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Orthopedic and Dental Industry News Complete Archive »

FDA

FDA Issued Final Guidance on Custom Medical Devices BY ANDREW VAHRADIAN, OCTOBER 15, 2014

The FDA issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal regulations. While much of the final guidance is identical to the January 2014 draft, there have... more

Premarket Approvals Being Awarded Twice as Quickly This Year Compared to 2013 BY ANDREW VAHRADIAN, AUGUST 19, 2014

According to new analysis provided by the Evaluate Group, the average premarket approval (PMA) review time in 2014 has been 18.4 months, twice as quick as the average time of 35.9 months in 2013. The Center for Devices and Radiological... more

FDA Clears the MicrO2 Sleep Apnea Device by MicroDental Laboratories - the First CAD/CAM Milled Sleep Apnea Device BY EDITOR, AUGUST 6, 2014

MicroDental Laboratories announced that the FDA has cleared the company's MicrO2 Obstructive Sleep Apnea Device. The first CAD/CAM milled Obstructive Sleep Apnea device, the MicrO2 offers dentists a new, innovative option for treating the growing number of patients diagnosed with... more

FDA Initiates Educational Program to Stimulate Faster Medical Device Development BY ANDREW VAHRADIAN, JULY 23, 2014

The FDA initiated its National Medical Device Curriculum, a program that will be utilized to educate students and entrepreneurs about the agency's process for evaluating medical devices. The program will provide students at academic institutions and science and technology innovators/entrepreneurs... more

Blue Belt Technologies Receives 510(k) Clearance for Patellofemoral Joint Replacement Application BY EDITOR, JULY 17, 2014

Blue Belt Technologies has received FDA clearance to market their latest surgical application for the Navio Surgical System, patellofemoral joint (PFJ) replacement surgery. The PFJ application expands the Navio Surgical System’s indications from unicondylar knee replacement to offer the full... more

FDA Approves the ReWalk Robotic Exoskeleton BY ANDREW VAHRADIAN, JULY 2, 2014

ReWalk Robotics received marketing approval from the U.S. FDA for its ReWalk Personal System for home and community use. The ReWalk device is a custom-fit, wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with lower... more

Proposed Expedited Regulatory Program For Medical Devices Addressing Unmet Medical Needs BY ANDREW VAHRADIAN, MAY 14, 2014

The FDA proposed a new expedited program that would provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology and devices. The Expedited Access... more

FDA Agrees to File PMA Amendment for Wright Medical’s Augment Product BY MATTHEW JAFFE, MARCH 11, 2014

Wright Medical reached an agreement with the Office of Device Evaluation (ODE) of the FDA regarding the approval of the company’s Augment Bone Graft product, intended for use as an alternative to autograft in hindfoot and ankle fusion procedures. The... 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

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

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

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

FDA Issues Final Rule on Unique Device Identifiers BY LAUREN UZDIENSKI, SEPTEMBER 23, 2013

The FDA issued a final rule on unique device identifiers (UDIs) last Friday, formalizing a long-awaited plan to apply unique labels to medical devices. The system is designed to provide more robust post-market surveillance, allowing the FDA to "identify product problems more quickly, better target recalls and improve patient safety." more

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

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

FDA to Conduct Study on Metal-on-Metal Hip Implant Corrosion BY ANDREW VAHRADIAN, AUGUST 13, 2013

In order to close a loophole in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, the FDA issued a proposed order in January that required metal-on-metal (MoM) hip arthroplasty implant manufacturers to... 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

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

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

New FDA Measures Aim to Improve the Regulatory Process for Medical Devices BY ANDREW VAHRADIAN, JUNE 28, 2013

In recent weeks, the FDA has proposed two measures that address its ambition to improve the efficacy of the medical device regulatory review process. The first measure issued by the FDA was a draft Investigational Device Exemption (IDE) guidance aimed... more

Blue Belt Technologies Announces US FDA Clearance to Market its STRIDE Unicondylar Knee System BY EDITOR, JUNE 5, 2013

Blue Belt Technologies, Inc., an innovative medical technology company commercializing robotic-assisted solutions for orthopedic surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its STRIDE Unicondylar Knee implant system. The... more

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

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

Study Reveals Rise in FDA Inspections and Warnings BY ANDREW VAHRADIAN, MAY 15, 2013

Over the last five years, medical device manufacturers have been inspected progressively more by the FDA, which has lead to an increase in the volume of warning letters issued by agency quality system inspectors. According to a study released by... more

Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus(TM) Internal Fixation Anterior Lumbar Interbody Fusion Device BY EDITOR, MARCH 12, 2013

Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a company with a mission to provide physician-inspired solutions for patients with spinal disorders, announced today that the Company has received clearance from the U.S. Food and Drug Administration... more

FDA Seeks to Maintain Consistent Clinical Data Requirements BY ANDREW VAHRADIAN, MARCH 8, 2013

The FDA has published a proposed rule that would require the clinical studies conducted outside the U.S. supporting medical device product registrations to be in accordance with Good Clinical Practice (GCP). These are standards upheld by the International Conference on... more

FDA Issues Draft Guidance on Third-party Device Review Program BY ANDREW VAHRADIAN, FEBRUARY 22, 2013

The FDA issued a new draft guidance document regarding the accreditation process for medical device companies utilizing its Third Party Review Program (TPRP). The draft aims to establish a regulatory framework that will be consistent with third party parameters currently... more

FDA to Tighten Regulation on Metal-on-Metal Hip Implants BY ANDREW VAHRADIAN, JANUARY 24, 2013

In order to close a loophole in the Medical Device Amendments of 1976, the federal law under which medical devices were first regulated, the FDA has issued a proposed order that will require metal-on-metal (MoM) hip arthroplasty implant manufacturers to... more

FDA Reports Shorter Device Review Times BY LAUREN UZDIENSKI, DECEMBER 24, 2012

Two years ago, the FDA announced plans to modernize their device division, aiming to minimize review times and simplify the regulatory process. Now the agency reports progress on their initiatives, with 510(k) review times decreasing for the first time since 2005, the 510(k) backlog reduced by two-thirds and the PMA review time decreasing by one-third. Further, the percentage of devices being approved is increasing, a sign of "improvements in the quality of applications and the consistency of review standards." more

Off-label Drug Promotion Upheld by Federal Court BY ANDREW VAHRADIAN, DECEMBER 7, 2012

A U.S. Court of Appeals has ruled that the FDA's ban on the off-label promotion of drugs between physicians and medical sales representatives violates a person's First Amendment right to free speech. The three-judge panel came to a 2-1 majority... more

FDA Aims to Improve Device Quality, Not Just Compliance BY LAUREN UZDIENSKI, NOVEMBER 6, 2012

In comments last month, Steve Silverman, Director of the CDRH's Office of Compliance, addressed new objectives for the FDA's device office: working with industry to improve not just compliance with existing regulations, but device quality. Silverman says this will hinge... more

FDA Announces Plans to Reduce 510(k) Assessment Timeframes BY ANDREW VAHRADIAN, OCTOBER 29, 2012

Following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year, the FDA has published guidance regarding reformed review timeframes and performance goals for 510(k) premarket notification of medical devices. The new targets are... more

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

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

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

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

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

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

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

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

FDA Publishes Draft Guidance on "Refuse to Accept" 510(k) Policy BY LAUREN UZDIENSKI, AUGUST 21, 2012

The FDA released draft guidance last week on a new "refuse to accept" policy for 510(k)s. The policy would implement an additional layer of preliminary review for 510(k)s to certify that an application "meets a minimum threshold of acceptability and should be accepted for substantive review." The initial review is largely administrative and designed to identify missing or incomplete components of an application. The FDA said they would notify the applicant of the outcome of this preliminary review within 15 days of receiving the 510(k). more

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

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

FDA to Review Metal-on-Metal Data This Week BY LAUREN UZDIENSKI, JUNE 27, 2012

Today the FDA's Orthopaedic and Rehabilitation Devices Panel will convene to review safety and efficacy data on metal-on-metal hips. The panel will look at data from published MoM literature as well as registry data from around the world. more

Von Eschenbach Calls for a "Modernized" FDA BY LAUREN UZDIENSKI, JUNE 20, 2012

In an editorial published by the Wall Street Journal, former FDA commissioner Andrew Von Eschenbach said a "modernized" FDA would get devices more quickly to the patients who need them and better equip the agency to track the devices once they're on the market. Without change, the authors write, patients will continue to face illness, disability and even death while they wait, and the innovation will be incentivized to move overseas. more

CDRH's Shuren Touts Improvements in FDA Process BY LAUREN UZDIENSKI, JUNE 14, 2012

In comments delivered in Memphis this week, CDRH Director Jeff Shuren announced that efforts to improve efficiency and speed up the regulatory process are paying off. Dr. Shuren said that decision times are decreasing and the FDA is engaging in less back-and-forth with devicemakers, and that progress will only continue with the support from the newly-authorized MDUFA III. "The good news is we're seeing the canary in the coal mine is actually singing these days," Shuren said of the CDRH. more

