 12, 2009

Earnings Nobel Biocare reported 4Q:08 revenue of EUR 162.6 ($229.2 million), down 13% from 4Q:07. 4Q net profit of EUR 24.9 million ($32.3 million) was down 45% from the year-ago period and missed estimates of EUR 29.0 million ($40.9) million.... more

Imaging for Low Back Pain Does Not Improve Outcomes BY LAUREN UZDIENSKI, FEBRUARY 9, 2009

A review published in this week's edition of the Lancet analyzes the results of six lower-back imaging studies to evaluate whether routine scans correlate to better outcomes for patients suffering from low back pain. The paper, which is summarized here... more

ARGOSpine: Not Just Another Meeting BY JOHN MCCORMICK, FEBRUARY 9, 2009

We have often heard the complaint from spine surgeons that there are "too many spine meetings these days". Our accumulating frequent flyer points support the notion. The Paris-based annual ARGOSpine Symposium is different, however and deserves some distinction from the... more

Musculoskeletal News Roundup 5-Feb-09 BY LAUREN UZDIENSKI, FEBRUARY 5, 2009

Earnings CONMED Corp. reported 4Q:08 revenues of $179.2 million, down 5% versus 4Q:07 and beating estimates by $2.26 million. Non-GAAP diluted earnings per share were $0.34, down 23% from 4Q:07 and beating estimates by $0.05. The company reported 4Q:08 arthroscopy... more

Musculoskeletal News Roundup 29-Jan-09 BY LAUREN UZDIENSKI, JANUARY 29, 2009

Earnings Kensey Nash reported FQ2:09 revenues of $20.8 million, up 6% over the year-ago period and beating estimates by $0.4 million. Net income for the quarter was $5.2 million, or $0.44 per diluted share, beating estimates by $0.04 and representing... more

Geron Study Marks a New Era for Stem Cell Research BY LAUREN UZDIENSKI, JANUARY 27, 2009

Geron announced this week that it received an FDA green light to initiate a human clinical study for their embryonic stem cell treatment for spinal cord injuries. The cell formulation, known as GRNOPC1, will be injected in up to 10... more

NASS Announces More Stringent Disclosure Policy BY LAUREN UZDIENSKI, JANUARY 26, 2009

The North American Spine Society (NASS) adopted a new transparency policy requiring surgeons presenting at conferences to disclose both industry relationships and the dollar amount of any payments. Failure to disclose information could result in sanctions including suspension or expulsion... more

Musculoskeletal News Roundup 15-Jan-08 BY LAUREN UZDIENSKI, JANUARY 15, 2009

Earnings Alphatec Spine announced that, based on preliminary financial data, the company will report record consolidated quarterly revenues for 4Q:08 of approximately $28.4 million, an increase of approximately 33% over revenues from the prior year fourth quarter. For the year... more

More Trouble for ArthroCare BY JOHN MCCORMICK, JANUARY 15, 2009

This morning ArthroCare, the well known minimally invasive sports medicine company, announced that it received a letter from the Nasdaq stock exchange that its stock is to be de-listed at the open of trading tomorrow - Friday, January 16. Although... more

Musculoskeletal News Roundup 8-Jan-09 BY LAUREN UZDIENSKI, JANUARY 8, 2009

Earnings CONMED Corp. lowered 4Q:08 revenue projections to $176-$178 million, 9% lower than forecast and approximately 7% lower than 4Q:07. Reduced revenues were attributed to unfavorable foreign currency exchange fluctuations and lower than anticipated sales of capital equipment to hospitals.... more

SPORT Data Quantifies Cost-Effectiveness of Laminectomy, Fusion BY LAUREN UZDIENSKI, JANUARY 5, 2009

Using the data collected from the SPORT trial, researchers at Rush University Medical Center evaluated the cost-effectiveness of spinal surgery in stenosis patients with and without spondylolisthesis. The study considered the direct and indirect costs of laminectomy and fusion against... more

Musculoskeletal News Roundup 18-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 18, 2008

Funding In addition to its regularly scheduled payments, Orthofix International will make a $10 million debt prepayment on December 29th in advance of the scheduled maturity. According to Executive Vice President and CFO Bob Vaters, "This is a good time... more

Musculoskeletal News Roundup 11-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 12, 2008

Earnings Wright Medical reiterated 4Q:08 revenue and earnings guidance on a call this week and lowered 2009 guidance based on less favorable foreign exchange rates. The company is now calling for 2009 revenues in the range of $510 million to... more

For Patients in Pain, Scans May Not Offer a Diagnosis BY LAUREN UZDIENSKI, DECEMBER 9, 2008

Imaging technology may be an ubiquitous part of modern medical practice, but a New York Times article suggests that the frequency and sensitivity of MRI and CT scans may reveal musculoskeletal abnormalities without showing what causes a patient's pain. These... more

Musculoskeletal News Roundup 4-Dec-08 BY LAUREN UZDIENSKI, DECEMBER 4, 2008

Earnings Stryker announced a 2008 dividend of $0.40 per share, an increase of 21% over the 2007 dividend, which is payable January 30, 2009. President and CEO Stephen MacMillan said the increased dividend reflects the company's continued growth and strong... more

Musculoskeletal News Roundup 20-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 20, 2008

Earnings Medtronic reported FQ2:09 revenues of $3.57 billion, up 14% (8% constant currency) over the year-ago period and missing estimates by $0.12 billion. Non-GAAP net earnings and diluted earnings per share were $758.0 million, or $0.67 per diluted share, missing... more

Musculoskeletal News Roundup 6-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 6, 2008

Earnings Alphatec Spine, Inc. announced that consolidated revenues for 3Q:08 were $25.8 million, an increase of 27.1% from the $20.3 million reported for the 3Q:07. U.S. revenues for 3Q:08 were $21.5 million, an increase of 27.7% from the $16.8 million... more

Musculoskeletal News Roundup 30-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 30, 2008

Earnings Exactech reported 3Q:08 revenues of $37.9 million, missing revenues by $0.9 million and representing an increase of 27% over the year-ago period. Among segments, knee revenue increased 16%; organic hip implant revenue increased 8%; biologic services revenue increased 12%;... more

Musculoskeletal News Roundup 22-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 22, 2008

Earnings CONMED reported 3Q:08 revenues of $179.4 million, up 9% over the year-ago period and beating estimates by $2.95 million. Arthroscopy was up 18% (17% constant currency), contributing $69.5 million to total sales. On a non-GAAP basis, diluted earnings per... more

NASS Compendium: Industry Showcases the Latest in Spine BY LAUREN UZDIENSKI, OCTOBER 21, 2008

Last week we attended NASS in Toronto, where we saw the launch of a number of new products as well as the release of new clinical data and the first wave of 3Q:08 earnings results. M&A M&A news was quiet... more

ISTO's NuQu Shows Promise for Cartilage Regneration BY LAUREN UZDIENSKI, OCTOBER 17, 2008

At NASS this week, ISTO Technologies announced promising data from an animal study evaluating their NuQu cell therapy for the treatment of degenerative disc disease. NuQu is a non-invasive cell therapy derived from juvenile chondrocytes and delivered with a protein... more

Musculoskeletal News Roundup 16-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 16, 2008

Earnings Biomet reported FQ1:09 revenues of $607.0 million, up 13% (9% constant currency) over the year-ago period. Excluding special charges, adjusted operating income was $171.6 million for FQ1:09, up 12% over FQ1:08. Among segments, reconstructive reported $449.3 million in sales,... more

Musculoskeletal News Roundup 9-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 9, 2008

M&A Life Spine, Inc. has acquired the "majority" of the intellectual property of Spinal Generations, LLC. Neither details on the acquired technology nor terms of the transaction were disclosed. Funding Harvard received a $125 million donation from Synthes Chairman Hansjorg... more

Musculoskeletal News Roundup 2-Oct-08 BY LAUREN UZDIENSKI, OCTOBER 2, 2008

M&A Arthro Kinetics announced that they are pursuing a potential asset sale. The company said this week that their current $5.0 million cash balance was not sufficient to sustain operations. Tecomet has been acquired from Cardinal Health by Charlesbank Capital... more

Orthopedic Venture Capital Down but not Out BY JOHN MCCORMICK, OCTOBER 2, 2008

What do the severe dislocations seen in the credit markets mean for the orthopedic device startup looking for venture capital? Duly noting we are not a venture capital firm (we perform buyouts), our observation from afar is that the venture... more

Musculoskeletal News Roundup 25-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 25, 2008

Funding Anulex Technologies, Inc. secured a $7.0 million growth capital term loan from Silicon Valley Bank. The company plans to use the proceeds to further their R&D efforts, complete their clinical study and expand their sales force. Anulex markets the... more

Musculoskeletal News Roundup 11-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 11, 2008

M&A Wright Medical Group, Inc. acquired the RAYHACK System for wrist reconstruction, which consists of "procedure-specific bone-cutting guides and fixation plates that allow precise shortening and repositioning of the radius and ulna." The system will be available in the U.S.... more

Musculoskeletal News Roundup 4-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 4, 2008

Earnings Inion reported 2Q:08 sales of EUR 1.8 million ($2.8 million), up 34% over 2Q:07. 1H:08 sales were EUR 2.59 ($4.1 million), a 12% increase over 1H:07. Operating loss for 1H:08 was EUR 4.85 million ($7.6 million), a 20% decrease... more

SPORT Subgroup Analysis Shows Discectomy Outcomes Vary by Herniation Level BY LAUREN UZDIENSKI, SEPTEMBER 2, 2008

A new study published in JBJS evaluated results from one arm of the SPORT trial to see if herniation level affected discectomy outcomes. The authors undertook the study after a recent randomized trial conducted by Dr. Heikki Osterman et al... more

Musculoskeletal News Roundup 28-Aug-08 BY LAUREN UZDIENSKI, AUGUST 28, 2008

Earnings AOI Medical Inc. reported a 1H:08 loss of $3.5 million, widening from a loss of $1.8 million in 1H:07. The company added in the press release that they're conducting a new clinical study for their Ascendex tools for the... more

Airplanes Spell Neck and Back Pain for 88% of Travelers BY LAUREN UZDIENSKI, AUGUST 19, 2008

If flight delays, crowded planes and extra fees weren't enough, a new survey from SpineUniverse adds achy necks and backs to the many pains of air travel. The organization conducted a survey this summer on airplane seats and your spine,... more

Musculoskeletal News Roundup 7-Aug-08 BY LAUREN UZDIENSKI, AUGUST 7, 2008

Earnings Alphatec Spine, Inc. reported consolidated revenues for 2Q:08 of $23.9 million, an increase of 27% from the $18.8 million reported in 2Q:07. U.S. revenues for 2Q:08 were $19.4 million, an increase of 20% from the $16.2 million reported in... more

Mesoblast Reports Promising Results from an Ongoing Stem Cell Study BY LAUREN UZDIENSKI, AUGUST 6, 2008

Mesoblast announced positive results from an Australian study evaluating the use of its proprietary stem cell therapy in the treatment of non-healing long bone fractures. 10 patients with 11 fractures were enrolled in the study and received the stem cell... more

Musculoskeletal News Roundup 31-July-08 BY LAUREN UZDIENSKI, JULY 31, 2008

Earnings Cryolife reported 2Q:08 revenues of $27.2 million, up 18% over the year-ago period and beating estimates by $1.4 million. Orthopedic tissue processing revenues declined 76% to $0.3 million, as the company has discontinued that segment of the business. Net... more

MIT Study Advances Non-Surgical Stem Cell Treatments for Spinal Cord Injuries BY HAL BRIGHAM, JULY 30, 2008

A recent joint study out of MIT's Picower Institute for Learning and Memory and the Karolinska Institute in Sweden may pave the way for the development of revolutionary, non-surgical treatments for spinal cord injuries. Headed by Konstantinos Meletis, a postdoctoral... more

Musculoskeletal News Roundup 24-July-08 BY LAUREN UZDIENSKI, JULY 24, 2008

Earnings Anika Therapeutics reported 2Q:08 revenue of $8.38 million, representing a 32% increase over 2Q:07 but missing estimates by $0.4 million. The company attributed sales growth to the strength of the Orthovisc line. Net income for 2Q:08 was $0.81 million,... more

Theken is Taken: Integra to Buy for up to $200 Million BY LAUREN UZDIENSKI, JULY 24, 2008

Integra LifeSciences this morning announced plans to acquire the Theken family of businesses - Theken Spine, Theken Disc and Therics - for $75.0 million (2.2x 2007 revenues) plus up to $125.0 million in future performance-based payments (up to 5.9x 2007... more

CMS Proposes National Non-Coverage Decision for IDET BY LAUREN UZDIENSKI, JULY 24, 2008

CMS proposed a national non-coverage decision for intradiscal electrothermic therapy (IDET), saying there is insufficient evidence that the procedure improves outcomes in the Medicare population. IDET is a minimally-invasive treatment for low back pain where a catheter and a heating... more

Musculoskeletal News Roundup 17-July-08 BY LAUREN UZDIENSKI, JULY 17, 2008

Earnings Biomet reported FQ4:08 revenues of $635.6 million, an increase of 16% (10% constant currency) over the year-ago period. Sales increased 10% in the U.S and 24% (11% constant currency) OUS. Recon sales increased 17% worldwide (12% constant currency) to... more

FzioMed's Oxiplex "Not Approvable" According to FDA Panel BY DAVID KRESSEL, JULY 16, 2008

On Tuesday, we attended the FDA's Orthopaedic & Rehabilitative Devices Panel, Oxiplex/SP was voted "Not Approvable" by a 5-2 vote, based largely on the sponsoring company's inability to definitively demonstrate product effectiveness. The two dissenters would have voted it "Approvable... more

Musculoskeletal News Roundup 10-July-08 BY LAUREN UZDIENSKI, JULY 10, 2008

IP Michigan-based Smart Disc, Inc. received a Notice of Allowance from the U.S. Patent and Trademark Office for U.S. patent application number 10/838,515, covering the company's artificial disc technology. The device can be implanted using a posterior approach and is... more

FDA Issues Warning Regarding Off-Label Use of rhBMP BY LAUREN UZDIENSKI, JULY 7, 2008

Last week the FDA released a public health notification regarding the off-label use of of rhBMP (InFuse, OP-1) in the cervical spine. The agency says that over the past four years there have been at least 38 reports of complications... more

Musculoskeletal News Roundup 3-July-08 BY LAUREN UZDIENSKI, JULY 3, 2008

Regulatory Interventional Spine announced that the FDA has conditionally approved its IDE application for the PercuDyn System, pending the company providing some additional information to the FDA. CEO Walter Cuevas commented that the company will now begin collecting data to... more

Musculoskeletal News Roundup 26-Jun-08 BY LAUREN UZDIENSKI, JUNE 27, 2008

Earnings Symmetry Medical reported 1Q:08 revenue of $101.9 million, up 57% from the year-ago period. Revenue was positively affected by the recent acquisitions of TNCO, Inc., Specialty Surgical Instrumentation Inc. and DePuy Orthopaedics, Inc.'s Massachusetts manufacturing facility. Net income for... more

Musculoskeletal News Roundup 12-June-08 BY ARMELLE WIART, JUNE 12, 2008

M&A Wright Medical Group, Inc. announced that it has acquired the foot and ankle product line of A.M. Surgical, Inc. The systems purchased address the decompression and soft tissue release procedures most commonly performed by foot and ankle surgeons. The... more

Twin Study Shows that Disc Degeneration May be Genetic BY LAUREN UZDIENSKI, JUNE 10, 2008

Results from the Finnish Twin Spine Study show that disc degeneration may not be the result of physical strain, but genetically determined. The study, which was initiated in 1991, examined 147 pairs of identical and 153 pairs of fraternal male... more

Musculoskeletal News Roundup 5-June-08 BY ARMELLE WIART, JUNE 6, 2008

Earnings Integra LifeSciences reported its financial results for the first quarter ending March 31, 2008. Total revenues were approximately $156.0 million, reflecting an increase of $33.0 million, or 27%, over the first quarter of 2007. Adjusted net income for the... more

