Musculoskeletal News Roundup 17-Dec-09
BY LAUREN UZDIENSKI, DECEMBER 17, 2009
Alphatec Holdings, Inc. announced that it has entered into a definitive agreement to acquire Scient'x Groupe SAS, a spinal implant company headquartered in France. The transaction is structured as an all-stock transaction such that 100% of outstanding Scient'x stock will be exchanged pursuant to a fixed ratio for 24 million shares of the Company's common stock.
Small Bone Innovations closed a $30.0 million credit facility from Drawbridge Special Opportunities Fund, an affiliate of Fortress Investment Group. The company plans to use the funds toward "accelerated business expansion and [to] refinance existing indebtedness."
Ouroboros Medical received CE mark clearance for its minimally-invasive OSS device, designed to contain graft material and expand in the interbody disc space.
Spinal Restoration received a Special Protocol Assessment letter from the FDA regarding its phase-III study of the Biostat System for chronic discogenic low back pain, which states that the study design, endpoints, and planned statistical analysis are adequate to support a Biologic License Application. The study, which begin enrolling in early 2010, is multicenter, randomized, blinded (patient and evaluator) and placebo-controlled. The Biostat System consists of the resorbable, human-derived BIOSTAT BIOLOGX Fibrin Sealant and a proprietary delivery system.
Product Introduction and Update
ConforMIS introduced a "new iteration" of its unicompartmental knee resurfacing device, the iUni G2. Enhancements to the iUni G2 include an "improved, patient-specific and wear-optimized design, instrument changes for even simpler surgical techniques" and iView imaging to aid in surgical planning.
Resorbable Orthopedics announced plans to launch its line of bone void fillers in 3Q:10.
curasan announced the results of an open clinical study evaluating the safety and efficacy of Curavisc, a hyaluronic acid product, in the treatment of chronic facet syndrome. After three weekly injections, 41% of a 60-patient cohort reported being free of symptoms and 46% reported a significant improvement.
ProChon Biotech announced plans to expand its BioCart Cartilage Regeneration System study to 10 sites in the U.S. and Israel by end of this year. The Phase-II study is randomized, double-arm, open-label and multicenter, comparing the safety and efficacy of the BioCart System to microfracture for the treatment of symptomatic cartilage defects.
BioMimetic Therapeutics shipped its first order of Augment Bone Graft to its exclusive Canadian distributor, Joint Solutions Alliance. Augment, which was recently approved by Health Canada and has a PMA submission pending, consists of rhPDG and beta-tricalcium phosphate.
Small Bone Innovations, Inc. formed a joint venture with Khazanah Nasional Berhad and Malaysian Technology Development Corporation. Based in Kuala Lumpur, Malaysia, SBi Asia Pacific "continues the execution of [SBi's] global hub strategy" and offers a "business-friendly economy, strong regional growth prospects, highly productive workforce, world-class infrastructure and central location in the Asia Pacific geography."
RTI Biologics donated nearly 500 spinal allografts to AIC-CURE International Children's Hospital in Kijabe, Kenya, which will be used in fusions to treat congenital spinal deformities, limb defects and vertebral reconstruction for tuberculosis infection in Kenyan children.