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

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

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

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

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

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

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

FDA Expands its Fast-Track Review Program, Innovation Pathway BY LAUREN UZDIENSKI, APRIL 10, 2012

The FDA announced yesterday that the agency has expanded their new Innovation Pathway, a fast-track program for novel medical devices, to include three new technologies designed to treat end-stage renal disease. more

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

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

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

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

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

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

Survey: FDA Scientists Address Leadership, Outside Influences, Decision Delays and More BY LAUREN UZDIENSKI, MARCH 9, 2012

A group called the Union of Concerned Scientists published a survey of 997 FDA scientists designed to evaluate "scientific integrity" at the agency, with questions covering resources, leadership and external influences. The UCS reports that responses have improved overall since the survey was last conducted in 2006, with more than twice as many respondents saying they believed the agency was "moving in the right direction". Further, 22% more respondents agreed that "FDA leadership is as committed to product safety as it is to bringing products to the market," which aligns with the change in tone that accompanied Margaret Hamburg's administration. more

Musculoskeletal News Roundup 8-Mar-12 BY LAUREN UZDIENSKI, MARCH 8, 2012

Corin, MAKO report earnings ... NLT Spine raises $5.7M ... Baxano receives CE mark for iO-Flex ... Synthes receives FDA warning letter ... Amedica launches Procet Facet Allograft Implant ... Crosstrees Medical completes enrollment in IDE study for VCF treatment ... Titan Spine creates EU subsidiary ... Vexim establishes German subsidiary 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

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

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

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

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

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

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

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

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

Industry, FDA Reach User Fee Agreement BY LAUREN UZDIENSKI, FEBRUARY 1, 2012

Reuters and others are reporting this morning that the FDA and industry have reached an agreement for the 2012 re-authorization of MDUFA, the legislation that allows the FDA to collect user fees from industry. User fees contribute about a third of the agency's budget. more

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

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

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

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

As Deadline Passes, User Fee Negotiations Continue BY LAUREN UZDIENSKI, JANUARY 17, 2012

Last Friday, the FDA announced agreements on user fee programs for drugs, generics and biosimilars, in time for a January 15th deadline for submitting the plans to Congress. The reauthorization for medical device user fees was not completed by the deadline and remains under negotiation. Bloomberg is now reporting that the FDA and device industry must come to a deal by February 15th, the date of a House Energy and Commerce health subcommittee meeting on the fees, or risk Congress taking over negotiations. more

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

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

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

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

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

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

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

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

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

Senate Bill Would Streamline FDA Process BY LAUREN UZDIENSKI, OCTOBER 17, 2011

Senators Amy Klobuchar (D-MN), Richard Burr (R-NC) and Michael Bennet (D-CO) have introduced new legislation that would relax the conflict-of-interest rules around FDA panels and mandate that the FDA use "all reasonable mechanisms to reduce review times". more

The Latest Developments for MDUFA III BY LAUREN UZDIENSKI, OCTOBER 12, 2011

The back-and-forth between industry and the FDA continues over the re-authorization of MDUFA, which grants industry user fees to the FDA. In the latest set of minutes from the ongoing negotiations, stakeholders address proposed changes to the process and how to achieve goals like shorter review times and a more transparent, predictable path to market. more

FDA, CMS Launch Joint Review Pilot BY LAUREN UZDIENSKI, OCTOBER 11, 2011

"Safe and effective" and "reasonable and necessary" will align in a new pilot program from the FDA and CMS. The two agencies will test the joint review of medical devices, enabling Medicare reimbursement coverage to coincide with market approval. Historically,... more

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

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

MDT's Ishrak: U.S. Should "Absolutely" Adopt EU Regulatory System BY LAUREN UZDIENSKI, OCTOBER 5, 2011

In comments to the Financial Times, Medtronic CEO Omar Ishrak criticized the FDA for a slow regulatory process that limits patient access to care. In the EU, "the response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers are less stringent," Mr Ishrak told the FT. He also spoke in favor of adopting a regulatory process more like the Europe's, adding, "It will certainly put products on the market more quickly, so from a very selfish device manufacturer perspective, absolutely." more

FDA Touts Advances in Regulatory Science BY LAUREN UZDIENSKI, OCTOBER 3, 2011

CDRH released a report yesterday highlighting the agency's activities in the field of regulatory science, efforts they say aid device manufacturers in product development and accelerate market approvals. more

Metal-on-Metal Hip Complaints Surging: NYT Analysis BY SANDER DUNCAN, AUGUST 23, 2011

The FDA received more complaints about metal-on-metal hip implants this year to date than in the preceding four years combined, according to a New York Times analysis of FDA data. more

FDA Releases Draft Guidance on the PMA BY LAUREN UZDIENSKI, AUGUST 16, 2011

Furthering its efforts at transparency in its regulatory processes, the FDA released new guidance on Monday regarding clinical study expectations for medical devices. Among the topics addressed in the document are selecting patients, sites and objectives, appropriate controls and sustaining a level of evidence. more

FDA Lowers User Fees in FY2012 BY LAUREN UZDIENSKI, AUGUST 2, 2011

The FDA will offset excessive user fee payments with a small reduction in fees for devicemakers in FY2012, according to documents released on Monday. Over the past few fiscal years, the agency has collected $9.5 million beyond what was appropriated, and this will be returned to industry in the form of a 7% reduction in registration fees as well as lower application submission fees. more

FDA and Industry React to the IOM's 510(k) Report BY LAUREN UZDIENSKI, AUGUST 1, 2011

The IOM's surprising recommendation that the 510(k) process should be scrapped was met with objections on Friday. Among the opposition to the proposal was the FDA, who requested this study back in 2009. more

IOM Calls 510(k) Process "Flawed", Recommends FDA Develop New System BY LAUREN UZDIENSKI, JULY 29, 2011

The long-awaited IOM report on the 510(k) framework was released this morning, and, not unexpectedly, the IOM found flaws in the system. Less expected was the recommendation that the 510(k) was beyond repair and the FDA should just start over. 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

FDA Studies Criticized by Editors of Leading Medical Journals BY LAUREN UZDIENSKI, JULY 21, 2011

Ahead of yesterday's House hearing, entitled Regulatory Reform Series #5 - FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs, Democrats asked the editors of leading medical journals to review two studies suggesting that the FDA is impeding U.S. device innovation. Their responses were scathing. more

Hamburg Appoints New Leadership at FDA BY LAUREN UZDIENSKI, JULY 14, 2011

The Wall Street Journal reports this morning that FDA commissioner Margaret Hamburg has created several new deputy commissioner roles, continuing to fill the responsibilities left vacant since former deputy commissioner Joshua Sharfstein's resignation. more

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

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

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

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

FDA Proposals to Improve Review Time, Communication, Staffing under MDUFA III BY LAUREN UZDIENSKI, JUNE 14, 2011

The FDA posted minutes from a recent MDUFA reauthorization meeting, providing some insight into difficulties in the current user-fee program and goals for MDUFA III. The program is currently set to expire at the end of FY 2012. 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 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

Metal-on-Metal Hips Under Fire as FDA Requests Post-Market Studies BY SANDER DUNCAN, MAY 11, 2011

The FDA has ordered all manufacturers of metal-on-metal hip implants to conduct studies of the devices. Metal-on-metal hips, once accounting for one-third of all artificial hips implanted annually in the United States, have come under fire recently following reports on high failure rates and increased wear debris. more

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

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

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

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

At Senate Hearing, FDA Under Fire BY SANDER DUNCAN, APRIL 18, 2011

The Senate Special Committee on Aging held a hearing Wednesday to explore how well the FDA balances safety and innovation when approving medical devices. The hearing is part of a broader bipartisan effort to review the FDA's 510(k) approval pathway. 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

IOM Completes Independent Review of the 510(k) Process BY SANDER DUNCAN, APRIL 5, 2011

The Institute of Medicine (IOM) completed its review of the FDA's 510(k) clearance protocol last week. The IOM study is the external component of an comprehensive review of the FDA's most common approval pathway for medical devices. Meanwhile, industry stakeholders are questioning the lack of medtech representatives on the IOM panel conducting the review. 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 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

Spurred by Recent Studies, House Panel Investigates Impact of Device Regulation BY SANDER DUNCAN, FEBRUARY 25, 2011

The House Energy and Commerce panel recently held a hearing on the “Impact of Medical Device Regulation on Jobs and Patients.” The hearing follows a trio of studies from Boston Consulting Group, PricewaterhouseCoopers and Stanford University which detail inefficiencies in the U.S. device approval process and the subsequent drag on medical innovation. more

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

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

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

FDA Introduces Medical Device Innovation Initiative BY LAUREN UZDIENSKI, FEBRUARY 8, 2011

The FDA announced this morning plans for a Medical Device Innovation Initiative, which is designed to make the regulatory process for new technologies more efficient. Among the proposed changes? Faster review times, permitting data collected OUS in submissions and clearer communication of data requirements more

X-Rays Go Mobile: FDA Clears First Radiology App BY LAUREN UZDIENSKI, FEBRUARY 7, 2011