Combined with BMP, Adipose-Derived Stem Cells Promote Spinal Fusion in Animal Model BY LAUREN UZDIENSKI, JUNE 4, 2008

A recent study published in JBJS shows some of the potential of adipose-dervived stem cells as a vehicle for gene therapy in promoting spinal fusion. Five groups of rats received stem cells and the BMP gene, stem cells, osteogenic media... more

Musculoskeletal News Roundup 29-May-08 BY ARMELLE WIART, MAY 29, 2008

M&A Kinetic Concepts, Inc. announced that it completed its acquisition of LifeCell Corporation. At the time of the expiration of the tender offer, 31.1 million shares of LifeCell common stock had been tendered representing approximately 90.75% of the outstanding shares... more

New Swiss Spine Registry Could Shape Practice Habits, Reimbursement BY LAUREN UZDIENSKI, MAY 27, 2008

In Switzerland, more than 135 surgeons are contributing data to a newly-implemented spine registry, reporting cost, efficacy and performance information on cervical and lumbar total disc arthroplasty and kyphoplasty procedures. The Swiss government started the program in December 2007 to... more

Musculoskeletal News Roundup 22-May-08 BY LAUREN UZDIENSKI, MAY 22, 2008

Earnings Medtronic reported FQ4:08 revenue of $3.86 billion, representing an 18% increase over the year-ago period and beating estimates by $0.14 billion. Currency translation had a positive impact of $160.0 million. Adjusted net earnings for the quarter were $884.0 million,... more

Musculoskeletal News Roundup 15-May-08 BY LAUREN UZDIENSKI, MAY 15, 2008

Earnings aap Implantate AG announced 1Q:08 revenues of EUR 8.0 million ($12.64 million), up 36% over the year-ago period. The company attributed the growth to a 146% increase in sales in its Trauma & Orthopaedics division, which contributed EUR 3.7... more

Notes from the Spine Arthroplasty Meeting BY JOHN MCCORMICK, MAY 14, 2008

The Spine Arthroplasty Society ("SAS") conference continues to be the forward thinking spine conference. The meeting's growing clinical stature and technology flare attracts surgeons and companies from around the globe seeking to bring cutting edge technologies to the market and... more

Musculoskeletal News Roundup 8-May-08 BY LAUREN UZDIENSKI, MAY 8, 2008

Earnings Artimplant announced 1Q:08 revenues of SEK 2.1 million ($0.35 million), down from SEK 3.9 million ($0.66 million) in 1Q:07. Net loss for the quarter was SEK 6.2 million ($1.04 million), or SEK 10 ($1.68) per share, a deterioration from... more

Musculoskeletal News Roundup 1-May-08 BY LAUREN UZDIENSKI, MAY 1, 2008

Earnings Anika Therapeutics reported 1Q:08 total revenues of $8.55 million, an increase of 46% over the year-ago period, which the company attributed to strong domestic and international sales of ORTHOVISC. Revenues beat analysts' expectations by $0.2 million. Net income for... more

Cervical Artificial Discs Reduce Costs for Patients BY LAUREN UZDIENSKI, APRIL 29, 2008

A new study funded by Medtronic and presented at this week's AANS meeting showed that compared to fusion, patients who underwent cervical disc replacement saved an average of $6,000 in the two years following treatment. 541 patients received either the... more

Musculoskeletal News Roundup 24-Apr-08 BY LAUREN UZDIENSKI, APRIL 24, 2008

Earnings Alphatec Holdings reported consolidated revenues for 1Q:08 of $23.2 million, an increase of 19% from the year-ago period. U.S. revenues for the first quarter of 2008 were $18.6 million, an increase of 12% from the year-ago period. Asia revenues... more

Musculoskeletal News Roundup 17-Apr-08 BY LAUREN UZDIENSKI, APRIL 17, 2008

Earnings Biomet reported FQ3:08 net sales of $603.1 million, a 14% increase over the year-ago period. Excluding the impact of foreign currency, net sales increased 10%. U.S. revenue was $351.6 million. Adjusted net income for the third quarter was $25.2... more

Musculoskeletal News Roundup 3-Apr-08 BY LAUREN UZDIENSKI, APRIL 3, 2008

Earnings aap Implantate reported 2007 revenue of EUR 28.0 million ($41.24 million), an increase of 52% over 2006. Net profit for the year was EUR 1.5 million ($2.21 million), down from EUR 1.6 million ($2.36 million) in 2006, which the... more

BioMimetic Dives on FDA Communication to J&J BY DAVID KRESSEL, APRIL 2, 2008

BioMimetic Therapeutics' shares dove sharply last week (and recovered somewhat less sharply) because the FDA raised the possibility that the active ingredient of all of the company's products, PDGF (Platelet-Derived Growth Factor), caused cancer. From Thursday's intraday high price per... more

Musculoskeletal News Roundup 27-Mar-08 BY LAUREN UZDIENSKI, MARCH 27, 2008

Earnings DJO Inc., formerly ReAble Therapeutics, reported 4Q:07 net sales of $170.7 million, a 97% increase over 4Q:06; the growth rate was due primarily to acquisitions, including ReAble's merger with DJO. The company reported an actual net loss of $57.3... more

Musculoskeletal News Roundup 20-Mar-08 BY LAUREN UZDIENSKI, MARCH 20, 2008

Earnings Biomet announced preliminary FQ3:08 revenues of $603.1 million, an increase of 14% over the year-ago period. By segment, reconstructive device sales increased 19% worldwide and 13% in the U.S.; knee sales increased 24% worldwide and 21% in the U.S.,... more

Musculoskeletal News Roundup 13-Mar-2008 BY LAUREN UZDIENSKI, MARCH 13, 2008

Earnings BioMimetic Therapeutics reported 4Q:07 revenues of $4.5 million, up from $1.9 million in 4Q:06 but missing analysts' estimates by $1.1 million. Revenues included $3.6 million of product sales of GEM 21S to Luitpold, $0.7 million of royalty income and... more

Musculoskeletal News Roundup 6-Mar-08 BY LAUREN UZDIENSKI, MARCH 6, 2008

Earnings Anika Therapeutics reported 4Q:07 product revenue of $7.9 million, in line with estimates and up from $5.08 million for the same period last year. The revenue growth was attributed to domestic and international sales of the ORTHOVISC product line,... more

Consumer Spending on Spine Increases, But Pain Persists; More Data is Needed on Treatment Options BY LAUREN UZDIENSKI, FEBRUARY 25, 2008

Consumer spending for spinal treatments rose 65% from 1997 to 2005, faster than overall health spending, with patients spending $86 billion to treat back and neck problems. These treatments included drugs, outpatient procedures, ER visits and surgery. However, back pain... more

Musculoskeletal News Roundup 21-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 21, 2008

Earnings ArthroCare reported 4Q:07 revenues of $87.5 million, beating estimates by $1.7 million, representing a 25% increase over the year-ago period. Net income was $14.5 million, or $0.50 per diluted share, missing estimates by a penny and representing a 78%... more

SPORT Tests Surgery in Spinal Stenosis Patients; Surgery Favored BY LAUREN UZDIENSKI, FEBRUARY 19, 2008

Data from the eagerly-anticipated final arm of the SPORT trial was released today. Results showed that patients receiving decompressive laminectomy for the treatment of spinal stenosis showed improved outcomes following the procedure. Prior arms of the $21 million SPORT trial... more

Musculoskeletal News Roundup 14-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 14, 2008

Earnings Hanger Orthopedic Group reported 4Q:07 net sales of $170.8 million, beating estimates by $7.5 million and representing an 11% over the year-ago period. Revenue growth was attributed to an increase in same-center sales from Hanger's patient care business, an... more

Musculoskeletal News Roundup 7-Feb-08 BY LAUREN UZDIENSKI, FEBRUARY 7, 2008

Earnings Smith & Nephew announced 4Q:07 revenues of $967.0 million, beating estimates of $933.0 million and reflecting a 25% (reported) increase over 4Q:06. Adjusted earnings per share was $0.16, in line in estimates and up 10% over the year-ago period.... more

Musculoskeletal News Roundup 31-Jan-08 BY LAUREN UZDIENSKI, JANUARY 31, 2008

Earnings Kensey Nash reported FQ2:08 total revenues of $19.6 million, missing estimates by $0.05 million and up 14% over the year-ago period. Net sales of biomaterials products increased 15% to $11.5 million, which the company attributed to orthopedic sales. The... more

The New York Times Questions Prodisc, Surgeons, Hospitals, Industry and FDA BY DAVID KRESSEL, JANUARY 30, 2008

In the January 30th issue of the New York Times, healthcare reporter Reed Abelson takes a critical look at spine surgery, and in particular a novel device called Prodisc in an article titled "Financial Ties Are Cited as Issue in... more

Musculoskeletal News Roundup 25-January-08 BY LAUREN UZDIENSKI, JANUARY 24, 2008

Earnings JNJ reported 4Q:07 revenues of $15.96 billion, up 17% over the year-ago period and beating consensus estimates of $15.4 billion. Net income was $2.37 billion, or $0.82 per share, missing estimates by $0.04. Depuy reported 4Q:07 sales of $1.21... more

Musculoskeletal News Roundup 17-Jan-07 BY LAUREN UZDIENSKI, JANUARY 17, 2008

Earnings Biomet reported earnings for 2FQ:08 last week, with net sales up 11% to $578.1 million over the comparable quarter. Worldwide, knee sales were up 17%, and hip was up 12%. Extremity sales increased 11% and bone cements and accessories... more

Musculoskeletal News Roundup 10-Jan-08 BY LAUREN UZDIENSKI, JANUARY 10, 2008

M&A ArthroCare Corp. acquired DiscoCare, Inc., whom the company describes as "a third-party billing and reimbursement service provider," for $25 million in cash plus potential future milestone payments. The company says, "This acquisition will allow ArthroCare to significantly expand its... more

ArthroCare in the News Again with the Acquisition of DiscoCare BY LAUREN UZDIENSKI, JANUARY 9, 2008

Last week ArthroCare announced a $25 million deal to acquire DiscoCare, described in the press release as a "medical billing and reimbursement service provider." Specifically, DiscoCare provides reimbursement assistance to physicians using Arthrocare's plasma disc decompression (PDD) device; though it... more

Musculoskeletal News Roundup 3-Jan-08 BY LAUREN UZDIENSKI, JANUARY 3, 2008

M&A Curis, Inc. entered into an agreement to sell and assign its remaining BMP-7 technologies to Stryker Corporation. Curis will receive an initial payment of $1.0 million as well as additional cash payments based on specified clinical, regulatory and sales... more

Musculoskeletal News Roundup 27-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 27, 2007

M&A Sandvik AB said its Sandvik Materials Technology division has acquired Medtronic's specialty instrument manufacturing plant in Memphis. Medtronic plans to move the plant's purchasing, receiving and quality functions to the company's development and logistics center nearby. The transaction is... more

Musculoskeletal News Roundup 20-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 20, 2007

M&A BioMimetic announced the impending sale of its dental business and GEM 21S product to Luitpold Pharmaceuticals. Luitpold, who has been distributing the product since 2003, will pay BioMimetic $40.0 million in addition to ongoing royalty and milestone payments. The... more

Medtronic Expands in China with Weigao Joint Venture BY LAUREN UZDIENSKI, DECEMBER 19, 2007

Medtronic announced plans yesterday to bring spine and orthopedic therapies to the Chinese market through a joint venture with Shandong Weigao Group Medical Polymer Company Limited. Under the joint venture agreement, the companies will sell spine and orthopedic products, including... more

Spine's Evolution Keeps Pregnant Women Upright BY LAUREN UZDIENSKI, DECEMBER 17, 2007

The New York Times reported last week that post-doctoral fellow at Harvard discovered what keeps pregnant women upright amid changes to abdominal mass and center of gravity: the lumbar curve in the lower back and reinforcement of the lumbar vertebrae.... more

Expanding Their Presence in Spine, Exactech Plans to Acquire Altiva BY LAUREN UZDIENSKI, DECEMBER 11, 2007

Exactech announced yesterday plans to acquire all outstanding shares of Altiva for a payment of $7.0 million in cash and Exactech common stock. The company previously announced a purchase valuation of Altiva totaling $25.0 million. Prior to the news of... more

Musculoskeletal News Roundup 29-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 29, 2007

Regulatory Amedica received FDA clearance for their Valeo™ Pedicle Screw system, a low profile and modular pedicle screw system intended for non-cervical pedicle fixation from the T1 through L5. Corin announced FDA clearance for additional sizes of its Cormet hip... more

Musculoskeletal News Roundup 21-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 21, 2007

Earnings Medtronic reported FQ2:08 revenue of $3.12 billion, beating estimates by $0.02 million and representing a 2% increase over the year-ago period. Net earnings for FQ2:08 were $666.0 million, or $0.58 per diluted share, beating estimates by $0.02 but down... more

Musculoskeletal News Roundup 15-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 15, 2007

Earnings Artimplant announced 3Q:07 revenue of SEK 2.6 million, up from SEK 0.9 million in the year-ago period. 3Q:07 net loss was SEK 3.6 million, down from SEK 10.4 in 3Q:06. Earnings per share, including a non-recurring item, amounted to... more

Regeneration Technologies and Tutogen to Merge BY DAVID KRESSEL, NOVEMBER 13, 2007

This morning Regeneration Technologies (RTI) and Tutogen announced their intent to merge. These are two of the larger players in the tissue processing business though their businesses have surprisingly little overlap. RTI has been more focused on allograft hard tissue... more

N-Spine Bought By Synthes for $75+ Million BY DAVID KRESSEL, NOVEMBER 13, 2007

Swiss orthopedics giant Synthes announced today that it is purchasing N-Spine for $30 million cash upfront, $45 million cash for certain milestones and additional undisclosed payments for reaching certain sales targets. Synthes is one of the leaders in the spine... more

Researchers Find Stem Cells in Intervertebral Discs BY LAUREN UZDIENSKI, NOVEMBER 12, 2007

Jefferson Medical College researchers reported in the November 1 edition of Spine that they had discovered, for the first time, stem cells in the intervertebral discs of the human spine. The discovery of these cells could ultimately pave the way... more

Musculoskeletal News Roundup 8-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 8, 2007

Earnings Anika reported 3Q:07 product revenues of $7.28 million, up from $5.49 million in 3Q:06. The company attributed the sales growth to strong domestic and international sales of ORTHOVISC®. Net income for 3Q:07 was $1.8 million, or $0.16 per diluted... more

Musculoskeletal News Roundup 1-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 1, 2007

Earnings DJO reported 3Q:07 net revenues of $119.8 million, up 5.8% over 3Q:06. Excluding a 2006 revenue benefit from shipping terms and clearing of product backorders associated with Aircast, 3Q:07 revenue was up 7.6% to $121.8 million, in line with... more

A NASS Compendium BY JOHN MCCORMICK, OCTOBER 31, 2007

Last week, six members of our firm attended the North American Spine Society (NASS) annual meeting in Austin, TX talking to surgeons, companies and scientists about the latest technology, market and clinical developments in the spinal implant industry. We are... more

Musculosketal News Roundup 25-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 25, 2007

Earnings ArthroCare Corp. reported 3Q:07 total revenues of $78.5 million, an increase of 21% over the comparable quarter. Revenues missed estimates by $0.11 million. The company reported net income of $11.1 million, or $0.39 per share, up 28% over 3Q:06... more

Synthes Gets Approvable Letter from FDA for ProDisc®-C BY LAUREN UZDIENSKI, OCTOBER 25, 2007

Synthes announced this morning that they received an Approvable Letter from the FDA regarding their PMA application for the ProDisc®-C, the company's artificial cervical disc. A full approval order will be made once Synthes' manufacturing processes are reviewed by the... more

Musculoskeletal News Roundup 18-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 18, 2007

Earnings Biomet reported FQ1:08 sales of $552.3 million, up 9% over the comparable quarter. The company reported a net loss for the quarter of $42.9 million, down from an income of $104.4 million for FQ1:07. The company attributed the loss... more

