Healthcare Industry News: HSMN NewsFeed
News Release - February 27, 2006
ReGen Biologics, Inc.: CMI(TM) Labeling Expanded in Europe to Include Lateral UseFRANKLIN LAKES, N.J.--(HSMN NewsFeed)--Feb. 27, 2006--ReGen Biologics, Inc.(OTCBB:RGBI ) announced today an expansion of the CE Mark labeling for its CMI(TM) device in Europe to include use in the lateral meniscus. The company has successfully marketed a medial CMI in Europe for the past five years.
The CMI is a collagen scaffold, which guides tissue remodeling in the injured meniscus after partial meniscectomy. Approximately 35% of meniscus procedures involve the lateral meniscus, and long-term clinical effects from lateral meniscus injuries can be more severe than on the medial side, potentially leading to a higher rate of indication for the CMI. The Company estimates a total of approximately 130,000 medial and lateral procedures are eligible for use of the CMI in Europe, which approximates 15% of the world-wide market.
"Degenerative changes tend to progress more rapidly after partial meniscectomy on the lateral side due the anatomy of the knee," commented Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer. "Thus there is a large unmet need in the market that the lateral CMI will help address."
Dr. William Rodkey, ReGen's Vice President of Scientific Affairs, will be overseeing a post-market surveillance in Belgium, Italy, Germany, and Spain over the next several months. "Through working with key investigators in several countries we will refine the recommended surgical technique and begin building a patient database regarding the clinical benefits of the lateral CMI procedure," Dr. Rodkey stated.
A full product launch is expected in the second half of 2006.
About ReGen Biologics, Inc.:
ReGen Biologics is an orthopedic products company that develops, manufactures and markets innovative tissue growth and repair products for U.S. and global markets. ReGen's patented collagen scaffold technology includes applications in orthopedics, general surgery, spine, cardiovascular and drug delivery. The Company's first approved product using its collagen scaffold technology is the CMI(TM), which is cleared for sale in Europe and marketed through the Company's European subsidiary ReGen Biologics AG.
ReGen is headquartered in Franklin Lakes, NJ and manufactures its collagen scaffold products in its ISO Certified facility located in Redwood City, CA. For more information on ReGen, visit www.regenbio.com.
Source: ReGen Biologics
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.