Message #29 From:
NewsBot Date: November 13, 2006 05:30:00 AM
RGBI News ReGen Biologics Announces Results of FDA Appeal
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.
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™,
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.