TranS1 Priced Above Range in NASDAQ Debut BY LAUREN UZDIENSKI, OCTOBER 17, 2007

Wilmington, N.C.-based spine company TranS1 began trading on the NASDAQ today following Tuesday's IPO. The stock debuted at $15 per share, above the $12-$14 per share forecasted by underwriters Lehman Brothers Holdings Inc. and Piper Jaffray, and raised a total... more

Musculoskeletal News Roundup 11-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 11, 2007

M&A With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced... more

Warning Letters Encourage Spine Companies to Seek More Data, Tougher Indications BY LAUREN UZDIENSKI, OCTOBER 10, 2007

Two recent FDA warning letters issued in the spine space show regulators cracking down on industry marketing practices, putting pressure on devicemakers to conduct more trials and pursue harder-to-get indications for their products. In August, Spineology received an FDA warning... more

Musculoskeletal News Roundup 4-Oct-07 BY LAUREN UZDIENSKI, OCTOBER 4, 2007

M&A Orthofix acquired the rights to all of the intellectual property related to the InSWing™ interspinous process spacer. InSWing is designed to relieve pain associated with lumbar spinal stenosis and can be used in a minimally invasive surgical procedure. Orthofix... more

Musculoskeletal News Roundup 28-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 28, 2007

Legal Federal prosecutors announced on Thursday the terms of a settlement with Zimmer, Depuy, Biomet, Smith & Nephew and Stryker following an investigation into physician compensation practices. Zimmer, Depuy, Biomet and Smith & Nephew entered into deferred prosecution agreements and... more

Alphatec Holdings, Inc. Announces Pricing of Common Stock Offering BY EDITOR, SEPTEMBER 23, 2007

CARLSBAD, Calif., Sep 21, 2007 -- Alphatec Holdings, Inc. (Nasdaq:ATEC), a medical technology company focused on the design, development, manufacturing and marketing of products for the surgical treatment of spine disorders, announced the pricing of its public offering of 8,800,000... more

Musculoskeletal News Roundup 20-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2007

Earnings AOI Medical reported a 1H:07 loss of $1.8 million, increasing from a loss of $0.97 million in the comparable half. The company attributed the loss to increased expenses. They expect their product, the Balloon Assisted Management of Spine Fractures,... more

An Interview with Dr. Kazumasa Ueyama BY EDITOR, AUGUST 28, 2007

The interview below was first published in ArgoSpine News in December 2006. As part of our sponsorship of ArgoSpine, we're republishing select ArgoSpine News content for our audience. In this entry, Dr. Ueyama discusses spinal stenosis, his practice in Japan... more

Musculoskeletal News Roundup 23-Aug-07 BY LAUREN UZDIENSKI, AUGUST 23, 2007

Earnings aap Implantate announced 38% growth in revenues following its consolidation with Fame Medical Group. Revenues in 1H:07 totaled EUR 12.7 million. Highlights from 2Q:07 include a reported double-digit increase in international sales in the Trauma & Joint Reconstruction segment... more

Synthes and Globus to Settle BY JOHN MCCORMICK, AUGUST 21, 2007

Yesterday, the Philadelphia Inquirer (article here) reported that Synthes and Globus have settled their long running legal dispute for an undisclosed amount. The agreement stipulates that Globus that it will not solicit or hire Synthes employees for one year. This... more

Musculoskeletal News Roundup 16-Aug-07 BY LAUREN UZDIENSKI, AUGUST 16, 2007

Earnings BioMimetic Therapeutics reported a 2Q:07 net loss of $6.4 million, or $(0.35) per share, beating estimates of $(0.39) per share and improving from a net loss of $3.9 million, or $(0.42) per share, in 2Q:06. 2Q:07 Revenues were $0.5... more

Musculoskeletal News Roundup 9-Aug-07 BY LAUREN UZDIENSKI, AUGUST 9, 2007

Earnings Biologics: Orthovita reported 2Q:07 revenues of $14.85 million, beating estimates of $14.13 million and reflecting a 33% increase over 2Q:06. Sales growth was attributed to increased U.S. sales of VITOSS® FOAM and VITAGEL® products. Net loss decreased to $3.17... more

Musculoskeletal News Roundup 2-August-07 BY LAUREN UZDIENSKI, AUGUST 2, 2007

Earnings Large Joint: Exactech announced 2Q:07 revenue of $31.6 million, beating estimates of $29.9 million and up 19% from the comparable quarter. CEO Bill Petty attributed the growth to "acceptance of our new products and continuing success of our products... more

CMS Finalizes 2008 Reimbursement Increases BY LAUREN UZDIENSKI, AUGUST 2, 2007

CMS released its final rule for the FY2008 Inpatient Prospective Payment System (IPPS). As we noted when the draft rule was announced in April, ortho payments will mostly increase next year. The rule also confirms that CMS will implement new... more

Musculoskeletal News Roundup 26-July-07 BY LAUREN UZDIENSKI, JULY 26, 2007

Earnings Stryker reported revenues of $1.46 billion, beating estimates of $1.44 billion and increasing 16% from $1.26 billion in 2Q:06. 2Q:07 earnings were $269.1 million, or $0.65 per share, beating estimates of $0.61 and up from $0.52 in the comparable... more

TranS1 Files for $80 Million IPO BY JOHN MCCORMICK, JULY 25, 2007

Spine company TranS1 registered for an initial public offering of common stock yestderday. Like all IPOs, TranS1 has a few hurdles to pass through before actually going public, but the company has taken the first important step which is to... more

Musculoskeletal News Roundup 19-July-07 BY LAUREN UZDIENSKI, JULY 19, 2007

M&A DJO announced on Monday plans for merger with ReAble (formerly Encore Medical). ReAble will acquire all outstanding shares of DJO stock, a transaction valued at approximately $1.6 billion and including the assumption of debt. The transaction will be funded... more

FDA Panel Supports BRYAN Cervical Disc, but not Superiority Claim BY JOHN MCCORMICK, JULY 17, 2007

Today was a long day in Gaithersburg, Maryland exploring the ins and outs of wear debris and Bayesian statistics. Luckily the dirty work was left to an 11-member panel of sober experts appointed by the FDA to make recommendations on... more

Musculoskeletal News Roundup 12-July-07 BY LAUREN UZDIENSKI, JULY 12, 2007

M&A Biomet Inc. shareholders accepted an $11.4 billion buyout offer from a private equity consortium attempting to acquire the medical device maker. The consortium, LVB Acquisition LLC, announced Thursday that nearly 83 percent of Biomet's shares were tendered. The company... more

Los Cabos: An Expansive Spine Meeting BY JOHN MCCORMICK, JULY 9, 2007

The week prior to the 4th, we attended the Spine Technology Education Group meeting in Los Cabos, Mexico, which addressed numerous topics on innovative techniques in spine surgery. Kudos to Drs. Phillips, Albert and Vaccaro for organizing a meeting that... more

Orthopedic News Roundup 28-June-07 BY LAUREN UZDIENSKI, JUNE 28, 2007

Regulatory Life Spine announced 510(k) clearance for its static anterior cervical plating system Neo®-SL. The system features an integrated lock that allows bone screws to be securely fixated without any additional locking components. The FDA approved new labeling for Genzyme's... more

Scient'x USA Announces Appointment of Federico P. Girardi, M.D. to Scientific Advisory Board BY EDITOR, JUNE 25, 2007

MAITLAND, Fla., June 25 /PRNewswire/ -- Scient'x USA, manufacturer of innovative spinal implant technologies, today announced that Federico P. Girardi, M.D. will be joining their Scientific Advisory Board. Dr. Federico Girardi is an Assistant Attending Orthopaedic Spine Surgeon at the... more

Orthopedic News Roundup 21-June-07 BY LAUREN UZDIENSKI, JUNE 21, 2007

Regulatory TiGenix submitted an application to market ChondroCelect to European regulatory authority the European Medicines Agency for the Evaluation of Medicinal Products. The application is supported by clinical data comparing ChondroCelect to microfracture, where, according to the company, ChondroCelect was... more

An Interview with Jean-Pierre Elsig, M.D., President of the 11th Argos Symposium BY ANDREW BENKARD, JUNE 15, 2007

The interview below was first published in Argos Spine News in December 2006. As part of our sponsorship of Argos, we'll be bringing a series of Argos content to our audience throughout the year. In this entry, Dr. Jean-Pierre Elsig... more

FDA: Interbody Fusion Devices Now Class II BY LAUREN UZDIENSKI, JUNE 13, 2007

Effective July 12, intervertebral body fusion devices that contain bone grafting material will be reclassified from class III into class II. Interbody devices that contain a therapeutic biologic (e.g., bone morphogenic protein) will remain in class III. A guidance document... more

Orthopedic News Roundup 7-June-07 BY LAUREN UZDIENSKI, JUNE 7, 2007

M&A The private equity consortium set to acquire Biomet increased its buyout offer to $46.00 per share in cash, or an equity value of $11.4 billion. The new offer represents a 32.3% premium over the April 2006 common stock closing... more

Orthopedic News Roundup 31-May-07 BY LAUREN UZDIENSKI, MAY 31, 2007

Regulatory CMS released a proposed non-coverage decision for lumbar artificial disc replacements following a review of Synthes' Pro-Disc-L. The agency found that LADR is not reasonable and necessary for Medicare recipients over 60 based on lack of relevant data and... more

Surgery Favored in Latest SPORT Data BY LAUREN UZDIENSKI, MAY 30, 2007

Spinal fusion is evaluated in the second of three SPORT studies, and patients who selected the surgery to treat degenerative spondylolisthesis had better outcomes when compared with nonsurgical treatment. However, when the results were analyzed on an intention-to-treat basis, there... more

On the CMS Lumbar Disc Non Coverage Proposal BY JOHN MCCORMICK, MAY 29, 2007

At the end of Friday, CMS published a sweeping proposal that denies coverage for all lumbar artificial discs in the age 60-and-over Medicare population. The proposal can be found here on the CMS website. Falling into line with its previous... more

Biomet Receives New Round of Federal Subpoenas BY ARIELLA P. GOLOMB, MD, MAY 29, 2007

Just as one DOJ investigation seemed to be coming to a close, Biomet reported late last week that the company is facing new subpoenas from federal prosecutors. The government is requesting documents from as far back as 1999 relating to... more

Orthopedics News Roundup 24-May-07 BY LAUREN UZDIENSKI, MAY 24, 2007

Earnings Medtronic reported FY2007 earnings of $12.3 billion, an increase of 9% over FY2006. Adjusted income was up 10% to $2.8 billion, or $2.41 per share, an increase of 15% over the previous year. For the fourth quarter, revenue was... more

Amedica Files for $75 Million IPO BY JOHN MCCORMICK, MAY 23, 2007

Yestderday, Utah-based Amedica Corp. filed an initial public offering Securities and Exchange Commission to sell up to $74.75 million in common stock. The company's technology platform is in silicon nitride ceramics as applied to various types of orthopedic implants including... more

Orthopedic News Roundup 15-May-07 BY LAUREN UZDIENSKI, MAY 16, 2007

Earnings BioMimetic Therapeutics reported a 1Q:07 net loss of $5.7 million or $(0.34) per share, beating estimates of $(0.37) and comparing to a net loss of $3.8 million, or $(2.22) per share, in 1Q:06. The company reported revenues of $0.25... more

Orthopedic News Roundup 10-May-07 BY LAUREN UZDIENSKI, MAY 10, 2007

Earnings Biologics Integra LifeSciences announced 1Q:07 revenues of $123.0 million, beating estimates of $119.25 million and reflecting a 60% increase over 1Q:06. Net income for the quarter was $9.07 million, or $0.33 per share, meeting analysts' estimates. President and CEO... more

Greetings from Berlin: Notes from Spine Arthroplasty 7 BY JOHN MCCORMICK, MAY 4, 2007

In the past, the Spine Arthroplasty Society (SAS) conference was about spinal disc replacement and had a decidedly commercial tone. Disc replacement was the promised land and market forecasts predicting billions and billions proliferated. The future is now and the... more

Orthopedic News Roundup 3-May-07 BY LAUREN UZDIENSKI, MAY 3, 2007

Earnings Spine Kyphon reported that worldwide revenues in 1Q:07 increased 40% to $128.1 million, which includes $18.1 million in X-STOP® Interspinous Process Decompression (IPD®) sales from the St. Francis acquisition. In the U.S., revenues increased 34% to $101.1 million, while... more

Orthopedic News Roundup 26-Apr-07 BY LAUREN UZDIENSKI, APRIL 26, 2007

Earnings Large Joints Zimmer reported income of $233.4 million, or $0.98 per share, beating estimates of $0.93. The quarter compares to a profit of $205.6 million, or $0.82 per share in 1Q:06. Revenue rose 10% to $950.2 million from $860.4... more

"Significant" Delay for Stryker's OP-1 Putty BY LAUREN UZDIENSKI, APRIL 25, 2007

Stryker's 1Q:07 earnings call last week highlighted strong profits, but Chief Executive Stephen MacMillan noted a potential snag in its pipeline - OP-1 putty, the company's bone morphogenic protein for spinal fusion indications, may not reach the market until late... more

Orthopedic News Roundup 19-Apr-07 BY LAUREN UZDIENSKI, APRIL 19, 2007

Earnings Stryker announced 1Q:07 earnings on Wednesday. Net income increased to $243.5 million, or $0.59 per share, beating analysts' estimates of $0.58 per share. In the comparable quarter, net income was $147.5 million, or $0.36 per share. Revenues increased 13%... more

Orthopedic News Roundup 5-Apr-07 BY LAUREN UZDIENSKI, APRIL 4, 2007

Earnings aap Implantate AG announced 2006 revenues of EUR 18.5 million, up 38% from the previous year. The aap Group attributed the growth to the Biomaterials segment, where sales increased by 64% to EUR 12.2 million. Biomaterials now generates two... more

Congress, Industry Aim to Broaden Pediatric Device Research BY LAUREN UZDIENSKI, APRIL 4, 2007

With a small market and conditions that are relatively rare, pediatrics hasn't drawn a lot of product development in the device space. As a result, children may receive devices that aren't appropriately sized for them or are lacking in data... more

Spine Reimbursement: Lehman Brothers visits with CMS BY JOHN MCCORMICK, APRIL 2, 2007

The Lehman Brothers medical device research team had a fruitful visit to the beltway last week notably with Steve Phurrough, Director of the Coverage and Analysis Group at CMS and Herb Khun, CMS's Deputy Administrator. One of Lehman's findings related... more

Orthopedic News Roundup 29-Mar-07 BY LAUREN UZDIENSKI, MARCH 29, 2007

Earnings BioMimetic Therapeutics announced 4Q:06 financial results, reporting a net loss of $5.3 million or $0.34 per share and beating analysts' estimates of a loss of $0.37 per share. This compares to a net loss of $9.2 million, or $5.82... more

J&J Bets on Prognostic Tests in Ortho BY ARIELLA P. GOLOMB, MD, MARCH 28, 2007

There is much developmental focus in the orthopedic industry on creating products that treat patients earlier in the continuum of care with the goal of slowing irreversible disease progression. When earlier intervention is dramatic, it is necessary to have a... more

Orthopedic News Roundup 22-Mar-07 BY LAUREN UZDIENSKI, MARCH 22, 2007

Earnings Inion announced year-end results for 2006 on Wednesday, reporting a 25% decline in revenues. 2006 sales totaled EUR 5.7 million, compared with EUR 7.6 million in 2005. R&D spending increased 17% to EUR 5.6 million from EUR 4.8 million... more

Orthopedic News Roundup 8-Mar-07 BY LAUREN UZDIENSKI, MARCH 8, 2007

Earnings Orthofix International N.V. announced 4Q:06 revenue of $116.1 million, an increase of 45% over 4Q:05 and just missing estimates of $116.6 million. $28.1 million of 4Q:06's revenue can be attributed to the September 2006 acquisition of Blackstone Medical, Inc.... more

Orthopedic News Roundup 1-Mar-07 BY LAUREN UZDIENSKI, MARCH 1, 2007

Earnings Biologics LifeCell reported 4Q:06 product revenues of $39.3 million, an increase of 45% over $27.0 million in 4Q:05, but missed analysts' estimates of $39.5 million. The growth was attributed to increased demand for the Company's AlloDerm® Regenerative Tissue Matrix.... more

