ReGen Biologics, Inc. (OTC: RGBI) announced today that the company
is in receipt of a not substantially equivalent (NSE) letter from the
U.S. Food and Drug Administration (FDA) regarding the 510(k)
submission for its Collagen Scaffold device.
The FDA indicated the device is not substantially equivalent to
existing Class II devices already in receipt of FDA clearance. ReGen
filed the 510(k) submission in late 2006 based on guidance received
from FDA following the Company's appeal of an original NSE decision
based on the Company's initial 510(k) submission in December 2005.
"Obviously we are disappointed with this latest decision regarding
our 510(k) submission. We believe we have provided the FDA with
adequate information to support clearance of the 510(k), and that the
FDA has failed to adequately consider the appropriate regulatory and
scientific issues required of this review," stated Gerald E. Bisbee,
Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics.
"The Company is pursuing the next steps in appealing the NSE decision
through FDA administrative channels. We believe that a fair appeal
process involving sports medicine experts from outside the FDA will
result in the submission being cleared," Dr. Bisbee stated.
"The United States represents a key marketplace, and we believe
this product will fill a large and important need among surgeons and
patients. We will continue to pursue FDA marketing clearance via the
options available to us. The Company has adequate cash to support
operations through the anticipated appeal process, however we will
continue to evaluate all levels of spending throughout the
organization to help ensure our ability to complete the task at hand.
While the FDA NSE decision necessitates a longer timeframe, we are
committed to doing everything within our power to obtain U.S.
clearance," Dr. Bisbee continued.
"We will continue our marketing and training programs in Europe
through our Swiss subsidiary, ReGen AG, and ReGen AG will continue to
direct world-wide market adoption," concluded Dr. Bisbee.
Additional information regarding the status of FDA clearance
efforts and other business updates will be provided as information
becomes available.
Conference Call Information:
ReGen will host a conference call to review the Company's plans
and answer questions.
What: ReGen Biologics Informational Conference Call
When: September 25, 2007 at 12:00 p.m. Eastern
Dial-in numbers: (800) 510-9691 (domestic) and (617) 614-3453
(international) pass code # 90065915
Contact: Al Palombo, Cameron Associates, (212) 554-5488 or
al@cameronassoc.com
If you are unable to participate, an audio replay of the call will
be available beginning two hours after the call and will be available
until October 2, 2007. The replay can be accessed by dialing (888)
286-8010 (domestic) or (617) 801-6888 (international) using
confirmation pass code # 26015020.
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 matrix
technology includes applications in orthopedics, general surgery,
spine, cardiovascular and drug delivery. ReGen's first approved
product using its collagen matrix technology is the CMI(TM), a
meniscus implant cleared for sale in the Europe Union and marketed
through ReGen's European subsidiary, ReGen Biologics AG.
ReGen is headquartered in Hackensack, NJ and manufactures its
collagen matrix 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.