Orthopedic News Roundup 5-Oct-06
BY HUYEN NGUYEN, OCTOBER 5, 2006
Earnings Update: Tutogen Medical, Inc. provided an update on its 4Q:06 projected revenues which are estimated at ~$10.8 million, representing a 36% increase over the comparable quarter of 2005. Revenues for the fiscal year will be ~$38 million, an increase of 19% year-over-year. 4Q:06 sales will increase 35% in the U.S. and 37% internationally. Tutogen plans to report its full 4Q:06 financial results in early December 2006.
Clinical Update: Last week at NASS, Synthes announced that results from its PRODISC®-L Total Disc Replacement (PRODISC-L) trial indicated that patients who received the PRODISC-L experienced post- and peri-operative outcomes that were better than those of patients undergoing circumferential spinal fusion. Overall success was measured by a composite of primary measures including pain, patient satisfaction and overall radiographic success. Arthrosurface, Inc. announced that patients who have received the HemiCAP® implant for the shoulder or hip have recently crossed over their respective three year post-surgery marks. In addition, patients resurfaced with the Arthrosurface system for the great toe are also approaching their two year milestones.
Distribution Agreement: Pioneer Surgical Technology and Regeneration Technologies, Inc. (RTI) signed a distribution agreement for Pioneer to distribute RTI's BioSet™ DBM. BioSet DBM is intended for use as a bone void filler in many types of surgical procedures.
Government Funding: National Institutes of Health-National Institute of Arthritis and Muskuloskeletal and Skin Diseases (NIH-NIAMS) awarded Spire Corporation a two-year, $399,243 (grant) to develop a new type of nanotechnology coating for wear-resistant orthopedic devices with specific applications for spinal implants.
Legal: Relating to a previous patent infringement ruling between Smith & Nephew and Synthes, the Federal District Court for the Western District of Tennessee ruled in favor of Smith & Nephew Inc., granting the company's request for a permanent injunction directed at Synthes' Trochanteric Fixation Nail (TFN) and Proximal Femoral Nail (PFN) products. The ruling prevents Synthes from promoting, distributing or selling its TFN and PFN products indicated for treatment of intertrochanteric fractures in the U.S. Synthes did not issue its own press release, but through Reuters, a spokesman stated that this injunction will not hurt Synthes' sales in the U.S., and the Company will appeal the ruling.
Product Introduction & Update: Medtronic, Inc. announced the introduction of its ARCUATE™ XP, ARCUATE™ Systems and the CD HORIZON® LEGACY™ PEEK Rod device. The ARCUATE™ systems are a minimally invasive, controlled cement delivery method for orthopedic procedures relating to vertebral body compression fractures (VCF). The CD HORIZON® LEGACY™ PEEK Rod is a pedicle-based, posterior rod for patients who undergo spinal fusion surgery. Smith & Nephew's Endoscopy division introduced the KINSA Suture Anchor, a technology that provides a fast, secure and consistent method for repairing shoulder instability. DJO Incorporated announced the release of the DonJoy® HAT TRICK™, a patented headguard designed to reduce the risk of concussion in soccer.
Regulatory Update: Genzyme Corp. received expanded CE Mark labeling approval for its Synvisc® (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Prior approvals were for use in hip and knee OA patients. Cytori Therapeutics, Inc. received 510(k) clearance for its Celution™ Cell Concentration System as a cell saver device. The Celution™ is a fully automated cell processing device with per-patient consumables.