The FDA announced on Friday that they've cleared the first mobile radiology app, meaning that scans like x-rays, CTs and MRIs can now be viewed on the go. The app is called Mobile MIM, and it's available for the iPad, iPhone and iPod Touch. 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

FDA Announces 510(k) Changes BY LAUREN UZDIENSKI, JANUARY 19, 2011

Deferring some of the more controversial decisions, the FDA announced 25 changes to the 510(k) process that primarily address transparency and clarity in the submission process. CDRH director Jeffrey Shuren said the agency would not implement the class IIB designation, which would address devices that require more comprehensive review, at this time. 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

FDA Deputy Commissioner Joshua Sharfstein to Step Down BY LAUREN UZDIENSKI, JANUARY 5, 2011

FDA Deputy Commissioner Joshua Sharfstein will resign his position at the agency after less than two years, according to a report in the Wall Street Journal. Dr. Sharfstein and Commissioner Margaret Hamburg ushered in a more stringent administration when they were appointed to the FDA in early 2009, driving an increase in warning letters and initiating a review of ReGen Biologics' market clearance for Menaflex. 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

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

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

FDA Responds to Device Industry Study BY LAUREN UZDIENSKI, NOVEMBER 30, 2010

FDA News reported (subscription required) comments from agency spokesman Dick Thompson in response to a device industry survey published last week. The study, partially funded by the MDMA, concluded that the agency's process is slow, costly and unpredictable compared to the EU's. more

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

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

Study: FDA Process "Unpredictable," "Characterized by Disruptions and Delays" BY LAUREN UZDIENSKI, NOVEMBER 22, 2010

A new medtech survey found that compared to the U.S. regulatory process, European approvals were faster, and EU regulatory authorities received substantially higher ratings in the area of "predictability," "reasonableness" and "transparency." As for "overall experience," 75% of respondents rated their regulatory experience in the EU excellent or very good, compared to 16% for the FDA. 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

Legislators Ask for More Transparency from FDA on 510(k) Recommendations BY LAUREN UZDIENSKI, OCTOBER 21, 2010

In a letter to FDA Commissioner Margaret Hamburg, a dozen members of the House Energy and Commerce Committee have requested greater transparency from the agency on their plans for 510(k) reform. 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

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

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

AdvaMed: FDA's Class IIb Proposal is Too Broad BY LAUREN UZDIENSKI, SEPTEMBER 27, 2010

When the FDA released a list of proposed changes to the 510(k) process, AdvaMed praised the agency for incorporating a new class IIb designation for devices that may require additional data. However, as more information emerged about the scope of class IIb, AdvaMed withdrew their support, noting that they recommended additional controls for a "small, focused" subset of devices narrower than what the FDA seems to have in mind. more

FDA and CMS Propose Simultaneous Reviews BY LAUREN UZDIENSKI, SEPTEMBER 20, 2010

The FDA and CMS are considering overlapping reviews of new products, which the agencies say could reduce the time between marketing and reimbursement decisions. more

Amid Industry Concerns, FDA User Fees to Increase Oct. 1 BY LAUREN UZDIENSKI, SEPTEMBER 15, 2010

The FDA will increase medical device user fees by 8.5% starting October 1. User fees, which have been in place since 2002, contribute to funding device reviews and are designed to get devices to market more quickly, though the FDA has struggled to meet performance goals. 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

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

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

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

CDRH Recommends Changes to the 510(k) BY LAUREN UZDIENSKI, AUGUST 4, 2010

The CDRH announced the conclusion of its internal 510(k) review, which culminated in a 120-page document proposing certain changes to the process. The agency says the recommendations are designed to "foster device innovation, create a more predictable regulatory environment and enhance device safety." 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

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

FDA to Release 510(k) Report BY LAUREN UZDIENSKI, JUNE 29, 2010

MassDevice reports that the results of the FDA's internal study of the 510(k) process may be available in the next few weeks. While CDRH director Jeff Shuren has kept quiet on any potential changes that may be implemented (the center had previously targeted September for certain revisions to the 510(k) process), he did confirm that "we're not recommending to get rid of the 510(k) program." 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 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

FDA May Make Application Info Public BY LAUREN UZDIENSKI, MAY 25, 2010

Per the recommendations of a transparency task force, a wider range of information about drug and device applications may become publicly available. Currently, the FDA only makes approvals public; an exception is made for applications that call for a panel recommendation, and of course some companies provide updates on their FDA filing status. 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

Jeffrey Shuren to Host CDRH Town Hall Meetings BY LAUREN UZDIENSKI, MAY 18, 2010

ucm195424.pngToday CDRH director Jeffrey Shuren will host a town hall meeting in Bloomington, Minnesota. On the agenda is an overview of the device group's 2010 priorities, but Shuren is also looking to get feedback from the device industry and the public.

Future town hall meetings will be held in Boston on June 22nd and Los Angeles in October. more

FDA Announces Changes to Panel Review Process BY LAUREN UZDIENSKI, APRIL 27, 2010

With the number of PMA applications on the rise, the FDA is adjusting how review panels weigh in on a device. Effective this Saturday, the FDA will implement changes to the panel review process and how panels frame their conclusions,... more

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

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

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

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

Dental News Roundup March 2010 BY LAUREN UZDIENSKI, MARCH 31, 2010

technician2_small.jpg FDA accepts PMA application from Ondine Biopharma Corporation, developers of the Periowave Photodisinfection System . . . Astra Tech launches OsseoSpeed TX implant line . . . Sirona introduces new 3D software for CEREC . . .Nobel Biocare provides clinical data on NobelActive, All-on-4 Solution and TiUnite . . . DTI, Nobel and Straumann strength management teams more

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

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

ReGen's Menaflex "Likely Safe"; FDA Weighing Next Steps BY LAUREN UZDIENSKI, MARCH 24, 2010

regen_logo.gifA CDRH panel convened yesterday to review the science behind the beleaguered Menaflex collagen meniscus implant, which has been the subject of near-constant scrutiny since its 510(k) clearance in December of 2008. 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

NIH, FDA Introduce "Fast Track" Initiative for New Devices BY LAUREN UZDIENSKI, MARCH 3, 2010

The NIH and FDA plan to collaborate on ways to bring innovative products to market sooner. postdoc_fda_logo1_small.jpg Among other actions, the two agencies plan to create a Joint Leadership Council, which will focus on encouraging researchers to think about regulatory issues early in the technology development cycle. The council will also work to incorporate the latest scientific data into the FDA review process. more

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

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

Industry and Public Weigh in on 510(k) Process BY LAUREN UZDIENSKI, FEBRUARY 19, 2010

Yesterday the FDA hosted an all-day public hearing to gain feedback on its 510(k) process, looking specifically at issues of predicate devices, new technologies, submission volume and post-market surveillance. The event was webcast and opened to a packed house -... 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

FDA Approves Xiaflex as the First Non-Surgical Treatment for Dupuytren's Contracture BY LAUREN UZDIENSKI, FEBRUARY 11, 2010

The FDA approved a BLA for Auxilium's Xiaflex (collagenase clostridium histolyticum) last week, following a unanimous panel recommendation (registration required) in September. Xiaflex is the first non-surgical treatment for Dupuytren's Contracture, which is characterized by a bending of the fingers... more

FDA to Fund Device Registry in 2011 BY LAUREN UZDIENSKI, FEBRUARY 9, 2010

As outlined in President Obama's proposed budget for the 2011 fiscal year, the FDA has increased their operating budget for the upcoming year by about 23% to $4 billion. The agency has said the bulk of the increase will be... 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

510(k) Under Review at the FDA BY LAUREN UZDIENSKI, FEBRUARY 3, 2010

Despite some prior indications that the 510(k) process would remain as-is for now, it seems 510(k) reform is now taking a prominent spot on the FDA's agenda for 2010, with one report saying "revisions" to the pathway should be in... more

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

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

Shuren Named Director of the CDRH BY LAUREN UZDIENSKI, JANUARY 25, 2010

Jeffrey Shuren, M.D. has been named director of the CDRH. He has served as acting director since Dan Schultz resigned in August of 2009, stating at the time that he aimed to review the 510(k) pathway, establish predictable regulatory pathways... more

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

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

PMAs Scrutinized at JAMA, American Journal of Therapeutics BY LAUREN UZDIENSKI, JANUARY 5, 2010

Over the past several years, the 510(k) pathway has repeatedly drawn criticism for being too lax. Now the more stringent PMA process is raising similar concerns following studies published in JAMA and the American Journal of Therapeutics. Both studies reviewed... 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

No Changes Imminent for the 510(k) Process BY LAUREN UZDIENSKI, DECEMBER 14, 2009

According to an editorial published in the Minneapolis Star Tribune, Dr. Jeffrey Shuren, acting director of the CDRH, has confirmed that no sweeping changes are imminent for the 510(k) process. The rigor of the 510(k) pathway has been a subject... 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 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

FDA: Pain Pumps Associated with Adverse Events in Shoulder Surgery BY LAUREN UZDIENSKI, NOVEMBER 18, 2009

