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Orthopedic and Dental Industry News

September 2009

Richard Ravitch Resigns from Alphatec Holdings, Inc. Board of Directors BY EDITOR, SEPTEMBER 30, 2009

CARLSBAD, Calif., Sep 30, 2009 (BUSINESS WIRE) -- Alphatec Holdings, Inc. (NASDAQ:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus... more

Looming Tantalum Shortage May Impact Orthopedic Devices BY LAUREN UZDIENSKI, SEPTEMBER 29, 2009

A new report from Roskill Information Services predicts a worldwide shortage of tantalum, a porous metal used in coating orthopedic devices. Tantalum has been demonstrated to facilitate a bond between an implant and the surrounding bone, with additional benefits including... more

FDA to Hold a Public Hearing on Internet, Social Media Marketing BY LAUREN UZDIENSKI, SEPTEMBER 29, 2009

The FDA has announced plans to hold a two-day public hearing this November to gain feedback on the use of the internet and social media tools to promote drugs and devices. These platforms include YouTube, Wikipedia, Facebook, Twitter and any... more

Scient’x Announces Its Dynamic Solutions for the Spine Strategy and Concurrent Launch of Isobar Evolution BY EDITOR, SEPTEMBER 28, 2009

GUYANCOURT, France--(BUSINESS WIRE)--Scient'x Groupe S.A.S. (Scient'x) announces its focus on offering Dynamic Solutions for the spine. This corporate strategy positions Scient'x to be the worldwide leader in providing Dynamic Solutions for both non-fusion* and fusion procedures. The cornerstone of the... 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

Senators React to the Medical Device Tax BY LAUREN UZDIENSKI, SEPTEMBER 22, 2009

Last week the senators from Minnesota and Indiana, both states with thriving medical device industries, sent a letter to Max Baucus opposing the Senate Finance Committee's healthcare reform proposal. Echoing the sentiments of AdvaMed and others, the senators argue that... more

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

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

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

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

Senate Introduces Healthcare Reform Plan, Including Fees for Devicemakers BY LAUREN UZDIENSKI, SEPTEMBER 16, 2009

Today Senator Max Baucus formally introduced the Senate Finance Committee's long-awaited healthcare reform proposal, which would cost $856 billion and does not include a public option, would not require employers to purchase insurance for employees and would bar certain payer... more

Fewer Adverse Events in Daytime Trauma Surgery BY LAUREN UZDIENSKI, SEPTEMBER 15, 2009

A new study in JBJS found slightly increased complication rates among patients who had after-hours orthopedic trauma surgery, emphasizing the impact of overtired clinicians and more limited hospital resources at night. Researchers enrolled 203 patients who presented in the ER... more

Integra Acquries IST BY JOHN MCCORMICK, SEPTEMBER 14, 2009

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

JBJS: Orthopedics in 2020 BY LAUREN UZDIENSKI, SEPTEMBER 10, 2009

An article in JBJS outlined the evolving need for musculoskeletal care in the coming decade, addressing changes in demographics, disease incidence, treatment modalities and delivery of orthopedic services. These factors illustrate some of the growth drivers in orthopedics and help... 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

New Reform Proposal Calls for Savings from Devicemakers BY LAUREN UZDIENSKI, SEPTEMBER 9, 2009

A Senate healthcare reform plan introduced by Max Baucus over the weekend includes a $4 billion annual tax on the medical device industry to help offset the cost of healthcare reform. The tax would be implemented in 2010 and is... more

Experts Raise Questions on Diagnosing and Treating Low Bone Mass BY LAUREN UZDIENSKI, SEPTEMBER 8, 2009

An article in the New York Times this week discussed osteopenia, a controversial diagnosis made when bone density is lower than average but does not meet the clinical criteria for osteoporosis. Osteopenia was defined by the WHO in 1994, and... more

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

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

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

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

ReGen's Menaflex to Receive a CMS National Coverage Decision BY LAUREN UZDIENSKI, SEPTEMBER 1, 2009

CMS announced this week plans to initiate a national coverage determination on ReGen Biologics' Menaflex, a collagen scaffold for the treatment of meniscal tears. NCDs are relatively uncommon, with CMS issuing 18-24 decisions each year, and few of them relate... more


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