Conference Calendar

October 28-29 - Musculoskeletal New Ventures Conference

November 5-8 - American Academy of Implant Dentistry

Complete Calendar »

Earnings Calendar

Oct 29 @ 8:30 AM ET - Dentsply International

Oct 29 @ 5:00 PM ET - K2M Group Holdings, Inc

Complete Calendar »

Read our research via:
email art

Weekly Email

rss art

RSS



app icon

iPhone

app store icon

Kindle



Orthopedic and Dental Industry News Complete Archive »

Biologics

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

Histogenics Proposes $65M IPO BY ANDREW VAHRADIAN, OCTOBER 8, 2014

Histogenics Corporation filed an S-1 to raise up to $65 million through an 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. Histogenics' principal... 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

Zimmer to Acquire ETEX Holdings BY ANDREW VAHRADIAN, OCTOBER 3, 2014

Zimmer Holdings entered into an agreement to acquire ETEX Holdings, Incorporated, a biologics company that develops proprietary nanocrystalline calcium phosphate-based biomaterials for the repair and regeneration of bone damaged by trauma or disease. ETEX offers porous, injectable and moldable bone... more

Researchers Reveal Nasal Septum Cells’ Ability to Treat Articular Cartilage Defects BY ANDREW VAHRADIAN, SEPTEMBER 12, 2014

A team of researchers at the University and the University Hospital of Basel, revealed that cartilage cells extracted from the nasal septum, called nasal chondrocytes, not only are able to adapt to the environment of the knee joint, but also... more

Researchers Develop a New Delivery Approach for Bone Regeneration BY ANDREW VAHRADIAN, AUGUST 28, 2014

A team of researchers at MIT have developed a new approach to bone regeneration and reconstruction called "layer-by-layer assembly". The approach utilizes a very thin, porous, nanostructured, biodegradable poly(lactic-co-glycolic acid) scaffold sheet that incorporates a polyelectrolyte multilayer coating containing active... 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

Researchers Develop New Shape-memory Polymer for Craniomaxillofacial Reconstruction BY ANDREW VAHRADIAN, AUGUST 21, 2014

A team of researchers at Texas A&M University have developed a new shape-memory polymer (SMP) for craniomaxillofacial (head, face or jaw) reconstruction and filling of bone defects. The "self-fitting" material expands with warm salt water and molds to the precise... more

Nobel Biocare is Considering a Sales Process BY ANDREW VAHRADIAN, JULY 31, 2014

Nobel Biocare, the second largest dental implant developer, confirmed that it is exploring a sales process. This verifies that private equity firms and other medical device companies have reached out to assess a buyout. The company affirmed further that the... more

Mariel Therapeutics to Acquire Stryker's BMP-7 Assets BY ANDREW VAHRADIAN, JULY 9, 2014

The biopharmaceutical company, Mariel Therapeutics, entered into a definitive agreement to acquire Stryker's Bone Morphogenetic Protein-7 (BMP-7) assets, intended for the potential treatment of osteoarthritis (OA), chronic kidney disease (CKD) and other organ fibrosis conditions, lupus, and obesity. BMP-7, which... 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

Orthocell Limited Announces IPO BY ANDREW VAHRADIAN, JUNE 2, 2014

Orthocell Limited announced its intention to list on the Australian Securities Exchange (ASX) by launching an initial public offering (IPO) process, proposing to raise $8 million by offering 20 million shares at an offer price of $0.40 a share. Orthocell... more

Researchers Develop New Hydrogel with Enhanced Degradation Kinetics BY ANDREW VAHRADIAN, MAY 22, 2014

Bioengineers at Rice University have developed a novel thermogelling hydrogel that holds potential as a bioscaffold that would support bone and other three-dimensional tissue regrowth through stem cell delivery. The new material, detailed in the American Chemical Society journal Biomacromolecules,... more

Pig-derived Implants Demonstrated to Grow Human Muscle Tissue BY ANDREW VAHRADIAN, MAY 15, 2014

Researchers at the University of Pittsburgh, demonstrated that implanting thin sheets of a scaffold-like material originating from pigs, incited stem cells to regenerate new muscle tissue in human male patients with various disabling leg injuries. Human muscle possesses a moderate... 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

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

Researchers Conduct Study on Lizard Cartilage in Hopes of Discovering New Insights into Human Cartilage Regeneration BY ANDREW VAHRADIAN, MARCH 26, 2014

Unlike muscle, human cartilage does not have the ability to heal itself, and as a result of injury or disease, cartilage can become damaged or even wear away, leading to pain and discomfort. This inability to regenerate and heal cartilage... 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

Researchers Develop Novel Approach to Grow Cartilage BY ANDREW VAHRADIAN, FEBRUARY 26, 2014

In a recent study published in the Proceedings of the National Academy of Sciences, a team of Duke University biomedical engineers developed a polymer scaffold that utilizes gene therapy vectors to induce stem cells to create the required growth factor... 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

Wright Medical Acquires Solana Surgical and OrthoPro for $126M BY ANDREW VAHRADIAN, FEBRUARY 3, 2014

Wright Medical announced that it has acquired Solana Surgical, a developer of extremity orthopedic products aiming to restore motion while relieving pain, and entered into a definitive agreement to acquire OrthoPro, a developer of surgical products for the Foot &... more

Amedica Prices IPO BY ANDREW VAHRADIAN, JANUARY 30, 2014

Amedica Corporation announced terms for its initial public offering (IPO) earlier this week, further demonstrating that orthopedics and spine is coming back into favor with the public investment community. The company plans to raise between $32 million and $38 million... 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

Integra Completes its Acquisition of Confluent Surgical BY ANDREW VAHRADIAN, JANUARY 21, 2014

Integra LifeSciences Holdings Corporation completed its acquisition of Confluent Surgical, Inc. from Covidien for $265 million or 4.1x LTM FY2012 revenues. Confluent Surgical develops dural repair, surgical sealants and adhesion barrier products which include: DuraSeal, DuraSeal Exact/Xact, VascuSeal and SprayShield.... 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

MiMedx Prices $34 million Public Offering BY ANDREW VAHRADIAN, DECEMBER 18, 2013

MiMedx Group, Inc., a developer of regenerative biomaterials and bioimplants processed from human amniotic membrane, priced an underwritten public offering of 5,000,000 shares of its common stock at a price to the public of $6.80 per share for gross proceeds... 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

Harvard to Collaborate with Charité on Musculoskeletal Tissue Engineering BY ANDREW VAHRADIAN, OCTOBER 2, 2013

The Wyss Institute for Biologically Inspired Engineering at Harvard University has entered into a collaboration agreement with Charité - Universitätsmedizin Berlin, in order to expedite clinical translation of new materials and tissue engineering technologies for the orthopedics and connective tissue... 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

Wright Medical Receives Not Approvable Decision from the FDA for its Augment Bone Graft Product BY ANDREW VAHRADIAN, AUGUST 9, 2013

Wright Medical announced that it received a not approvable letter from the FDA in response to its Pre-Market Approval (PMA) application for its Augment Bone Graft, intended for use as an alternative to autograft in hindfoot and ankle fusion procedures.... 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

Researchers Develop Material with the Potential to Promote Bone Formation BY ANDREW VAHRADIAN, FEBRUARY 11, 2013

Researchers at the Universities of Edinburgh and Southampton have discovered an amalgamation utilizing stem cells and a new lightweight plastic that can support bone formation. In the study, published in Advanced Functional Materials, the researchers determined that by combining bone... more

Senate Committee Releases Report on Medtronic's Infuse BY LAUREN UZDIENSKI, OCTOBER 25, 2012

The Senate Finance Committee released a report on bias in literature relating to Medtronic's Infuse, concluding that the company was "heavily involved in drafting, editing and shaping the content of medical journal articles" supporting the use of Infuse. Documents subpoenaed by the Senators reportedly indicate that Medtronic urged authors to under-report adverse events associated with Infuse or emphasize the benefit of a bone graft substitute in preventing donor-site pain. As documented previously, Medtronic paid millions to the researchers aiding the development of Infuse. 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

Gel-One HA Injection Found Not to Infringe BY JOHN MCCORMICK, AUGUST 7, 2012

Last week, Hyaluronic acid (HA) manufacturer Seikagaku and its distribution partner Zimmer were determined by a U.S. federal jury not to infringe on Genzyme's Synvisc-One HA injection. 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 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 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

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 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 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

Spine Publishes Oxiplex IDE Data BY LAUREN UZDIENSKI, APRIL 17, 2012

FzioMed announced today that the journal Spine has published results from the Oxiplex pivotal clinical study. Oxiplex is an absorbable gel that is applied to epidural tissue during lumbar laminectomy, laminotomy and discectomy procedures to prevent the formation of adhesions post-operatively. Adhesion barriers are intended to the reduce pain, radiculopathy and lower extremity weakness associated with the formation of scar tissue after surgery. 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

Clinical Roundup April 2012 BY LAUREN UZDIENSKI, APRIL 9, 2012

Cemented vs. uncemented hip hemiarthroplasty ... Returning to running after hip resurfacing surgery ... Adipose-derived stem cells in skeletal muscle-healing in a rat model ... Cortoss IDE results in vertebroplasty ... Patterns of disc degeneration ... Are local anesthetics associated with chondrotoxicity? 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

Kuros Partners with Synthes on Synthetic Matrix BY LAUREN UZDIENSKI, MARCH 20, 2012

Kuros announced this morning that the company has partnered with Synthes on the development of their synthetic matrix technology. The press release said only that the indications will encompass "certain fields", though Kuros has traditionally focused on trauma, wound and spinal applications. 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

Zimmer, ISTO Advance Engineered Juvenile Cartilage Studies BY LAUREN UZDIENSKI, FEBRUARY 8, 2012

Zimmer and ISTO Technologies provided an update yesterday on their research program on engineered juvenile cartilage for the repair of damaged knees. The company plans to enroll up to 225 patients at 25 sites in a new phase III study, which will compare the use of the DeNovo ET Engineered Tissue Graft to microfracture for the repair of cartilage defects in the knee. 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

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

Smith & Nephew, CONMED Ink Biologics Deals BY LAUREN UZDIENSKI, JANUARY 4, 2012

Both Smith & Nephew and CONMED announced biologics deals today, with Smith & Nephew spinning off their biologics division and CONMED signing an allograft and PRP distribution deal. 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

Geron Ends Embryonic Stem Cell Research Program BY LAUREN UZDIENSKI, NOVEMBER 17, 2011

Geron announced this week that the company would end its research into stem cells and focus instead on its novel cancer agents. The company is notable for being the first to initiate an embryonic stem cell research program in the U.S., led by an investigational product for repairing damage to the spinal cord. The company attributed the decision to shutter the stem-cell program to "capital scarcity and uncertain economic conditions." more

Infuse Linked to Cancer BY LAUREN UZDIENSKI, NOVEMBER 7, 2011

Eugene Carragee, who devoted the entire June issue of his Spine journal to concerns about Infuse, has now identified a link between cancer and the graft material. He presented his data at NASS last week. 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 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

