Musculoskeletal News Roundup 11-Oct-07
BY LAUREN UZDIENSKI, OCTOBER 11, 2007
M&A
With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced the acquisition last year, it was valued at up to $240.0 million.
Regulatory
Medtronic received an FDA warning letter claiming that Medtronic marketed the SATELLITE™ Spinal System for use in unapproved indications. The letter also alleges that Medtronic announced the launch of the ARCUATE™ system before it received market clearance and that some product claims were not FDA-approved. Medtronic has 15 days to respond to the letter.
Biospace med received 510(k) clearance for EOS, a new digital x-ray imaging system. According to the press release, the system uses a dose of radiation that is up to 10 times lower than other commercially available film systems without compromising image quality. The system can also capture a full or partial body image, and multi-planar images can be obtained simultaneously in an upright, weight bearing position. Whole-body and upright imaging can be valuable for orthopedic surgeons evaluating spine and joint alignment.
AOI Medical announced that the FDA has extended the review period for the company's Balloon Assisted Management of Spine Fractures (BAMF) product an additional 90 days. AOI said it now expects to meet with the FDA again in late October, and if no clinical trials are required, the BAMF Spine product will be launched in 1Q:08. If trials are required, the company expects to launch in 2H:08.
Funding
Spinal Restoration, Inc. closed a $16 million Series B round of equity financing. Sante Health Ventures and MB Venture Partners joined Series A lead and founding investors Austin Ventures and Path4 Ventures in the round. Spinal Restoration plans to use the funds to complete an IDE clinical trial for the Biostat™ Disc Augmentation System, the company's minimally invasive biologic treatment for discogenic low back pain.
Osiris Therapeutics, Inc. has entered into a financing agreement for up to $30 million from Friedli Corporate Finance, Inc. Friedli Corporate Finance is owned by Peter Friedli, the Chairman of Osiris' Board of Directors. According to the press release, the transaction gives the company "greater flexibility" as they complete phase III clinical trials and move toward market clearance for pipeline products.
Product Introduction
K2M announced the Phase II launch of its PYRENEES Cervical Plate System. In a press release, the company said the number of sets available in the market has nearly doubled since the company's initial launch in August, which will help meet increased demand for the product.
License Agreements
NuVasive licensed its "insert and rotate" method technology to Theken Spine, LLC. Under the agreement, Theken Spine was granted a non-exclusive license to use NuVasive's patented "insert and rotate" method in exchange for royalty payments to be made to NuVasive. The patented "insert and rotate" method is a means of inserting a device between adjacent vertebrae and then rotating the device to separate and stabilize those vertebrae. No terms were announced.
Partnerships
The Regenerative Medicine Institute at NUI Galway announced this week plans for a four-year research collaboration with Smith & Nephew aimed at developing new treatments for bone and joint diseases.
Operations
This week Ossur announced the opening of its Asia Pacific operations in Shanghai, China. The company estimated the Chinese market at $35 billion and said that expanding to Asian markets was part of the company's 2010 vision. Ossur added that they chose China because of its investment opportunities, distribution and supply chain network and proximity to key Asian markets.
Miscellaneous
Amedica Corporation received the HAP Paul Award from the International Society for Technology in Arthroplasty (ISTA) for a paper it presented on the in-vitro testing and evaluation of its silicon nitride ceramic bearings for total hip arthroplasty. The award was presented to Amedica last week at ISTA's 20th Annual Congress in Paris and is given for "outstanding research in new technology for joint replacements."
