ReGen moves meniscus implant closer to the US:
This article was originally published in Clinica
Executive Summary
Orthopaedic products firm ReGen Biologics has moved a step closer to taking its collagen meniscus implant (CMI) to the US market, after submitting to the FDA the manufacturing module of its premarket approval application for the product. The first product to use the Franklin Lakes, New Jersey firm's patented core technology, the CMI uses the body's own healing process to grow new tissue in the meniscus, and restore activity levels for patients with meniscus loss. The company said it expected to file a preclinical module in the next few months, and to conclude with the filing of a clinical module in the first or second quarter of 2005. The CMI is currently distributed in several countries, including Australia, Chile and those in Europe, on a non-exclusive basis, through the Centerpulse unit of Zimmer Holdings.