The FDA is requiring manufacturers of pain pumps, including I-Flow and Stryker, to revise the labeling on their devices following reports of cartilage damage correlated with use of the pumps. Pain pumps are not indicated for intra-articular infusion after orthopedic... 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

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

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

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

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

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

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

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

FDA Panel Recommends DePuy's Ceramic-on-Metal Hip for Approval BY LAUREN UZDIENSKI, AUGUST 18, 2009

An FDA panel unanimously determined on Tuesday that DePuy's ceramic-on-metal hip, the Pinnacle CoMplete, is safe and effective, essentially recommending it for market approval. The panel also recommended modifying the labeling and undertaking a post-market study as conditions for approval.... more

CDRH Director Resigns BY LAUREN UZDIENSKI, AUGUST 13, 2009

FDA's director of the Center for Devices and Radiological Health, Dr. Daniel Schultz, is resigning his post following a "mutual agreement" with FDA commissioner Margaret Hamburg. The news follows complaints from critics that Schultz's oversight of the device industry may... 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

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

FDA Commissioner Plans a "Hard Look" at the CDRH BY LAUREN UZDIENSKI, JUNE 22, 2009

In an interview with the Wall Street Journal last week, FDA Commissioner Margaret Hamburg spoke to some of the ongoing concerns about the regulatory process for medical devices, saying the agency would take a "hard look" at the CDRH. The... 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

HealthpointCapital Interviews Gerald Masoudi, Co-Chair of the Food and Drug Practice Group at Covington & Burling LLP and Former FDA Chief Counsel BY LAUREN UZDIENSKI, JUNE 15, 2009

Gerald Masoudi is a partner in Covington & Burling LLP's Washington, DC office and co-chair of the Food and Drug practice group. Mr. Masoudi most recently served as Chief Counsel of the Food and Drug Administration. HealthpointCapital: Could you... 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

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

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

Hamburg and Sharfstein Share Their Vision for the FDA BY LAUREN UZDIENSKI, JUNE 2, 2009

In an editorial published in the New England Journal of Medicine, FDA Commissioner Margaret Hamburg and Deputy FDA Commissioner Joshua Sharfstein impart their vision of the agency as an advocate for the public health, speaking to concerns about infectious disease,... 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

FDA to Offer $2M in Pediatric Device Grants BY LAUREN UZDIENSKI, MAY 18, 2009

The FDA is offering $2.0 million in grants to support the development of medical devices for pediatric patients. The aim of the grants is to encourage devices designed specifically for the "size, growth, development and body chemistry" characteristics of pediatric... 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

FDA to Evaluate Clearance Process for ReGen's Menaflex BY LAUREN UZDIENSKI, MAY 13, 2009

The Wall Street Journal reports that the FDA will review its clearance of ReGen Biologics' Menaflex device. The Journal previously alleged that ReGen had undue influence on the regulatory process, making campaign donations to politicians who lobbied for the device's... 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

CDRH Holds Rare Meeting to Address Controversies and Plan for the Future BY LAUREN UZDIENSKI, APRIL 28, 2009

According to a report in the New York Times, CDRH officials met last week to discuss the "strategic direction" of the device-approvals division in the wake of both internal and external backlash. The events of this meeting have not been... more

FDA Requiring Safety and Effectiveness Data on Certain Class III Devices BY DAVID KRESSEL, APRIL 9, 2009

The FDA announced yesterday that it would be requiring companies who manufacture 25 specific devices marketed prior to 1976 to submit safety and effectiveness data so they can gauge product risk. The agency says this is in response to January's... 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

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

President Obama Nominates FDA Commissioner BY LAUREN UZDIENSKI, MARCH 17, 2009

President Obama announced his nominee for FDA commissioner over the weekend, naming Margaret A. Hamburg as the potential successor to Andrew von Eschenbach as the head of FDA. Joshua Sharfstein, the Baltimore Health Commissioner, will serve as Hamburg's deputy--unlike Hamburg,... more

The FDA Continues to Become More Conservative, Despite ReGen Experience BY DAVID KRESSEL, MARCH 13, 2009

In a recent Wall Street Journal article we blogged about last week, it was alleged that ReGen Biologics was able to put extreme pressure on FDA employees to ensure their Menaflex meniscus repair device was cleared via 510(k). If these... 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

ReGen's 510(k) Clearance Under the Microscope at the WSJ BY LAUREN UZDIENSKI, MARCH 5, 2009

When ReGen Biologics received 510(k) clearance last December for its meniscal repair product, Menaflex, it looked like a happy ending for the company after two failed FDA submissions and a long back-and-forth with the agency. Now it appears the story... 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 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

FDA, HHS Issue New Rules for IRBs BY ELOISE AUSTIN, FEBRUARY 4, 2009

A new set of companion regulations put in place on January 15, 2009 by the FDA and HHS Office for Human Research Protections (OHRP) will expand federal registration requirements for institutional review boards. Previously, the OHRP managed a registry of... 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

GAO Recommends PMA Submissions for All Class III Devices BY LAUREN UZDIENSKI, JANUARY 20, 2009

Last week the US Government Accountability Office (GAO) released its long-awaited report on the FDA's medical device approvals process. As expected, the report suggested that FDA review was too lax for certain class III devices cleared under 510(k) submission. Specified... 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

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

Congress to Investigate FDA Over Allegations of Misconduct BY LAUREN UZDIENSKI, NOVEMBER 25, 2008

In a letter to FDA Commissioner Andrew von Eschenbach last May, eight scientists at the FDA signed a letter questioning the integrity of certain unnamed product approvals. Now Congress has intervened, with representatives John Dingell and Bart Stupak (both D-Michigan)... 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

FDA Panel Recommends ReGen's Collagen Scaffold for 510(k) Clearance BY LAUREN UZDIENSKI, NOVEMBER 18, 2008

Last week the CDRH's Orthopaedic and Rehabilitation Devices Panel met to discuss ReGen Biologics' 510(k) application for its Collagen Scaffold, which is indicated for "reinforcement and repair of chronic soft tissue injuries of the meniscus." Beleaguered ReGen has received two... more

With Polls Closed and Votes Counted, What's in Store for the Device Industry? BY LAUREN UZDIENSKI, NOVEMBER 5, 2008

The morning after this historic election, President-Elect Barack Obama and an incoming Democratic Congress promise government-wide change and progress. How will the medical device industry be affected by the new administration? While details of the new administration's healthcare proposals are... 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

New York Times Questions the Safety, Efficacy of 510(k)s BY LAUREN UZDIENSKI, OCTOBER 27, 2008

The New York Times has joined a chorus of concern over the 510(k) process, suggesting in an article yesterday that 510(k)s are outdated (FDA device laws were passed "when devices played a much smaller role in medicine") and allow new... 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

Little Known FDA Clearance Path Gains Steam BY ELOISE AUSTIN, OCTOBER 9, 2008

The FDA "de novo" classification pathway is an often overlooked but potentially valuable regulatory clearance process for device manufacturers. The pathway involves a streamlined reclassification process for devices that are low-risk but have no sufficiently equivalent (NSE) predicate (i.e. have... more

GAO Report Could Shake Up the 510(k) Process BY LAUREN UZDIENSKI, OCTOBER 6, 2008

The 510(k) clearance process as we know it - roughly 90 days of FDA review time and minimal data requirements - could become more burdensome in the next few years as the FDA responds to what's widely expected to be... 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 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

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

FDA's Sentinel Program Will Track Medical Device Performance BY LAUREN UZDIENSKI, AUGUST 11, 2008

Following on the heels of the New York Times' call for a national joint registry, the FDA has announced plans to expand its Sentinel Initiative to encompass medical devices. The Sentinel program, launched in May, strives to be "a national,... 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

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

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

FDA Reports Shorter PMA, 510(k) Review Times BY LAUREN UZDIENSKI, JUNE 25, 2008

Companies filing PMAs or 510(k)s in the past few years have seen a reduction in review time, according to a new report from the FDA. 2002's MDUFMA, which was reauthorized last year through 2012, played a large role in speeding... 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 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 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

BioMimetic's GEM OS1 Study Can Proceed as Planned BY LAUREN UZDIENSKI, APRIL 22, 2008

In an "unusual and positive" move, the FDA has sent BioMimetic Therapeutics a letter confirming that the company's GEM OS1 IDE study can proceed as planned. This news comes three weeks after an FDA communication to J&J regarding an increase... 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 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

Amid China Fears, the White House Seeks to Broaden FDA's Access to Foreign Plants BY LAUREN UZDIENSKI, FEBRUARY 26, 2008

Baxter's heparin has been in the news lately following four deaths and hundreds of bad reactions, and with it the revelation that the Chinese plant that manufactured some of the heparin's ingredients had not been inspected by the FDA. Similarly,... more

Reports to Congress Find FDA Conducting Fewer Inspections, Lagging Innovation BY LAUREN UZDIENSKI, FEBRUARY 4, 2008

Does FDA have the resources it needs to oversee the device industry? This question emerges from GAO testimony reported in the Wall Street Journal (subscription required) delivered last week to a House subcommittee as well as a recent report from... more