Orthopedics News Roundup 15-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 15, 2007

Earnings Tutogen announced results for first fiscal quarter ending December 31, 2006. Total revenues increased 43% to $11.5 million, compared to $8.0 million in the comparable quarter of fiscal year 2006. U.S. revenues increased 50%, and international revenues increased 27%... more

Zimmer Acquiring MIS Spinal Implant Company Endius BY DAVID KRESSEL, FEBRUARY 12, 2007

After the markets closed on Friday, Zimmer announced an agreement to acquire Endius, Inc., a Massachusetts-based spine company. Endius has developed a minimally invasive instrument kit, Atavi, and associated implants for spinal fusion. The Atavi comes as a cartridge the... more

Orthopedics News Roundup 1-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 1, 2007

Earnings Kyphon Inc. announced 4Q:06 sales totaling $112.6 million, an increase of 31% over the $85.8 million in net sales reported for the 4Q:05. Net income for 4Q:06 increased 228% to $12.2 million, or $0.26 per diluted share, compared to... more

Orthopedics News Roundup 18-Jan-07 BY LAUREN UZDIENSKI, JANUARY 18, 2007

Earnings Lifecore Biomedical reported earnings for the second quarter ending December 31, 2006. Net income fell to $1.37 million, or $.10 per diluted share during the quarter from $1.39 or $.10 per diluted share, in the quarter ending December 31,... more

Orthopedic News Roundup 11-Jan-07 BY LAUREN UZDIENSKI, JANUARY 11, 2007

M&A Paragon Medical has entered into an agreement to acquire OMC Precision Products and Tutela Medicus. OMC provides machining, finishing and assembly of implants, primarily for the spinal and neurological markets, and Tutela offers product development services to device manufacturers... more

Orthopedic News Roundup 28-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 28, 2006

M&A Kyphon has signed definitive agreements to acquire all spine-related assets of Israeli company Disc-O-Tech Medical Technologies, Ltd. in a multi-stage transaction. Terms are summarized as follows: Kyphon will pay Disc-O-Tech $60 million upon execution of the definitive agreements; Kyphon... more

Kyphon to Acquire Disc-O-Tech Assets for $240 Million BY JOHN MCCORMICK, DECEMBER 21, 2006

With a one-two punch, Kyphon is snapping up niche assets in the spine industry to expand its franchise as a leading provider of unique minimally invasive devices to spine surgeons. It's been only two weeks since Kyphon announced it's blockbuster... more

Orthopedic News Roundup 14-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 14, 2006

Regulatory CryoLife received FDA 510(k) clearance for its ProPatch™ Soft Tissue Repair Matrix, an announcement that drove its stock up 9%. Among other applications, ProPatch can be used to reinforce tissues repaired by sutures or by suture anchors during tendon... more

Orthopedic News Roundup 7-Dec-06 BY LAUREN UZDIENSKI, DECEMBER 7, 2006

Earnings Stryker announced this week that the Board of Directors has declared a year-end cash dividend of $0.22 per share, an increase of 100% over the $0.11 dividend declared in December 2005. The dividend is payable January 31, 2007 to... more

Q&A with Christine Horton, Co-Founder of CoreSpine Technologies BY ARIELLA P. GOLOMB, MD, DECEMBER 4, 2006

CoreSpine Technologies is an early stage spinal device company. We talked with one of its founders about the company, its products and market potential.

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Medicare Panel Debates Spinal Fusion Study Design BY JOHN MCCORMICK, DECEMBER 1, 2006

Yesterday we attended the the Medicare Coverage Advisory Committee (MCAC) meeting on spinal fusion at the Centers for Medicare and Medicaid Services (CMS) in Baltimore, MD. The purpose of the meeting was to determine the type of data needed to... more

Orthopedic News Roundup 30-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 30, 2006

Earnings ORTHOsoft reported 3Q:06 revenues of CAN $3.8 million (US $3.3 million), up 59% from CAN $2.4 million (US $2.1 million) in 3Q:05. ORTHOsoft manufactures computer aided orthopedic surgery devices, and they attribute the 3Q:06 growth to increased navigation systems... more

Intial SPORT Trial Outcomes Subject to Interpretation, but Tend to Favor Surgery BY JOHN MCCORMICK, NOVEMBER 22, 2006

The first arm of the Spine Patients Outcome Research Trial ("SPORT") study was released by the Journal of the American Medical Association yesterday. The $13.5 million NIH funded SPORT study has been designed to determine the efficacy of spine surgery... more

Medtronic Sofamor Danek's Spinal Business Continues To Grow BY ARIELLA P. GOLOMB, MD, NOVEMBER 21, 2006

For 2Q:07, Medtronic reported overall revenue of $3.08 billion, which represented year over year growth of 11% (10% on a constant currency basis), beating analyst estimates of $2.97 billion. During the quarter spinal instrumentation generated revenues of $421 million, an... more

Orthovita to Raise $23 Million BY JOHN MCCORMICK, NOVEMBER 17, 2006

This morning Orthovita announced that it hopes to do a 7.7 million share offering at $3.25 a share in order to raise approximately $23 million net of fees. At least $9 million of the proceeds is expected to be used... more

Orthopedic News Roundup 16-Nov-2006 BY LAUREN UZDIENSKI, NOVEMBER 16, 2006

Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more

MDMA Conference Provides Reimbursement Advice BY ARIELLA P. GOLOMB, MD, NOVEMBER 13, 2006

Last week we attended the 9th Annual MDMA Coverage Reimbursement and Health Policy Conference in Washington D.C. As we've previously discussed, the MDMA events are a terrific opportunity for small- to medium-sized device companies to network, provide insight on topical... more

Orthopedics News Roundup 9-Nov-06 BY LAUREN UZDIENSKI, NOVEMBER 10, 2006

Earnings: Tissue Grafting: Regeneration Technologies, Inc. announced revenues of $18.1 million for 3Q:06, compared to $22.5 million for 3Q:05. RTI said the decrease in revenues was due to fewer tissues available for processing demand and reduced orders from primary distributors.... more

Orthopedic News Roundup 19-Oct-06 BY HUYEN NGUYEN, OCTOBER 19, 2006

Earnings Dental: Lifecore Biomedical announced that 1Q:07 net sales increased 12% to $15 million. Net income for the quarter was $1.1 million, representing a year-over-year increase of 9%. The Company was in-line with analysts' estimates and reported earnings of $0.08... more

Orthopedic News Roundup 12-Oct-06 BY HUYEN NGUYEN, OCTOBER 12, 2006

Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more

Orthopedic News Roundup 5-Oct-06 BY HUYEN NGUYEN, OCTOBER 5, 2006

Earnings Update: Tutogen Medical, Inc. provided an update on its 4Q:06 projected revenues which are estimated at ~$10.8 million, representing a 36% increase over the comparable quarter of 2005. Revenues for the fiscal year will be ~$38 million, an increase... more

NASS Notes BY ARIELLA P. GOLOMB, MD, SEPTEMBER 29, 2006

With the 2006 NASS meeting winding down, we thought we'd share some highlights from Seattle. SPORT Clinical Trial Session a Tease On Wednesday, the two-hour, much-anticipated session on SPORT results focused on SPORT background information - but not the data... more

MDT Spinal & Navigation Business Update at NASS BY HUYEN NGUYEN, SEPTEMBER 29, 2006

Yesterday, Medtronic Spinal and Navigation business division hosted an analyst meeting during the North American Spine Society (NASS) meeting in Seattle to provide an update on its current operations. Given the recent FDA panel recommendation for approval of their cervical... more

Invibio Provides Our Readers Information On Their New Composite Material ENDOLIGN BY ARIELLA P. GOLOMB, MD, SEPTEMBER 25, 2006

Invibio, principal supplier of PEEK polymer, an increasingly important material used in orthopedic applications, announced earlier this month the launch of a new device material, ENDOLIG(TM) composite, a biocompatible carbon fiber reinforced thermoplastic material. On their website, the company highlights... more

Orthopedic News Roundup 21-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 21, 2006

Earnings: Biomet reported its 1Q:07 earnings totaled $0.44 per share (excluding the adoption of the share-based payment) which was $0.01 more than what analysts were expecting. Revenues increased by 5% to $508 million (foreign currency had a $3 million favorable... more

Medtronic's Disc Recommended for FDA Approval BY ARIELLA P. GOLOMB, MD, SEPTEMBER 20, 2006

Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System. After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded... more

Regeneration Technologies Continues To Break Its Chains BY HUYEN NGUYEN, SEPTEMBER 12, 2006

After the market closed yesterday, Regeneration Technologies (RTI) announced it amended a prior distribution agreement with its largest distributor, Medtronic Sofamor Danek USA, Inc. (MSD) regarding domestic spinal allograft distribution. Currently, RTI derives 60% of its annual revenues (~$45 million)... more

Orthopedic News Roundup 7-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 7, 2006

Appointment: Ranier Technology Limited has appointed John C. Moran to its Board of Directors. Previously, Mr. Moran was a President of Synthes Spine and a Director of Spine Solutions, Inc. Active Implants Corporation (AIC) has hired Richard Treharne, PhD. as... more

Orthopedic News Roundup 31-Aug-06 BY HUYEN NGUYEN, AUGUST 31, 2006

Appointment: SpineVision® SA has hired Julian Mackenzie as its new Chairman and CEO. Previously, Mr. Mackenzie was with Wright Medical serving as Director General and CFO. Business Update: Donor Referral Services of North Carolina is at the center of a... more

Orthopedic News Roundup 24-Aug-06 BY HUYEN NGUYEN, AUGUST 24, 2006

Appointment: IsoTis OrthoBiologics has hired Gene B. Reu as Vice President of Operations. Prior to joining IsoTis, Mr. Reu served as Vice President & General Manager of Coblation Technologies with Arthrocare, Inc. Business Update: ArthroCare Corp. announced it has received... more

FDA Panel to Vote On Medtronic's Cervical Disc BY ARIELLA P. GOLOMB, MD, AUGUST 23, 2006

The FDA's Orthopaedic and Rehabilitation Devices Panel will be meeting on September 19, 2006. The committee will discuss, make recommendations and vote on a premarket approval application for Medtronic's Prestige ST artificial cervical disc. This metal on metal, ball and... more

Orthopedic News Roundup 17-Aug-06 BY HUYEN NGUYEN, AUGUST 17, 2006

Earnings: Biologics: Tutogen reported 3Q:06 sales of $10 million and a net loss of $1.1 million, or $0.07 per fully diluted share compared to the same quarter last year. The Company would have experienced breakeven results without ~$1.1 million in... more

Synthes 1H:06 Results, Sales Up 15% BY HUYEN NGUYEN, AUGUST 16, 2006

Yesterday Synthes reported consolidated 1H:06 financials with sales of $1.2 billion, representing an increase of 14% (15% constant currency). Consolidated sales for 1H:06 in Europe, Asia Pacific, North America and elsewhere increased by 16.8%, 16.6%, 14.7% and 10.5%, respectively. For... more

Synthes PRODISC Receives FDA Approval BY JOHN MCCORMICK, AUGUST 15, 2006

Yesterday Synthes Spine received a letter from the FDA indicating that its PRODISC lumbar total disc replacement device PMA has been approved. Typically when a PMA is approved, the FDA attaches conditions and restrictions to use of the device and... more

Orthopedic News Roundup 10-Aug-06 BY HUYEN NGUYEN, AUGUST 10, 2006

Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more

US Spine Enters Into GPO Agreement BY ARIELLA P. GOLOMB, MD, AUGUST 9, 2006

Group Purchasing Organizations have historically been responsible for purchases surrounding low preference commodity products such as bed linens and gloves. Over time GPOs have been migrating to higher physician preference items. Today's announcement by US Spine that they have entered... more

Orthofix to Buy Blackstone Medical for $333 Million BY JOHN MCCORMICK, AUGUST 7, 2006

This morning Orthofix International, NV (NasdaqGS: OFIX) announced that it has signed an agreement to acquire independent spinal implant developer Blackstone Medical, Inc. for $333 million in cash. Blackstone revenues were $22mm in 2Q:06 and EBIT was approximately $2mm. Trailing... more

Orthopedic News Roundup 3-Aug-06 BY HUYEN NGUYEN, AUGUST 3, 2006

Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... more

Disc Dynamics Receives FDA Go Ahead for Nucleus Study BY JOHN MCCORMICK, AUGUST 1, 2006

Disc Dynamics, a Minnesota-based spine start-up, has just received an IDE from the FDA to commence a study on its DASCOR minimally invasive nucleus replacement technology. The DASCOR is a polyurethane device which has a modulus of elasticity similar to... more

Kyphon's Growth Continues BY DAVID KRESSEL, JULY 28, 2006

Kyphon (KYPH) reported a strong 2nd Quarter this week. Quarterly revenue broke the $100m mark, and at $101m, handily beat analysts' estimates of $98.6m. Overall, revenue was up 35% compared to the year ago period, with domestic revenue up 28%... more

Orthopedic News Roundup 27-Jul-06 BY HUYEN NGUYEN, JULY 27, 2006

Earnings Results: Biologics: Anika Therapeutics announced 2Q:06 net sales increased 11% to $7.1 million. Product revenues grew 74% while licensing, milestone and contract revenue was down 77%. The large product sales growth was partially driven by higher demand for OrthoVisc®;... more

Medtronic Settles with DOJ on Kickbacks for $40 Million BY DAVID KRESSEL, JULY 18, 2006

Medtronic announced yesterday that it has settled with the Department of Justice regarding a qui tam lawsuit related to sales and marketing practices in its Spine group, particularly kickbacks to surgeons. Qui tam lawsuits are better known as whistleblower suits.... more

Orthopedic News Roundup 12-Jul-06 BY HUYEN NGUYEN, JULY 12, 2006

Appointment: Biomet, Inc. appointed Charles E. Niemier as President of EBI's operations following the resignation of its former president, Bart J. Doedens, M.D. Mr. Niemier has been a member of the senior management team and Board of Directors for more... more

FDA Grants IDE For Medtronic's DIAM(TM) Spinal Stabilization System BY ARIELLA P. GOLOMB, MD, JULY 10, 2006

Medtronic, Inc. announced today that the FDA granted an investigational device exemption (IDE) to the DIAM(TM) Spinal Stabilization System for use in a clinical safety and effectiveness study. The DIAM System will be measured against posterior lumbar interbody fusion, the... more

Tutogen Reports 2Q:06 Financials BY HUYEN NGUYEN, JULY 7, 2006

Tutogen Medical ("TTG") reported 2Q:06 (ending March 31, 2006) revenue increased 21% during the 2Q:06 to $9.1 million and net income for the quarter totaled $22,000 compared to a net loss of $1.1 million last year. During the quarter, TTG's... more

Orthopedic News Roundup 6-Jul-06 BY HUYEN NGUYEN, JULY 6, 2006

Appointments: Tutogen Medical appointed Dr. Karl Koschatzky to the position of Managing Director. Dr. Koschatzky will replace Manfred Kruger, who was Tutogen's President of International operations and Managing Director of the German subsidiary. IsoTis OrthoBiologics appointed James William (Jim) Poser,... more

Medicrea Completes Public Offering BY HUYEN NGUYEN, JUNE 30, 2006

This week, Medicrea announced it had completed its public offering by listing its shares on the Euronext Exchange. The Company issued 1,459,396 new shares at €7.94 per share or a total of €11.58 million. Proceeds from the offering will help... more

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN, JUNE 29, 2006

Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's... more

NuVasive Gets IDE Approval for NeoDisc BY JOHN MCCORMICK, JUNE 28, 2006

This morning NuVasive announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the FDA to begin clinical trial enrollment of its NeoDisc cervical disc replacement device. The NeoDisc outcomes will be compared to the traditional... more

Orthofix Appoints New Head of Corporate Development BY JOHN MCCORMICK, JUNE 13, 2006

This morning Orthofix announced the appointment of Michael M. Finegan as Vice President of Corporate Development and head of the Company's new Corporate Development Group. His duties will include identifying external opportunities for the company to increase its revenues and... more

Breakthrough For Rare Orthopedic Genetic Disorder; Broad Implications For Orthopedics BY ARIELLA P. GOLOMB, MD, JUNE 9, 2006

