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
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
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
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York Times has joined a chorus of concern over the 510(k) process, suggesting in an article yesterday that 510(k)s are outdated (FDA device laws were passed "when devices played a much smaller role in medicine") and allow new...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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 New York Times call for GPO reform. Takeaway: GPO market reform will change your... more
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
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
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
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
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
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
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, 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
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
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 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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
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
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. (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
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
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
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
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
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
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
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
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
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
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
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 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
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
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
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
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
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
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...
