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Orthopedic and Dental Industry News Complete Archive »

Orthopedic News Roundup 8-Dec-05 BY HUYEN NGUYEN, DECEMBER 8, 2005

Due to last week's Merrill Lynch investor conference (subscription may be required), investors have regained confidence in the orthopedic sector after the industry faced some hurdles within the past few months. In our HealthpointCapital Weekly Valuation Index, P/E (price-to-earnings) jumped 6% compared to a week ago and 8% versus a month ago (see table below). The Orthopedic Index continues to climb steadily as we approach the beginning of a new year.

Appointment: NuVasive appointed Jeffrey Rydin to the position of Senior Vice President, U.S. Sales, a newly created position within the Company. Previously, he was an Area Vice President at DePuy Spine for three years.

Clinical Update: Orthovita presented initial findings on its IDE pilot studies on the CORTOSS® vertebral compression fracture in vertebroplasty and kyphoplasty at the 91st Scientific Assembly and Annual Meeting of the Radiological Society of North America held in Chicago, IL. Preliminary findings showed improvement in treating patients with CORTOSS® in osteoporotic vertebral compression fractures. Medtronic has completed enrollment for its clinical trial on the PRESTIGE® LP Cervical Disc. Patients who receive this disc will have a minimum of two years follow up after surgery.

Distribution Agreement: Inion Ltd. and Aesculap have entered into an exclusive distribution agreement for Inion S-1™ Spinal range of biodegradable medical devices. Aesculap will distribute this product in the U.S. and Canada for three years. Since June 2004, Inion has also had a distribution agreement with Aesculap in sports medicine. As an adjunct to the previous U.S. distribution agreement with Polyganics for its Neurolac® resorbable nerve guide, Ascension Orthopedics has extended the agreement to its worldwide distribution network.

Financing: Headquartered in Paris, France SpineVision announced that the company is spinning off its non-fusion technology R&D to create a new wholly-owned subsidiary, FlexSpine, based in Singapore, after raising $16 million in a Series D financing.

Licensing & Service Agreements: Wright Medical Group has entered into an exclusive licensing agreement with the University of Minnesota for the rights to the University's U.S. patent number 6,793,659 intramedullary nailing technology. Wright will use this technology to complement its current MICRONAIL™ Intramedullary Fixation System for distal radius fracture repair. Osprey Biomedical Corporation, an allograft tissue bank based in Wilmington, DE, signed an agreement with Clearant, Inc. to use the CLEARANT PROCESS® to sterilize its bone allograft implants. Osprey's product portfolio includes precision milled cervical allograft implants, and the Company is working to develop a lumbar allograft product line as well.

Regulatory Update: Orthovita ("VITA") has submitted a PMA to the FDA to move manufacturing of its VITAGEL™ Surgical Hemostat in-house. Although available for sale since January 2005, VITA has outsourced manufacturing of VITAGEL™ to Angiotech Pharmaceutics. Osteotech received an additional 510(k) clearance for its Grafton Plus® DBM Paste. Last week, the bone paste was cleared for use as bone graft substitutes in orthopedic procedures; this week, the FDA has extended its indication for dental, oral and cranio/maxillofacial procedures. Inion Ltd. received 510(k) clearance for its Inion S-1™ Biodegradable Anterior Cervical Fusion System. The system is a graft containment used in cervical spinal fusion applications. IsoTis Biologics received 510(k) clearance for its OrthoBlast II® that is intended for use as bone void fill in orthopedic procedures.

Miscellaneous: Corin Group PLC provided some unfavorable earnings guidance for the fiscal year. Ceramic use in medical devices is nothing new, but companies and scientists are finding new ways to improve ceramic applications in medical implants. And of course, every week there seems to be articles discussing the hot topics of gainsharing or reimbursement.

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