Regen Biologics Gets FDA Clearance
BY JOHN MCCORMICK, DECEMBER 22, 2008
This morning Regen Biologics announced that it received its long awaited FDA 510(k) clearance to market its collagen meniscus implant for the knee. This marks the end of a long and tortured back and forth between the company and the FDA which took the better part of a decade.
The implant, recently renamed Menaflex, is a resorbable surgical mesh composed mainly of type I collagen. It is sutured into damaged or removed meniscus tissue and it acts as a resorbable scaffold which guides new meniscus tissue growth.
While this FDA clearance is only indicated for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus, that represents over 60% of the meniscal repair surgeries per year. The world-wide annual volume of partial meniscectomies (medial and lateral) is over 1 million. And that excludes the installed base of patients who have already had such treatments over the past decade. In short, there is a substantial market potential for this type of technology.
Regen Biologics has been selling in Europe for several years and has been planning a USA launch which they now they get to implement. Whew!