Dental News Roundup September 2011 BY LAUREN UZDIENSKI, SEPTEMBER 29, 2011

Nobel Biocare launches bond issue ... Straumann may purchase own shares ... Astra Tech launches Atlantis 3D Editor ... Biomet 3i rebrands digital products under BellaTek name, launches OsseoGuard Flex membrane and new app for clinicians and patients ... Align to close NJ facility ... Straumann names Regional Head North America 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

Baxter Buys Ceremed's Ostene BY LAUREN UZDIENSKI, AUGUST 23, 2011

Ceremed announced today that their Ostene hemostat, including all branding and manufacturing rights, has been sold to Baxter for an undisclosed amount. Ceremed says the divestiture will "free up assets needed to focus on bringing new products to market." 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 4-Aug-11 BY LAUREN UZDIENSKI, AUGUST 4, 2011

ATEC, ANIK, ARTC, BMTI, EXAC, SNN, SMA announce earnings . . . Ellipse Technologies announces series C round . . . CMS announces IPPS final rule . . . KFx Medical sues Arthrex . . . Tornier initiates IDE study 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

Olympus Biotech Launches Opgenra, Formerly OP-1 BY LAUREN UZDIENSKI, JULY 7, 2011

Olympus Biotech announced this week that the company launched their BMP-7 product, which they've named Opgenra, in Europe. Olympus acquired Opgenra, formerly OP-1, from Stryker late last year, paying $60 million for the OP-1 portfolio and the New Hampshire facility that manufactures it. 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

Spine Journal Dedicates Latest Issue to Infuse Controversy BY LAUREN UZDIENSKI, JUNE 29, 2011

The backlash against Infuse is escalating this week with the announcement that the Spine Journal would dedicate its June issue to bias in published data on Infuse. In addition to highlighting the under-reporting of adverse events, the journal argues for improvements in transparency and disclosure requirements in the scientific literature. more

Senators Request Infuse Documents from Medtronic BY LAUREN UZDIENSKI, JUNE 22, 2011

In a letter to Medtronic, Senators Baucus and Grassley requested documentation relating to Infuse consultants, adverse events, FDA reporting and journal articles. The investigation follows recent news concerning a link between Infuse and male sterility. more

BMTI Hits New 52-Week Low BY LAUREN UZDIENSKI, JUNE 9, 2011

BioMimetic Therapeutics announced on Tuesday that they've completed enrollment in their Augment Rotator Cuff Graft pilot study, and they've also been granted some additional patent protection for Augment through 2029. Despite this news, the stock sank to a new 52-week low. 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

Infuse Linked to Infertility in Men BY LAUREN UZDIENSKI, MAY 25, 2011

A retrospective review of Medtronic's Infuse study published in the Spine Journal this week showed a correlation between male patients treated with Infuse and sterility. Medtronic and the surgeon investigators in the study attributed the side effect to surgeon technique and not Infuse itself, which is why it had generally been excluded in previously published studies. more

Kensey Nash Buys Norian from Synthes BY LAUREN UZDIENSKI, MAY 24, 2011

Kensey Nash paid $22 million to acquire the assets of Synthes' Norian subsidiary. The deal includes an R&D agreement, a supply agreement and the acquisition of a manufacturing facility. The divestiture was a condition of Synthes' settlement with the government over allegations that the company facilitated unauthorized clinical studies of Norian XR, a bone graft substitute. more

Histogenics Acquires ProChon Biotech in an All-Stock Transaction BY LAUREN UZDIENSKI, MAY 18, 2011

Histogenics acquired ProChon Biotech in an all-stock exchange this week, with the companies declining to announce a dollar amount for the transaction. Both companies are developing autologous cartilage regeneration products. 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 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

ReGen Says "Enough is Enough" BY LAUREN UZDIENSKI, MARCH 22, 2011

ReGen called the FDA out for its "blatantly arbitrary and unfair" practices in a press release this afternoon, declining a hearing over the rescission of its Menaflex device. 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

Dental News Roundup February 2011 BY LAUREN UZDIENSKI, FEBRUARY 28, 2011

Nobel, Straumann announce earnings . . . 3D Systems launches dental printer . . . BIOLASE introduces Waterlase iPlus laser . . . Nobel Biocare adds IPS e.max CAD crown to the NobelProcera line . . . VITA announces shade guide improvements . . . Biomet 3i's social networking campaign . . . Vident, Patterson announce distribution agreement . . . Astra Tech partners with 3Shape A/S 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

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

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

Orthofix, NuVasive Settle Patent Suit BY LAUREN UZDIENSKI, DECEMBER 16, 2010

Orthofix announced yesterday that a lawsuit brought by NuVasive over IP relating to Orthofix's Trinity Evolution has been settled for an undisclosed amount. more

Musculoskeletal News Roundup 16-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 16, 2010

Theken Spine wins Ohio grant . . . Ellipse Technologies receives CE mark for the PRECICE limb lengthening device . . . Memometal Technologies launches MemoDerm Acellular Dermal Matrix and Smart Toe II Hammertoe Fixation System . . . Zimmer receives reimbursement premium from Japan for the Trabecular Metal Modular Cup . . . Stryker files patent infringement suit against Zimmer . . . Lanx appoints CEO more

Musculoskeletal News Roundup 9-Dec-10 BY LAUREN UZDIENSKI, DECEMBER 9, 2010

SBi sells shoulder assets . . . Ortho Kinematics raises $2M . . . FDA clears VITA's Vitoss Bioactive Foam-2X . . . Life Spine announces first cases with the OCTAVE Posterior Fusion System . . . WMGI initiates limited rollout of the PRO-TOE VO Hammertoe Fixation System . . . BMTI begins enrollment on Augment Rotator Cuff pilot study . . . Audax Medical licenses biomaterial from Brown University . . . NeoStem entity to bring orthopedic stem cell treatments to Shijiazhuang, China . . . EXAC resolves DOJ investigation more

Cephalon Forms Strategic Alliance with Mesoblast BY LAUREN UZDIENSKI, DECEMBER 9, 2010

Cephalon has entered into a strategic alliance with Mesoblast, paying $130 million up front and up to an additional $1.7 billion in milestone payments related to stem cell applications for degenerative conditions of the cardiovascular and central nervous systems. more

Stryker to Divest OP-1 BY LAUREN UZDIENSKI, DECEMBER 7, 2010

Stryker announced yesterday that they would sell their OP-1 family of products to Olympus for $60 million. These products include the OP-1 Implant, OP-1 Putty, Opgenra and Osigraft, all of which are intended for use in orthopedic applications and are thought to generate annual sales of around $94 million. 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

Kuros Regains Biomaterials Rights from Baxter BY LAUREN UZDIENSKI, NOVEMBER 15, 2010

Kuros announced that they have regained rights to three biomaterials that were in development with Baxter. The original agreement was signed in 2005 and related to combining Baxter's Tisseel fibrin sealant with Kuros' technology. more

Musculoskeletal News Roundup 11-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 11, 2010

ATEC, ANIK, KH and TSON announce 3Q . . . SYST acquires surgical power tools . . . MAKO closes public offering . . . ConforMIS launches next-generation iDuo G2 . . . SYK's Triathlon knee has lowest three-year revision rate compared to competitive systems, according to U.K. data . . . SYK receives subpoenas related to OtisKnee and PainPump . . . Arthrex to distribute KNSY's Cartilage Repair Device in Europe more

Musculoskeletal News Roundup 4-Nov-10 BY LAUREN UZDIENSKI, NOVEMBER 4, 2010

ARTC, DJO, EXAC, MAKO, VITA, OSTE, RITX, SNN, SMA report 3Q . . . Xylos receives grant funding . . . FDA clears ArthroCare's SpeedFix Suture Anchor . . . NeoStem receives Chinese reimbursement for an orthopedic stem cell treatment . . . Salient Surgical announces 500,000th patient treated with Transcollation . . . CA judge throws out CareFusion's anti-trust suit against Medtronic more

UCLA Scientists Receive $5.4M Grant for Stem Cell Research BY LAUREN UZDIENSKI, NOVEMBER 3, 2010

California's state stem cell agency awarded a $5.4 million grant to UCLA orthopedic surgery professors Dr. Bruno Peault and Dr. Chia Soo, who will conduct their research at UCLA's Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. Drs. Peault and Soo will use the funds to form and regenerate bone from adipose-derived stem cells. more

Dental News Roundup October 2010 BY LAUREN UZDIENSKI, OCTOBER 29, 2010

Align, Straumann, Zimmer report 3Q . . . Align receives approval to market Invisalign in China . . . FDA to hold an advisory panel on dental amalgam . . . Nobel launches Replace Select TC . . . Straumann initiates controlled rollout of MembraGel 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

Smith & Nephew to Develop Cartilage Regeneration Product with Nanotope BY LAUREN UZDIENSKI, OCTOBER 19, 2010

Nanotope, Inc., a portfolio company of Arrowhead Research Corporation, has entered into an agreement with Smith & Nephew to develop a cartilage regeneration product. The press release states that Smith & Nephew will conduct and pay for preclinical and clinical studies. Nanotope will also receive up to $26.6 million in milestone payments, plus additional royalties. more

FDA to Rescind Market Clearance for ReGen's Menaflex BY LAUREN UZDIENSKI, OCTOBER 15, 2010

Conceding that the agency succumbed to political pressure during their Menaflex review, the FDA has decided to rescind ReGen's clearance for the collagen-based meniscal device. This decision is unprecedented, with the New York Times noting that this is the first time the agency publicly admitted to wrongly approving a drug or device or that outside pressures influenced their review process. Menaflex will be the FDA's first rescission. more

Dental News Roundup September 2010 BY LAUREN UZDIENSKI, SEPTEMBER 30, 2010

Straumann launches new CAD/CAM portfolio . . . VITA expands shade range . . . EPA may require dentists to recycle mercury waste . . . BIOLASE increases sales force . . . Zimmer Dental to distribute RTI biologics worldwide . . . Sirona announces management changes 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

Musculoskeletal News Roundup 16-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 16, 2010

NUVA lowers guidance . . . HydroCision acquired by three VC firms; new President and CEO appointed . . . TiGenix closes seed financing round for new pharma spinoff . . . Creaspine, Ranier Technology receive CE mark clearances . . . Medtronic introduces Kyphon Cement Delivery System in Europe . . . SpineAlign Medical introduces European Observational Registry for the VerteLift System . . . Medtronic wins certain rulings in ongoing patent infringement suit brought by Synthes . . . Synthes sues Biomet, former sales rep more

RTI Biologics Licenses Adult Stem Cell Technology BY LAUREN UZDIENSKI, SEPTEMBER 13, 2010

RTI Biologics announced a collaboration with Athersys this morning, whereby RTI will have access to Athersys' Multipotent Adult Progenitor Cell (MAPC) technology. RTI plans on developing the cells for orthopedic applications. 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

Stryker Settles OP-1 Allegations in Massachusetts BY LAUREN UZDIENSKI, AUGUST 26, 2010

The Massachusetts Attorney General's office announced today that Stryker has settled a number of allegations over off-label marketing for OP-1 for $1.35 million. 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