A Single Codon Mutation Causes A Debilitating Disease Fibrodysplasia Ossificans Progressiva (FOP) is a rare autosomal dominant genetic disorder that causes muscles and other connective tissue to turn into bone and is estimated to affect one in two million patients... more

A Preliminary Abstract from SPORT Published BY DAVID KRESSEL, JUNE 7, 2006

Among the many interesting talks and posters at the International Society for the Study of the Lumbar Spine annual meeting, data from the Spine Patient Outcomes Research Trial (SPORT) will be presented. The overall study compares non-operative treatment to surgical... more

Orthopedic News Roundup 1-Jun-06 BY HUYEN NGUYEN, JUNE 1, 2006

Appointment: A medical imaging company ONI Medical appointed Victor Ruiz to Vice President, of the Corporate Strategy and Marketing division. Mr. Ruiz's past experience include world-famous imaging companies: GE Medical Systems and Cardinal Health Inc. Clinical Update: LDR Spine announced... more

Orthopedic News Roundup 25-May-06 BY HUYEN NGUYEN, MAY 25, 2006

Appointment: IsoTis OrthoBiologics appointed Barbara Boyan to its Board of Directors. Ms. Boyan is a co-founder of OsteoBiologics, Inc. (OBI) and a professor in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and at... more

New Findings on X STOP Published BY DAVID KRESSEL, MAY 25, 2006

In this month's issue of the Journal of Neurosurgery: Spine, there is a paper discussing findings related to the use of St. Francis' X STOP to treat degenerative lumbar spinal stenosis with low grade degenerative spondylolisthesis. The data was from... more

Medtronic Spine Grows 17% BY JOHN MCCORMICK, MAY 24, 2006

Medtronic is trading up this morning after yesterday afternoon's announcement of double digit across the board revenue and earnings growth. Spine revenues notably grew at 17%. With fiscal 2006 ending on April 28, 2006, companywide revenue for the 2006 fiscal... more

Orthopedic News Roundup 18-May-06 BY HUYEN NGUYEN, MAY 18, 2006

This week, DePuy Spine and many patients were excited to hear that the Centers for Medicare and Medicaid Services (CMS) has agreed to local coverage of DePuy's Charite artificial disc for patients under 60 years of age. According to CMS,... more

CMS Changes its Charite Decision BY DAVID KRESSEL, MAY 17, 2006

In a surprising but welcome change of heart, the Centers for Medicare and Medicaid Services revised its proposed National Noncoverage Decision and will reimburse the Charite in specific circumstances. In the February draft of the NCD, CMS proposed national noncoverage... more

FDA Gives Facet Solutions Go Ahead for IDE BY JOHN MCCORMICK, MAY 9, 2006

Yesterday, Facet Solutions, Inc. announced that the FDA granted the Company an IDE approval for its Anatomic Facet Replacement System (AFRS). The device has been developed to provide lumbar spinal stenosis and facet degeneration patients with a motion preserving alternative... more

New Data on Raymedica's Motion Preservation Device BY DAVID KRESSEL, MAY 8, 2006

In advance of the 6th Annual Spine Arthroplasty Society Meeting, Raymedica has announced interim results on its PDN-SOLO clinical trial. The trial is called "An International Multi-Center Clinical Evaluation of the PDN-SOLO(R) Device" and will be presented on the morning... more

1Q:06 Earnings Summary BY HUYEN NGUYEN, MAY 4, 2006

To update from previous blog, twenty of twenty-four orthopedic companies reported revenues and earnings for the period of January 1, 2006 to April 1, 2006. Excluding Inion, Osteotech, RTI (Regeneration Technologies) and Tutogen, which have not reported yet, total orthopedic... more

1Q:06 Preliminary Earnings Summary BY HUYEN NGUYEN, APRIL 27, 2006

The first group of orthopedic companies reported their 1Q:06 this week and took in $5.3 billion so far. The total aggregated revenues for the quarter were up by 7% from $4.9 billion in 1Q:05. The industry netted $637.8 million, a... more

Medtronic Countersues Kyphon BY DAVID KRESSEL, APRIL 19, 2006

As we reported in March, Kyphon and Dr. Harvinder Sandhu filed an IP suit against Medtronic, and now Medtronic has parried with its own lawsuit. Medtronic has countersued Kyphon, claiming Kyphoplasty infringes on 3 patents relating to balloons for use... more

FDA Approves CORTOSS Study Modifications BY JOHN MCCORMICK, APRIL 17, 2006

This morning Orthovita announced that the FDA has approved its request to modify it's CORTOSS study design. The prospective randomized controlled multi-center IDE study is underway in the U.S. and is designed to demonstrate that CORTOSS is safe and effective... more

Orthopedic News Roundup 6-Apr-06 BY HUYEN NGUYEN, APRIL 6, 2006

The announcement of Biomet hiring investment bank Morgan Stanley, sent its stock price up 11% in one day. With news of Dane Miller resigning and the Company hiring a banker, there were many speculations suggesting Biomet is for sale. However,... more

Orthopedic News Roundup 30-Mar-06 BY HUYEN NGUYEN, MARCH 30, 2006

Dane Miller of Biomet called it quits a week after releasing its 3Q:06 earnings report. Last week, the Company reported earnings per share (EPS) of $0.43 which was in line with Street's estimate but did not meet analysts' expectation for... more

Orthopedic News Roundup 23-Mar-06 BY HUYEN NGUYEN, MARCH 23, 2006

This week at HealthpointCapital, we compiled a brief synopsis of the 2006 Orthopedic Industry, projecting that total revenue in 2006 will grow by 12% for the year. Appointment: Two notable extremities companies named their new CEOs this week: Wright Medical... more

2006 Orthopedic Industry Forecast - Strong Growth to Continue BY EDITOR, MARCH 21, 2006

Our current forecast for the orthopedic industry projects continued long term growth of 15%. For 2006, we expect growth to be slightly below this trend, at 12%. Despite continued strength in other segments of the industry, hip and knee reconstruction... more

Scientific Advisory Board AAOS Sessions BY JOHN CHOPACK, MARCH 16, 2006

In addition to the Top Sessions we chose, we have added AAOS presentations by our Scientific Advisory Board members. Please click on the link at the bottom to view the entire list. Wednesday, March 22 10:30 AM - 12:30 PM127Changing... more

Our Top Picks -- AAOS 2006 Educational Sessions BY JOHN CHOPACK, MARCH 14, 2006

With the AAOS in Chicago fast approaching, we have put together a list of "Hot Sessions" to check out. Please click on the link at the bottom to view the entire list. Adult Reconstruction, Hip and KneeSunday, March 26, 2006... more

Analyst Meetings during AAOS BY KAREN FEDER, FEBRUARY 23, 2006

Looking ahead to the AAOS 73rd Annual Meeting on March 22-26, 2006 taking place at the McCormick Place Convention Center in Chicago, we wanted to post the latest information on Company Analyst meetings that will be held in Chicago: -... more

Orthopedic News Roundup 23-Feb-06 BY LAING RIKKERS, FEBRUARY 23, 2006

Financing: BioMimetic Therapeutics, Inc. filed a registration statement for an Initial Public Offering. Earnings: Medtronic 3Q Earnings climb 23 percent. CryoLife fourth quarter 2005 revenues increased 13% over fourth quarter 2004 Gross margins for full year 2005 increased to 53%... more

NuVasive Prices Public Offering BY JOHN CHOPACK, FEBRUARY 2, 2006

NuVasive announced today that its public offering of 6.7 million new shares and 796,000 secondary shares priced today at $19.25. The gross amount of the offering totaled $144 million with $129 million net proceeds going to the Company. NuVasive's initial... more

Archus Orthopedics Raises $35m BY DAVID KRESSEL, JANUARY 18, 2006

Archus Orthopedics announced today that they have closed a Series C financing, raising $35m from institutional and strategic investors. J&J's corporate VC arm, J&J Development Corp., led the round. Archus' current investors, including MPM Capital, InterWest Partners and Polaris Venture... more

Kyphon/Sandhu Lawsuit against Medtronic Announced BY JOHN MCCORMICK, JANUARY 17, 2006

The spine patent dispute du jour isn't about "555" these days: it's about "665". Today, an intellectual property lawsuit between Kyphon and Sofamor Danek filed in November of last year was unsealed (at Kyphon's request) after the two parties were... more

New Medical Device Treats Osteoporosis BY DAVID KRESSEL, JANUARY 12, 2006

A New Jersey company, Juvent, is introducing a new way to treat osteoporosis. The product was initially developed at the State University of NY at Stony Brook, with funding from the US Army and NASA. The Juvent 1000 Dynamic Motion... more

ProDisc Moves One Step Closer to US Launch BY DAVID KRESSEL, JANUARY 9, 2006

Synthes announced that the FDA sent it an "approvable letter" for the ProDisc-L. The device was deemed safe and effective for treating degenerative disc disease (DDD) at a single level in the lumbar spine, from L3-S1. The FDA expects to... more

Another New Year Acquisition: Kyphon Announces Acquisition of InnoSpine, Inc. BY JOHN CHOPACK, JANUARY 4, 2006

Kyphon announced that it had signed a definitive agreement to acquire InnoSpine, Inc., a privately held company focused on developing and marketing its proprietary technology for the treatment of low back pain as a consequence of disc degeneration. Kyphon will... more

SpineMark Closes $10m BY HUYEN NGUYEN, DECEMBER 14, 2005

SpineMark is an operator of clinical and research-oriented spine centers, founded in 2004 as a joint venture between TBI Holdings (the management company of Texas Back Institute) and Management Technology Resources. The Company announced a closing of the first $10... more

St. Francis Gets FDA Approval BY JOHN MCCORMICK, NOVEMBER 22, 2005

After and long and contentious approval process with the FDA, St. Francis Medical Technologies, Inc. announced this morning that it has received FDA approval to market its X STOP Interspinous Process Decompression System. X STOP (and the interpinous processes paradigm... more

CMS Publishes Reimbursement Codes for Kyphoplasty BY JOHN MCCORMICK, NOVEMBER 3, 2005

Earlier this morning Kyphon (Nasdaq: KYPH) shouted from the mountaintop: CMS has posted new CPT codes for Kyphoplasty which effectively brings reimbursement to a national level. The codes include percutaneous vertebral augmentation, RVUs for additional thoracic of lumbar vertebral bodies,... more

SpineMedica Gets $10.6 million in VC Funding BY JOHN MCCORMICK, NOVEMBER 1, 2005

SpineMedica Corp., a Florida-based artificial spinal disc developer, has raised $10.6 million in Series A funding. SpineMedica's artificial disc, called SaluDisc, is designed to mimic the mechanical and physical properties of the native disc. In late August, SpineMedica announced that... more

HealthpointCapital Attends the 5th Annual Inspiration Meeting in France BY TIM BERKOWITZ, NOVEMBER 1, 2005

Posted by Tim Berkowitz and Anne Villeneuve. We attended late last week the Inspiration (International Spine Research and Innovation) meeting in Cannes. More than 70 spine surgeons from twenty-three countries discussed: cervical spinal tumors canalar stenosis with degenerative scoliosis in... more

Blue Shield of California Denies Lumbar Artificial Disc Coverage BY JOHN MCCORMICK, OCTOBER 31, 2005

Ten days ago California's Blue Cross and Blue Shield met and, based on the available evidence, decided they would not cover artificial disc replacements at this time. Some interesting technical discussions are posted here: Blue Cross Blue Shield April 2005... more

Orthopedic News Roundup 27-Oct-05 BY HUYEN NGUYEN, OCTOBER 27, 2005

It has been a busy week for many CEOs and CFOs in the orthopedic device sector. In the past two weeks orthopedic companies reported 3Q:05 sales of $4.7 billion which was a 12% increase over the 3Q:04. Net earnings for... more

NuVasive Files IDE for Cervical Nucleus BY JOHN MCCORMICK, OCTOBER 24, 2005

Only two months ago NuVasive, Inc. acquired the NeoDisc cervical disc nucleus technology from Pearsalls and just this morning NuVasive announced that it has filed an IDE for the device. Back when they bought the NeoDisc, they said this was... more

Lumbar Artificial Discs: A Class Action Lawsuit? BY JOHN MCCORMICK, OCTOBER 20, 2005

Another cloud is on the horizon for lumbar artificial discs. This time, injury lawyers Bagolie Friedman announced in the wee hours of this morning that it has formed the International Charite Artificial Disc Practice Group based on their belief there... more

Orthopedic News Roundup 20-Oct-05 BY HUYEN NGUYEN, OCTOBER 20, 2005

Some orthopedic stocks declined as two of the big five ortho-companies reported their 3Q:05 earnings this week. Stryker Corp. and DePuy (division of JNJ) both reported top line sales growing at 14%. On Tuesday, Stryker reported below street's estimates by... more

An Interview with Dr. Edward Benzel BY JOHN MCCORMICK, OCTOBER 19, 2005

Last week, we had the good fortune of catching up with Dr. Edward Benzel, Chairman of the Cleveland Clinic Spine Institute. We spent a few minutes with him at this year's Congress of Neurological Surgeons in Boston. At The Cleveland... more

Orthopedic News Roundup 13-Oct-05 BY HUYEN NGUYEN, OCTOBER 13, 2005

The allograft industry was scrutinized recently due to the highly publicized case of Biomedical Tissue Services (BTS). The company is being investigated by the Brooklyn district attorney's office for operating a scam to profit from body parts. The first company... more

Congress of Neurological Surgeons Clinical Papers Summary -- Free Download BY JOHN MCCORMICK, OCTOBER 13, 2005

We attended the Congress of Neurological Surgeons' 55th Annual Meeting in Boston this year. The meeting was refreshingly scientific and the theme was education. In concert with our learning experience at the conference, we have summarized 21 selected clinical papers... more

NASS Notes BY JOHN MCCORMICK, OCTOBER 6, 2005

NASS Notes The North American Spine Society's 20th Annual Meeting in Philadelphia had a mature and thoughtful character this year compared to the fever pitch of prior meetings. The theme of this year's meeting was physician responsibility with major speeches... more

Call to Action: Local Non-Coverage Draft Policy for Artificial Discs BY KELLI HALLAS, OCTOBER 3, 2005

By Kelli Hallas Vice President of Field Reimbursement Services Emerson Consultants, Inc. [Editor's note: We welcome consultant Kelli Hallas as a guest blogger. See a profile of Emerson Consultants, Inc. here.] Last month CMS issued a National draft non-coverage decision... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

Hot NASS Sessions BY JOHN MCCORMICK, SEPTEMBER 16, 2005

The North American Spine Society ("NASS") meeting this year is overwhelming us all with clinical and technology learning opportunities at the various sessions and meetings this year. We have taken the liberty of narrowing down the hundreds of sessions... more

Invibio Expands Further into Asia-Pacific Market BY JOHN MCCORMICK, SEPTEMBER 15, 2005

Invibio scored a coup in Japan recently. Today the Company announced that the Japanese Ministry of Health has approved for use the first implantable medical device using the Company's PEEK-OPTIMA polymer. The device is an arthroscopic tissue repair system used... more

CMS (Medicare) opens a National Coverage Determination (NCD) request to review coverage of the lumbar artificial disc BY BARB PETERSON, SEPTEMBER 14, 2005

[Update: We're moving this entry to the top of the blog since it is sparking a lot of interest from our readers.] more

Abbott Invests $15 million in Replication Medical BY JOHN MCCORMICK, SEPTEMBER 14, 2005

Yesterday Abbott Spine announced that it invested $15 million in Replication Medical, Inc., a developer of implantable hydrogel devices intended for the treatment of degenerative spinal disc disease. Valuation data was not available even from the best of our sources,... more

NuVasive Adds Hansen Yuan to Board of Directors BY JOHN MCCORMICK, SEPTEMBER 14, 2005

This morning, NuVasive, Inc. announced that it has added Hansen A. Yuan, M.D. to the Company's Board of Directors. Dr. Yuan will serve on the Compensation Committee and the Nominating and Corporate Governance Committee. He replaces Arda M. Minocherhomjee, PhD,... more

