Orthopedic News Roundup 17-Nov-05
BY HUYEN NGUYEN, NOVEMBER 17, 2005
Regulatory Update: Osteobiologics received FDA clearance on its OsteoChondral Transplant (OCT) Comprehensive System Instruments. The system is intended for the treatment of osteochondral (cartilage) defects in the knee. BioSyntech received an approval from Health Canada, Therapeutic Products Directorate, Medical Devices Bureau, to begin its pivotal clinical trial for BST-CarGel®. The study will be in five different locations though out Canada consisting of 80 patients with ages ranging from 18 to 50 years. BST-CarGel® is intended to repair localized lesions and is applied during an MIS procedure. The FDA issued several extensions to clear 510(k) product applications this week. The ruling was an extension of the original due date on November 15th, 2005. Despite the absence of a 510(k) approval, the Agency is allowing these companies to continue marketing its products as long as they are aggressively pursuing a PMA approval while they are under active review by the FDA: amongst them are Osteotech's Grafton®DBM, LifeNet's OPTIUM DBM™ and IsoTis OrthoBiologics' OrthoBlast®II. Since we are on the topic of FDA, check out our newly published research on the FDA Approval for Orthopedic Devices:What the Process Demands and How to Adapt Your Strategy.
Clinical Update: BioniCare Medical Technologies released its Phase IV trial of its BioniCare Knee Device confirming the device's safety and efficacy in treating symptoms associated with osteoarthritis (OA) of the knee. A prior study showed that 62% of candidates for total knee replacement were able to postpone surgery at the end of four years compared to 7% in a control group.
Earnings: Medtronic reported its 2Q:05 with spinal revenues growing at 20%, or $516 million, compared to 2Q:04. In the quarter, spinal biologics increased by more than 30% worldwide, while outside of the U.S. Medtronic's dynamic stabilization product line continues to gain momentum and holds the number position in Europe.
Financing: Portland Orthopaedics, an Australian-based hip prosthesis company, announced that it has raised $5 million in financing before going public on the Australian Stock Exchange. The Company is offering 20 million shares at $0.25 per share with total market capitalization of $33 million.
Government Funds: FzioMed received a Small Business Innovation Research (SBIR) Phase I grant by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health (NIH). The grant is intended to support the research and development of the Oxiplex® technology for applications in acceleration of bone healing and spinal fusion procedures.
Distribution & Licensing Agreement: ReGen Biologics, Inc. has signed a two-year distribution agreement with Hoscenter to market its ReGen® CMI™ in most of Spain. Hoscenter is a sports medicine distributing company with headquarter in Madrid, Spain. dj Orthopedics has renewed a three-year term soft goods supply contract with HealthTrust Purchasing Group ("HPG"). HPG is a purchasing organization that serves more than 1200 healthcare facilities in the U.S. Baxter's subsidiaries signed an exclusive worldwide right with Kuros Biosurgery AG to develop and commercialize a portfolio of hard and soft tissue-repair products. These products will combine Baxter's fibrin-based biomatrix, TISSEEL® Fibrin Sealant, with Kuros' proprietary biologics and associated binding technology.
Mergers & Acquisitions: Encore Medical announced the acquisition of Compex Technologies ("CMPX") for a total value of $109 million in a stock-for-stock merger transaction. CMPX is a pain management and rehabilitation company.
Organization Update: Small Bone Innovations (SBI) announced it has created five business units to support its goal of becoming a world leader in the extremity sector. These units are: Arthroplasty; Internal Fixation; External Fixation; Tissue Technology; and International Business.
Appointment: Alphatec Spine, a portfolio company of HealthpointCapital, announced that Todd Fanning has become President of the allograft division. Previously, Mr. Fanning was Vice President, Sales and Marketing for Abbott Spine. SpineMedica has named Lew Bennett as its new Chief Executive Officer. Mr. Bennett is a well-known orthopedic industry veteran who has held various positions with successful companies such as; NuVasive, Sofamor Danek, Smith & Nephew, Howmedica and Ethicon, a division of JNJ. Smith & Nephew Endoscopy, a division of Smith & Nephew, appointed Sally L. Maher to Vice President, Research and Development, and Joseph G. Darling to Vice President of Marketing. Ms. Maher has been with the Company since 1999 and Mr. Darling was previously with Baxter International. Synthes has elected Jobst Wagner to its Board of Directors. Mr. Wagner is a President of the Supervisory Board of the REHAU Group. Based in Switzerland, REHAU group is a manufacturer and systems supplier in the construction, automotive and industry sectors.
Miscellaneous: Due to high demand for musculoskeletal care, OhioHealth's McConnell Heart Health Center is opening a 24,000 square foot McConnell Spine, Sport and Joint Center. Featherlite is a manufacturer of custom trailers and mobile medical vehicles, announced that it has built a 53-foot mobile medical lab for Wright Medical Technology. NovaBone Products LLC was mentioned in The Business Journal of Jacksonville. Based in Jacksonville, FL NovaBone develops synthetic bone graft materials for use in oral/periodontal, cranio-maxillofacial and orthopedic surgery. Is there a link between the quality of patient care and hospital performance-based bonuses? Absolutely! A writer for The New York Times (NYT) examines this topic as we Blog a summary of the article.
