• BioMimetic Therapeutics (Franklin, Tennessee) reported that it has completed enrollment in its Canadian pilot clinical study with its lead orthopedic product candidate GEM OS1 Bone Graft. As a result of the preliminary data obtained, the company has received authorization from the Canadian government to expand the study from the original 20 patients up to 60 patients. Subject to the results of the expanded study, the company intends to file for Canadian product registration for orthopedic indications in 2007. The company also has completed enrollment in its U.S. pilot clinical study for foot and ankle fusions and its Swedish pilot clinical study to evaluate the treatment of distal radius fractures. To date, there have been no product related serious adverse events attributed to GEM OS1 in any of the three studies. BioMimetic is developing GEM OS1 for use in open surgical treatment of fractures and bone fusions where the use of bone graft, a material used to augment bone healing, is indicated.

• Cyberonics (Houston) reported that it received FDA approval for a harmonized/modularized VNS Therapy System labeling format. The new format combines the previously separate pulse generator manuals for the refractory epilepsy and treatment-resistant depression indications into a single manual. The new Pulse Generator Physician's Manual includes all PMA-approved indications and clinical information in a modular format so that any future updates or expansions to the labeling will require amendments only to the specific, affected module. Since many of the contraindications, warnings and other information are the same for the pulse generator and the lead, the modular approach also has been applied to the Model 302 Lead Physician's Manual. Cyberonics also reported receiving FDA approval on modifications and enhancements made to VNS Therapy, Model 250, Version 7.1.4 Programming Software. This latest version of software is compatible with all approved VNS Therapy generator models and has several features specifically designed for the future DemiPulse (Model 103) single connector and DemiPulse Duo (Model 104) dual connector generators.

• Kensey Nash (Exton, Pennsyvlania) reported that it has received FDA 510(k) clearance for its next-generation TriActiv FX Embolic Protection System. The product is expected to be launched shortly. The clearance was based on data collected from the ASPIRE (Angioplasty in SVGs with Post-Intervention Removal of Embolic Debris) study which demonstrated that major adverse cardiac events were reduced to 3.2% by using the TriActiv FX System as an adjunct to stenting in treating saphenous vein grafts. The company said the TriActiv is the only distal embolic protection system that actively removes the debris from the vessel by gently flushing the treatment area within the vessel.

• Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, reported that it has initiated its Phase II multi-center clinical study of Lymphoseek, a lymphatic tissue targeting agent being developed by the company. Neoprobe was granted authorization by the FDA earlier this year to begin patient enrollment in a Phase II study to evaluate the safety and efficacy of Lymphoseek, intended to be used in biopsy procedures for the detection of lymph nodes in breast and melanoma cancers.

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