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Orthopedic and Dental Industry News

October 2010

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

Stryker to Buy BSX's Neurovascular Business for $1.5B BY LAUREN UZDIENSKI, OCTOBER 28, 2010

Boston Scientific announced this morning that they agreed to sell their neurovascular business to Stryker for $1.5 billion in cash, of which $1.4 billion is payable at closing and $100 million will be payable at the achievement of certain milestones. more

Study Finds Diagnostics and Narcotics Overutilized for the Treatment of Chronic Neck Pain BY LAUREN UZDIENSKI, OCTOBER 27, 2010

A healthcare utilization survey conducted in North Carolina found that just over 2% of the adult population suffered from chronic neck pain, and in analyzing the non-surgical treatments reported by those patients, the study's authors determined that certain treatment modalities in common use may not align with current best evidence. more

Medtech Report Shows M&A Values Increasing BY LAUREN UZDIENSKI, OCTOBER 25, 2010

A new report from Ernst & Young shows that 2010 M&A valuations in the medical technology sector are picking up from 2009. The report identifies 89 transactions valued at $16.9 billion initiated through 1H:10, which compares to 172 transactions worth $15.7 billion in all of 2009. 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

Merlot OrthopediX Enters into Exclusive Global Agreement with Alphatec Spine to Develop and Market Merlot's Bone Anchorage Technology for the Treatment of Spine Disorders BY EDITOR, OCTOBER 21, 2010

Merlot OrthopediX, Inc., a Cleveland Clinic spin-off company jointly owned by Cleveland Clinic, Cleveland, OH, Frantz Medical Group, Mentor, OH and Dr. Isador Lieberman, M.D., M.B.A., Texas Back Institute, Plano, Texas, announced today that it has entered into an exclusive agreement with Alphatec Spine, Inc. to develop and commercialize Merlot's novel bone anchorage technology for use in spine surgery. 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

ReGen "Takes Exception" to FDA's Menaflex Rescission BY LAUREN UZDIENSKI, OCTOBER 19, 2010

ReGen put out a strongly-worded press release yesterday, saying they "take exception" to the FDA's "totally unbelievable" decision to rescind market clearance for their Menaflex device. more

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

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

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

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

Musculoskeletal News Roundup 14-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 14, 2010

Biomet announces FQ1:11 . . . Core Essence Orthopaedics raises $1.5M . . . Medical Tracking Solutions launches iTraycer . . . 1,000th Zimmer Natural Nail Cephalomedullary Nail implanted . . . Vertiflex enrolls 200 patients in its Superion IDE study . . . Pioneer Surgical to manufacture and distribute SpineSmith's Cequence anterior cervical plate . . . Cardo Medical seeks capital . . . Pioneer Surgical to open manufacturing and distribution facility in Scotland more

AAOS Launches Joint Registry Pilot Program BY LAUREN UZDIENSKI, OCTOBER 13, 2010

A national large joint registry championed by AAOS will be launched this month as a pilot program at 15 hospitals. The registry will track results based on details about patients, doctors, hospitals and implants with the aim of improving outcomes, and many large-joint manufacturers have voiced their support for the program. more

How Does the Brain Protect Dental Implants? Lizard Model Gives Clues BY LAUREN UZDIENSKI, OCTOBER 12, 2010

An ancient species of New Zealand lizard may have something to teach us about dental implants. A natural tooth is bound to the alveolar bone by the periodontal ligament, or PDL, which sends signals to the brain that help protect the tooth from the forces of chewing. Dental implants lack the PDL, and scientists were wondering what keeps the tooth safe in the absence of that ligament. They turned to a lizard for the answers. more

Alphatec Holdings Announces Appointment of Michael O'Neill, FCMA, as Chief Financial Officer BY EDITOR, OCTOBER 11, 2010

Alphatec Spine announced the appointment of Michael O'Neill, FCMA, as the Company's Chief Financial Officer, Vice President and Treasurer, effective October 11, 2010. Peter C. Wulff will transition to the newly created position of Senior Vice President, Strategic Initiatives, effective immediately. more

Musculoskeletal News Roundup 7-Oct-10 BY LAUREN UZDIENSKI, OCTOBER 7, 2010

Medyssey and RSB Spine announce 3Q:10 revenue growth . . . Wright Medical receives Department of Defense grant to study OSTEOSET T . . . Product launches and clinical updates at NASS . . . NUVA sues Globus for patent infringement . . . Synthes and Norian announce settlement . . . BioMimetic Therepeutics to expand Tennessee facility . . . DiFUSION augments management team more

Alphatec Spine Announces Four New Product Launches in the MIS, Biologics and Thoracolumbar Market Segments at the North American Spine Society (NASS) Annual Meeting BY EDITOR, OCTOBER 6, 2010

Alphatec Spine received CE Mark approval for commercial sale in the European Union and other jurisdictions for its HeliFix Interspinous Spacer System and Solus ALIF System. Additionally, the company announced two new product releases in the U.S. market, the Aspida Anterior Lumbar Plating System and the PureGen Osteoprogenitor Cell Allograft. more

Sen. Grassley Questions the Value of GPOs BY LAUREN UZDIENSKI, OCTOBER 6, 2010

On the heels of a GAO report highlighting changes GPOs have made to their codes of conduct since 2002, Sen. Chuck Grassley's staff has voiced questions on the cost savings GPOs offer the healthcare system. GPOs purport to lower costs for member hospitals by negotiating prices with manufacturers, but they charge fees to participating vendors and have also been accused of reducing competition and stifling innovation with single-source contracts. more

DJO to Undertake $300 Million Debt Offering BY JOHN MCCORMICK, OCTOBER 5, 2010

This morning DJO Incorporated, familiar to the industry as DJ Orthopedics, announced it was going to undertake a $300 million senior subordinated note offering. Throughout the year, corporations have taken advantage of the record-low interest rate environment and have been... more

Alphatec Spine, Inc. Releases PureGen Osteoprogenitor Cell Allograft to Facilitate Bone Regeneration and Announces First Patient Procedure Performed in the World BY EDITOR, OCTOBER 5, 2010

Alphatec Spine today announced the release of its PureGen Osteoprogenitor Cell Allograft at the North American Spine Society Meeting (NASS) in Orlando, FL. PureGen is a highly concentrated, pure population of adult stem cells that originates in bone marrow and is collected from live, healthy donors for optimal cell functionality. more

Five-year Distribution and Licensing Agreement Executed between CREASPINE SAS and SCIENT'X SA BY EDITOR, OCTOBER 1, 2010

CREASPINE SAS and SCIENT'X SA, a wholly owned subsidiary of Alphatec Holdings, Inc., today announce they have entered into a five-year exclusive worldwide Distribution and Licensing Agreement. Under the terms of the Agreement, CREASPINE will manufacture and provide to SCIENT'X... more

Wright Medical Settles with Government, Enters 5-Year CIA BY SANDER DUNCAN, OCTOBER 1, 2010

Wright Medical Group announced yesterday that it has settled with the DOJ over their investigation into Wright's consulting practices. The company has entered into a 12-month deferred prosecution agreement (DPA) with the government, under which Wright will not face charges... more


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