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

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

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

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

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

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

"Unretrieved Device Fragments" Can Injure Patients, FDA Warns BY LAUREN UZDIENSKI, JANUARY 23, 2008

On its website last week, the FDA warned of the risks of debris left behind by medical devices, called unretrieved device fragments, or UDFs. These risks include local tissue reaction, infection, perforation and obstruction of blood vessels and death. While... more

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

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

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

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

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

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

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 8-Nov-07 BY LAUREN UZDIENSKI, NOVEMBER 8, 2007

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

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

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

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

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

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

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

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

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

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

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

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

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 20-Sept-07 BY LAUREN UZDIENSKI, SEPTEMBER 18, 2007

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

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

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

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

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

FDA to Change Inspection Policy BY ED ROSS, JULY 25, 2007

In the coming months, the FDA plans to implement significant changes in how the agency conducts inspections. First, the FDA plans to close seven regional offices within the Office of Regulatory Affairs (ORA), leaving only six operational. Remaining offices will... more

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

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

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

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

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

Cormet Gets FDA Approval, Stryker To Market As Early As 3Q:07 BY ARIELLA P. GOLOMB, MD, JULY 5, 2007

On Tuesday the FDA approved Corin's Cormet Hip Resurfacing System, introducing competition for Smith & Nephew's Birmingham Hip Resurfacing System in the U.S. Prior to Tuesday's announcement, the BHR was the only resurfacing system approved for the U.S. market. An... 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

New Provisions May Threaten Industry Support for MDUFMA II BY LAUREN UZDIENSKI, JUNE 19, 2007

At a House hearing last week, Advamed President and CEO Stephen Ubl voiced concerns over a draft of MDUFMA II, among them the possibility that the legislation will limit federal preemption. Preemption is the constitutional mandate that federal law, including... more

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

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

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

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

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

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

MDMA Celebrates 15 Years: Past Achievements and Looking Ahead BY LAUREN UZDIENSKI, MAY 21, 2007

Last week's Medical Device Manufacturers Association Annual Meeting in Washington, D.C. gave us an opportunity to applaud the passion and dedication that defined MDMA's past accomplishments and will carry future negotiations on regulatory, reimbusement and marketplace issues for smaller device... 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 3-May-07 BY LAUREN UZDIENSKI, MAY 3, 2007

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

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

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

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

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

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

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

FDA Announces Recommendations for MDUFMA II BY LAUREN UZDIENSKI, APRIL 17, 2007

The Medical Device User Fee and Modernization Act (MDUFMA II) will expire this September, and yesterday the FDA submitted their proposed recommendations for the Act's reauthorization. MDUFMA is medical device user fee program, wherein industry pays fees to support the... more

Orthopedic News Roundup 12-Apr-07 BY LAUREN UZDIENSKI, APRIL 12, 2007

Earnings Vertebron announced in a press release that 1Q:07 was its most profitable quarter ever. The Company attributes the growth to a significant sales increase over the comparable quarter last year as well as a company-wide restructuring in 3Q:06. Vertebron... more

FDA Makes Post-Approval Device Study Info Public BY LAUREN UZDIENSKI, APRIL 10, 2007

Plans for more rigorous post-marketing policy are underway at the FDA with a new website that tracks post-approval device studies. The website names the manufacturer, device, study description and study status. There is no specific info on clinical studies because... more

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

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

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

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

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

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

New Limitations for Industry Advisors BY LAUREN UZDIENSKI, MARCH 23, 2007

A proposed regulation from FDA commissioner Dr. Andrew von Eschenbach will alter the role industry advisors play on the agency's committees. The New York Times reported that if the measure is approved, advisors with more than $50,000 a year in... 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

FDA Approves Medtronic's INFUSE For Certain Oral Maxillofacial and Dental Applications BY ARIELLA P. GOLOMB, MD, MARCH 14, 2007

Medtronic announced yesterday that they received FDA approval to market INFUSE for oral maxillofacial and dental regenerative bone grafting procedures. This news follows the FDA Dental Products Advisory Panel recommendation for approval last fall. INFUSE has already been FDA approved... 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

Cormet Gets FDA Panel's Conditional Support BY ARIELLA P. GOLOMB, MD, FEBRUARY 23, 2007

Yesterday, the FDA Advisory Panel met and recommended Corin's Cormet hip resurfacing device for approval with conditions including a post marketing approval study, surgeon training and labeling. Prior to the meeting FDA raised questions about Corin's PMA submission relating to... 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

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

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

Orthopedics News Roundup 8-Feb-07 BY LAUREN UZDIENSKI, FEBRUARY 8, 2007

Earnings Biologics Regeneration Technologies, Inc. reported 4Q:06 revenues of $19.1 million, down 5% from $20.1 million in 4Q:05. The Company reported net loss of $6.7 million, compared to a net lossn of $1.7 million for 4Q:05. Net loss per diluted... more

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

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

Orthopedics News Roundup 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

MDMA Looks Ahead: MDUFMA, Reimbursement, Gainsharing and More BY LAUREN UZDIENSKI, JANUARY 22, 2007

This afternoon MDMA held its monthly call, outlining policy changed that are on the horizon for 2007. We've outlined some of their comments below: MDUFMA Negotations for MDUFMA II have been ongoing since February of 2006. The FDA has recently... more

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

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

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

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

Orthopedic News Roundup 16-Nov-2006 BY LAUREN UZDIENSKI, NOVEMBER 16, 2006

Earnings: Langer reported their 3Q:06 results on Tuesday, which included a net loss of approximately $553,000, or $.06 per share on a fully diluted basis. Compared to 3Q:05, there was a net income $236,000, or $.02 per share on a... more

MDMA Conference Provides Reimbursement Advice BY ARIELLA P. GOLOMB, MD, NOVEMBER 13, 2006

Last week we attended the 9th Annual MDMA Coverage Reimbursement and Health Policy Conference in Washington D.C. As we've previously discussed, the MDMA events are a terrific opportunity for small- to medium-sized device companies to network, provide insight on topical... more

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

New Regulations for Device Reprocessors BY LAUREN UZDIENSKI, OCTOBER 17, 2006

Last July, we covered the debate between third-party reprocessors and original equipment manufacturers (OEMs.) Last month, the FDA issued new regulations for reprocessing of single-use devices (SUDs). The FDA now requires reprocessed devices to be marked "prominently and conspicuously," a... more

Justice Department Charges Former FDA Chief BY JOHN MCCORMICK, OCTOBER 16, 2006

Today the Justice Department filed criminal charges against former FDA chief Lester Crawford with lying about his ownership of stock in companies regulated by the FDA during his tenure. He has been accused with falsely reporting that he had sold... 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

Medtronic's Disc Recommended for FDA Approval BY ARIELLA P. GOLOMB, MD, SEPTEMBER 20, 2006

Yesterday's FDA Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval of Medtronic's PRESTIGE Cervical Disc System. After reviewing the 24 month, ~500 patient multi-center randomized clinical trial data, Wall Street Journal (subscription required) reported that the FDA panel concluded... more

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

Group Purchasing Organizations and Market Reform: What's Ahead for Device Companies? BY EDITOR, SEPTEMBER 5, 2006

February 2010 update: This report is no longer available for purchase. Learn more here.     Fact: GPO-negotiated contacts drive more than $100 billion in device purchases by hospitals.     News Item: The DOJ, the Connecticut Attorney General, three U.S. Senators, and the... 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

Allograft Industry Faces Another Donor Scandal BY ARIELLA P. GOLOMB, MD, AUGUST 28, 2006

Donor Referral Services of North Carolina is at the center of a new scandal surrounding donor tissue and was shut down by the FDA on August 18, 2006. The order forced the facility to cease manufacturing and to retain Human... more

FDA Panel to Vote On Medtronic's Cervical Disc BY ARIELLA P. GOLOMB, MD, AUGUST 23, 2006

The FDA's Orthopaedic and Rehabilitation Devices Panel will be meeting on September 19, 2006. The committee will discuss, make recommendations and vote on a premarket approval application for Medtronic's Prestige ST artificial cervical disc. This metal on metal, ball and... more

Synthes PRODISC Receives FDA Approval BY JOHN MCCORMICK, AUGUST 15, 2006

Yesterday Synthes Spine received a letter from the FDA indicating that its PRODISC lumbar total disc replacement device PMA has been approved. Typically when a PMA is approved, the FDA attaches conditions and restrictions to use of the device and... more

Orthopedic News Roundup 10-Aug-06 BY HUYEN NGUYEN, AUGUST 10, 2006

Earnings: Biologics: Orthovita reported 2Q:06 product sales came in at $11.2 million, up 32% compared to 2Q:05. On a non-GAAP basis net loss for the quarter was $5.1 million, or a loss of $0.10 per share. The Company did not... more

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

Orthopedic News Roundup 3-Aug-06 BY HUYEN NGUYEN, AUGUST 3, 2006

Earnings: Biologics: IsoTis OrthoBiologics reported 2Q:06 revenue of $10.8 million, up 43% compared to $7.5 million in 2Q:05. Its U.S. division grew 22%, while international revenues grew 39%. The Company has three distribution channels: U.S. independent agents, international distributors and... more

