Musculoskeletal News Roundup 1-Dec-11
BY LAUREN UZDIENSKI, DECEMBER 1, 2011
Funding
IlluminOss Medical completed a $4.0 million debt financing round, according to a regulatory filing. The financing consists of debt, options and warrants. No other details were available.
Regulatory
Nextremity Solutions obtained ISO 13485 certification and CE mark certification of the NEXTRA Hammertoe Correction System. The NEXTRA System was introduced for limited release at the American Orthopaedic Foot & Ankle Society Congress last July, with a global launch to commence in early 2012.
Oxford Performance Materials announced that the FILL-SQUALE cervical cage, which is made from polyetherketoneketone-based OXPEKK-IG, recently received regulatory approvals in Argentina and Peru. The company says these approvals mark the first entrance of OXPEKK-IG and OSD devices into these markets.
RSB Spine received a revised FDA clearance letter for the InterPlate System as both an interbody implant with integrated fixation and an anterior screw fixation device, adding that the FDA recently instituted new product codes for stand-alone interbody devices with integrated fixation. The company reports that the new code for lumbar interbody devices is OVD, and the new code for cervical interbody devices is OVE. In addition to these new product codes, the InterPlate retained code KWQ for anterior screw fixation in the spine.
Product Introduction and Update
Arthrosurface announced that over 30,000 patients have received the company's HemiCAP implants for shoulder, knee, hip, toe and ankle applications. Further, the Arthrosurface technology is now available in all 50 states and in more than 25 countries worldwide. The company also noted that there are now over 100 sources referencing the Arthrosurface HemiCAP implants in the medical literature.
Legal
ArthroCare announced that it has reached an agreement in principle to settle the private securities class action suits pending against the company and two of its former officers. The company would pay the class $74.0 million to settle the claims, pending the approval of a Texas court.
Operations
Zimmer announced plans to establish a new research and development center in Beijing, China, collaborating with local researchers and healthcare providers to meet the "unique needs" of the Asian market and "[strengthening] the company's position in one of the fastest growing countries in the region."
Distribution
Bacterin signed an exclusive agreement with Jeil Medical Corporation for distribution of Jeil's LeForte System in the U.S. and Canada. The company says the LeForte System is used in CMF procedures and "complements Bacterin's existing expertise and product offerings in the tissue grafting arena." The company plans a beta-launch of the LeForte System next month, followed by a full product release in 2Q:12.
Appointments
Ascendx Spine appointed Maria Pilar Debelius-Kinsey Sales and Marketing Manager, Europe. Previously Ms. Debelius-Kinsey served as General Manager of Sofamor Danek Iberica Medtronic and Sales Operations Director for SpineVision.
