Musculoskeletal News Roundup 2-Sept-10
BY LAUREN UZDIENSKI, SEPTEMBER 2, 2010
M&A
Sanofi-aventis made a bid to acquire Genzyme in an all-cash transaction valued at approximately $18.5 billion, or $69.00 per share. Genzyme rejected the proposal, saying it undervalues the company.
Funding
Orthofix obtained a new five-year credit facility valued at $300.0 million, which includes a $200.0 million senior secured revolving line of credit and a $100.0 million senior secured term loan. JP Morgan Chase acted as sole bookrunner along with RBS Citizens. The company plans to use the proceeds to pay off their prior facility as well as for capital expenditures and other general corporate purposes.
Regulatory
Ascension Orthopedics received 510(k) clearance to market the TITAN Modular Total Shoulder System. This pyrocarbon system provides a "bone-preserving option" for patients needing total or hemi shoulder arthroplasty.
Mazor Surgical received FDA clearance to market the SpineAssist robotic surgical system and the C-Insight 3D imaging system as one unit. The company reports that they will begin U.S. sales of the combined system in 2011.
As the FDA prepares changes to its 510(k) program, the agency reports that Heather Rosecrans, director of CDRH's 510(k) Office of Device Evaluation, will retire on September 15th.
Intellectual Property
Amedica received U.S. patent No. 7,776,085 B2, which the company describes as covering a knee implant prosthesis that features a monoblock ceramic tibial component for articulation with natural or prosthetic (resurfaced) femoral surfaces.
TiGenix received U.S. patent 7,780,994, covering "Composite biomaterials comprising calcium phosphate materials, collagen and glycosaminoglycans." The company notes that, "This patent forms the core protection of our ChondroMimetic product family."
Recognition
U.S. News and World Report released its annual list of the best hospitals in orthopedics. Topping the list was the Hospital for Special Surgery, followed by the Mayo Clinic, Massachusetts General Hospital, Cleveland Clinic and Johns Hopkins.