Disc Dynamics Receives FDA Go Ahead for Nucleus Study BY JOHN MCCORMICK, AUGUST 1, 2006

Disc Dynamics, a Minnesota-based spine start-up, has just received an IDE from the FDA to commence a study on its DASCOR minimally invasive nucleus replacement technology. The DASCOR is a polyurethane device which has a modulus of elasticity similar to... more

FDA Grants IDE For Medtronic's DIAM(TM) Spinal Stabilization System BY ARIELLA P. GOLOMB, MD, JULY 10, 2006

Medtronic, Inc. announced today that the FDA granted an investigational device exemption (IDE) to the DIAM(TM) Spinal Stabilization System for use in a clinical safety and effectiveness study. The DIAM System will be measured against posterior lumbar interbody fusion, the... more

Orthopedic News Roundup 6-Jul-06 BY HUYEN NGUYEN, JULY 6, 2006

Appointments: Tutogen Medical appointed Dr. Karl Koschatzky to the position of Managing Director. Dr. Koschatzky will replace Manfred Kruger, who was Tutogen's President of International operations and Managing Director of the German subsidiary. IsoTis OrthoBiologics appointed James William (Jim) Poser,... more

Zimmer Gains FDA Approval For Ceramic Hip BY ARIELLA P. GOLOMB, MD, JULY 6, 2006

Zimmer announced today that it received FDA approval of its Premarket Approval Application (PMA) to market the Trilogy AB® Ceramic-on-Ceramic Acetabular System. Zimmer originally submitted its request for approval to market the Trilogy AB products in December 2004. The product... more

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN, JUNE 29, 2006

Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's... more

NuVasive Gets IDE Approval for NeoDisc BY JOHN MCCORMICK, JUNE 28, 2006

This morning NuVasive announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the FDA to begin clinical trial enrollment of its NeoDisc cervical disc replacement device. The NeoDisc outcomes will be compared to the traditional... more

Decline in FDA Enforcement Activity BY ARIELLA P. GOLOMB, MD, JUNE 27, 2006

Yesterday, Representative Henry Waxman (D-CA) released a report entitled, "Prescription for Harm: The Decline in FDA Enforcement Activity," which was prepared by the House Committee on Government Reform, Special Investigations Division. After 15 months of investigation and a review of... more

Update on the Statistical Method for Clinical Trials BY NICK ADAM, JUNE 26, 2006

The CDRH recently published a "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Draft Guidance for Industry and FDA Staff". The draft guidance describes the FDA's suggestions for the use of Bayesian statistics in the... more

Orthopedic News Roundup 22-Jun-06 BY HUYEN NGUYEN, JUNE 22, 2006

Appointment: Smith & Nephew appointed Michael G. Frazzette as President of the Endoscopy division and a member of the Company's Group Executive Committee. Mr. Fazzette recently served as President & CEO of MicroGroup, Inc., a private, equity-owned contract manufacturer of... more

Who is Les Weinstein? BY LAUREN UZDIENSKI, JUNE 21, 2006

You may not know his name, but Les Weinstein plays a crucial role at the Center for Devices and Radiological Health (CDRH). Appointed in 2000 as the agency's first Ombudsman, he is an external voice of neutrality in disputes between... 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

A Voice for Innovation: MDMA BY LAING RIKKERS, JUNE 16, 2006

On June 14th and 15th, we attended the Medical Device Manufacturers Association (MDMA) Annual Meeting. The organization provides medical device entrepreneurs an opportunity to have their voices heard on the hill. Innovation in our industry generally comes from the smaller... more

Who's Who of the Medical Device Lobby BY ARIELLA P. GOLOMB, MD, JUNE 14, 2006

The Hill, "The Newspaper for and about the U.S. Congress", posted on its website last week a list of 14 top medical device industry lobbyists. Leading this list is Stephen Ubl, who is seen as "a triple-A superweight." Newly appointed... more

Class III Continues for Bone Growth Stimulation BY LAING RIKKERS, JUNE 9, 2006

On Friday, June 2, the FDA's Orthopedic and Rehabilitation Devices Panel met to discuss the RS Medical petition to reclassify noninvasive bone growth stimulators from Class III to Class II. In a 4-2 vote, the panel recommended leaving the bone... 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

FDA Gives Facet Solutions Go Ahead for IDE BY JOHN MCCORMICK, MAY 9, 2006

Yesterday, Facet Solutions, Inc. announced that the FDA granted the Company an IDE approval for its Anatomic Facet Replacement System (AFRS). The device has been developed to provide lumbar spinal stenosis and facet degeneration patients with a motion preserving alternative... more

Orthopedic News Roundup 27-Apr-06 BY HUYEN NGUYEN, APRIL 27, 2006

Appointment: Stryker Corp. appointed three officers to the company: Luciano Cattani, Vice President, Group President, International; Elizabeth A. Staub, Vice President of Regulatory Affairs and Quality Assurance, Stryker Corporation and Bronwen R. Taylor, Chief Compliance Officer, Stryker Corporation. Mr. Cattani... more

Orthopedic News Roundup 20-Apr-06 BY HUYEN NGUYEN, APRIL 20, 2006

Many orthopedic companies will be reporting their 1Q:06 results in the next few weeks. The table below provides a listing of conference call dial-in numbers and webcasts for the investment community. How the overall orthopedic industry fared in the first... more

FDA Approves CORTOSS Study Modifications BY JOHN MCCORMICK, APRIL 17, 2006

This morning Orthovita announced that the FDA has approved its request to modify it's CORTOSS study design. The prospective randomized controlled multi-center IDE study is underway in the U.S. and is designed to demonstrate that CORTOSS is safe and effective... more

Impact of Direct-to-Consumer Advertising BY MATTHEW JAFFE, APRIL 6, 2006

Kevin Bozic, MD of UCSF presented the impact of Direct to Consumer Advertising (DTCA) in Orthopedics during the Health Policy Symposium at AAOS. Since the FDA issued a draft guidance for consumer directed advertisements in the late 90's, first pharmaceutical... more

F.D.A. Chief Nominated by Bush BY LAING RIKKERS, MARCH 16, 2006

Yesterday, President Bush nominated Dr. Andrew C. von Eschenbach as the commissioner of the Food and Drug Administratration (F.D.A.). Dr. von Eschenbach has been the acting commissioner since September 2005 when his predecessor, Lester Crawford, abruptly resigned. There was initially... more

Orthopedic News Roundup 23-Feb-06 BY LAING RIKKERS, FEBRUARY 23, 2006

Financing: BioMimetic Therapeutics, Inc. filed a registration statement for an Initial Public Offering. Earnings: Medtronic 3Q Earnings climb 23 percent. CryoLife fourth quarter 2005 revenues increased 13% over fourth quarter 2004 Gross margins for full year 2005 increased to 53%... more

Biomet Gets FDA Approval BY SHELLY ACHAIBAR, JANUARY 6, 2006

Biomet received FDA approval for the C2a-Taper Acetabular System, a ceramic-on-ceramic hip replacement system. Biomet's FDA approval follows Stryker, Wright Medical, Encore Medical, Smith & Nephew and Zimmer. President and CEO Dane A. Miller, Ph.D. stated, "We are pleased to... more

Orthopedic News Roundup 8-Dec-05 BY HUYEN NGUYEN, DECEMBER 8, 2005

Due to last week's Merrill Lynch investor conference (subscription may be required), investors have regained confidence in the orthopedic sector after the industry faced some hurdles within the past few months. In our HealthpointCapital Weekly Valuation Index, P/E (price-to-earnings) jumped... more

Orthopedic News Roundup 1-Dec-05 BY HUYEN NGUYEN, DECEMBER 1, 2005

Appointment: OrthoSoft announced that Max Link has joined its Boards of Directors. With over 25 years of experience, Mr. Link is a very well-recognized individual in the medical device and pharmaceutical industry. He was CEO and Chairman of Centerpulse when... more

St. Francis Gets FDA Approval BY JOHN MCCORMICK, NOVEMBER 22, 2005

After and long and contentious approval process with the FDA, St. Francis Medical Technologies, Inc. announced this morning that it has received FDA approval to market its X STOP Interspinous Process Decompression System. X STOP (and the interpinous processes paradigm... more

Biomimetics gets FDA Pre-Market Approval BY JOHN MCCORMICK, NOVEMBER 21, 2005

Biomimetic Therapeutics, Inc. announced today that it has received approval from the FDA for GEM 21S, a fully synthetic regeneration system for the treatment of periodontal bone defects. According to the management, this is the first totally synthetic product combining... 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

HealthpointCapital posts latest report: FDA Approval for Orthopedic Devices BY EDITOR, NOVEMBER 15, 2005

What the Process Demands and How to Adapt Your Strategy

Our latest report describes the entire FDA approval process for orthopedic devices, and gives you 21 questions that help make your approval effort more thorough. more

