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Orthopedic and Dental Industry News Complete Archive »

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 impact on sales). Excluding currency, during the quarter reconstructive revenue grew 8% (knee 10%, hip 7%, extremity 12%, dental 10%). External fixation sales were down 11% while internal fixation was up only 1%. Overall spinal sales declined by 7% (spinal implants and orthobiologics 5%, spinal stimulation 9%) during the quarter.

Clinical Update: ApaTech announced that it has launch a multicenter international study to compare its Actifuse™ Synthetic Bone Graft with Infuse® Bone Graft. The study will be called APPRAISE (A Prospective PLF Randomised Actifuse InfuSe Evaluation) which will compare Actifuse granules, mixed with operative site blood only, to Infuse, used according to its manufacturer's recommendations, in instrumented Posterolateral Lumbar spinal Fusion (PLF) procedures.
NuVasive, Inc. announced the first in-human-U.S. implantation of its NeoDisc cervical disc replacement device. This procedure is part of a prospective, randomized, controlled, multi-center clinical trial to evaluate the safety and efficacy of NeoDisc compared to traditional anterior cervical discectomy and fusion.

Dr. William Giannobile, a professor of dentistry at the University of Michigan, presented new data on BioMimetics' only approved product, GEM21S, at the American Academy of Periodontology meeting in San Diego this week. GEM21S is short for "Growth-factor Enhanced Matrix," a combination of tricalcium phosphate (TCP) and recombinant human platelet-derived growth factor (PDGF). The focus of the data was comparing the TCP+Buffer population to the GEM21S outcomes, and these were clearly positive.

Regulatory Update: Medtronic announced its PRESTIGE® Cervical Disc System has received a unanimous recommendation for approval from the FDA's Orthopedic and Rehabilitation Devices advisory panel. The panel's recommendation will be considered by the FDA in its review of the Premarket Approval (PMA) application for the device. Active Implants Corp. announced it has received a CE Mark of approval for its Hip Buffer in Europe. The Hip Buffer is a flexible polycarbonate polyurethane cap that fits snugly over the top of the femur after the cartilage is removed, assuming the role of cartilage in cushioning the inner joint. Facet Solutions, Inc. announced it has received CE Mark Approval to market its Anatomic Facet Replacement System (AFRS™) in Europe. The Anatomic Facet Replacement System (AFRS™) is the first anatomic facet arthroplasty device designed to provide patients with lumbar spinal stenosis and facet degeneration a motion preserving alternative to fusion.

Operational Update: ApaTech announced it has officially opened its 10,000 square feet manufacturing facility and new international headquarter at Elstree, UK. This facility will be the focus for the global supply of Actifuse bone graft substitute.

Financing: LDR announced it closed a $14 million Series B financing and had participation from all of its original inestors: Austin Ventures, Rothschild Private Equity, PTV Sciences and Path4 Ventures. Of the totaled $14 million, $5 million was contributed by an undisclosed outside investor. Proceeds will be used to support the IDE studies on its second generation cervical and lumbar artificial discs and to drive continued revenue growth and expansion into the US spinal sales market.

Business Update: IsoTis S.A. announced that the administrative Court of Appeal in the Netherlands have set a fine of €326,715 for IsoTis N.V. and IsoTis S.A. regarding the timing of regulatory filings to the AFM following the merger the two companies in 2002. As previously reported, the Company recorded a provision for the total amount of the potential liability, €653,430 (€326,715 for each company).

Service Agreement: LifeNet and Gift of Life Michigan announced a strategic partnership which will significantly enhance Michigan's tissue donor program associated with new state legislation that allows for donations in conjunction with the state medical examiner system.

Appointment: Kyphon Inc. announced the appointment of Maureen L. Lamb and Alexandre M. DiNello to its executive management team. Ms. Lamb was named Vice President, Chief Financial Officer and Treasurer. She was previously with Photon Dynamics, Inc., where she was Chief Financial Officer. Mr. DiNello joined the firm as Vice President, Research & Development. Prior to joining Kyphon, Mr. DiNello had over seventeen years of medical device industry experience including senior research and development and strategic development positions. Langer, Inc. has appointed Sara Cormack as Vice President and Chief Financial Officer. Ms. Cormack was previously with PG&E Corporation. CoreSpine Technologies, LLC has nominated Hansen Yuan, M.D. as Technical Advisor. Dr. Yuan is currently a Professor of Orthopedic Surgery at SUNY Upstate Medical University in Syracuse, New York. Alphatec Holdings, Inc. has named Bret B. Abshire, M.D., MS to its Scientific Advisory Board. Dr. Abshire is a member of the neurosurgical faculty at the University of California, San Diego, where he serves as Assistant Clinical Professor of Surgery. He is also Vice Chair of the Surgery Department at the Southwest Healthcare System in Southern California and maintains a private, general neurological practice performing surgery for brain tumors and cerebrovascular disease.

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