Musculoskeletal News Roundup 13-Sept-07
BY LAUREN UZDIENSKI, SEPTEMBER 13, 2007
M&A
Medtronic and Kyphon announced that the FTC and the U.S. Department of Justice antitrust division granted early termination of the waiting period for the companies' merger. Additional antitrust authorities must still approve the transaction, which is expected to close in 1Q:08.
iMDs completed the acquisition of Frontier BioMedical, Inc., a provider of pre-clinical animal research services to the medical device industry. According to the press release, iMDs' orthopedics-focused services now include product innovation, product development, intellectual property development, animal research, product supply and supply chain management.
Regulatory
Spineology received an FDA warning letter for marketing its OptiMesh Deployable Grafting System for unapproved uses. The FDA says that on the company website and in a DVD distributed at NASS's 2006 annual meeting, Spineology promoted OptiMesh for procedures involving structural support, an application for which OptiMesh had not been approved.
Theken Spine announced FDA clearance for a pedicle screw that will be added to its Coral Spinal System. Co-developed with Dr. Eric A. Seybold, the screw is a fenestrated, friction-head, polyaxial screw for the lumbar and thoracic regions. The product is expected to be fully launched by the end of 2007.
Inion Oy received the CE mark for expanded indications for its Inion Hexalon™ biodegradable screw. The screw can now be used in procedures for the foot, ankle, hand and wrist. Inion received FDA approval for these additional indications in the U.S. in August.
Public Offerings
Alphatec Holdings, Inc. announced plans to offer 8,000,000 shares of common stock pursuant to an effective registration statement in an underwritten public offering. Alphatec intends to grant the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of common stock to cover any over-allotments. Canaccord Adams Inc. will serve as the sole book runner of the public offering.
Legal
DJO shareholders have filed a class action lawsuit against the company regarding its proposed sale to a unit of ReAble Therapeutics Inc. Among other things, the lawsuit alleges that individual executives named as defendants approved the proposed merger for an inadequate price and without adequately marketing the company to other potential buyers.
License Agreements
Alphatec Holdings, Inc. announced the entry into an exclusive worldwide license for a unique technology system that is focused on providing a solution for vertebral compression fracture indications. The company's wholly owned subsidiary, Alphatec Spine, Inc., and Stout Medical Group LP. entered into an Exclusive License Agreement that provides Alphatec Spine with an exclusive worldwide license to jointly develop and commercialize Stout's vertebroplasty technology system and implant called the "V-Stent". The V-Stent is an expandable titanium cage that can be implanted minimally invasively into a vertebral body to treat compression fractures of the vertebral body.
Depuy Spine and Syndicom announced a one-year agreement whereby Syndicom will provide software and consulting services to develop and host SpineShare, an online community where DePuy Spine sales representatives and medical device experts can "share their product knowledge, sales experiences, and product insights with their colleagues." Financial terms of the agreement were not disclosed.
Ceraspine SAS entered into an exclusive distribution agreement with SpineSource, Inc. whereby SpineSource will distribute a novel PEEK implant in the U.S. beginning in 4Q:07.
Appointments
Alphatec Holdings, Inc. announced that veteran operations executive Kermit Stott has joined the company as Vice President of Operations. Parallel with the cost improvement initiatives previously announced, Mr. Stott will be focused on helping Alphatec accelerate steps to standardize and streamline certain aspects of its enterprise-wide functions such as human resources, finance and information technology to support growth, while also leveraging its scale more effectively in areas such as manufacturing, to benefit product cycle times and new product launches. Mr. Stott, who was selected after an extensive search, was formerly General Manager of Lean Operations for Edwards Lifesciences Corporation, a global leader in cardiovascular disease treatments with extensive global operations, since 2005.
SpineVision announced several appointments over the past week: Stephan N. Buttron, former Director of Regulatory Affairs at Kyphon, was appointed Vice President of Worldwide Regulatory and Quality Affairs. Additionally, Matthew Tilley was named Vice President of U.S. Sales; Tilley joined the company from Small Bone Innovations, where he was manager of its hybrid sales force of direct and distributor representatives throughout 11 Western states. Finally, this morning the company announced that Vittorio Casazza would join the firm as General Manager of SpineVision's Italy subsidiary. He was formerly a Business Director at Wright Medical Italy.