Orthopedic News Roundup 27-Oct-05 BY HUYEN NGUYEN, OCTOBER 27, 2005

It has been a busy week for many CEOs and CFOs in the orthopedic device sector. In the past two weeks orthopedic companies reported 3Q:05 sales of $4.7 billion which was a 12% increase over the 3Q:04. Net earnings for... more

NuVasive Files IDE for Cervical Nucleus BY JOHN MCCORMICK, OCTOBER 24, 2005

Only two months ago NuVasive, Inc. acquired the NeoDisc cervical disc nucleus technology from Pearsalls and just this morning NuVasive announced that it has filed an IDE for the device. Back when they bought the NeoDisc, they said this was... more

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

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

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

Orthopedic News Roundup 29-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 29, 2005

It's all about spine this week. With NASS in full swing in Philadelphia, many companies eagerly issued press releases during the conference. Clinical: Cervical-Stim® is a post-operative cervical brace that generates a uniformed, low-level pulsed electromagnetic field (PEMF) at the... more

FDA: Direct-to-Consumer Promotion for Devices BY HUYEN NGUYEN, SEPTEMBER 27, 2005

On November 1 and 2, 2005 the FDA will hold a two-day public meeting on direct-to-consumer ("DTC") advertising of prescription drugs and medical devices. The FDA is requesting comments from interested individuals and/or groups that are most affected by DTC... more

Lester Crawford Abruptly Quits FDA BY JOHN MCCORMICK, SEPTEMBER 26, 2005

FDA Commissioner Lester Crawford abruptly resigned Friday after a lengthy tenure as Acting Commissioner and a tenuous confirmation process. The decision shocked agency staff and neither the FDA nor the White House has given an explanation for the resignation. There... more

Novel Products to Rejuvenate Hip Market Growth BY JOHN CHOPACK, SEPTEMBER 21, 2005

The rate of growth in the hip market has been somewhat lackluster since the 2Q:04. That quarter marked the first two FDA approvals for ceramic-on-ceramic hips for Stryker and Wright Medical. For the 12 months prior to the 2Q:04, Stryker... more

FDA: Trial Design for Spinal Devices BY LAING RIKKERS, SEPTEMBER 9, 2005

Today, the FDA hosted approximately 200 people at an Advisory Committee meeting to look at the "Design of Clinical Studies for Spinal Devices to Treat Mild to Moderate Low Back Pain". FDA has been struggling over the past year with... more

Orthopedic News Roundup 9-Sept-05 BY HUYEN NGUYEN, SEPTEMBER 9, 2005

The FDA Orthopedic and Rehabilitation Devices Panel held a meeting September 8th and 9th to rule on two important issues: Smith & Nephew's hip resurfacing device and the design of clinical studies for spinal devices. You can find background information... more

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

Facet Joint Arthroplasty Milestone: Archus Initiates U.S. Clinical Trial BY JOHN MCCORMICK, AUGUST 30, 2005

Archus Orthopedics, Inc. announced this morning that it has formally initiated enrollment in the U.S. clinical trial of its Total Facet Arthroplasty System or TFAS(TM). The TFAS(TM) is patented spinal implant designed to treat spinal stenosis. The device replaces degenerative... more

Anulex Receives FDA Clearance for Annular Repair Technology BY JOHN MCCORMICK, AUGUST 23, 2005

Anulex Technologies, Inc., a company focused on soft tissue repair of the spine, announced yesterday that it received a 510(k) clearance from the FDA recently. Inclose is a simple umbrella shaped polymer implant that seals the opening in the annular... more

FDA to Hold "Town Hall" Type Meetings BY JOHN MCCORMICK, AUGUST 16, 2005

Press reports are surfacing that the FDA is planning a series of Public-Input meetings at various locations this fall called the "Vision Tour". As we currently understand it, top andministrators and scientists, including Commissioner Lester M. Crawford, plan on attending... 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

Differentiating the Needs of Key Stakeholders to Obtain Reimbursement for New Technologies BY KELLI HALLAS, AUGUST 9, 2005

By Kelli Hallas Vice President of Field Reimbursement Services Emerson Consultants, Inc. [Editor's note: We welcome consultant Kelli Hallas as a guest blogger.] In order for new technologies to receive reimbursement in today's healthcare market, they must show substantial clinical... more

Orthopedic News Roundup 29-Jul-05 BY HUYEN NGUYEN, JULY 29, 2005

Earnings: Please refer to the table (below) for individual company sales and earnings. It's all about earnings this week... Biologics: Clearly, the big winner this week is LifeCell Corp. who reported strong earnings on Monday stock was up 24% at... more

Orthopedic News Roundup 22-Jul-05 BY HUYEN NGUYEN, JULY 22, 2005

Appointment: Tutogen Medical appointed Terry Hill, MD to Director of Quality Assurance and Quality Control. He has worked with various tissue banks prior to joining Tutogen. Clinical Update: At the 12th International Meeting on Advanced Spine Techniques (IMAST) Conference, Dr.... more

NuVasive Files IDE for Cervical Disc BY JOHN MCCORMICK, JULY 6, 2005

This morning NuVasive announced that that it filed for an IDE from the FDA to investigate the safety and efficacy of its Cerpass(TM) ceramic-on-ceramic cervical disc. The filing was completed at the end of June. Approval of the IDE from... more

Healthcare Policy Conference Notes BY LAING RIKKERS, JUNE 30, 2005

Greetings from the SG Cowen and ISI Health Care Policy Conference in Washington D.C. It's been a full day covering Medicare, Medicaid, FDA, Specialty Hospital Policy and Gainsharing. We've heard from Representative Pete Stark (D-CA) and Senator Debbie Stabenow (D-MI),... more

Orthopedic News Roundup 24-Jun-05 BY HUYEN NGUYEN, JUNE 24, 2005

The New York Times covers (registration required) the obstacles facing evidence-based medicine in a cardiac-centric article that touches on orthopedics. Hospitals are pressuring device prices down, and TheStreet.com gives a good quick treatment to the the reimbursement issue we cover... more

Knowing the Policies BY LAING RIKKERS, JUNE 16, 2005

We think reimbursement and regulatory issues are critical in orthopedics. On June 30th, John McCormick and I will be attending the SG Cowen and ISI Health Care Policy conference in Washington D.C. It looks like a great set of speakers... more

Senate Panel Approves Crawford as FDA Head BY JOHN MCCORMICK, JUNE 15, 2005

Lester Crawford's lengthy approval process to formally serve as FDA Commissioner took a great leap forward today when the Senate Committee on Health, Education, Labor and Pensions approved his nomination. To date, he has held the post of Acting Commissioner... more

No Hanky Panky at FDA: Crawford Confirmation Moves Forward BY JOHN MCCORMICK, JUNE 9, 2005

An inquiry requested by Wyoming Senator Mike Enzi, concluded yesterday clearing acting Food and Drug Administration Commissioner Lester Crawford of having an extramarital affair with an agency employee. The inquiry was conducted by the inspector general of the Department of... more

An Interview with Dr. Charles Rosen on Artificial Disc Clinical Trials BY JOHN MCCORMICK, MAY 23, 2005

In our efforts to poll surgeons on the subject of artificial lumbar discs, we have been tracking down advocates as well as dissenters in order to get a balanced view. Last month at AANS we interviewed Dr. Fred Geisler who... more

Artificial Discs: A Discussion with Dr. Fred H. Geisler BY JOHN MCCORMICK, APRIL 25, 2005

Last week I caught up with Dr. Fred Geisler at AANS in New Orleans to discuss artificial disc clinical trials and surgeon adoption of artificial discs. Throughout the week, Dr. Geisler led the Academy as the principal thought leader on... more

Notes on the New FDA Oversight Board and Pending Lester Crawford Nomination BY JOHN MCCORMICK, FEBRUARY 14, 2005

This morning, newly sworn in House and Human Service Secretary Mike Leavitt announced the creation of a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they are on the market. The Board will continually update physicians and... more

Johnson & Johnson (NYSE:JNJ) Reports 4Q:04 Results: We Examine DePuy's Charite BY JOHN CHOPACK, JANUARY 31, 2005

JNJ reported revenues of $12.8 billion for the 4Q:04 which was a 13% increase over the 4Q:03. DePuy, JNJ's orthopedic division, reported revenues of $952 million for the 4Q:04. This was a 19% increase as reported and a 15% increase... more

Orthofix gets Long-Awaited PMA BY JOHN MCCORMICK, JANUARY 10, 2005

In late December, Orthofix (Nasdaq: OFIX) announced a significant milestone: it received an FDA approval to market its Cervical-Stim' bone growth stimulator as an FDA Class III device. That makes Orthofix the first and only company to provide an FDA-approved... more

Smith & Nephew (SNN:NYSE) Receives FDA Approval For Ceramic-Ceramic Hip and Introduces Imageless Computer-Assisted Surgical Navigation System. BY JOHN CHOPACK, JANUARY 10, 2005