Medtronic to Acquire Osteotech for $123M BY LAUREN UZDIENSKI, AUGUST 17, 2010

Medtronic and Osteotech have signed a definitive agreement under which Medtronic will acquire Osteotech in an all-cash transaction valued at approximately $123 million, or $6.50 per share. This represents a 65% premium over yesterday's close of $3.94 and around a 1.3x multiple on trailing 12-month revenues. more

BioMimetic Therapeutics Receives Orphan Drug Designation for PDGF Treatment of Osteochondritis Dissecans BY LAUREN UZDIENSKI, AUGUST 12, 2010

BioMimetic Therapeutics announced this morning that it has received orphan drug designation from the FDA for their PDGF technology in the treatment of osteochondritis dissecans (OCD) of the knee, elbow or ankle. Similar to an HDE designation for devices, orphan drugs address conditions affecting less than 200,000 people in the United States. more

Musculoskeletal News Roundup 12-Aug-10 BY LAUREN UZDIENSKI, AUGUST 12, 2010

Earnings aap Implantate reported 2Q:10 revenues of EUR 7.0 million ($8.5 million), down 13% over the year-ago period; adjusting for the divestiture of their analytics business, sales increased by 23% over 2Q:09. The company is planning to further acceleration of... 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

Ortho Gets a TED Talk BY JOHN MCCORMICK, JULY 26, 2010

Watching TED talks on iTunes - or an iPad for that matter - is the futurist's equivalent of a basketball fan's immersion into March Madness. TED, which stands for Technology, Entertainment, Design is a non-profit organization devoted to spreading forward-thinking... 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

Dental News Roundup June 2010 BY LAUREN UZDIENSKI, JUNE 30, 2010

Biomet reports F4Q:10 earnings . . . Discus Dental acquires Zap Lasers . . . Euroteknika launches Universal + implant system in the U.K. . . . 20% of Britons are missing five teeth or more . . . 3M closing an Oklahoma plant used by its Espe dental products unit . . . Fibrocell Science appoints three new clinical advisors more

FDA Sets Panel Date for Amplify, Medtronic's Other BMP-2 BY LAUREN UZDIENSKI, JUNE 28, 2010

The FDA announced that on July 27, a CDRH panel will convene to discuss the PMA for Medtronic's Amplify, a BMP-2 matrix designed for single-level posterolateral lumbar fusions. The material has a different formulation and carrier than InFuse and is indicated as a treatment for degenerative disc disease. 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

Connecticut Researchers Turn Stem Cells into Chondrocytes BY LAUREN UZDIENSKI, JUNE 14, 2010

In April, a team of University of Connecticut researchers published a paper on their "direct, rapid, progressive, and substantially uniform" method of developing embryonic stem cells into chondrocytes, the cells that form cartilage. Now a profile published on UConn's website walks readers through the process of developing the technology and how the team is working to commercialize it. 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

BioMimetic Hiring a Sales Force for Augment BY LAUREN UZDIENSKI, JUNE 2, 2010

BMTI.pngBioMimetic plans to launch Augment in the U.S. with a mix of 100 independent and direct sales reps, whom they say will cover about 75% of all U.S. foot and ankle procedures. The company intends to increase their sales force to 150 to 200 reps within two to three years of Augment's launch. Internationally, the company will set up independent distributors or partners in Europe and Australia and has a partnership in place in Canada. more

Dental News Roundup May 2010 BY LAUREN UZDIENSKI, MAY 28, 2010

NADX's go-shop period ends . . . Smile Brands cancels its IPO . . . Sirona launches new products . . . Straumann receives award for Roxolid . . . Regenerating teeth from stem cells 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 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

NuVasive Initiates "Legal Dispute" Over Stem Cell IP BY LAUREN UZDIENSKI, APRIL 21, 2010

nuvasiveLOGO.jpgYesterday afternoon on their 1Q:10 conference call, NuVasive revealed that they initiated a "legal dispute" against Orthofix over IP related to Osteocel, the stem-cell-based bone graft substitute acquired by NuVasive from Osiris in 2008. 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

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

Baxter to Acquire ApaTech for up to $330 million BY ARIELLA P. GOLOMB, MD, MARCH 1, 2010

apatech%20logo_small.JPGBaxter announced plans to acquire ApaTech for up to $330 million, with $240 million in cash up front (a 4x revenue multiple) and additional milestone payments of up to $90 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

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 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

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

Anika Acquires Fidia Advanced Biopolymers for ~$34M BY LAUREN UZDIENSKI, JANUARY 4, 2010

On December 31, Anika Therapeutics announced the acquisition of Fidia Advanced Biopolymers for $17.1 million in cash and 1.9 million shares of stock, which values the deal at roughly $34.0 million. Fidia is a tissue engineering company based in Abano... more

Ortho Products Top List of 2009 Health Innovations BY LAUREN UZDIENSKI, DECEMBER 21, 2009

CNN published a list of the top 10 health innovations of 2009, and two orthopedic products made the list: a bone graft substitute made from wood and the economical Jaipur Knee. Researchers in Italy have discovered a way to convert... 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 10-Dec-09 BY LAUREN UZDIENSKI, DECEMBER 10, 2009

M&A The Yorkshire Post reported that DePuy Orthopaedics acquired Finsbury Orthopaedics. Finsbury has a range of hip, knee and small joint replacement products, including a hip resurfacing device. No details of the transaction were disclosed. Funding BioMedFlex raised $0.25 million... 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

Musculoskeletal News Roundup 19-Nov-09 BY LAUREN UZDIENSKI, NOVEMBER 19, 2009

Earnings ArthroCare restated its earnings from 2004 through 2Q:09. The company reported total revenue for 2008 of $314.2 million, up 12% over 2007. Relative to prior-year periods, 1Q:09 revenues increased 2% to $78.8 million; 2Q:09 revenues decreased 6% to $80.8... 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

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

Biomet Acquires Cartilix BY LAUREN UZDIENSKI, OCTOBER 20, 2009

Biomet has acquired the assets of Cartilix for an undisclosed sum. The target company is developing ChonDux, a new technology that uses a biological adhesive and hydrogel to fill lesions in the articular cartilage. Previous investors in the company include... 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

BMTI Study Shows Non-Inferiority for Augment Bone Graft BY LAUREN UZDIENSKI, OCTOBER 14, 2009

Yesterday BioMimetic Therapeutics released positive results from its North American pivotal study of Augment bone graft, the company's fully-synthetic, PDGF-derived PMA candidate. On a modified intent-to-treat basis, Augment achieved its primary endpoint of non-inferiority to autograft in attaining foot and... 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

ChrondroCelect Receives First-of-Its-Kind EU Market Clearance BY LAUREN UZDIENSKI, OCTOBER 8, 2009

TiGenix announced that ChondroCelect, its ACI treatment for cartilage regeneration, has been cleared by the European Commission for sale on the EU market. This is the first product to be approved in the EU as an advanced therapy medicinal product,... 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

FDA: Menaflex Clearance Shows "Definite Threats" to the 510(k) Process BY LAUREN UZDIENSKI, SEPTEMBER 24, 2009

Yesterday the FDA issued a preliminary report on the process by which ReGen Biologics obtained 510(k) market clearance for its Menaflex device, concerns that were first publicized by the Wall Street Journal earlier this year. The Journal initially reported that... 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

Hydroxyapatite-Producing Bacteria May Improve Implant Performance BY LAUREN UZDIENSKI, SEPTEMBER 21, 2009

A strain of bacteria capable of producing hydroxyapatite (HA) could result in more effective coatings for medical devices, according to early research out of Birmingham, England. When applied to common materials for joint replacement devices, serratia bacteria were shown to... 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

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

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

Sea Worm Provides Model for Surgical Adhesive BY LAUREN UZDIENSKI, AUGUST 24, 2009

Scientists at the University of Utah have uncovered a way to produce a synthetic adhesive based on a natural glue created by the sandcastle worm. This ocean worm builds its home by sticking pieces of sand and shells together, and... 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

FDA Panel Votes Against Durolane BY LAUREN UZDIENSKI, AUGUST 19, 2009

An FDA panel determined in a 6-1 vote that Q-Med's single-injection Durolane, a hyaluronic acid, should not receive market approval. The panel raised efficacy concerns based on study data showing limited benefit for the product compared to placebo. The panel... more

Stem Cells Generate Replacement Tooth in a Mouse Model BY LAUREN UZDIENSKI, AUGUST 13, 2009

Researchers in Japan have successfully used stem cells to grow a tooth in a mouse model in what the Wall Street Journal calls "the first time scientists have developed a fully functioning three-dimensional organ replacement." The replacement tooth's structure, hardness... more

Musculoskeletal News Roundup 13-Aug-09 BY LAUREN UZDIENSKI, AUGUST 13, 2009

Earnings BioMimetic Therapeutics reported 2Q:09 royalty and sublicense revenue of $0.4 million, missing estimates by $0.1 million. The company reported a net loss of $6.3 million, or $0.32 per share, beating estimates by $0.17. Among the highlights for the quarter... more

Musculoskeletal News Roundup 6-Aug-09 BY LAUREN UZDIENSKI, AUGUST 6, 2009

Earnings Alphatec Spine, Inc. announced financial results for FQ2:09. Consolidated revenues for the second quarter 2009 were $32.3 million, an increase of 35% from 2Q:08 and an increase of 5% over first quarter 2009. Adjusted EBITDA reached $2.8 million in... more

Osiris' New Biosurgery Division to Focus on Bone Repair BY ARIELLA P. GOLOMB, MD, AUGUST 5, 2009

Osiris Therapeutics has been at the forefront of developing stem-cell-based products in orthopedics, most notably with their commercialization of Osteocel. That product line was sold to NuVasive last year, leaving Orthofix (who had previously distributed Osteocel under the name Trinity)... 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

Circulating Blood May Help Generate Bone BY LAUREN UZDIENSKI, JULY 28, 2009

A new study published in the journal Stem Cells found that circulating blood may hold the potential to generate bone. Scientists evaluated blood samples from patients with fibrodysplasia ossificans progressiva (FOP, a rare genetic disorder where bone forms outside the... 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

Synovis Life Technologies to Acquire Pegasus Biologics for $12.1 million BY LAUREN UZDIENSKI, JULY 10, 2009

Synovis Life Technologies, Inc. announced plans this week to acquire Pegasus Biologics, Inc. for $12.1 million in cash (a 1.3x revenue multiple.) Pegasus manufactures a collagen-based soft tissue scaffold as well as a wound healing device. According to the Synovis... 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

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 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 21-May-09 BY LAUREN UZDIENSKI, MAY 21, 2009

Earnings Medtronic reported FQ4:09 revenue of $3.8 billion, representing a 5% increase (constant currency) over FQ4:08 and in line with estimates. Adjusted EPS for the quarter was $0.82, also in line with estimates. Spine and biologics revenue was $881.0 million,... more

More Trouble for InFuse as Fraudulent Data Makes Headlines BY LAUREN UZDIENSKI, MAY 20, 2009

The New York Times reported last week that a former surgeon at Walter Reed Army Medical Center falsified data on InFuse that was published in (and later retracted by) JBJS. The study in question evaluated the use of InFuse for... 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

