ReGen Biologics (OTC: RGBI) today announced that the Company has
recently responded to the FDA's request for additional information
regarding the Company's December 2006 510(k) pre-market notification
for its collagen scaffold device.
"The FDA had a number of questions and requests for additional
data to support its review of substantial equivalence for the ReGen
collagen scaffold", commented Gerald E. Bisbee, Jr., Ph.D., Chairman
and Chief Executive Officer of ReGen Biologics. "Based upon recent
meetings with the FDA, we believe this submission together with
previously submitted information responds fully to FDA questions, and
provides sufficient information to support a clearance decision." Dr.
Bisbee continued, "We expect to continue our support of the FDA's
review, and will provide an update as soon as we have more definitive
information."
Dr. Bisbee concluded, "Pending a final decision from the FDA, we
have been hard at work developing our U.S. marketing and distribution
plans, including establishing an independent network of specialized
sales agents, which will allow us to efficiently engage experienced
sales professionals with existing surgeon relationships."
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, which is cleared for sale in Europe and marketed
through ReGen's European subsidiary, ReGen Biologics AG. ReGen has
submitted a 510(k) to the FDA in the U.S. for clearance of its
collagen scaffold device.
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 2006 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.