SNN became the fourth orthopedic manufacturer to gain FDA approval of a ceramic-on-ceramic hip behind Stryker Corp., Wright Medical and Encore Medical. Ceramic-on-ceramic hips offer superior wear characteristics compared to traditional polyethylene and metal-on-metal hips providing the potential to last... more

FDA Issues Final Good Tissue Practices Rule BY ROBIN R. YOUNG CFA, NOVEMBER 29, 2004

Literally millions of patients have benefited from receiving tissues donated by their fellow humans. Formerly wheelchair bound patients now walk. Formerly sightless patients now see. Patients with debilitating back pain now enjoy active lives. Cancer patients, auto accident victims. The... more

VIOXX Wars Good News for Large Joint Reconstruction Market BY ROBIN R. YOUNG CFA, NOVEMBER 29, 2004

The lawyer's ads are all over the country and all over the two broadest media outlets we know - television and the internet. "Learn about Vioxx, the Vioxx recall and potential health risks!" "Are you a Vioxx Patient? Find out... more

The FDA Approves Charite Disc Arthoplasty BY ROBIN R. YOUNG CFA, NOVEMBER 3, 2004

Hats off to DePuy Spine for winding this approval through the FDA so masterfully. The timing (to coincide with NASS) was exactly right. The website is excellent and we repeat some key points from it later in this commentary. Future... more

Cartilage Repair Comes of Age: An Interview with Gerald 'Gary' Bisbee, CEO of ReGen Biologics, Inc. BY JOHN MCCORMICK, OCTOBER 25, 2004

Cartilage repair is coming of age. One of the leaders in this emerging technology is ReGen Biologics. During the recent HealthpointCapital Biologics Summit, we spent a few quality moments interviewing Gary Bisbee, CEO of ReGen Biologics. JM: Introduce our Readers... more

Ceramic-on-Ceramic Hip Arthroplasty: Impact on the Market BY JOHN CHOPACK, OCTOBER 25, 2004

Given that the first ceramic-on-ceramic hip arthroplasty approval came approximately a year and half ago, we thought it would be a good time to analyze its effect on the market to date and what we expect in the future. Although... more

VIOXX: Systemic Problems Doom Another Systemic Drug BY ROBIN R. YOUNG CFA, OCTOBER 4, 2004

Since its introduction, more than 91 million prescriptions for VIOXX have been written in the United States for patients with arthritis pain in either the hip or knee. If one were to include all the prescription Cox-2 inhibitor drugs like... more

Wright Medical (WMGI: NASDAQ) Lowers 3Q:04 Earnings Guidance by $0.04 BY JOHN CHOPACK, SEPTEMBER 27, 2004

WMGI announced that it was lowering its previous earnings per share guidance of $0.13-$0.15 to a range of $0.09-$0.11, or approximately $3.2 - $3.9 million. However, the Company maintained its current revenue projections for the 3Q:04 of $68 - $70... more

The FDA's Ortho Panel Puts an Arrow in St. Francis BY ROBIN R. YOUNG CFA, SEPTEMBER 13, 2004

You can always tell who the pioneers are by the arrows in their backs. St. Francis's first FDA panel meeting was not pretty and the outcome knocked start-up firm St. Francis Medical back on its heels. On September 3/2004, the... 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

Blood Sucking Invertebrates Declared Medical Device by FDA BY ROBIN R. YOUNG CFA, JULY 12, 2004

The FDA has approved leeches for clinical use and has, furthermore, declared them a medical device. This approval, once again, brings into question the definition of a medical device. InFuse', for example, is a medical device even though it's an... more

DePuy, Stryker and Synthes Receive Most FDA Approvals YTDwhile Zimmer lags BY ROBIN R. YOUNG CFA, JUNE 21, 2004

Fill the salesman's bag. Advance the art and practice of orthopedics. Create superior returns for your shareholders. None of these are possible without the FDA's initial and ongoing approval. So far this year, the FDA has granted 214 orthopedic device... more

510(k) Approvals BY EDITOR, JUNE 21, 2004

  Device Applicant 510(k) Decision Date 1 acumed lower extremity congruent plate s acumed llc K033639 1/15/2004 2 titanium cannulated interference screw advanced biomaterial K033749 2/23/2004 3 aesculap absorbable craniofix aesculap, inc. K040080 3/31/2004 4 abc caudal and cranial extension... more

Only One Clinical Trial Counts with the Charite BY ROBIN R. YOUNG CFA, JUNE 14, 2004

The FDA panel's recommendation was unanimous. That's the bottom line. Based on a single clinical trial, each member of that panel voted for eventual commercialization of the Charité disc arthroplasty. And what a clinical trial: 304 patients, randomized, prospective, lead... more

It's About Time! Mobile-Bearing Knee Is Headed for a Down Classification BY JOHN CHOPACK, JUNE 7, 2004

On Wednesday of last week, (June 2/2004) an FDA panel recommended to down classify both the tricompartmenal and unicompartmental mobile bearing knee by a vote of 6 to 2 and 5 to 3, respectively. Although this doesn't guarantee that the... more

FDA Panel Decides Charite Approvable with 5 Conditions BY ROBIN R. YOUNG CFA, JUNE 2, 2004

Despite being implanted in several thousand patients over the course of the past decade, it was a group of 205 Charité patients that the FDA panel scrutinized today before arriving at its recommendation to approve the Charité for commercial sale... more

Miniature Spine Surgery Robot Approved by FDA BY ROBIN R. YOUNG CFA, MAY 17, 2004

The FDA last week approved Mazor Technologies innovative miniature spine surgery robot, SpineAssist, for use in all types of spine surgeries. The device is no bigger than a soda pop can. Sitting on top of the spine, it guides spine... more

FDA Approves Second Growth Factor for the Spine BY ROBIN R. YOUNG CFA, APRIL 12, 2004

With InFuse® (BMP 2) selling at a rate of $1 million per day for Medtronic's Sofamor Danek subsidiary, the news that Stryker Corporation has received approval to sell OP-1 (BMP 7) for spinal indications is significant news. Three years ago,... more

FDA approves use of polymethylmethacrylate (PMMA) in spine - specifically for Vertebral Compression Fractures BY ROBIN R. YOUNG CFA, APRIL 5, 2004

Kyphon announced this morning that its application to receive FDA approval for its PMMA bone cement product, KyphX® HV-R™ Bone Cement, has been approved. This will be the first approved PMMA bone cement for use in the spine. PMMA has... more

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

Down Classification of Mobile Bearing Knee for Total Knee Arthroplasty Commentary BY JOHN CHOPACK, FEBRUARY 2, 2004

Currently, DePuy is the only orthopedic manufacturer FDA approved to market a mobile bearing knee in the U.S. While a majority of manufacturers market their mobile knee prosthesis overseas, most have been content on waiting for the FDA to down... more

Charite Artificial Disc FDA Approval Expected Mid-2005 – according to DePuy Spine BY ROBIN R. YOUNG CFA, JANUARY 26, 2004

In last week's JNJ conference call with analysts, management stated that its DePuy Spine division was expecting FDA approval for the Charité Artificial Disc in the United States by the first half of 2005. The Charité Disc, which was obtained... more

FDA Orthopedic Panel recommends spine cages be down-classified — 510(k) approvals now possible BY ROBIN R. YOUNG CFA, JANUARY 2, 2004

The FDA's orthopedic panel met this past December 11th and recommended that the FDA reclassify intervertebral body cages from a Class III to a Class II medical device. Class III devices are defined as life sustaining or life supporting devices... more

New York Times Caves In to Market Forces - Attempts Major Surgery on Spine Industry BY ROBIN R. YOUNG CFA, JANUARY 2, 2004

An estimated twenty five million people will have back pain severe enough to seek medical attention in the United States this year. Roughly 1% of them will also have spine fusion surgery. And, according to the New York Times in... more

Spine implant maker Blackstone Medical to post 100% revenue growth for 2003 - landing at $40 million BY EDITOR, DECEMBER 15, 2003

To put Blackstone's accomplishment in perspective, Interpore Cross' spine implant sales are expected to end this year at $45 million, up 20% from last year's $36 million. At their current growth rate, Blackstone could overtake Interpore in 2004. Like Interpore,... more

Encore Medical Receives FDA approval for Ceramic on Ceramic Hip Components BY EDITOR, DECEMBER 1, 2003

Let the new offering of stock begin! Encore now joins Stryker and Wright Medical with a ceramic-on-ceramic acetabular component. For both of the prior companies, this longer lasting hip replacement has been a significant driver of both revenues and cash... more

It's going to be a great Quarter, Year and Decade BY EDITOR, JULY 14, 2003

Despite being asked by the Merrill analyst to comment on the prospects for the Next Gen product (manufactured by Zimmer... oops, she meant Next Generation), Biomet's CEO, Dane Miller, was his usual wry self as he announced that overall sales... more

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

10 Felony Counts Against Guidant! BY EDITOR, JUNE 16, 2003

Yes, it is cardiovascular. But the issue hits all medical device companies. How bad could this get? Do you remember the Pedicle Screw cases? That bad, maybe worse if jail time develops. What happened? Last Thursday Guidant was charged with... more


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