Alphatec Spine Announces Acquisition of Cortek BY EDITOR, SEPTEMBER 13, 2005

Allograft business gives independent spinal implant company a complete product line. CARLSBAD, California, September 13, 2005 /PRNewswire/ -- Alphatec Spine, Inc., ("Alphatec") one of the largest independent spinal implant companies, announced today the purchase of all assets of Cortek, Inc.,... more

FDA: Trial Design for Spinal Devices BY LAING RIKKERS, SEPTEMBER 9, 2005

Today, the FDA hosted approximately 200 people at an Advisory Committee meeting to look at the "Design of Clinical Studies for Spinal Devices to Treat Mild to Moderate Low Back Pain". FDA has been struggling over the past year with... more

Orthopedic News Roundup 9-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 9, 2005

The FDA Orthopedic and Rehabilitation Devices Panel held a meeting September 8th and 9th to rule on two important issues: Smith & Nephew's hip resurfacing device and the design of clinical studies for spinal devices. You can find background information... more

Orthofix Hires Chief Operating Officer BY JOHN MCCORMICK, SEPTEMBER 6, 2005

This morning, Orthofix International N.V. (NASDAQ: OFIX) announced that Alan W. Milinazzo, 45, has joined the Company as its Chief Operating Officer (COO). Milinazzo joins Orthofix as an experienced hand in the medical device field with decades of experience, most... more

Orthopedic News Roundup 01-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 1, 2005

This week, we decided to post the Orthopedic News Roundup for Thursday, instead of Friday due to the upcoming holiday. Clearly the biggest headline this week is the announcement of a take-over bid by Musculoskeletal Transplant Foundation ("MTF") for Osteotech... more

Osteotech: Hostile to Shareholders? BY JOHN MCCORMICK, AUGUST 30, 2005

As many of you now know, the venerable (and world's largest) non-profit tissue bank Musculoskeletal Transplant Foundation (MTF) announced on Monday that is had proposed to acquire all of the outstanding common stock of Osteotech, Inc. (Nasdaq: OSTE) for $6.25... more

Facet Joint Arthroplasty Milestone: Archus Initiates U.S. Clinical Trial BY JOHN MCCORMICK, AUGUST 30, 2005

Archus Orthopedics, Inc. announced this morning that it has formally initiated enrollment in the U.S. clinical trial of its Total Facet Arthroplasty System or TFAS(TM). The TFAS(TM) is patented spinal implant designed to treat spinal stenosis. The device replaces degenerative... more

Anulex Receives FDA Clearance for Annular Repair Technology BY JOHN MCCORMICK, AUGUST 23, 2005

Anulex Technologies, Inc., a company focused on soft tissue repair of the spine, announced yesterday that it received a 510(k) clearance from the FDA recently. Inclose is a simple umbrella shaped polymer implant that seals the opening in the annular... more

More NuVasive Acquisition Activity BY JOHN MCCORMICK, AUGUST 19, 2005

NuVasive has been acquiring non-fusion technologies faster than we can write about them. The most recent announcement this week was the acquisition of dynamic stabilization technology from River Bend, LLC for 51,308 shares of NuVasive common stock or about $1... more

HealthpointCapital attends Inaugural Meeting of the Sisyphean Spinal Society BY TIM BERKOWITZ, AUGUST 11, 2005

Reflections on the Inaugural Meeting of the Sisyphean Spinal Society We were honored to attend the inaugural meeting of the Sisyphean Spinal Society ("SSS") which was held on July 14th-17th in Bermuda. SSS is a non-profit organization dedicated to research,... more

Notes on NuVasive's Acquisition of NeoDisc™ BY JOHN MCCORMICK, AUGUST 11, 2005

Late last week, NuVasive, Inc. announced the acquisition of the NeoDisc™ (download product brochure) technology and assets from Pearsalls Limited, a UK medical product developer that has a core competence in surgical suture material. The transaction requires a closing payment... more

Innovative Spinal Technologies Raises $39 Million BY JOHN MCCORMICK, AUGUST 3, 2005

Innovative Spinal Technologies, Inc. (IST), the Texas Back Institute affiliate that develops of spine products, intellectual property and services, announced yesterday that it has closed a $39 million Series B financing. IST is is clearly making the leap from incubator... more

CMS Denies Add-On Payments for Charite BY JOHN MCCORMICK, AUGUST 2, 2005

In an unambiguous statement yesterday, CMS took a hard line and denied add-on payments for J&J's Charite artificial lumbar disc. In this document on pages 309 - 322, CMS balanced numerous comments, studies and outcomes against each other and came... more

Orthopedic News Roundup 29-Jul-05 BY HUYEN NGUYEN, JULY 29, 2005

Earnings: Please refer to the table (below) for individual company sales and earnings. It's all about earnings this week... Biologics: Clearly, the big winner this week is LifeCell Corp. who reported strong earnings on Monday stock was up 24% at... more

Orthopedic News Roundup 22-Jul-05 BY HUYEN NGUYEN, JULY 22, 2005

Appointment: Tutogen Medical appointed Terry Hill, MD to Director of Quality Assurance and Quality Control. He has worked with various tissue banks prior to joining Tutogen. Clinical Update: At the 12th International Meeting on Advanced Spine Techniques (IMAST) Conference, Dr.... more

Disc Dynamics Receives CE Mark Approval for the DASCOR™ Disc Nucleus Replacement BY JOHN CHOPACK, JULY 20, 2005

Disc Dynamics announced that it has just recently received approval of its DASCOR™ Disc Arthroplasty System. The DASCOR™ is a patented spinal disc nucleus implant designed to treat back pain associated with degenerative disc disease. Until recently, degenerative disc disease... more

Kyphon Soars BY JOHN MCCORMICK, JULY 8, 2005

Today (Friday) Kyphon, Inc. stock rose 12% after it raised its financial outlook for the second quarter of this year thanks to: - Better than expected sales in both its U.S. and international operations. - Better selling and marketing efficiencies.... more

NuVasive Files IDE for Cervical Disc BY JOHN MCCORMICK, JULY 6, 2005

This morning NuVasive announced that that it filed for an IDE from the FDA to investigate the safety and efficacy of its Cerpass(TM) ceramic-on-ceramic cervical disc. The filing was completed at the end of June. Approval of the IDE from... more

U.S. Spinal Technologies raises $4 Million BY JOHN MCCORMICK, JUNE 29, 2005

U.S. Spinal Technologies, LLC (commonly known as U.S. Spine) announced yesterday that they have successfully raised a cumulative $4.1 million from private investors and one major financial institution. This Florida based spine start-up was founded by Doris Blake in 2003.... more

Ranier Technology Secures $7.3m Funding BY JOHN MCCORMICK, JUNE 14, 2005

Today Ranier Technology Limited, a UK based artificial disc manufacturer announced that it received £4 million ($7.3 million) in an institutional venture capital round. The funding was provided by FNI Venture Capital, which was a previous investor in Ranier's first... more

Interview with Mike Callahan of Invibio BY JOHN MCCORMICK, JUNE 14, 2005

Today we are publishing our recent interview with Mike Callahan Managing Director of Invibio, ltd. Many of you know Invibio as a principal supplier of PEEK polymer to the industry an increasingly important material used in orthopedic applications. Q: How... more

Wall Street Journal Profiles J&J Charite BY JOHN MCCORMICK, JUNE 7, 2005

Today the Wall Street Journal profiled J&J's Charite artificial disc. The overall tone of the article was "this may be a good thing, but...", ergo the press is raising questions once again. The familiar benefits of the disc were noted... more

NuVasive Acquires Cervical Plate BY JOHN MCCORMICK, JUNE 6, 2005

NuVasive (nasdaqNM: NUVA) announced on Monday that they are acquiring RSB Spine's dynamic cervical plate technology and a right of first refusal for additional products developed by RSB for about $14.5 million in cash and stock. In addition, RSB will... more

An Interview with Dr. Charles Rosen on Artificial Disc Clinical Trials BY JOHN MCCORMICK, MAY 23, 2005

In our efforts to poll surgeons on the subject of artificial lumbar discs, we have been tracking down advocates as well as dissenters in order to get a balanced view. Last month at AANS we interviewed Dr. Fred Geisler who... more

Non-Fusion and the City: Last Week's Spine Conferences BY JOHN MCCORMICK, MAY 9, 2005

Last week orthopods and neurosurgeons converged on the Big Apple for two major conferences dedicated to spinal non-fusion technologies: the Swiss Spine Institute's Non-Fusion Course and the Spine Arthroplasty Society's Fifth Annual Meeting.   Swiss Spine Institute Non-Fusion Course The... more

Zimmer (ZMH:NYSE) Crushes the Street - Again. BY JOHN CHOPACK, MAY 2, 2005

During the 4Q:04 Zimmer beat analyst expectations by $0.07 in earnings-per-share and $18 million in revenues. For their encore, Zimmer reported 1Q:05 adjusted earnings-per-share (diluted) of $0.75 and revenues of $829 million which was exceeded analysts' forecasts by $0.08 and... more

CMS Holding Pattern a Blow to J&J BY JOHN MCCORMICK, MAY 2, 2005

Last week, the United States Centers for Medicare & Medicaid Services (CMS) issued a "hold" decision on whether or not to issue 2006 add-on payments for procedures using J&J's Charité artificial lumbar disc.' This flies in the face of apparently... more

Wright Medical (WMGI:NASDAQ) Reports 1Q:05 BY JOHN CHOPACK, MAY 2, 2005

Wright reported 1Q:05 revenues of $82.6 million which was a 10% increase over the 1Q:04. Excluding the effect of currency, WMGI revenues increased 9%. The 10% growth in revenues was almost 3% slower than the revenue growth reported during the... more

SpinalMotion Receives $20 million in Funding BY HUYEN NGUYEN, MAY 2, 2005

In the past few years, we have seen many new spine companies emerge with innovative technologies in the disc arthroplasty market. We did a quick search in our own HealthpointCapital proprietary orthopedic database and found that there are approximately 35... more

Artificial Discs: A Discussion with Dr. Fred H. Geisler BY JOHN MCCORMICK, APRIL 25, 2005

Last week I caught up with Dr. Fred Geisler at AANS in New Orleans to discuss artificial disc clinical trials and surgeon adoption of artificial discs. Throughout the week, Dr. Geisler led the Academy as the principal thought leader on... more

Stryker Corp. (SYK:NYSE) Reports 1Q:05 Financials; Beats the Street by $0.02 BY JOHN CHOPACK, APRIL 25, 2005

SYK reported 1Q:05 revenues of $1.2 billion which was a 16% increase over the 1Q:04 and beat analyst expectations by $2 million. The Company reported earnings of $0.42 per diluted share which was $0.02 better than analyst were forecasting. The... more

Elderly Population: New Census Bureau Forecast BY JOHN MCCORMICK, APRIL 25, 2005

Last Thursday the US Census Bureau released new state-by-state projections on the aging of the U.S. population which showed not only how it expects the nation to age, but how the population is expected to shift geographically over the next... more

AANS 2005: A Trip Report BY JOHN MCCORMICK, APRIL 25, 2005

Last week we joined the droves of neurosurgeons at AANS in New Orleans to check out papers, presentations, posters and product. Always a quiet and less populated conference compared to the annual NASS spine meeting, AANS offers a hard science... more

Medtronic and Michelson Finally Settle for $1.35 billion BY JOHN MCCORMICK, APRIL 25, 2005

The four year spine patent dispute between Dr. Gary Michelson and Medtronic, Inc. came to a mind-boggling conclusion on Friday when Medtronic announced that it would settle for a cool $1.35 billion - the largest one-time intellectual property award in... more

Gain-Sharing: The Lawyers View BY JOHN CHOPACK, APRIL 18, 2005

Background on Gain Sharing. The Hospital Corporation of America ("HCA") has recently asked the Office of Inspector General ("OIG") of the Department of Health & Human Services ("HHS") to allow for "gain-sharing" arrangements. These gain-sharing arrangements would allow hospitals to... more

The Industry Subpoenaed: Our Perspective BY JOHN MCCORMICK, APRIL 4, 2005

The healthcare industry has long been the subject of regulation by complex laws that do not exist in other industries and which, under certain circumstances, may seem almost excessive and counter-intuitive. The enforcement of these laws has been significant and... more

Biomet (BMET:NASDAQ) Reports 3Q:05 Results; Knee Revenues Increase 31% BY JOHN CHOPACK, MARCH 28, 2005

Biomet reported an 18% increase in net sales which totaled $482 million during the 3Q:05. The company also reported earnings, excluding any one-time costs associated with its recent Interpore Cross or Biomet Merck acquisitions, totaled $0.40 per diluted share which... more

Synthes, Inc. (SYST:VX) Reported Sales and Net Earnings for FY2004 BY HUYEN NGUYEN, MARCH 28, 2005

As an addendum to the January 2005 financial sales release, on March 16/2005, Synthes provided the investment community with the group's sales and earnings financial reports for fiscal year 2004. Synthes reported on both a consolidated and pro forma basis.... more

Preservation of Motion in the Lumbar Spine: A Trip Report BY JOHN MCCORMICK, MARCH 21, 2005

At the end of last week, we attended the University of South Florida's "Preservation of Motion in the Lumbar Spine" course to check in on how leading surgeons are coming along with motion preserving spinal procedures and related surgical implant... more

What Price Innovation? | EDITORIAL | BY JOHN MCCORMICK, MARCH 21, 2005

I was struck by economist Paul Krugman's article "America's Senior Moment" in the most recent New York Review of Books. In the article Krugman assails the Bush Administration's push for social security "privatization" with the fervor of a campus radical,... more

ArthroCare (ARTC:NASDAQ) Beats Analyst Expectations in the 4Q:04 BY JOHN CHOPACK, MARCH 21, 2005

ARTC reported $42.7 million in net revenues during the 4Q:04 which was a 31% increase over the 4Q:03 and $600 thousand higher than analyst expectations. For 2004, revenues totaled $154.1 million compared to $118.9 million during 2003 which represents a... more

4Q:04 Orthopedic Wrap-up BY JOHN CHOPACK, MARCH 14, 2005

We have aggregated the 4Q:04 and 3Q:04 reported revenues (includes the effects of foreign currency) for 16 public orthopedic companies. Although we would have liked to use revenue growth rates which excluded foreign currency, a majority of the companies report... more

2005 AAOS: Louder, Yet Quieter than Ever Before BY JOHN CHOPACK, MARCH 1, 2005

The 2005 American Academy of Orthopaedic Surgeon Annual Conference was unique to recent meetings. It was louder in terms of the amount of marketing, size of exhibits and mass advertising, yet it was quieter in terms of business development and,... more

2005 AAOS Analyst Meeting Reviews BY JOHN CHOPACK, MARCH 1, 2005

This year we attended Smith & Nephew's, Biomet's, Stryker's, and Encore Medical's analyst meetings. All were very professional and well attended. Here are our notes from each: Smith & Nephew Overview: Although Smith & Nephew posted the best large joint... more

FIVE HOT AAOS Sessions Plus 20 others worth a close look BY EDITOR, FEBRUARY 22, 2005

Overwhelmed with all the education opportunities? Join the club. Good news for you, though - the HealthpointCapital research team has whittled down the program to 26 of the most controversial and best-hosted side sessions. Minimally Invasive Breaks Out Every year... more

Spine Segment Outlook BY JOHN MCCORMICK, FEBRUARY 22, 2005

HealthpointCapital, LLC research has initiated a new program of making our market forecasts of the several orthopedic medical device segments available to our subscribers. This article, the first of a series, summarizes our spine market forecast which comes from our... more

2005 American Academy of Orthopaedic Surgeons (AAOS) Preview BY JOHN CHOPACK, FEBRUARY 14, 2005

It's here again, the annual AAOS conference. Thousands are ready to descend on Washington, D.C. the week of February 21st to learn of new surgical techniques, new products and to develop business and relationships. While it is hard to predict... more

Kyphon Reports 2004 Results: Brief Thoughts on the Size of the VCF Market BY JOHN MCCORMICK, FEBRUARY 14, 2005

