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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 18-Jun-09 BY LAUREN UZDIENSKI, JUNE 19, 2009

The bankruptcy trustee for Innovative Spinal Technologies announced plans to pay creditors by selling the company's patent portfolio and other IP. The company's products include the AXIENT motion-preserving pedicle screw system; the PARAMOUNT MIS pedicle screw system; the PARAMOUNT IBF Implant System, designed for a minimally-invasive transforaminal approach; and the CORDANT ACP Anterior Cervical Plate System.

Anulex raised $10.2 million in a Series D financing led by Affinity Capital, Delphi Ventures, MB Venture Partners, New Enterprise Associates, SightLine Partners and Split Rock Partners. Anulex's President and CEO Rich Lunsford said funds would support enrollment and follow-up on a post-market study for the Xclose anular repair device, among other uses.

Biomerix received an ISO 13485 Certificate of Registration, which represents a key regulatory requirement in the EU and other international markets. The company is developing a biointegrative scaffold for soft tissue repair.

BioMimetic Therapeutics submitted to the FDA the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its PMA application for Augment Bone Graft. Still outstanding is the clinical data module, which the company intends to file in 4Q:09. The company also received ISO 9001:2008 certification and ISO 13485:2003 recertification.

Eminent Spine received 510(k) clearance on June 1 for its Fang anterior lumbar buttress plate.

Product Introduction and Update
Alphatec Holdings, Inc. announced that, as of June 1,2009, over 115 patients in eight European countries have been treated with the OsseoFix Spinal Fracture Reduction System, the company's innovative product for the treatment of vertebral compression fractures.

HydroCision introduced the SpineJet Percutaneous Access Set for the treatment of herniated discs. The device enables surgeons to cut and remove nucleus with a high-velocity water jet.

VTI received a Medical Device Excellence Award for its InterFuse Interbody Fusion System. Surgeon Paul Asdourian, M.D. says that among the device's benefits, the InterFuse "allows for a large footprint to be created through a less-invasive unilateral posterior approach, which provides spine surgeons the option of fusing a patient while potentially reducing tissue dissection and nerve root retraction."

The U.S. Attorney in Philadelphia has indicted Norian (parent company Synthes) and four Synthes executives relating to improper promotion of Norian XR and Norian SRS bone cements. The U.S. Attorney alleges that the cements were used in an unauthorized study of vertebral compression fractures.

BioSyntech, Inc. announced statistically significant, preliminary results from its BST-CarGel randomized clinical trial. The 80-patient study is comparing the application of BST-CarGel to a microfractured cartilage lesion in the knee to microfracture alone. At 12 months, 22 BST-CarGel patients were found to have improved repair tissue quality, which was attributed to device. Final results are expected in 1H:10.

Medtronic disclosed information about $800,000 in payments to a former U.S. Army surgeon who allegedly falsified data about InFuse. The company said the payments were for consulting and speaking engagements and were not related to the study in question.

Wright Medical Group, Inc. will underwrite a foot and ankle fellowship grant for the Orthopaedic Research and Education Foundation (OREF). The grant period is 2009 through 2010, and the application, review and selection process for the grant will be conducted by OREF, independently of Wright Medical.

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