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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 9-Sept-10 BY LAUREN UZDIENSKI, SEPTEMBER 9, 2010

Amedica closed a $30.0 million financing, consisting of $15.0 million in private equity and a debt facility of $15.0 million. Creation Capital served as placement agent, and Zions First National Bank provided the debt facility. The company says proceeds will be used for expansion, mergers and acquisitions and sales and marketing support.

Aesculap received 510(k) clearance to market the S4 Cervical Occipital Plating System, indicated for the treatment of degenerative disease or fracture in C1-T3 and the occiput-T3.

BioMimetic Therapeutics met with the FDA to confirm that its Augment PMA was on track. Following the meeting, the company announced that they continue to anticipate a panel meeting by early 2011 and, assuming a positive response, market approval by mid-2011. The company also reported that its second-generation product, Augment Injectable Bone Graft, will follow a medical device pathway and that the company will begin enrolling an IDE study once the FDA approves the protocol, potentially by 4Q:10.

K2M received 510(k) clearance to market the CHESAPEAKE Anterior-Lumbar Stabilization System. According to the press release, the system is made from PEEK and offers zero-profile fixation utilizing the company's tifix Locking Technology, which allows the screw to form an "autogenic lock" with the implant.

Viking Systems received 510(k) clearance for their Next Generation 3DHD visualization system, which can be used for a number of minimally-invasive applications, including spine.

Intellectual Property
BioMimetic Therapeutics received U.S. patent 7,799,754, entitled "Compositions and Methods for Treating Bone" and covering "methods of treating impaired bone to facilitate strengthening and healing of bone" using PDGF and defined matrix materials. Additionally, the company received EU patent No. 1812076, entitled "Platelet-Derived Growth Factor Compositions and Methods of Use Thereof" and covering compositions of PDGF with defined matrix materials.

Eden Spine received a U.S. patent and an EU patent covering the PERFX-2, a posterior dynamic stabilization system.

Tornier announced early clinical results from seven patients who received their pyrocarbon shoulder prostheses. The company reports that with an average follow-up of 12 months, patients are "very satisfied, they are pain-free, and their range of motion is excellent."

Misonix entered into an exclusive three-year distribution agreement with Cormedica s.a.s., whereby Cormedica will distribute the BoneScalpel Ultrasonic Bone Cutter throughout France. The deal includes annual minimum purchase requirements.

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