Last week, Kyphon Inc. (Nasdaq: KYPH) met or exceeded analysts' expectations and announced net sales of $62.4 million for 4Q:04, an increase of 57% over the $39.7 million in net sales reported in 4Q:03 Earnings per fully-diluted share for 4Q:04... more

Synthes Reported Fourth-Quarter and Fiscal Year 2004 Earnings Results BY HUYEN NGUYEN, FEBRUARY 7, 2005

Synthes, Inc. (SYST.VX), a worldwide maker, developer and distributor of orthopedic trauma implants, biological devices and spinal hardware, reported financial results for fourth-quarter and fiscal year 2004 on January 20/2005. SYST reported sales for 4Q:04 at $469.4 million, an increase... more

Johnson & Johnson (NYSE:JNJ) Reports 4Q:04 Results: We Examine DePuy's Charite BY JOHN CHOPACK, JANUARY 31, 2005

JNJ reported revenues of $12.8 billion for the 4Q:04 which was a 13% increase over the 4Q:03. DePuy, JNJ's orthopedic division, reported revenues of $952 million for the 4Q:04. This was a 19% increase as reported and a 15% increase... more

Direct-to-Consumer Advertising Takes Hold in Orthopedics | EDITORIAL | BY JOHN CHOPACK, JANUARY 24, 2005

Direct-to-consumer advertising has become the most powerful means of marketing pharmaceuticals over the last decade. For years we have seen these strange advertisements which typically only mention the name of a drug and the manufacturer, but withhold any information regarding... more

Orthofix gets Long-Awaited PMA BY JOHN MCCORMICK, JANUARY 10, 2005

In late December, Orthofix (Nasdaq: OFIX) announced a significant milestone: it received an FDA approval to market its Cervical-Stim' bone growth stimulator as an FDA Class III device. That makes Orthofix the first and only company to provide an FDA-approved... more

The Night Before an Orthopedic Christmas BY ROBIN R. YOUNG CFA, DECEMBER 20, 2004

'Twas the night before Christmas, when all through the industry Not a creature was stirring, not even Zielinski; The lights were hung round Warsaw, Memphis and Kalamazoo with care, In hopes that St. Nicholas soon would be there; The CFOs... more

The John Brown Era Comes to an End at Stryker BY ROBIN R. YOUNG CFA, DECEMBER 13, 2004

He doesn't look old enough to retire. And when he started, he didn't look old enough to be CEO. Yet 27 years after becoming Stryker's CEO, John Brown is letting go and stepping down. The man walking in the door... more

Falling Dollar's Impact on Q4 Sales Greater Than Originally Forecast BY ROBIN R. YOUNG CFA, DECEMBER 6, 2004

Seventy percent of the sales days in this quarter are now history. Wall Street's analysts are forecasting that sales for four of the largest orthopedic companies will come in at $2.478 billion, combined, in this final quarter. They will almost... more

FDA Issues Final Good Tissue Practices Rule BY ROBIN R. YOUNG CFA, NOVEMBER 29, 2004

Literally millions of patients have benefited from receiving tissues donated by their fellow humans. Formerly wheelchair bound patients now walk. Formerly sightless patients now see. Patients with debilitating back pain now enjoy active lives. Cancer patients, auto accident victims. The... more

VIOXX Wars Good News for Large Joint Reconstruction Market BY ROBIN R. YOUNG CFA, NOVEMBER 29, 2004

The lawyer's ads are all over the country and all over the two broadest media outlets we know - television and the internet. "Learn about Vioxx, the Vioxx recall and potential health risks!" "Are you a Vioxx Patient? Find out... more

When is the Spine Bubble Going to Burst? BY ROBIN R. YOUNG CFA, NOVEMBER 22, 2004

This is a copy of the key note address I presented at last week's InSpine conference in Dallas. That conference, which was organized by Sharon O'Reilly's excellent MedTech Insights group and co-sponsored by Dr. Stephen Hochschuler's Texas Back Institute and... more

MTF Extends its Dominance of Allograft Industry BY ROBIN R. YOUNG CFA, NOVEMBER 22, 2004

For an undisclosed amount, MTF Foundation (a non-profit 501(c) 3 corporation) has agreed to purchase the $40 million (annual revenue) allograft business of the American Red Cross. With this purchase, MTF will account for, we estimate, approximately 45% of the... more

Are Metal Implants Days Numbered? BY ROBIN R. YOUNG CFA, NOVEMBER 22, 2004

In this past edition of the Device and Diagnostics letter was a short item from the Hospital for Special Surgeries recent alumni association meeting. Dr. Rocky Tuan, chief of the Cartilage Biology and Orthopedics Branch of the National Institute of... more

Let us now sing praises of Blackstone Medical BY ROBIN R. YOUNG CFA, NOVEMBER 8, 2004

The word in the aisles at NASS was that two private companies were "hot": Globus Medical and K2. But one company was "lava hot". Blackstone Medical. Now the largest private spinal implant company in the industry at $50 million in... more

Are Allograft Implant Revenues Stabilizing? BY ROBIN R. YOUNG CFA, NOVEMBER 8, 2004

For the five public allograft companies, sales for the first nine months of 2004 are running at around $234 million ($323 million annualized). Sales growth is slightly up - about 6%. Which is good news. Last year, public company allograft... more

For Spine Patients, It's a Wild, Wild Web BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

Google the word "spine" and patients are directed to web sites for mattress suppliers, artificial disc specialists in the Netherlands and personal injury lawyers. We know, we tried. But that doesn't stop patients suffering from back pain from cruising the... more

Kyphon Reports Both Rising Sales and Rising Legal Activity BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

You can always tell what managers are really thinking by the order of their comments on conference calls. For the quarter just ended (September 30/2004) Kyphon reported a 59% jump in net sales $55.8 million. Earnings soared to $6.1 million,... more

Seventy one percent Alloderm jump fuels LifeCell's Third Quarter BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

Alloderm, LifeCell's donated decellularized human dermal tissue, just continues to gain surgeon champions at what appears to be accelerating rates. Alloderm sales reached $11 in the September quarter, up 71% from the prior year's $6.4 million in sales for the... more

The FDA Approves Charite Disc Arthoplasty BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

Hats off to DePuy Spine for winding this approval through the FDA so masterfully. The timing (to coincide with NASS) was exactly right. The website is excellent and we repeat some key points from it later in this commentary. Future... more

Troubling Consistency at Sofamor Danek BY ROBIN R. YOUNG CFA, OCTOBER 25, 2004

Two whistle blower lawsuits in the last 13 months. Two court rulings in favor of Dr. Gary Michelson's claim that Sofamor Danek infringed his property rights. A court ordered permanent injunction against Sofamor Danek last month in a patent case.... more

Medicare (CMS) Adds Express Lane for New Orthopedic Technology BY ROBIN R. YOUNG CFA, OCTOBER 11, 2004

The Center for Medicare and Medicaid Services announced on October 6 that it is going to implement seven new and specific improvements which, in the aggregate, should speed up development of new technology codes as well as simplify coverage and... more

Spine Wars: Michelson vs. the Industry? BY ROBIN R. YOUNG CFA, OCTOBER 4, 2004

If we've heard it once, we've heard it a dozen times. Gary Michelson, with attorneys in tow, haunts spine company booths at conferences like the upcoming NASS or CNS informing them of patent violations on the fly. Yikes! And last... more

ERRATA BY ROBIN R. YOUNG CFA, OCTOBER 4, 2004

In our article last week summarizing the excellent State and Future of the Orthopaedic Industry conference in Chicago last week, we made the following errors: We stated in our table that Recon sales rose 38% to $7.5 billion. We were... more

The View From 50,000 Feet BY ROBIN R. YOUNG CFA, SEPTEMBER 27, 2004

'One person turns 50 years old every 7 seconds. Someone fractures a bone every 14 seconds. There is one vertebral fracture every minute. There are 700,000 sports injuries annually in the United States.' With these statements, John Engelhardt opened the... more

The Top Conferences This Season BY ROBIN R. YOUNG CFA, SEPTEMBER 27, 2004

It's conference season. Between now and the end of the year there is essentially one conference per week featuring orthopedic companies. One can only wonder who is managing the store while these CEOs and CFOs are out slinging PowerPoint Presentations.... more

Now, Here's an Issue: Payments by medical device manufacturers to surgeons BY ROBIN R. YOUNG CFA, SEPTEMBER 13, 2004

Last week, Sofamor Danek disclosed in an SEC filing that a second "whistle-blower" lawsuit had been filed against it regarding payments to physicians. The case is under seal in Federal Court in Minneapolis. The first lawsuit against Sofamor Danek on... more

Management Change at Raymedica BY ROBIN R. YOUNG CFA, AUGUST 23, 2004

Tony Phillips, the long time CEO of Raymedica has left the firm to pursue other interests. Members of Raymedica's board, specifically Kent Archibald, are now running the company. John Viscogliosi, another board member and member of the Viscogliosi Brothers investment... more

Public Company Orthopedic Revenues Rise 17% First Half 2004 BY ROBIN R. YOUNG CFA, AUGUST 23, 2004

As reported by public orthopedic companies, sales for the first half were $8.7 billion, up 17% from the prior year's $7.4 billion. This compares to sales growth in the first half of 2003 of 18%. One year earlier, in the... more

The Struggle to Reimburse Disc Arthroplasty BY ROBIN R. YOUNG CFA, AUGUST 23, 2004

Two weeks ago, the Centers for Medicare and Medicaid Services (CMS) published its most recent ruling concerning reimbursement for the $10,600 disc replacement implant (versus, by the way, $4,800 for a BAK cage). CMS ruled that disc arthroplasty products like... more

Mapping the Future of Spine BY ROBIN R. YOUNG CFA, AUGUST 16, 2004

A small but select group of leading spine surgeons, entrepreneurs, venture capitalists and leading strategic spine companies met for three days last month at a remote, cell phone challenged location to debate, dissect and discuss the future of the spine... more

Is Kyphon #2 Behind Sofamor Danek in terms of Spine Industry Market Power? BY ROBIN R. YOUNG CFA, AUGUST 16, 2004

On the heels of its first $50 million quarter, Rich Mott, Kyphon's CEO, predicted that his firm would post revenues between $210 and $212 million for the year ending this December. Three years ago, in 2001, Kyphon booked sales of... more

Wall Street Disconnects Performance from Valuation in Orthopedics BY ROBIN R. YOUNG CFA, AUGUST 2, 2004

What if Ray Elliott could take a dollar and grow it to $1.30 over the course of a single year - and do it year in and year out for a decade? What if the number of customers asking for... more

Sales Are Flat but Working Capital is Building at Regeneration Technologies BY ROBIN R. YOUNG CFA, JULY 26, 2004

For the June quarter, RTI reported sales hit $23.1 million. Last year RTI's sales for the same period were $23.1 million. That is not much progress. Working capital, on the other hand, rose 55% to $49 million (due to declining... more

What is the Second Generation Disc Arthroplasty Implant? BY ROBIN R. YOUNG CFA, JULY 26, 2004

Last week Stryker announced it was offering $120 million in cash, plus as much as double that amount in future royalties to buy a 'second generation' disc arthroplasty implant. The implant, developed by SpineCore, is a single piece (three components... more

First Resorbable (Non-Allograft) Interbody Implant Introduced in Europe BY ROBIN R. YOUNG CFA, JULY 12, 2004

Macropore Biosurgery, Inc. (Frankfurt: XMP) announced last week that the European regulatory agency had approved it s HYDROSORB' Boomerang' spine fusion implants. (By the way, who names these products? Boomerang?) Made from Polylactic Acid, the material resorbs in the body... more

Disc Arthroplasty's Steep Learning Curve BY ROBIN R. YOUNG CFA, JULY 12, 2004

We now have data from the early disc arthroplasty patients. The good news is that a 17 year follow-up study of 51 disc arthroplasty (non-fusion) patients was presented at the recent EuroSpine conference in Porto, Spain. The bad news is... more

Here Comes Dynamic Stabilization for Spine BY ROBIN R. YOUNG CFA, JULY 12, 2004

Can Dynamic Stabilization implants address the problem of adjacent level disease? From initial clinical trial data, the answer appears to be yes. Considering that these devices are FDA approved and, in fact, have been available in one form or another... more

HealthpointCapital Announces Purchase of 33% share in Scient'X S.A., Developer of Innovative Spinal Implant Technologies BY EDITOR, JUNE 28, 2004

Scient'X is leader in the developing fieldof motion preservation and dynamic stabilization for spine surgeries New York, NY., USA and Paris, France, June 29 -- HealthpointCapital Partners L.P., the private equity affiliate of HealthpointCapital, and Scient'x S.A., the spinal implant... more

Errata: OP-1. HDE not PMA BY ROBIN R. YOUNG CFA, JUNE 28, 2004

Small errors are one thing, but confusing a Human Device Exemption (HDE) for PMA was a noticeable slip-up. I wish I could say that it was a test to see if you were paying attention; it wasn't. Actually, it was... more

NuVasive's Honeymoon Continues BY ROBIN R. YOUNG CFA, JUNE 21, 2004

The IPO was oversubscribed. Demand for the Company's 6.5 million share offering was so strong at $11 per share, that the company (at the underwriter's urging) was compelled to issue another 382,991 shares. This brought the total amount of money... more

510(k) Approvals BY EDITOR, JUNE 21, 2004

  Device Applicant 510(k) Decision Date 1 acumed lower extremity congruent plate s acumed llc K033639 1/15/2004 2 titanium cannulated interference screw advanced biomaterial K033749 2/23/2004 3 aesculap absorbable craniofix aesculap, inc. K040080 3/31/2004 4 abc caudal and cranial extension... more

Laurence Fairey Gets Back in the Game. BY ROBIN R. YOUNG CFA, JUNE 21, 2004

Jumping back into the fray after 4 years of semi-retirement, former Sofamor Danek and Richards senior executive, Laurence Fairey has agreed to become President and Chief Operating Officer of Wright Medical today. Laurence Fairey is one of the best regarded... more

Good-Bye Interpore Cross BY ROBIN R. YOUNG CFA, JUNE 21, 2004

20 years ago, Interpore brought to market coral based bone void fill. The coral, which remains in abundant supply, came from some distant south pacific atoll. But what really turned the money key initially, and later the interest of shareholders,... more

75% of Spine Fusion Patients Show Evidence of Adjacent Level Disease BY ROBIN R. YOUNG CFA, JUNE 14, 2004

Spinal fusion creates a new disease? Probably, yes. Increasingly, studies are pointing to recurrent problems in patients who have had fusion, including degeneration of the levels adjacent to the fusion. As Dr. Charles Ray, one of the spine industry's leading... more

Only One Clinical Trial Counts with the Charite BY ROBIN R. YOUNG CFA, JUNE 14, 2004

The FDA panel's recommendation was unanimous. That's the bottom line. Based on a single clinical trial, each member of that panel voted for eventual commercialization of the Charité disc arthroplasty. And what a clinical trial: 304 patients, randomized, prospective, lead... more

FDA Panel Decides Charite Approvable with 5 Conditions BY ROBIN R. YOUNG CFA, JUNE 2, 2004

Despite being implanted in several thousand patients over the course of the past decade, it was a group of 205 Charité patients that the FDA panel scrutinized today before arriving at its recommendation to approve the Charité for commercial sale... more

CMS Sets Disc Arthroplasty Procedure Payments at Discectomy Levels - $4,200-6,300 BY ROBIN R. YOUNG CFA, MAY 24, 2004

Insufficient data from manufacturers forced the Center for Medicare and Medicaid Services (CMS) last week to set payment rates for Disc Arthroplasty at rates far, far below the true cost of a disc arthroplasty procedure. For Spinal repair, CMS has... more

InFuse® Add-On Payment Extended One Year by CMS - Good News for an Estimated 500 Patients (About 2% of the Infuse® Patient Population) BY ROBIN R. YOUNG CFA, MAY 24, 2004

The InFuse® add-on payment of $8,900 was extended for one year by the Centers for Medicare and Medicaid Services last week. Medicare, which provides supplemental healthcare cost reimbursement for American elderly patients, directly affects an estimated 15% of the spine... more

