Musculoskeletal News Roundup 20-May-10
BY LAUREN UZDIENSKI, MAY 20, 2010
Regulatory
Anika Therapeutics announced that the FDA has accepted corrective actions taken in response to a 2008 warning letter and that any restrictions imposed by the letter have been lifted. The letter resulted from quality systems violations stemming from the lack of a sink outside a sterile room.
The FDA cleared Mesoblast to begin a Phase II clinical study of NeoFuse, their allogeneic stem cell product, in cervical fusion cases.
At their analyst day this week, Stryker announced that its final two outstanding FDA warning letters have been resolved. The company reports that the FDA found corrective actions at their Cork, Ireland and Portage, Michigan sites to be sufficient.
Product Introduction and Update
DePuy Mitek announced plans to launch the Bristow-Latarjet Instability Shoulder System in the U.S. and Europe in the next few weeks. The company says the system is the first instrument set specifically designed to be used in both open and arthroscopic Latarjet or Bristow procedures.
Local Indiana press published a story on OrthoX. The company is developing a bone cement that "should last 100 times longer than bone cements currently in use," and they anticipate FDA clearance and commercialization in September.
Legal
The DOJ has recovered $20.0 million from 18 hospitals in Alabama, Florida, Indiana, Michigan, Minnesota, New York and South Carolina settling allegations of fraudulently billing Medicare for kyphoplasty cases.
Distribution
SpineGuard announced that MBA will be the exclusive distributor of SpineGuard's PediGuard device in Italy, Portugal, Spain and the UK. PediGuard, which is CE-marked and FDA-cleared, is designed to aid in pedicle screw placement.
Collaborations
B1 Medical announced that Invibio will provide scientific support for B1's development of a PEEK-OPTIMA polymer suture anchor and a PEEK-OPTIMA device for small joint replacement.
Appointments
Cardo Medical named Stephen Liu, M.D. to its Board of Directors. Per the press release, Dr. Liu currently serves as Chairman and Chief Executive Officer of ChiMed, Inc., a visual health content provider for consumers in Asia, and Chairman of First China Capital Partners, a boutique merchant bank based in China, Hong Kong, and Taiwan. From 1992 until 2006, Dr. Liu served on the faculty at the UCLA School of Medicine and was a team physician for UCLA athletics. The company adds, "We anticipate Dr. Liu's relationships to impact our strategy for Asia, particularly Taiwan and China."
