ReGen Biologics: FDA rejects claim that its surgical mesh product is equivalent to class 2 devices

By Lisa Kerner

Charlotte, N.C., Aug. 7 - ReGen Biologics, Inc. said the Food and Drug Administration has determined that the company's collagen scaffold device is not substantially equivalent to existing class 2 devices already in receipt of FDA clearance.

The company has filed an appeal to the 510(k) submission decision, according to a news release.

ReGen's collagen scaffold device is designed to be used as a surgical mesh for soft tissue reinforcement, including for repair of meniscus defects.

"While we are disappointed with this initial decision from the FDA, we continue to believe that the collagen scaffold device should be regulated as a class 2 device," chairman and chief executive officer Gerald E. Bisbee Jr. said in the release.

"The evidence demonstrated by extensive data on over 300 patients, as well as our marketing experience in Europe, provides a strong rationale for this product being made available to surgeons and patients in the United States."

ReGen Biologics is an orthopedic products company based in Franklin Lakes, N.J.

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