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May 20-23 - Current Concepts in Joint Replacement Spring 2012
May 23-25 - 13th EFORT Congress 2012
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Orthopedic and Dental Industry News
March 2010
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
Alphatec Holdings, Inc., the parent company of Alphatec Spine, Inc., announced today the closing of its previously announced acquisition of Scient'x Groupe SAS, a spinal implant company headquartered in France. The combined company will be the third-largest independent spinal company with a global span of product distribution. more
Dental Technologies, Inc. (DTI) today announced the appointment of Jeffrey Zellmer to the position of Chief Financial Officer (CFO). Mr. Zellmer has over 25 years of financial executive experience, including five years as CFO of publicly-traded Silicon Graphics, Inc. Most recently, he was Vice President of Finance for Lam Research Corporation, a publicly-traded technology company. more
Yesterday the news circulated that CareFusion, an upstart in the vertebral compression fracture market, has sued Medtronic for violating antitrust laws. With a 619-page complaint in a Federal Court no less. Antitrust? A newcomer suing the incumbent right out of the box? Talk about going against a time-honored tradition! more
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
A 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
While the healthcare reform package is concerned primarily with broadening medical coverage for the uninsured and underinsured, dental care is not excluded from the legislation. The final bill includes a number of benefits designed to support dentistry and train providers, though the ADA has criticized reform efforts for not going far enough to expand access to dental care. more
The House passed a healthcare reform package last night by a small margin, and now the final vote is in the Senate's hands. The House first passed the Senate's version of the bill from last year and then proceeded to pass a reconciliation bill consisting of revisions to the Senate's version. These changes included a last-minute adjustment to the medical device industry tax, which is now set at 2.3% annually. more
Dental Technologies, Inc. (DTI), one of the largest networks of dental laboratories in North America, today announced the appointment of Lee Culp, CDT to the position of Chief Technology Officer (CTO). "We are very pleased to have Lee join the company," said Kimberly L. Bradshaw, President and CEO of DTI. "For years Lee has been an advocate for advancing technology in our industry and has been closely involved in its development." more
ANIK, ATEC report 4Q:09 . . . ATEC shareholders approve Scient'x Acquisition . . . Non Linear Technologies, Spinal Restoration close funding rounds . . . CareFusion launches kyphoplasty balloon . . . Integra launches new products for spine . . . New vertebroplasty data released more
Alphatec Holdings, Inc. announced today that at a special meeting of stockholders held on March 16, 2010, its stockholders approved the issuance of 24,000,000 shares of the Company's common stock in connection with the acquisition of Scient'x Groupe SAS. Approximately 78% of the shares of the Company's common stock that were eligible to vote on the matter were voted. Of the shares that were voted, over 99% voted in favor of the transaction. The Company expects the closing of the transaction to be completed prior to the end of the first quarter. more
Alphatec Holdings, Inc. will host a Technology Day for investors and analysts on Friday, April 23, 2010 from 8:30am to 11:30am Eastern Time, at the NASDAQ MarketSite located in Times Square in New York, New York. Dirk Kuyper, the Company's President and Chief Executive Officer, will host the meeting. During the meeting Mr. Kuyper will provide updates on the Company's strategy and product pipeline. The agenda will include presentations from several leading spine surgeons to discuss key spine market segments and the Company's product offerings. more
Congress appears to be moving closer to a vote on healthcare reform. While no vote is scheduled, Speaker Pelosi believes she has the support of House legislators as well as the mechanics in place to pass the legislation. The method by which the Senate's version of the bill will become law will not require a House vote, a process known as "deeming" a bill. more
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
With healthcare reform projected to cost $950 billion, the pharma, device and hospital industries have generally consented to help fund the changes - in the device industry's case, to the tune of $20 billion over the next decade, which will be realized through an excise tax proposed to be implemented in 2011. AdvaMed is pushing on behalf of the industry to lock in that $20 billion as a cap, reports Reuters. more
Wear debris and surgical technique are at the center of a New York Times article on metal-on-metal total hip components, with the paper suggesting that metal-on-metal correlates to poorer outcomes and higher revision rates. The article cites a metal-on-metal revision rate of 1-3%, with women affected more frequently than men. more
Corin, Osteotech and Integra report 4Q . . . Baxter to acquire ApaTech for up to $330.0 million . . . Intrinsic Therapeutics closes on $18.0 million of a $20.0 million round . . . FDA schedules Orthopaedic and Rehabilitation Devices Panel meeting for Menaflex . . . Aetna and United Healthcare reverse prior policies and announce that they will cover NuVasive's XLIF . . . Congress delays Medicare pay cut more
The NIH and FDA plan to collaborate on ways to bring innovative products to market sooner. 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
Aetna and United Healthcare both announced that they will cover XLIF, reversing non-coverage policies and allowing the procedure to shed its "investigational" status. more
Baxter announced plans to acquire ApaTech for up to $330 million, with $240 million in cash up front (a 4x revenue multiple) and additional milestone payments of up to $90 million. more
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