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Orthopedic and Dental Industry News Complete Archive »

Orthopedic News Roundup 27-Apr-06 BY HUYEN NGUYEN, APRIL 27, 2006

Appointment: Stryker Corp. appointed three officers to the company: Luciano Cattani, Vice President, Group President, International; Elizabeth A. Staub, Vice President of Regulatory Affairs and Quality Assurance, Stryker Corporation and Bronwen R. Taylor, Chief Compliance Officer, Stryker Corporation. Mr. Cattani joined Stryker since 2001 and was promoted to Group President in 2005. Ms. Staub has been with Stryker since 1989. Ms. Taylor joined Stryker in 2000 as CFO for Stryker South Pacific division. Orthovita has hired Christine J. Arasin as Vice President Business Development and Corporate Counsel. From 2000 to 2003, Ms. Arasin was with Morgan, Lewis & Bockius LLP where she served as Orthovita's outside counsel.

Clinical Update: Cryolife announced that its preliminary results for the BioDisc™ clinical study reported that patients experienced significant reduced back pain and improved function after having the BioDisc™ implanted. The study targeted patients suffering from disc herniations in the lumbar spine at the L4/L5 and L5/S1 intervertebral levels. Nine patients were assessed after six week and three months post-surgery; they will be evaluated again at six months, one year and two years after surgery. Osiris Therapeutics, Inc. completed enrollment of 55 patients in a Phase I/II clinical trial of its Chondrogen™. Chondrogen™ is a preparation of adult stem cells formulated for injection into the knee to help repair the meniscus. In the Journal of Arthroscopy and Related Surgery, a study was published showing that using ArthroCare's Coblation® technology preserved the same amount of tissue in the bovine model as a mechanical shaver in the treatment of the meniscus.

Initial Public Offering: Earlier this year, BioMimetic Therapeutics, Inc. announced the filing of its initial public offering (IPO) with the SEC. The Company is offering 4.5 million shares of common stock at the price range of $11.00 to $13.00 per share. If approved, the Company will trade under the ticker symbol "BMTI" on the Nasdaq National Market.

Licensing & Service Agreement: Zimmer entered into a five year supply agreement with HCA for its orthopaedic implants. HCA is a provider of healthcare services. It has a network of approximately 180 hospitals and more than 90 outpatient surgery centers in 22 states, England and Switzerland.

Product Introduction & Update: St. Francis Medical Technologies announced the official launch of its X STOP® Interspinous Process Decompression (IPD®) System. The X STOP® is intended to treat patients suffering from lumbar spinal stenosis (LSS). Since approval, there have been more than 500 surgeons trained for this IPD procedure. At the American Association of Neurological Surgeons (AANS) annual meeting in San Francisco, Integra LifeSciences introduced the CUSA® brand to its ultrasonic aspirator product family. CUSA® product line was acquired through the acquisition of Radionics from Tyco. BREG, a division of Orthofix International N.V., launched the e-PainCare ambulatory infusion pump, a delivery of local anesthetics to a post-operative wound site.

Warning Letter: Earlier this month, OrthoHelix received a warning letter from the FDA regarding a failed inspection of the manufacturing facility in Akron, OH during January 10-31, 2006. The FDA ruled that OrthoHelix has violated the Correction and Removal Regulation and Quality System Regulation codes of the FDA, this, subsequently cause the MaxLock™ Driver system to be misbranded and adulterated. The MaxLock™ system is a plate and screw system intended to treat patients with foot and ankle injuries.

Miscellaneous: More and more celebrities are publicly supporting orthopedic surgeries as Sally Field joins the baby boomer generation list. At the American Association of Neurological Surgeons (AANS) in San Francisco, a study was reported showing that surgeons believe that minimally invasive surgery for herniated spinal disc seems to be better for patients than traditional approach. In the Journal of Bone and Joint Surgery, a study showed that laser light can target gene therapy for knee injuries. Wright Medical is featuring a live surgery of its GRAFTJACKET® Regenerative Tissue Matrix on Wednesday, May 3 at 7:00PM EST.

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