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

Teriparatide (Forteo) May Accelerate Bone Healing BY LAUREN UZDIENSKI, APRIL 15, 2009

Teriparatide, a recombinant form of parathyroid hormone marketed by Eli Lilly as Forteo, has been shown to stimulate stem cell production and accelerate the healing of fractured bones, according to study data presented at the Orthopaedic Research Society meeting in... 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

WSJ Reports on ReGen's Campaign Donations BY LAUREN UZDIENSKI, APRIL 7, 2009

The WSJ published additional details of its investigation into ReGen Biologics' FDA clearance for its Menaflex meniscal implant. New information out this morning includes details of campaign donations from ReGen executives to the New Jersey politicians who stood behind ReGen... 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

Musculoskeletal News Roundup 26-Mar-09 BY LAUREN UZDIENSKI, MARCH 26, 2009

Regulatory Bonesupport received the CE mark for Cerament Bone Void Filler, a ceramic bone substitute primarily used for the treatment of osteoporotic fractures. IlluminOss Medical received the CE mark for its Photodynamic Bone Stabilization System. According to the company, the... more

Musculoskeletal News Roundup 19-Mar-09 BY LAUREN UZDIENSKI, MARCH 19, 2009

Earnings TiGenix announced 2008 financial results this week, reporting a widening net loss as the company prepares to launch ChondroCelect in Europe. The company's net loss was EUR 15.2 million ($21.4 million), an increase of 27% over 2007. As the... more

Stryker Facing Federal Grand Jury Investigation Over the Marketing of OP-1 BY LAUREN UZDIENSKI, MARCH 12, 2009

As Stryker's long-awaited FDA panel session for OP-1 approaches, the company announced that it's facing a federal grand jury investigation into marketing practices surrounding the device. Specifically, allegations include the illegal promotion of OP-1 products and Calstrux, misbranding of devices... more

Musculoskeletal News Roundup 12-Mar-09 BY LAUREN UZDIENSKI, MARCH 12, 2009

Earnings BioMimetic Therapeutics reported a net loss in 4Q:08 of $12.2 million, or $0.65 per share, widening from a net loss of $6.9 million, or $0.37 per share, in 4Q:07. Analysts had forecast a net loss of $0.53 per share.... more

Biologic Orthopaedic Society Formed to Promote the Use of Orthobiologics BY LAUREN UZDIENSKI, MARCH 9, 2009

At AAOS last month, Allan Mishra, M.D. and Pietro S. Randelli, M.D. co-chaired the inaugural meeting of the Biologic Orthopaedic Society, a new organization designed to further the study and market adoption of biologics worldwide. Prior to BOS's formation, “No... more

Musculoskeletal News Roundup 5-Mar-09 BY LAUREN UZDIENSKI, MARCH 5, 2009

Earnings Alphatec Spine reported consolidated revenues for 4Q:08 of $28.4 million, an increase of 33% from the $21.3 million reported for 4Q:07. U.S. revenues for 4Q:08 were $22.0 million, an increase of 29% from the $17.1 million reported for 4Q:07.... 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

Stem Cell Summit Takeaways: Our Perspective BY JOHN MCCORMICK, FEBRUARY 19, 2009

Robin Young's Fourth Annual Stem Cell Summit was about as far removed as you could get from the grim economic headlines. Companies at the summit were presenting in the halo of a market forecast suggesting that this current $65 million... more

NY Times Highlights Platelet-Rich Plasma Therapy BY LAUREN UZDIENSKI, FEBRUARY 18, 2009

The New York Times ran an article on Monday describing platelet-rich plasma therapy (or PRP), a relatively inexpensive and promising autologous treatment for sports injuries. The treatment, which has attracted a host of professional athletes (the article names two Pittsburgh... 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

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

Mesoblast to Begin Stem Cell Study for the Prevention of Knee OA BY LAUREN UZDIENSKI, JANUARY 23, 2009

Mesoblast announced this week that the company received Australian institutional ethics committee approval to begin a clinical study evaluating the use of its adult stem cell product, RepliCart, for the prevention of OA in patients who have had ACL repair.... more

Musculoskeletal News Roundup 22-Jan-08 BY LAUREN UZDIENSKI, JANUARY 22, 2009

Earnings aap Implantate pre-announced 4Q:08 and full-year 2008 revenues of EUR 7.1 million ($10.0 million) and EUR 31.2 million ($44.0 million), respectively. 4Q:08 revenues declined 24% from the year-ago period, which the company attributed to "more orders from global partners"... 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

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

Regen Biologics Gets FDA Clearance BY JOHN MCCORMICK, DECEMBER 22, 2008

This morning Regen Biologics announced that it received its long awaited FDA 510(k) clearance to market its collagen meniscus implant for the knee. This marks the end of a long and tortured back and forth between the company and the... 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

Obama May Broaden Federal Funding for Stem Cell Research BY LAUREN UZDIENSKI, DECEMBER 8, 2008

When George W. Bush took office in 2001, one of his first executive orders was to restrict federal funding of stem cell research based on his belief that destroying embryos to obtain the cells was equivalent to destroying human life.... 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 26-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 26, 2008

M&A Trading was suspended for Portland Orthopaedics on news that the company may be selling its assets. Intellectual Property BioMimetic Therapeutics has received patent No. 11/159,533 covering its PDGF technology, including Augment Bone Graft and Augment Injectable Bone Graft. The... 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 13-Nov-08 BY LAUREN UZDIENSKI, NOVEMBER 13, 2008

Earnings aap Implantate AG reported sales for the first nine months of 2008 of EUR 24.2 million ($35.0 million), up 30% from the same period last year. The company attributed the sales growth to the Traumatology & Orthopaedics division, where... 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

Traumatized Muscle Offers Clues to Cell Repair and Regeneration BY LAUREN UZDIENSKI, NOVEMBER 3, 2008

A study published this month in JBJS identifies progenitor cells in traumatized human tissue - which could lead to new options in tissue engineering. The authors point out that while there are multiple sources of progenitor cells (such as bone... 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

BioMimetics' Experience A Microcosm of Current Credit Crisis within Ortho BY DAVID KRESSEL, OCTOBER 27, 2008

This evening, BioMimetic Therapeutics (BMTI) issued a press release stating it has reached a settlement with Deutsche Bank regarding BMTI's holdings of auction-rate securities (ARS). BMTI told investors on its 2Q08 conference call that it had approximately $60 million of... 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

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

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 18-Sept-08 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2008

M&A BoneSupport acquired Ultrazonix, the developer of an ultrasound-based treatment for alleviating pain associated with herniated discs. The product is FDA-cleared and CE-marked. Financial terms were not disclosed. Funding Formae received an investment of $0.5 million from BioAdvance, the Biotechnology... 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

Histogenics Raises $9mm BY JOHN MCCORMICK, SEPTEMBER 2, 2008

A cartilage company raising venture money is a not-so-common development in the world of sports medicine. In this instance, Waltham, MA based Histogenics just announced it has raised $9 million from venture investors. Of interest, Stryker was included in the... more

Beyond Building Bones, BMP-7 May Fight Obesity BY LAUREN UZDIENSKI, AUGUST 25, 2008

Researchers at Boston's Joslin Diabetes Center have identified what could be a surprising new way to treat obesity - BMP-7, the bone growth protein familiar to the orthopedic sector as the active protein in Stryker's OP-1, may also support weight... more

Musculoskeletal News Roundup 14-Aug-08 BY LAUREN UZDIENSKI, AUGUST 14, 2008

Earnings BioMimetic Therapeutics reported a 2Q:08 net loss of $9.2 million, or $0.50 per diluted share, widening from a net loss of $6.4 million, or $0.35 per diluted share, in 2Q:07. Clinical highlights for the quarter include the announcement of... 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

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

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

ACL Repair for Young, Active Patients: Heightened Risks Create Opportunity for Regenerative Technologies BY LAUREN UZDIENSKI, JULY 16, 2008

Researchers at the Mississippi Sports Medicine and Orthopaedic Center have found a failure rate nearing 24% for ACL reconstruction in young, athletic patients, according to a new study. Of 61 patients aged 15-39 who underwent ACL reconstruction, 14 were deemed... more

JBJS: ReGen's Collagen Meniscus Implant Improves Clinical Outcomes for Some Patients BY LAUREN UZDIENSKI, JULY 8, 2008

A new JBJS study comparing ReGen Biologics' collagen meniscus implant, Menaflex, with partial meniscectomy was published this week, and the publication comes as a rare bit of good news for the struggling ReGen. At 311 patients, the multi-center study was... 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

In3 on the State of the Medical Device Industry BY LAUREN UZDIENSKI, JUNE 24, 2008

China was a hot topic at the In3 Medical Device Summit, but one event focused on the device industry more broadly: where devices have been and where they're heading. The presentation, led by David Cassak of Windhover Information, described the... more

Musculoskeletal News Roundup 19-June-08 BY LAUREN UZDIENSKI, JUNE 19, 2008

Funding Exactech received a $40.0 million syndicated line of credit which will be used to fund future acquisitions and refinance debt, among other expenses. SunTrust Bank served as lead agent with participation by Compass Bank. M&A clickNsettle announced plans... more

FzioMed Awaits FDA Panel Meeting on Oxiplex/SP Gel Approval BY HAL BRIGHAM, JUNE 17, 2008

Having already received market approval in 49 countries, FzioMed now has its sights set on U.S. clearance for its Oxiplex/SP Gel, an adhesion barrier used in lumbar spinal surgery. The FDA announced last week that the Oxiplex technology will be... 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

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

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

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

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

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 10-Apr-08 BY LAUREN UZDIENSKI, APRIL 10, 2008

M&A Kinetic Concepts, Inc. announced plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading price. KCI... more

Kinetic Concepts, Inc. to Acquire LifeCell for $1.7 billion BY LAUREN UZDIENSKI, APRIL 7, 2008

Kinetic Concepts, Inc. announced this morning its plans to acquire LifeCell for $1.7 billion, or $51.00 per share, which represents an 18% premium over LifeCell's closing price on Friday and a 26% premium over the 90-day volume weighted average trading... 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 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

Stem Cells are Here and Now BY JOHN MCCORMICK, FEBRUARY 29, 2008

This week we attended Robin Young's packed-to-the-gills Stem Cell Summit in New York along with many of the industry's leading scientists and executives. The takeaway was loud and clear: the path to commercialization of this technology is happening faster than... 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

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 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

Lifecore Taken Private BY DAVID KRESSEL, JANUARY 16, 2008

Lifecore announced yesterday that it has entered into definitive documentation to be acquired by affiliates of the private equity firm Warburg Pincus for $239m, implying an enterprise value of $200m. Lifecore has two business units. One sells dental implants and... 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

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 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

BioMimetic Sells Dental Business, Reports Positive GEM OS®1 Data BY LAUREN UZDIENSKI, DECEMBER 18, 2007

There were two big announcements from BioMimetic Therapeutics this week, the first being an announcement that came yesterday on the impending sale of the dental business and the GEM 21S product to Luitpold Pharmaceuticals, which currently markets GEM 21S. BioMimetic... more

