FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--ReGen Biologics, Inc. (OTCBB: RGBI) today announced that it has received a letter in which the FDA provided that ReGen may submit a new 510(k) for clearance of its collagen scaffold (CS) device with modified indications for use in the meniscus. These modifications were suggested to the FDA by ReGen during the appeal process and they are consistent with the current indications for use of the CMI in Europe and its use in the multicenter clinical trial in the United States.
