Healthcare Industry News: HSMN NewsFeed
News Release - November 13, 2006
ReGen Biologics Announces Results of FDA AppealFRANKLIN LAKES, N.J.--(HSMN NewsFeed)--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.
Gerald E. Bisbee, Jr., Ph.D., Chairman and CEO, said, "We are delighted that the FDA has provided a pathway toward Class II clearance for the CS in the U.S. and we will work diligently to complete pre-filing discussions with FDA staff and file the revised 510(k)."
The FDA letter came in response to ReGen's appeal of the FDA's not substantially equivalent (NSE) decision on the 510(k) premarket notification submitted to the FDA in June 2006. As a result of the discussions, the FDA upheld the NSE decision which cleared the way for a new 510(k) submission with revised indications and supported by clinical data from the U.S. multicenter trial.
The CS device is intended to be used as a surgical mesh for soft tissue reinforcement, with one of the designs developed for repair of meniscus defects. With nearly one million partial meniscectomy patients annually in the U.S. alone, the availability of this product for use in the meniscus will represent a significant treatment alternative for surgeons and patients.
About ReGen Biologics, Inc.:
ReGen Biologics is an orthopedic products company that develops, manufactures and markets innovative tissue growth and repair products for U.S. and global markets. ReGen's patented collagen scaffold technology includes applications in orthopedics, general surgery, spine, cardiovascular and drug delivery. ReGen's first approved product using its collagen scaffold technology is the CMI(TM), a meniscus application of its collagen scaffold technology, which is cleared for sale in Europe and marketed through the ReGen's European subsidiary, ReGen Biologics AG.
ReGen is headquartered in Franklin Lakes, NJ and manufactures its collagen scaffold products in its ISO Certified facility located in Redwood City, CA. For more information on ReGen, visit www.regenbio.com.
This press release contains forward-looking statements within the meaning of the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on the current expectations and beliefs of the management of ReGen and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including those discussed in the Risk Factors section of ReGen's 2005 annual report on Form 10-K and additional filings with the SEC. ReGen's filings with the SEC are available to the public at the Company's website at http://www.regenbio.com, from commercial document-retrieval services and at the Web site maintained by the SEC at http://www.sec.gov.
Source: ReGen Biologics
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.