Musculoskeletal News Roundup 13-Dec-07 BY LAUREN UZDIENSKI, DECEMBER 13, 2007

Earnings Tutogen reported FY07 revenues of $53.8 million, an increase of 42% over FY06. The Company reported net income of $6.8 million, or $0.36 per fully diluted share in fiscal year 2007 compared to a net loss of $0.6 million,... more

Osiris Reports Additional Results from Chondrogen Trial BY LAUREN UZDIENSKI, NOVEMBER 29, 2007

Osiris announced results from an ongoing Chrondogen study this week, with enrolled patients showing less pain and fewer degenerative bone changes when compared to patients receiving HA. Among the highlights: OA patients receiving Chondrogen experienced a statistically significant reduction in... 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

Periodontists' Meeting Highlights BY DAVID KRESSEL, NOVEMBER 5, 2007

We attended the American Academy of Periodontology meeting this past week in Washington DC. Although there weren't any revolutionary introductions, we noticed a few trends from the exhibit hall. *Straumann featured its first bone level implant and the etkon system.... 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

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

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

FDA Throws ReGen Biologics Another Curveball BY DAVID KRESSEL, SEPTEMBER 25, 2007

ReGen Biologics today announced it received a "Not Substantially Equivalent" (NSE) letter from the FDA in response to the 510(k) premarket notification the company submitted for its meniscal repair implant. In a press release and conference call, a clearly frustrated... more

Musculoskeletal News Roundup 6-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 6, 2007

Regulatory Inion Oy received FDA approval for its implant material BioRestore in dental and cranio-maxillofacial applications. The product is designed to fill bony voids or gaps in the skeleton. BioRestore is currently being reviewed by the FDA for use in... more

Musculoskeletal News Roundup 30-Aug-07 BY LAUREN UZDIENSKI, AUGUST 30, 2007

Earnings Globus Medical announced 2Q:07 revenues of $30.2 million, an increase of 52% over the comparable quarter. The company attributes the revenue growth to the expansion of its sales and distribution footprint, product introductions in its fusion, MIS and biomaterials... more

A Booming Business Opportunity: Biomaterials will keep baby boomers active while creating opportunities for developers BY EDITOR, AUGUST 22, 2007

Our own John Chopack Jr. is featured in the July/August issue of Orthopedic Design & Technology. We've republished the article for you here. Car manufacturers pitch their latest vehicles’ ability to go from zero to 60 mph in just five... more

After Setbacks, IsoTis Gets 510(k) Approval for Accell BY LAUREN UZDIENSKI, AUGUST 20, 2007

IsoTis announced this morning that the Accell family of products has been granted 510(k) approval by the FDA as a Class II device. The clearance follows nearly a year of back-and-forth between IsoTis and the FDA over the nature of... 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

Encouraging Data for GEM OS1 BY LAUREN UZDIENSKI, JULY 19, 2007

At the AOFAS meeting last week, BioMimetic Therapeutics reported further positive interim data from its ongoing clinical trials of GEM OS1 in foot and ankle fusion indications. The U.S. arm of the study is a randomized, prospective, controlled pilot study... 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

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

Changes to European Device Safety Regulations; Reprocessing, Biologics to be Addressed in Future Legislation BY ARMELLE WIART, JUNE 5, 2007

The European Parliament recently approved 141 amendments to the Medical Device Directive, the legal framework created in 1990 to regulate device safety throughout Europe. The approval follows a public comment period on the first draft of the Directive, which was... 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

"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

Society for Biomaterials a Product Pipeline Crystal Ball BY DAVID KRESSEL, APRIL 24, 2007

Last week, we attended the Society for Biomaterials' annual conference. The event showcases the latest academic research and its broad applications across medical specialties. Roughly a third of the poster presentations focused on orthopedics, and most of the rest related... 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

Female Stem Cells Regenerate Muscle Better than Male BY LAUREN UZDIENSKI, APRIL 11, 2007

New research out of the University of Pittsburgh Medical Center show that female stem cells have an edge over male stem cells in regenerating muscle. Johnny Huard et al suggest in the Journal of Cell Biology that this research is... 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

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 15-Mar-07 BY LAUREN UZDIENSKI, MARCH 14, 2007

Earnings Orthovita reported 4Q:06 revenues of $13.81 million, beating analysts' estimates of $13.76 million and reflecting 38% growth compared to $9.97 million in 4Q:05. Orthovita attributed the growth to increased U.S. sales of VITOSS® FOAM and VITAGEL®. OrthoLogic announced 2006... 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

Orthopedic News Roundup 22-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 22, 2007

Earnings Medtronic reported 3Q:07 (ended 1/26/07) Spinal and Navigation revenue of US $629.0 million, and the Spinal segment increased 12% over 3Q:06. Growth was attributed to the Biologics product line and the CD HORIZON® LEGACY™ family of products, which includes... more

The Quest to Regenerate Cartilage: TiGenix and Osiris Reveal Clinical Results BY ARIELLA P. GOLOMB, MD, FEBRUARY 20, 2007

Yesterday, TiGenix, a Belgium-based biomedical company, announced the results of their phase III multi-center randomized trial of ChondroCelect as first-line treatment for symptomatic knee cartilage defects. ChondroCelect is designed to be used in combination with autologous chondrocyte implantation (ACI) surgery... more

Orthopedics News Roundup 25-Jan-07 BY LAUREN UZDIENSKI, JANUARY 25, 2007

Earnings Stryker reported a 28% increase in sales of orthopedic implants and endoscopy products for 4Q:06. The Company earned $227.9 million, or 55 cents per share, meeting analysts' estimates, compared with a profit of $178.4 million, or 43 cents per... 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

Muscle and Bone, Fresh from the Printer BY LAUREN UZDIENSKI, JANUARY 16, 2007

MIT's Technology Review reported recently on a new development out of Carnegie Mellon and the University of Pittsburgh: a custom ink-jet printer that can print tissue using stem cells from mice and growth factor. This is how the Carnegie Mellon/University... more

Clinical Trials a Struggle for Blood Substitutes; Navy Study Blocked Again BY LAUREN UZDIENSKI, JANUARY 2, 2007

Following up on an earlier blog about orthopedics' demand for a blood substitute, new research developments don't bode well for two synthetic products. Elective orthopedic surgery has one of the highest rates of patient blood loss; an effective blood substitute... more

Regeneration Technologies and Cryolife to Enter Exchange and Service Agreement BY JOHN MCCORMICK, DECEMBER 19, 2006

Allograft companies, Regeneration Technologies (RTI) and Cryolife announced a non-cash exchange and service agreement this morning concerning their orthopedic and cardiovascular processing. With respect to orthopedics, starting January 1, CryoLife will work to transition existing tissue recovery and donation arrangements... more

Yet Again, Synvisc Will Not Have To Share Reimbursement Code BY ARIELLA P. GOLOMB, MD, DECEMBER 15, 2006

In October we reported that Genzyme, maker of the viscosupplement Synvisc, announced a CMS decision grouping all industry viscosupplementation products into the same reimbursement code in January 2007. The coding change meant that reimbursement for viscosupplementation treatments will be based... more

OrthoMimetics Raises Series A Financing BY DAVID KRESSEL, DECEMBER 6, 2006

OrthoMimetics announced it has completed a Gbp5 million Series A raise. Participants include Oxford Capital Partners, Schroders Investment Management, and Sloane Robinson Private Equity, as well as clients of Eden Financial, the placement agent. Joining the board will be Heidi... 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

INFUSE Moves into Dental BY JOHN CHOPACK, NOVEMBER 10, 2006

Medtronic, Inc. announced yesterday that the FDA Dental Products Advisory Panel had unanimously voted to recommend approval of INFUSE Bone Graft for certain oral and maxillofacial procedures. If the FDA agrees with that panel's recommendation, the US indications for INFUSE... 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 2-Nov-06 BY HUYEN NGUYEN, NOVEMBER 3, 2006

Earnings Biologics: Orthovita reported 3Q:06 product sales came in at $11 million, up 32% compared to 3Q:05. Net loss for the quarter was $3.7 million, or a loss of $0.07 per share. The Company beat analysts' EPS estimates by $0.02,... more

Synvisc To Share Reimbursement Code BY ARIELLA P. GOLOMB, MD, OCTOBER 31, 2006

In a press release yesterday, Genzyme, maker of Synvisc, announced a CMS decision that would group all viscosupplementation products into the same reimbursement code in January 2007. The company stated that they would fight hard to dispute this decision (through... 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

Will the FDA Be Able to Regulate Nanotechnology? BY ARIELLA P. GOLOMB, MD, OCTOBER 6, 2006

Nanotechonology is clearly making strides in the orthopedic marketplace. The question is, will the FDA will be able to keep up? Report Claims FDA Not "Nano Ready" Yesterday, Michael Tayor, an attorney and former Deputy Commissioner for Policy at the... 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

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

BioMimetics' Data Impresses BY DAVID KRESSEL, SEPTEMBER 19, 2006

Dr. William Giannobile, a professor of dentistry at the University of Michigan, presented new data on BioMimetics' only approved product, GEM21S, at the American Academy of Periodontology meeting in San Diego yesterday. GEM21S is short for "Growth-factor Enhanced Matrix," a... more

Orthopedic News Roundup 14-Sept-06 BY HUYEN NGUYEN, SEPTEMBER 14, 2006

Appointment: Orthovita, Inc. has appointed Albert J. Pavucek, Jr. Vice President Corporate Controller. Mr. Pavucek was with PDI, Inc. serving as Vice President, Finance and Operations. Awards & Recognition: Smith & Nephew plc announced that two of its products, the... more

Red Cross Fined over Blood Collection Violations; What Does It Mean for Orthopedics? BY LAUREN UZDIENSKI, SEPTEMBER 13, 2006

As the Wall Street Journal (subscription required) reported this week, the American Red Cross will be fined $4.2 million for failing to honor federal blood-collection regulations. More than 12,000 units of blood were recalled during 2002 and 2005, and these... 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

OrthoLogic Announces Termination of its Phase IIb Dose Response Trial BY JOHN CHOPACK, AUGUST 30, 2006

Orthologic reported yesterday that an interim analysis of its Chrysalin Phase IIb dose response distal radius fracture healing clinical trial did not meet its primary efficacy endpoint of having a benefit over a placebo in time to removal of immobilization.... 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

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

510(k) for ReGen Biologics' Collagen Scaffold Rejected BY HUYEN NGUYEN, AUGUST 9, 2006

On Monday, ReGen Biologics announced that it had received a letter from the FDA rejecting to approve the ReGen® collagen scaffold technology to be classified as a Class II medical device. In its exact words, the collagen scaffold technology, "is... more

Osiris Public Offering Raises $38.5M, Stock Trading Flat BY ARIELLA P. GOLOMB, MD, AUGUST 7, 2006

Osiris Therapeutics Inc. raised $38.5 million when it went public last Friday. The Company offered 3,500,000 shares of its common stock at a price of $11.00 per share and up to an additional 525,000 shares have been made available to... 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