It is Four Yards and a Cloud of Dust, But Still Good Progress for IsoTis at $6.5 Million in Q1:04 Revenues BY ROBIN R. YOUNG CFA, MAY 17, 2004

DBM is a tough market. Gains, when they come, come the way yardage comes in a hard fought football game; up front, with big sweaty linemen pounding the ball four yards at a time. It can be brutal, but it... more

Miniature Spine Surgery Robot Approved by FDA BY ROBIN R. YOUNG CFA, MAY 17, 2004

The FDA last week approved Mazor Technologies innovative miniature spine surgery robot, SpineAssist, for use in all types of spine surgeries. The device is no bigger than a soda pop can. Sitting on top of the spine, it guides spine... more

Medtronic's InFuse® cutting into DePuy Spine's Sales BY ROBIN R. YOUNG CFA, APRIL 19, 2004

For the quarter ended this past March, JNJ's DePuy spine division reported that sales growth rates for that division were slowing. For 2004, we forecast, sales of spinal implants industry-wide will rise 24% from last year's $2.9 billion to $3.6... more

FDA Approves Second Growth Factor for the Spine BY ROBIN R. YOUNG CFA, APRIL 12, 2004

With InFuse® (BMP 2) selling at a rate of $1 million per day for Medtronic's Sofamor Danek subsidiary, the news that Stryker Corporation has received approval to sell OP-1 (BMP 7) for spinal indications is significant news. Three years ago,... more

FDA approves use of polymethylmethacrylate (PMMA) in spine - specifically for Vertebral Compression Fractures BY ROBIN R. YOUNG CFA, APRIL 5, 2004

Kyphon announced this morning that its application to receive FDA approval for its PMMA bone cement product, KyphX® HV-R™ Bone Cement, has been approved. This will be the first approved PMMA bone cement for use in the spine. PMMA has... more

Kyphon Sues Disc-O-Tech alleging Patent Infringement and a NEW vertebral compression fracture balloon patent is issued by U.S. Patent office - but not to Kyphon You'll never guess who's got it BY ROBIN R. YOUNG CFA, APRIL 5, 2004

It was middle of the afternoon at Kyphon's headquarters, but after 6pm Eastern Standard Time when Kyphon issued an announcement that it was suing start-up company Disc-O-Tech in both U.S. District Court and at the International Trade Commission for patent... more

The NuVasive $92 Million S-1 BY EDITOR, MARCH 29, 2004

NuVasive, the San Diego based spinal implant company whose sales and losses for 2003 were $22.7 million and $10.1 million, respectively, has filed its registration statement to sell common stock and, with some luck and a large amount of perseverance,... more

$1 Million per Day in InFuse BY EDITOR, MARCH 29, 2004

We think it's true. Of course, Medtronic isn't saying anything outside of its well crafted public comments, but our informal content analysis of surgeon and sales commentary have us betting that Sofamor Danek has, indeed, crossed the $1 million per... more

Charite Clinical Trial Data Released at AANS 25% Owestry Pain Improvement, Better Motion than a BAK Cage BY EDITOR, MARCH 29, 2004

Phase III clinical trial data for JNJ's Charite artificial lumbar disc was presented last week at the AANS/CNS conference in San Diego. This equivalency study compared patients having the Charite with patients with the BAK Intervertebral body cage (see table... more

A Random Walk Down the Academy's Halls BY JOHN CHOPACK, MARCH 22, 2004

Stryker Corp. (SYK:NYSE), in similar fashion to last year, brought and introduced a majority of its operational leaders of its various operating divisions. However, a significant portion of the analyst meeting, especially Q&A, centered around Stephen MacMillan, President & COO,... more

Bye-Bye Interpore Cross BY ROBIN R. YOUNG CFA, MARCH 8, 2004

The last remaining, full line public spinal implant company is gone. This morning Biomet agreed to pay $280 million or 3.6x 2004 revenues (36x expected 2004 EBITDA) for Interpore Cross. This transaction, assuming it is completed, will vault Biomet into... more

The Machine Keeps Rolling - Zimmer Beats the Street, Again BY JOHN CHOPACK, FEBRUARY 23, 2004

The 4Q:03 conference call offered the first glimpse into how Zimmer's (NYSE:ZMH) integration of Centerpulse was progressing. Ray Elliott, CEO of the “New Zimmer”, offered some insights. Zimmer currently has “100 fulltime employees managing 250 major integration projects and 1,700... more

Interpore's 2003 Spine Sales +21%, but Weak Biologics Undermine Full Year Results BY ROBIN R. YOUNG CFA, FEBRUARY 23, 2004

Interpore Cross sold $44.6 million of spinal implants (not counting bone void fill) in 2003, a 21% increase over its level in 2002. Industry-wide, we estimate spinal implant sales rose 29% to $2.8 billion in 2003. Interpore's market share, we... more

Stryker Corp Reports 21% Sales Rise in 4th quarter BY JOHN CHOPACK, FEBRUARY 2, 2004

Stryker (SYK) reported that revenues totaled $1.1 billion in 4Q:03 and $3.63 billion for the full year 2003. This represented a 21% and a 20% increase over the respective periods last year. The increase in revenues helped drive a 27%... more

ArthroCare Fiscal 2003 Revenues Grow 34 Percent; Reports Strong 4th Quarter BY JOHN MCCORMICK, FEBRUARY 2, 2004

ArthroCare (ARTC) reported strong year-over-year revenue growth where total 2003 revenues reached $118.9 million compared with $88.8 million in 2002. Product sales in 2003 were $114.7 compared to $85.0 million in 2002. In 2003, gross margin on product sales increased... more

Wall Street Journal Features Orthofix's Innovative Ortho-Trac System for Back Pain BY JOHN MCCORMICK, FEBRUARY 2, 2004

It seems that rising orthopedic valuations on Wall Street are not the only voice hailing the "Decade of Orthopedics." The Wall Street Journal got into the act last Tuesday by writing a positive piece on one of the more interesting... more

Kyphon Packs $131 Million of Sales in Just 12 Months: Expects $186-190 million in 2004 BY ROBIN R. YOUNG CFA, FEBRUARY 2, 2004

Two years ago, in the 2001 year, Kyphon reported $36 million in sales. Approximately mid-way through the 2002 year, the company went public, selling 6 million shares at $15 each, netting $82 million. The underwriters tried, but failed to establish... more

Charite Artificial Disc FDA Approval Expected Mid-2005 – according to DePuy Spine BY ROBIN R. YOUNG CFA, JANUARY 26, 2004

In last week's JNJ conference call with analysts, management stated that its DePuy Spine division was expecting FDA approval for the Charité Artificial Disc in the United States by the first half of 2005. The Charité Disc, which was obtained... more

It's Almost Routine – Zimmer Crushes Analysts' Consensus Estimates... Again BY JOHN CHOPACK, JANUARY 26, 2004

Zimmer reported an abridged 4Q:03 financial report last week along with updated guidance for 2004. While many investors have come to expect Zimmer to exceed analyst expectations, we thought the 4Q:03 could represent the most difficult challenge for the Company... more

Osteotech Calls it Quits with SpineVision... Wall Street, for some reason, thinks that's a negative BY ROBIN R. YOUNG CFA, JANUARY 26, 2004

To quote from Dow Jones' press release, "Despite recording a $4.6 million profit in the first nine months of this year, Osteotech's metal spinal implant products have suffered big losses because an insufficient unit volume has failed to cover overhead... more

FDA Orthopedic Panel recommends spine cages be down-classified — 510(k) approvals now possible BY ROBIN R. YOUNG CFA, JANUARY 2, 2004

The FDA's orthopedic panel met this past December 11th and recommended that the FDA reclassify intervertebral body cages from a Class III to a Class II medical device. Class III devices are defined as life sustaining or life supporting devices... more

New York Times Caves In to Market Forces - Attempts Major Surgery on Spine Industry BY ROBIN R. YOUNG CFA, JANUARY 2, 2004

An estimated twenty five million people will have back pain severe enough to seek medical attention in the United States this year. Roughly 1% of them will also have spine fusion surgery. And, according to the New York Times in... more

Spine implant maker Blackstone Medical to post 100% revenue growth for 2003 - landing at $40 million BY EDITOR, DECEMBER 15, 2003

To put Blackstone's accomplishment in perspective, Interpore Cross' spine implant sales are expected to end this year at $45 million, up 20% from last year's $36 million. At their current growth rate, Blackstone could overtake Interpore in 2004. Like Interpore,... more

CMS Staff Recommends ICD-9 Code for Disc Nucleus Replacement (Arthroplasty) implants BY EDITOR, DECEMBER 8, 2003

Last week the staff for the Centers for Medicare and Medicaid Services (CMS) formally recommended an ICD-9-CM code for a total or partial spinal disc replacement prostheses. This is a key step to eventually receiving Medicare reimbursement for these devices.... more

Hard Core MIS BY EDITOR, DECEMBER 8, 2003

I may not be able to define it, but I know it when I see it. Seriously, NO trend in surgical medicine has been stronger than MIS. Twenty years ago balloon angioplasty – despite a nearly 80% failure rate –... more

The Krispy Kanary in the Orthopedic Mine is singing BY EDITOR, NOVEMBER 24, 2003

Like much of orthopedics, Krispy Kreme sells a lifestyle product. And the basic emotion encompassed in that product is comfort. For eighty five cents, Krispy Kreme delivers a nearly perfect, melt in your month donut and, with that, a happy,... more

Orthofix Buys Breg... combined sales rise to nearly $300 million and moves OFIX's estimated 2004 EPS to $2.60 from an estimated $1.70 in 2003. BY EDITOR, NOVEMBER 24, 2003

Charlie Federico liked his Physio-Stim distributor so much, that he decided to buy the company – for $150 million or 2.6x sales. This will be, by far, the largest transaction in Orthofix's history – and, we think, qualifies and that... more

What do the European Spine Journal, the American Society of Extra-Corporeal Technology and the Advances in Therapy Journal have in common? BY EDITOR, NOVEMBER 3, 2003

They all carried studies confirming the benefits of AGF. Despite one reviewers comment at NASS that there is a “paucity” of data regarding autologous growth factors (AGF) or other concentrated platelet products, there are at least three peer reviewed clinical... more

Kyphon has the look of a juggernaut BY EDITOR, NOVEMBER 3, 2003

KYPH, as it has each quarter since coming public, significantly outperformed both sales and earnings expectations last quarter. The numbers tell the story: $35.1 million in sales vs. $33.6 estimate and $20.7 million for the same period the year before.... more

Spine Tingling NASS BY EDITOR, OCTOBER 27, 2003

The North American Spine Society is the premier conference for the fastest growing sector of orthopedics. History was being made almost daily at this year's NASS Conference as scientists, surgeons and other participants wrestled with major therapeutic issues. This industry... more

It was indeed the Woodstock of Spine BY EDITOR, OCTOBER 15, 2003

All that was missing was mud and rain. We even had the crowds and chemical enhancements (basically caffeine). Certainly from the organizers perspective, crowded halls and rooms (standing room only usually) were mighty gratifying. From the attendees standpoint... we needed... more

Venture Capital "tone" dramatically positive BY EDITOR, SEPTEMBER 29, 2003

Dave Stassen, legendary medical device venture capitalist and principal at the $3 billion St. Paul Ventures in Minnesota is calling a turn in medical device venture investment. In his talk at the OrthoKnow symposium last week, Stassen recounted the recent... more

Spine Summit Line-Up Extraordinary BY EDITOR, SEPTEMBER 22, 2003

Presenting at our October 9th Spine Summit will be, in no particular order: The most innovative supplier of hemostatic products for the spine that no one has heard of. The best surgical assist (a semi-robot) for spine surgeons we've ever... more

Biomet's Announcement Offers 3rd Quarter Preview BY EDITOR, SEPTEMBER 22, 2003

What makes the Orthopedic Industry's current renaissance so interesting is not only how unexpected it is, but how unexpectedly broad and deep it is. Unlike the cardiovascular industry, which is riding the drug coated stent phenomenon, orthopedic revenues are bubbling... more

There's more than one way to grow bone BY EDITOR, SEPTEMBER 8, 2003

In this era of recombinant bone morphogenic proteins that cost $5,000 per patient per level, it's refreshing to note that there are more ways to jump start bone healing. Last week, Orthofix announced it had submitted data to the FDA... more

Rookie bone void fill may be best yet BY EDITOR, SEPTEMBER 2, 2003

Here's a trick question for all you orthopods reading this newsletter. Name the bone void fill for spinal applications with 9 years of documented clinical success, an FDA controlled randomized clinical trial and over 75,000 cases at 1,500 hospitals. Grafton?... more

A Shocking Move: Smith & Nephew Drops Out of Takeover Battle for Centerpulse without a Fight BY EDITOR, AUGUST 11, 2003

To our surprise, as well as most of the analyst on Wall Street, Smith & Nephew publicly announced its decision not to up its current offer of approximately $2.5 billion in order to triumph Zimmer Holdings approximate $3.1 billion offer.... more

Spine industry revenues set to triple over the coming decade BY EDITOR, AUGUST 11, 2003

Based on the dynamic duo of demographics and technological innovation (specifically disc arthroplasty and minimally invasive surgical tools and techniques) spine industry revenues will, we estimate, rise from $2 billion currently to $7.2 billion by 2012. Who will be the... more

SPINE Summit Scheduled for October 9th in NYC BY EDITOR, AUGUST 4, 2003

See you at the Summit!! It's been an extraordinary year for the Spine industry. CMS finally approved an add-on payment for InFUSE™. Just a few months ago Spine Solutions, a development stage company, sold to Synthes for $350 million. Link... more

Zimmer, Regeneration and Kyphon Leave Analysts Reeling. The others are merely excellent. BY EDITOR, JULY 28, 2003

Zimmer: There is no doubt in our mind that Zimmer is grabbing market share – quickly. It is clear that MIS at Zimmer is bigger than instruments and implants; it is really about (aside from improving patient outcomes) reimbursement. CEO... more

Interpore Cross posts 266% earnings increase on 25% sales increase BY EDITOR, JULY 21, 2003

$1.1 million in royalty revenue from AcroMed, combined with 25% increase in spinal implant revenues and the glimmer of a turnaround at AOM (MIS) set the stage for a sharp earnings increase for the second quarter. Royalties are now the... more

Sofamor Danek increases the size of its Bryan and Prestige Cervical Disc trials, we think. BY EDITOR, JULY 21, 2003

We have been hounding the overworked folks in Medtronic's investor relations department about last week's Bryan® and Prestige™ Cervical Disc clinical trial press release. Apparently, we were the only people who called with a question. All other Analysts calling in... more

It's going to be a great Quarter, Year and Decade BY EDITOR, JULY 14, 2003

Despite being asked by the Merrill analyst to comment on the prospects for the Next Gen product (manufactured by Zimmer... oops, she meant Next Generation), Biomet's CEO, Dane Miller, was his usual wry self as he announced that overall sales... more

METRx X-Tube is Cool BY EDITOR, JUNE 16, 2003

Sofamor Danek didn't pay us to say that, we just like the look of this new product. 250,000 patients a year decide to undergo a discectomy operation to “deflate the tire” of a herniated disc. Satisfaction rates are routinely 95%+.... more

$325 million for disc arthroplasty, again. BY EDITOR, MAY 12, 2003

This week the DePuy division of Johnson and Johnson reached an agreement to purchase the Link Spine Group of Bramford, CT, a unit of the Waldemar LINK GmbH company, Hamburg, Germany for $325 million plus future payments. Link Spine Group's... more

Merrill turns bearish on Orthopedics while Stephens puts its money into a sparkling Gem of a spine center. Guess who we think is the smarter investor! BY EDITOR, APRIL 7, 2003

Merrill Lynch's ratings downgrade of, in effect, the entire Orthopedics industry will rank, we think, with Business Week's infamous "Death of Equities" cover story - which coincided with the beginning of the greatest bull market in history - as one... more

Stephens funds a multi-faceted Gem of a Spine Center. BY EDITOR, APRIL 7, 2003

We attended last week's dedication of the new, 12 story Jackson T. Stephens Spine and Neurosciences Institute at the University of Arkansas for Medical Sciences and came away very impressed with the size and dedication of the new research and... more


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