Orthopedic News Roundup 11-Jan-07
BY LAUREN UZDIENSKI, JANUARY 11, 2007
M&A
Paragon Medical has entered into an agreement to acquire OMC Precision Products and Tutela Medicus. OMC provides machining, finishing and assembly of implants, primarily for the spinal and neurological markets, and Tutela offers product development services to device manufacturers and medical professionals.
Langer announced the acquisition of Regal Medical, a supplier of contracture management products and services focused on the long term care market. The purchase price was approximately $1.64 million.
Regulatory
Innovasis received FDA 510(k) clearance of its PEEK Box System as a Vertebral Body Replacement. The system was previously cleared as a Cement Restrictor, and the product joins the Le Forte Cranial Plating System, the Excella-M Pedical Screw System and the Opteryx Cervical Plate System in Innovasis' product line.
Biopure received a provisional opinion letter from United Kingdom Commission on Human Medicines, an interim step in the Company's marketing authorization application for Hemopure®. Hemopure is intended for the treatment of acutely anemic adult orthopaedic surgery patients.
Funding
IsoTis announced an intended public offering on the NASDAQ to raise between $30 million and $40 million. Net proceeds will support sales, marketing and general administrative activities; clinical research and product development activities and to fund working capital and other general corporate purposes.
Legal
ArthroCare will pay $2.75 million to MarcTec to settle a patent infringement lawsuit. In a press release, ArthroCare said that the settlement will be included in the Company's 2006 financial statements and future royalty payments related to the licensing of certain MarcTec patents. The settlement will reduce fourth quarter results by approximately $0.08 per share.
RSB Spine announced the repurchase of a right of 1st refusal for its InterPlate™ spine implant platform from NuVasive (NUVA). The right of first refusal was included in the sale of RSB's SmartPlate™ cervical plate to NuVasive in June of 2005.
Product Introduction and Update
Synergetics USA announced the sale of the first Sonopet Omni® ultrasonic aspirator for use exclusively in discectomies and intravertebral fusions. The device features the Long Claw™ surgical tip, which allows surgeons to reach deep inside the spine.
Small Bone Innovations (SBi) announced the first round of procedures using its UNI-Elbow™ Radio Capitellum System, which incorporates SBi's Precise Guidance Technology™ template and instrumentation. The UNI-Elbow is the first uni-compartmental elbow implant to become commercially available in the United States. The implant has 510(k) clearance from the FDA and is indicated for treatment of arthritic and traumatic conditions of the radio-capitellum joint.
K2M announced completion of the 500th surgery using its MESA™ Spinal System. First introduced at the NASS meeting in September, MESA was initially utilized in degenerative lumbar surgeries, but evolved for use in more complex deformity surgeries
Clinical
Anika and DePuy Mitek initiated a multi-center clinical study of ORTHOVISC® this week. The trial will evaluate ORTHOVISC for the treatment of pain caused by osteoarthritis in the shoulder joint. Patient enrollment is expected to be completed by the end of 2007.
Miscellaneous
Researches at the University of Auckland announced this week that they have developed a prototype of FleP, a Flexible Parallel Robot designed to perform realignment surgery on long bone fractures. According to the press release, FleP works by manipulating a broken bone back into place after a computer program assesses the injury. A surgeon oversees the whole procedure from behind a computer and issues commands through an interface or by voice.