Exactech's 2Q:06 - A Good Quarter BY HUYEN NGUYEN, AUGUST 2, 2006

On Tuesday, Exactech reported 2Q:06 revenues of $26.6 million, which represents an increase of 11% over 2Q:05. The Company reported $0.18 diluted earnings per share (EPS) and beat analysts' earnings estimates by $0.01. Net income for the quarter was a... more

LifeCell Reports Record 2Q:06 Earnings, Citing Growth of AlloDerm Sales BY TODD BARTELS, JULY 28, 2006

LifeCell Corporation, a maker of regenerative human tissue products, yesterday reported record 2Q:06 financial results. Product revenues were $35.7 million for the quarter, up 60% from the $22.3 million reported in 2Q:05. Growth in product revenues can be attributed to... 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

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

Smith & Nephew Acquires Osteobiologics BY ARIELLA P. GOLOMB, MD, JULY 11, 2006

Smith & Nephew plc (SNN) announced today that it has acquired Osteobiologics (OBI) for a net consideration of $72.3m in cash, representing ~20x OBI's 2005 revenues of $3.3m. The acquisition is expected to reduce SNN's earnings by $7m in 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 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

Smith & Nephew and Q-MED Form Hyaluronic Acid Treatment Alliance BY ARIELLA P. GOLOMB, MD, JUNE 28, 2006

Viscosupplementation to treat osteoarthritis has traditionally been performed with a course of three or five injections. Today Smith & Nephew Inc. and Q-MED AB announced an alliance which paves the way for the US marketing of DUROLANE, the first and... more

IND Approval Granted For Zimmer/ISTO Technologies' Neocartilage Graft BY ARIELLA P. GOLOMB, MD, JUNE 21, 2006

Each year, hundreds of millions of people injure the cartilage in their knees, shoulders and other joints. Today Zimmer Holdings and ISTO Technologies announced that the U.S. Food and Drug Administration (FDA) has approved ISTO's Investigational New Drug (IND) application... more

FDA Gives Orthovita The Go Ahead To Manufacture VITAGEL BY ARIELLA P. GOLOMB, MD, JUNE 16, 2006

Orthovita announced that it has obtained pre-market approval (PMA) from the FDA to market its VITAGEL(TM) surgical hemostat manufactured on-site at its Malvern, Pennsylvania facility. Orthovita has been distributing VITAGEL since the first quarter of 2005 through a distribution agreement... 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

Orthopedic News Roundup 8-Jun-06 BY HUYEN NGUYEN, JUNE 8, 2006

Business Update: NuVasive announced that 90% of its sales force is now exclusively distributing its spine surgery products. This exclusive 175 person sales force includes both direct and independent sales representatives. Development & Distribution Agreement: Ars Arthro Biotechnologie GmbH, a... 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

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

LifeCell Skyrockets BY JOHN MCCORMICK, APRIL 26, 2006

In the swarm of public earnings reports for the first quarter, we thought LifeCell's results were particularly newsworthy. Thanks to the Company's AlloDerm Regenerative Tissue Matrix which grew at an astounding 69% year-over-year ($25.3 million in 1Q:06 compared to $14.9... 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

BioMimetics Takes a Swing at Wrist and Other Extremity Fractures BY DAVID KRESSEL, MARCH 20, 2006

On the heels of BioMimetics' approval for GEM 21S for dental use, they initiated one clinical study on GEM OS1 for distal radius fractures and two on GEM OS1 in foot and ankle fusion. GEM OS1 is a combination of... 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

Orthologic Wrist Study Fails BY JOHN MCCORMICK, MARCH 15, 2006

Orthologic announced this morning that its 503-person clinical trial of its synthetic peptide Chrysalin to treat wrist fractures failed to meet its primary goal of accelerating recovery. In an instant, its market capitalization was cut in half and the company... more

Ceramics Getting Stronger? BY JOHN MCCORMICK, MARCH 15, 2006

Developments in ceramics has always been of great interest to participants in our industry. We thought we would alert you to this article in Wired Magazine that summarized some recent findings in ceramic technology. In essence, scientists are finding that... more

Orthopedic News Roundup 2-Mar-06 BY HUYEN NGUYEN, MARCH 2, 2006

We are preparing for AAOS in Chicago, IL and invite you to check back to our website for information on analyst meetings and our top picks of scientific events happening at AAOS. Earnings: Two hip & knee orthopedic companies (Exactech,... more

Tutogen Names New CFO BY DAVID KRESSEL, FEBRUARY 7, 2006

Tutogen Medical, a leading player in the allograft market, has named Robert Johnston to the post of CFO. Johnston joins Tutogen from Power Medical Interventions, where he was also CFO. He has been at a number of healthcare products companies... more

Muscle Stem Cells Used For Cartilage Repair BY DAVID KRESSEL, JANUARY 31, 2006

In an article published in February's Arthritis and Rheumatism, researchers at the University of Pittsburgh reported on their success in using stem cells to repair cartilage. Using a rat model, researchers extracted stem cells from adult muscle tissue, retrovirally transduced... more

Sen. Schumer Turns up Heat on Tissue Transplants BY JOHN MCCORMICK, JANUARY 16, 2006

It has now surfaced that Sen. Charles Schumer has sent a letter to the acting head of the Food and Drug Administration, Dr. Andrew von Eschenbach calling for more oversight of the tissue transplant industry noting that he was "deeply... more

Osteotech's Difficult Road Ahead BY JOHN MCCORMICK, NOVEMBER 29, 2005

Last Wednesday, Osteotech announced that their beleaguered Chief Executive Richard Bauer will retire at the end of December - sooner than expected. While he will remain on the Osteotech board, Sam Owusu-Akyaw, the Company's current president and chief operating officer,... more

Orthopedic News Roundup 17-Nov-05 BY HUYEN NGUYEN, NOVEMBER 17, 2005

Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices... more

Orthopedic News Roundup 3-Nov-05 BY HUYEN NGUYEN, NOVEMBER 3, 2005

We wrap up this quarter with aggregated earnings and sales in the public orthopedic sector of $560 million and $5 billion, respectively, as a few more companies reported this week. For 3Q:05, orthopedic sales were up by 13% ($5.0 billion... 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

MTF Withdraws Bid for Osteotech BY JOHN MCCORMICK, OCTOBER 18, 2005

Last night Osteotech, Inc. (Nasdaq: OSTE) communicated that Musculoskeletal Transplant Foundation ("MTF") has withdrawn its $6.25 a share bid. Today many shareholders voted with their feet and the stock has dropped by $1 a share to $3.88 (or over 20%).... more

Regeneration Technologies, Inc. Issues Voluntary Recall BY JOHN MCCORMICK, OCTOBER 14, 2005

Regeneration Technologies, Inc. (RTI) (Nasdaq: RTIX), the highly reputable allograft industry leader, said this morning that it issued a voluntary recall of allograft implants that have been processed from donor tissue received from Biomedical Tissue Services. RTIX attributed this to... 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

Lifecell Recalls BTS Products After Criminal Probe BY DAVID KRESSEL, OCTOBER 10, 2005

In the wake of an FDA, NYPD and Brooklyn district attorney's investigation into Biomedical Tissue Services, Lifecell has recalled and halted sales of all tissue from BTS. BTS's CEO is under investigation for illegally harvesting tissue from cadavers at a... more

A Follow-Up Interview with Gerald 'Gary' Bisbee, CEO of ReGen Biologics, Inc. BY JOHN MCCORMICK, OCTOBER 6, 2005

One of the leaders in this emerging meniscus repair market is ReGen Biologics. We recently had a chance to do a catch up with Gary Bisbee, CEO of ReGen Biologics who we interviewed last year. Disclosure: Individual members of HealthpointCapital,... more

ReGen Biologics Update: FDA Warning Letter BY JOHN MCCORMICK, SEPTEMBER 25, 2005

On Friday ReGen Biologics, Inc. reported that it received a warning letter dated September 16, 2005 from the FDA. The warning letter was a follow-up to the FDA Form 483 notice of inspectional observations received by ReGen and, along with... 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

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

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

Regeneration Technologies, Inc. Seeks to do $24 Million PIPE BY JOHN MCCORMICK, AUGUST 26, 2005

Allograft and tissue processing stalwart Regeneration Technologies, Inc. (Nasdaq: RTIX - News), announced Thursday that it entered into definitive agreements to undertake a private placement of its common stock with a group of accredited investors (institutional firms or wealthy individuals).... more

Orthopedic News Roundup 12-Aug-2005 BY HUYEN NGUYEN, AUGUST 12, 2005

This week we completed the orthopedic reporting calendar as a few more companies reported earnings, starting with Synthes, the number #1 trauma company worldwide. Synthes reported 20% growth in both top and bottom line for 1H:05. Consolidated sales reported at... more

Orthopedic News Roundup 5-Aug-05 BY HUYEN NGUYEN, AUGUST 5, 2005

This week we finish off the first half of 2005 reporting season with 17 orthopedic companies* released their financial numbers. In 2Q:05, in an aggregated total, orthopedic revenues increased 16% ($3.8 billion vs. $3.2 billion) and a 25% increased in... more

Osteotech Promotes Treasurer to CFO BY JOHN MCCORMICK, AUGUST 1, 2005

DBM developer Osteotech Inc. which is famous for producing Grafton, announced on Friday that Chief Financial Officer, Michael J. Jeffries, was retiring. This morning, the Company announced that Mark H. Burroughs, VP of Finance, would succeed him. Burroughs has been... more

Ceramics: Products and Manufacturers (from our Orthopedic Biomaterials 2005 report) BY EDITOR, JULY 18, 2005

This is an excerpt from our Orthopedic Biomaterials 2005 report, which is a comprehensive listing of all the products and manufacturers in this exciting space. The report has six more sections like this one (for the other orthopedic applications of... more

Synthetic Peptides Demonstrate Promise in Orthopedic Applications BY JOHN CHOPACK, JULY 6, 2005

Fziomed, Inc. recently announced that its Oxiplex Gel demonstrated efficacy in acting as a delivery platform for a novel peptide bone growth factor being developed by the Company. The study was presented at the 12th International Meeting on Advanced Spine... more

Mr. Theken buys Therics BY JOHN MCCORMICK, JULY 4, 2005

On Friday of last week, Tredegar Corporation announced that it sold the assets of Therics, Inc. to a new company controlled and managed by Randall R. Theken (not the actual Theken Spine company itself). The new stand-alone company will simply... more

IsoTis Appoints Jim Hart to Board BY JOHN MCCORMICK, JUNE 27, 2005

At a recent shareholders' meeting IsoTis OrthoBiologics announced that it appointed James (Jim) Hart to its Board of Directors. Jim is familiar to many of you as the former CEO of Opus Medical which was sold to ArthroCare for over... more

Allograft versus Xenograft BY JOHN CHOPACK, JUNE 15, 2005

One of our readers recently posted asking for everyone's opinion on allograft and xenograft. We thought we would give you our take first and then let the readers respond. First, we should define both for all the readers: allografts are... 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

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

When & Who will Transition Orthopedics to Regenerative Medicine? BY JOHN CHOPACK, MAY 23, 2005

Talk to anyone in orthopedics and all admit that a transition from replacing worn out joints and soft tissue to regenerating these parts is anticipated. But the $20 billion (size of the orthopedic market) questions are when and, more importantly,... more

