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ReGen announces European labeling expansion for CMI to include lateral use
By Elaine Rigoli
Tampa, Fla., Feb. 27 - ReGen Biologics, Inc. announced an expansion of the CE Mark labeling for its CMI device in Europe will include use in the lateral meniscus.
ReGen has successfully marketed a medial CMI in Europe for the past five years, according to a company news release.
The CMI is a collagen scaffold, which guides tissue remodeling in the injured meniscus after partial meniscectomy, a procedure to treat torn cartilage in the knee.
About 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 release said.
The company estimates about 130,000 medial and lateral procedures are eligible for use of the CMI in Europe, or 15% of the worldwide market.
"Degenerative changes tend to progress more rapidly after partial meniscectomy on the lateral side due [to] the anatomy of the knee," said Gerald E. Bisbee Jr., Ph.D, chairman and chief executive officer, in a statement. "Thus, there is a large unmet need in the market that the lateral CMI will help address."
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," Rodkey stated in the release.
A full product launch is expected in the second half of 2006, the release said.
Franklin Lakes, N.J.-based ReGen is an orthopedic products company that develops, manufactures and markets tissue growth and repair products.
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