Allograft: Whacked Again BY JOHN MCCORMICK, MAY 16, 2005

The allograft industry is a curious phenomenon. Companies in this segment of the orthopedic industry are stand alone processors of human cadaveric musculoskeletal tissue for surgical implantation. Companies are stand alone because it seems that the metal benders in Warsaw,... more

LifeCell (LIFC:Nasdaq) Beats Street Estimates by $0.03 and Revises Outlook for FY2005 BY HUYEN NGUYEN, MAY 2, 2005

LIFC reported strong product revenue growth in 1Q:05 as sales increased by 48%.' Product sales totaled $19.7 million compared to $13.3 million in 1Q:04. Sales were driven by higher demand for the AlloDerm® Regenerative Tissue Matrix used in complex hernia... 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

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

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

An Interview with BioSyntech's CEO, Claude LeDuc BY JOHN MCCORMICK, APRIL 18, 2005

Claude LeDuc, CEO Biosyntech Last week we interviewed Claude LeDuc, President and Chief Executive Officer of BioSyntech, a Canadian developer of thermosensitive gels that address articular cartilage repair and other clinical needs. JM: Introduce our readers to BST-Gel™ and... more

Osteotech (OSTE:NASDAQ) Reports 4Q:04 and 2004 Earnings BY JOHN CHOPACK, APRIL 4, 2005

OSTE reported 4Q:04 revenues of $20.4 million which was a 15% lower than 4Q:03 revenues of $24.0 million. Earnings totaled ($0.27) per diluted share which included a pre-tax gain of $1.1 million related to the sale of inventory and intellectual... 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

ReGen Biologics (OTC:RGBI) Reports Selected Financials for FY2004 and a Brief CMI Update BY HUYEN NGUYEN, MARCH 21, 2005

ReGen Biologics, Inc. (OTC:RGBI), a New Jersey-based tissue regeneration company, reported full year 2004 selected financial results on Friday of last week. In 2004, ReGen reported total sales of $504,000, a 72% increase over the $293,000 reported in 2003. Net... 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

LifeCell Corp. (NASDAQ:LIFC) Reported Strong Product Sales for 4Q:04 and FY:04 BY HUYEN NGUYEN, MARCH 14, 2005

LifeCell Corp. (NASDAQ:LIFC) reported a strong 49% increase in product revenues in 4Q:04 which was in line with consensus estimate of $0.04 per diluted share on a non-GAAP reporting standard. Product revenues in the 4Q:04 were $16 million compared to... 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

Exactech (EXAC:NASDAQ) Reports 4Q:04 Financials which were slightly below Analyst Expectations BY JOHN CHOPACK, MARCH 7, 2005

EXAC reported revenues of $21.3 million during the 4Q:04 which was a 14% increase over the 4Q:03 but was $300 thousand below analyst's expectations. Earnings-per-share on a diluted basis totaled $0.17 which was also slightly below analyst expectations of $0.16.... more

Orthovita (NASDAQ:VITA) Reported 4Q:04 and FY2004 in which Product Sales Rose by 62% and 59%, Respectively BY HUYEN NGUYEN, MARCH 7, 2005

A biomaterial company, Orthovita, Inc. (Nasdaq: VITA), reported 4Q:04 and FY2004 financial results with product revenues increased to 62% and 59%, respectively. Despite its consistent 60% top-line growth in Q3 & Q4, VITA failed to meet the street estimate of... 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

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

Genzyme Acquires Verigen AG BY JOHN MCCORMICK, FEBRUARY 14, 2005

On Tuesday of last week, Genzyme Corporation (Nasdaq: GENZ) announced another foray into the world of cartilage repair with the acquisition of Germany's Verigen AG. Founded only in 1999, Verigen has been selling a proprietary cell therapy system for cartilage... more

Millenium Biologix Released 3Q:05 Results BY HUYEN NGUYEN, FEBRUARY 14, 2005

Last week, Canadian's Millenium Biologix Corp. (TSX: MBC), a biomedical company that develops and supplies minimally invasive devices and skeletal tissue regeneration products, reported its 3Q:05 and its twelve months results for December 31, 2004. Millenium Biologix Corporation is the... more

Wright Medical (WMGI:NASDAQ) Reports 4Q:04 Financials BY JOHN CHOPACK, FEBRUARY 14, 2005

Wright reported both 4Q:04 and year-end 2004 financials on Thursday evening. 4Q:04 revenues totaled $77.7 million a 13% increase over 4Q:03 revenues and at the upper end of management's previous guidance of revenues of $76-$78 million. Revenues for the year... more

OrthoLogic Reports 2004 Results: Fired Up On All Burners BY JOHN MCCORMICK, JANUARY 31, 2005

On Thursday of last week, OrthoLogic Corp. (Nasdaq: OLGC) announced its Q4:04 results. The Company, which has effectively been a drug development company since the sale of its bone growth stim business, reported a net loss of $4.9 million or... 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

LifeCell (LIFC:NASDAQ) Reports Preliminary 4Q:04 Financials and Provides 2005 Outlook BY JOHN CHOPACK, JANUARY 24, 2005

LIFC reported that it anticipated 4Q:04 product revenues to total $16.0 million which is a 49% increase over the 4Q:03. The company is anticipating 2004 product revenues to total $59 million compared to the $39 million reported during 2003 (52%... more

Osteotech (OSTE: NASDAQ) Takes Charge and Shares Drop 33% Last Week BY JOHN CHOPACK, JANUARY 10, 2005

OSTE announced on Thursday that it was taking a $5.8 million pre-tax charge to write down assets during the 4Q:04. The Company now expects a loss of $0.28 to $0.31 for the fiscal year 2004 compared to the previous forecast... more

Wright Medical (WMGI:NASDAQ) Reports 28% biologics growth and 23% Hip growth in 3Q:04 BY JOHN CHOPACK, NOVEMBER 3, 2004

Wright Medical reported a blistering 28% rate of growth for its biologics products as well as a solid 23% rate of revenue growth for its hip products. Clearly, this is a company that is gaining market share from biomaterials. Hip... more

New 'Growth Factors' Mere Months from Commercialization BY ROBIN R. YOUNG CFA, AUGUST 30, 2004

On July 13/2004 a small group of researchers and businessmen presented to an FDA panel the results of 15 years of research and clinical study the net effect of which was a unanimous panel approval for a new, recombinant platelet-derived... more

Cartilage Repair Technologies Coming to Market BY ROBIN R. YOUNG CFA, AUGUST 30, 2004

Data from the largest clinical trial ever conducted on the human meniscus is starting to make its way into the FDA. The first module was submitted in early July. The next modules are being submitted over the course of 2004.... more

Wright Medical, Regeneration Technologies, LifeCell, Orthovita, MacroPore and Stellar International Slated to Join 30 Other Presenters at October Biomaterials Summit in New York BY ROBIN R. YOUNG CFA, AUGUST 23, 2004

Headlining this year's one-day Biomaterials Summit will be Wright Medical, Regeneration Technologies, LifeCell, Orthovita, MacroPore and Stellar International. All are leaders in the field and working on significant new technologies. Wright Medical, whose sales for the first half of 2004... more

VITOSS' and IMBIB deliver 52% Sales growth to Orthovita BY ROBIN R. YOUNG CFA, AUGUST 16, 2004

Calcium has been good to Orthovita; particularly the nano-particle version known as beta tri calcium phosphate, sold by Orthovita under the brand name VITOSS'. VITOSS' is offered in either blocks or morsels. Compared to HA-CC blends (Hydroxyapatite and Calcium Carbonate),... more

The Pathos of Osteotech BY ROBIN R. YOUNG CFA, AUGUST 2, 2004

Osteotech's stock price is now down to $3.87. With 17 million shares outstanding, the company's market value is $67 million. The last time Osteotech was valued so low was in September of 2001. In 2001, Osteotech lost $4.4 million on... more

LifeCell's Momentum Grows with 58% Sales Jump in June Quarter BY ROBIN R. YOUNG CFA, JULY 26, 2004

For the June quarter, LIFC reported that sales hit $15.1 million, a stellar 58% increase over prior year levels. Sales for the superstar product, Alloderm', accounted for 68% of the overall sales and rose 89% over prior year levels. The... more

We Use RTI for Soft Tissue and LifeCell for DBM? BY ROBIN R. YOUNG CFA, JUNE 28, 2004

We couldn't help but come to the following conclusion after reading RTI's Stryker notice last week: Stryker has accomplished the interesting task of contracting with the industry's #2 bone void fill supplier for soft tissue, and the industry's soft tissue... more

Orthovita Contracts for Cash and Hemostat from AngioTech BY ROBIN R. YOUNG CFA, JUNE 28, 2004

Cash and hemostats stop two kinds of bleeding. Last week, Orthovita (VITA) added both in an important and impressive deal with AngioTech. This deal will bring a new product to its growing arsenal of biomaterials, as well as a whopping... more

RTI Unveils Key Surgical Product Innovation BY ROBIN R. YOUNG CFA, JUNE 28, 2004

The best source of replacement body parts is the patient. Whether it is skin, tendons, bone, blood or whatever, harvesting from one spot to implant in another spot of the same patient is the gold standard, for more reasons than... more

ReGen Biologics Adds New Board Member BY JOHN MCCORMICK, JUNE 14, 2004

On Thursday, ReGen Biologics named William R. Timken, a founding partner of Hambrecht & Quist, to its Board of Directors. This is not necessarily a new relationship since Timken has been an investor and advisor to the Company for over... more

Biomaterials Driving Orthopedic Returns BY ROBIN R. YOUNG CFA, JUNE 7, 2004

Biomaterials are a disruptive technology platform. Consider the effect of titanium implants on stainless steel. Better yet, consider the effect of ceramics today on titanium. Ceramics represent an incremental $2,000 - $4,000 in revenue per implant over titanium and an... more

Biomaterials SUMMIT Set for October 15th in New York City BY ROBIN R. YOUNG CFA, MAY 24, 2004

It's been an extraordinary year for companies that employ or supply biomaterials. Sales are now running at a rate of $6 million per day and will, we believe, accelerate in 2005 with a new generation of growth factors, cartilage repair... more

World Congress of Biomaterials Opens Window to the Future of Orthopedics BY ROBIN R. YOUNG CFA, MAY 24, 2004

Over 2,000 scientists and entrepreneurs from 43 countries converged on Sydney, Australia last week to advance the extraordinary science and practice of biomaterials. Over 2,000 papers and posters were submitted representing some of the finest biomaterials science in the world.... more

CryoLife Continues to Struggle BY ROBIN R. YOUNG CFA, MAY 17, 2004

If CryoLife is to survive, it must achieve three fundamental goals: resolve its lawsuits, avoid trouble with any U.S. government agency and re-establish a reputation as a reliable supplier of biologic products to surgeons. Last week's quarterly update report from... more

Orthovita reports 59% Sales Growth; 3% Increase in Operating Loss to $2.5 million BY ROBIN R. YOUNG CFA, MAY 10, 2004

VITOSS sales rocketed in the quarter, beating our expectations and demonstrating that Orthovita is becoming one of the premier calcium based suppliers in orthopedics. VITOSS (a resorbable beta tri-calcium material) sales reached an estimated $4.5 million (the actual number included... more

Marking Time at AANS BY ROBIN R. YOUNG CFA, MAY 10, 2004

By Wednesday the most popular document circulating the floor of AANS was a crossword puzzle followed by USA Today's sports section. Compared to AAOS (which was like Times Square), AANS was a monastic retreat; for the exhibitors. For surgeons it... more

LifeCell Posts 92% Jump in Alloderm Sales - 55% Overall. Pretty Unusual for a Biomaterials Company? BY ROBIN R. YOUNG CFA, MAY 3, 2004

Watch what is happening in hernia repair and then start thinking cartilage, tendon and ligament. LifeCell, which could call itself a 'biomaterial' company, but won't - posted the #1 rate of revenue growth of all 'biomaterials' companies with an impressive... more

OrthoLogic Takes Aim at ENTIRE Growth Factor Market BY ROBIN R. YOUNG CFA, MAY 3, 2004

Taking a quote from Butch Cassidy and the Sundance Kid, 'Who are those guys?' Tom Trotter's OrthoLogic could eventually possess more 'growth factor' indications than Medtronic, operate at significantly lower costs than Medtronic and have obtained a drug approval for... more

Regeneration Technologies - Sales Rebound, Profit Margins Narrow'Lots of Activity Beneath the Surface BY ROBIN R. YOUNG CFA, MAY 3, 2004

Regeneration Technologies (RTI) is like the proverbial duck on the water, calm on the surface, but paddling like crazy beneath. For the first quarter ended March 31/2004, Regeneration reported a 19% increase in sales to $23.4 million, which was about... more

Fat Derived Stem Cells Reach Important Milestones to Commercialization for bone, cartilage and muscle repair BY ROBIN R. YOUNG CFA, APRIL 19, 2004

In two separate studies, stem cells derived from the patient's own fat tissue, otherwise known as adipose derived stem cells, were shown to adapt and grow into either bone tissue or heart muscle tissue, without requiring any external growth factors... more

Macropore Posts 140% Revenue Jump on Sales of Resorbable Polymers for Spine, Trauma and Carniomaxillofacial; Losses Continue, Though Reduced BY ROBIN R. YOUNG CFA, APRIL 19, 2004

Macropore, the San Diego based biomaterials company whose stock trades on the Frankfurt exchange (go figure), posted exceptional revenue growth for the December quarter. (They're a little behind on their announcements. March quarter numbers due in June?) Sales for the... 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

Regeneration Technology Powers Up R&D BY ROBIN R. YOUNG CFA, MARCH 22, 2004

After two disappointing quarters, Regeneration Technology's (NASDAQ NM:RTIX) message at AAOS was that the distribution system had to change in order to become more effective and that the company's new product pipeline had to grow. Roger Rose, RTI's VP of... more

Anika Therapeutics Announces First Annual Profit - and FDA approval for OrthoVisc® BY ROBIN R. YOUNG CFA, MARCH 1, 2004

The Acid Test for early stage Medical Device companies is profitability, before obtaining FDA approval for the core product.  It's an almost impossible feat, yet a couple companies have accomplished this over the years; Vascular Solutions almost seven years ago.;... more

Cryolife's Numbers Weren't Strong, But the Conference Call Tone Was BY ROBIN R. YOUNG CFA, MARCH 1, 2004

Allograft tissue processing revenues may be down ($30.8 million in 2003 vs. $55.4 million in 2002) but with BioGlue revenues up 33% to reach $27.8 million and an infusion of $20 million in cash, CryoLife's management had a definite spring... more

The Integra Eye for the Low-Cost Buy BY ROBIN R. YOUNG CFA, MARCH 1, 2004

Integra Life Sciences (IART), which reported a 58% jump in revenues to $185 million for the year ended December 31st, 2003, was downgraded by W.R. Hambrecht this past week. We have known IART CEO Stu Essig for quite a while... 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

Wright Medical – Best Company in Orthopedics? BY JOHN CHOPACK, FEBRUARY 23, 2004

For the just completed quarter and year, Wright Medical (NASDAQ:WMGI) reported, we believe, the best quarter and year in orthopedics. First, Wright's seven year investment in the Investigational Device Exemption (IDE) ceramic-on-ceramic clinical hip trial delivered huge dividends in 2003.... more

The Fog of Allograft Innovation BY ROBIN R. YOUNG CFA, FEBRUARY 9, 2004

Last week Regeneration Technologies (RTI), the third largest supplier of allograft products, reported that sales of allograft products to Medtronic Sofamor Danek (MSD) dropped 61% in the 4th quarter to $5.1 million. MSD is Regeneration's largest customer accounting for 60%... more

CryoLife Gets Some Financial Breathing Room BY ROBIN R. YOUNG CFA, FEBRUARY 2, 2004

Last week CryoLife announced that it had sold 3.4 million shares in a private placement, raising $20 million (before expenses). With cash levels sitting at approximately $11 million as of the end of 2003 and with quarterly losses running about... more

OrthoLogic Reports the First Quarter Without Bone Stimulation Revenues BY JOHN CHOPACK, FEBRUARY 2, 2004

It's official. Tom Trotter, CEO of OrthoLogic (OLGC), has completed his transition of OLGC from a medical device company to a pure play orthobiologics organization. The feat took Trotter approximately three years beginning in 2001. During that time he divested... more

Kensey Nash Announces 30% sales growth, 54% earnings growth BY JOHN MCCORMICK, JANUARY 26, 2004

Raises Fiscal 2004 Guidance. Ortho and sports medicine key growth driver. Biomaterials company Kensey Nash (KNSY) held a conference call to discuss its stellar Second Quarter earnings results last week. KNSY revenues were up 30% from $10.5 million to $13.7... more

LifeCell Guides to 21% Revenue growth in Q4 2003 on strength of Soft Tissue Allograft sales BY ROBIN R. YOUNG CFA, JANUARY 26, 2004

LifeCell continues to post very impressive top line growth. Sales in the fourth quarter broke out of its sub-$10 million plateau and reached a solid $11.1 million. For the past six quarters LifeCell has been posting between $8-10 million in... 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

CryoLife Posts Anemic 4th Quarter / Predicts Comeback in 2004 BY ROBIN R. YOUNG CFA, JANUARY 12, 2004

4th Quarter revenues came in roughly $3 million under the third quarter's reported $15.1 million and certainly below our own expectations for the quarter. Revenues for the December quarter were approximately $12.8 million, up slightly from the prior year's $12.2... more

CryoLife shores up its board with CFOs BY EDITOR, DECEMBER 15, 2003

Any volunteers for the audit committee? With roughly three quarters of cash left (assuming the current cash burn rate doesn't subside) and sizeable bank and litigation payments looming, management has decided to put a couple of savvy CFOs on its... more

Use of InFuse' expanded to include... BY EDITOR, DECEMBER 15, 2003

...more metal cages. Our friends in high places at Medtronic tell us that Sofamor Danek is considered to be Medtronic's best acquisition-ever. A worthy competitor calls the boys in Memphis “the machine.” Indeed. No doubt Mike DeMane's “threat” to replace... more

Wright Medical - Growing for the Long Run BY EDITOR, DECEMBER 15, 2003

Guidance to 2005? This is a famously conservative management, so to guide out to 2005 is cause to sit up and take notice. What's going on at Wright medical? Strong biologics and ceramic on ceramic hip components certainly. But, we... more

DJ Orthopedics Says new Acquisition would have added $0.13 to EPS in 2003 BY EDITOR, DECEMBER 8, 2003

Last Thursday, dj Orthopedics, Inc. (DJO) held a conference call to help investors wade through the new numbers from its acquisition of OrthoLogic's bone growth stimulation division. The deal is now signed, sealed and delivered. Bone growth stimulation products are... more

Conference Focus on Materials BY EDITOR, NOVEMBER 24, 2003

At the 78th annual reunion of the Société Française de Chirurgie Orthopédique et Traumatologique (SO.F.C.O.T.) held last week in Paris, the focus was clearly on new materials - ceramics, plastics and biologics. And among the most successful new materials companies... more

Oh yes, and Dynamite Comes in Small Packages, too. BY EDITOR, NOVEMBER 3, 2003

Demineralized Bone Matrix may have picograms of BMP, but it still delivers the goods to both patients and surgeons. We were wrong... really off base... last week when we took the bait offered in a NASS presentation and declared that... 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

Cementing its place in Orthopedics BY EDITOR, OCTOBER 8, 2003

Orthovita announced this week that it had been granted a patent covering 14 claims related to its ALIQUOT™ Micro Delivery System. ALIQUOT™ is a minimally invasive system to deliver the company's innovative and very interesting new product CORTOSS – which... more

Pre-Announcement Blues BY EDITOR, OCTOBER 8, 2003

Two major allograft suppliers, Regeneration Technologies and Osteotech, pre-announced 3rd quarter results last week and, as a result, endured fairly severe sell-offs. While the reasons given by each firm were different, the fact that it was these two suppliers caused... more

GenSci Set to Emerge from Bankruptcy with $50 Million in Cash, over $23 Million in Sales and a New DBM Product. BY EDITOR, SEPTEMBER 8, 2003

GenSci Orthobiologics is in the final stages of emerging from Chapter 11 bankruptcy. ISOTIS, the Netherlands based tissue engineering company, is merging with GenSci and setting the stage for a dramatic and interesting rebirth of this company that many, including... 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

Orthovita Books a 37% Pop in Sales and 83% Gross Margins. Can Break-even be far off? BY EDITOR, AUGUST 25, 2003

For the June quarter, Orthovita reported a 37% YOY jump in sales to $3.7 million. Gross margins were a stellar 83%. But losses for the quarter came in at $2.3 million (down from the prior year's $3.0 million loss for... more

More problems at CryoLife - and it goes well beyond sales or earnings. BY EDITOR, AUGUST 11, 2003

CryoLife reported a loss of $22.3 million on sales of $15.7 million for the quarter ended June 30. Orthopedic sales, which amounted to $280,000, were less than we'd expected and appear to have been delayed from management's earlier forecasts. But... more

In a testament to second chances, InFUSE gets CMS approval for $8,900. BY EDITOR, AUGUST 4, 2003

Rejected one year ago... Medtronic came back with new data and CMS, while rejecting InFuse again using one analytical approach found another way to show that InFUSE does indeed meet the threshold requirement for receiving a new technology add-on payment.... 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

The allograft industry post-CryoLife BY EDITOR, JUNE 30, 2003

It's been 19 months since a surgeon in central Minnesota unknowingly implanted a c.sordelli contaminated allograft tissue into a healthy 23 year old male. It's been 15 months since the Centers for Disease Control published its first findings from the... more

We have launched coverage of Osteotech and Orthologic and we briefly examine why Medicare Reimbursement is such a minor influence on orthopedic pricing. BY EDITOR, MAY 19, 2003

Osteotech is in the midst of a significant turn-around year with sales expected to reach or exceed $96 million and for cash flow (defined as EBITDA) to clear $23 million. This stands in contrast to last year's $83 million in... more


Complete Archive