ReGen Closes Bridge Financing
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Provides Update on Recent Events and Liquidity Position
HACKENSACK, N.J.--(Business Wire)--
ReGen Biologics (OTC: RGBO) announced today that it has entered into a bridge
financing agreement for up to $3 million aggregate principal amount of secured
convertible notes ("Notes") and closed on the first tranche of the agreement
with one of its principal investors. In the first closing under the bridge
financing, the Company received $250,000 in immediately available funds and
initial commitments for $1.5 million to be provided to the Company in increments
to be established with the investors.
In order to reduce its cash requirements, the Company has initiated various
personnel and other expense reductions and implemented a temporary employee
furlough program for U.S. based employees. These initiatives are expected to
have a significant impact on the Company`s ability to conduct certain aspects of
its operations. The Company is currently working on a restructuring plan and
will provide further updates regarding its plans and liquidity position as they
become available.
"A protracted FDA review and recent report by the FDA indicating that a
re-review of the clearance of the Menaflex device was going to be undertaken,
has severely reduced our financing options," explained Gerald E. Bisbee, Jr.,
Ph.D., Chairman and Chief Executive Officer. "This is unfortunate because it
appears from the report that the FDA came to that conclusion due, not to any
scientific issues, but to a number of internal FDA departures from processes,
procedures and practices; including as stated in the report, `…the presence of
widespread internal disagreement and confusion about the legal standard for
510(k) review…,` and an admission from the FDA`s Office of Chief Counsel that
certain aspects of the Menaflex review, …`supported ReGen`s long standing
argument that the Center was holding the CS device to the wrong review
standard.`" Dr. Bisbee concluded, "The science and resulting publications
solidly support the safety and clinical benefit associated with the use of the
Menaflex device."
Several ongoing events are believed to have contributed to the Company`s current
situation, including: conflict at the FDA between management and a group of
"whistleblowers" that began well before clearance of the Menaflex device;
pressure from certain members of Congress to investigate the whistleblowers`
accusations regarding the FDA`s Device Center; and long-standing congressional
interest in changing the 510(k) program.
Dr. Bisbee concluded, "ReGen employees and the broader network of consultants
and advisors have performed admirably over these past few years and we are
impressed with their service and commitment. We are also grateful for our
investors and the support of the many surgeons who have been trained and
patients who have received the Menaflex device."
The bridge financing provides for the issuance of up to $3 million aggregate
principal amount of Notes due April 2, 2010, accruing interest at 8% until the
due date and 12% thereafter until paid, and secured by a lien on the Company`s
assets. In connection with the bridge financing, the Company also issued five
year warrants to purchase common stock. The Notes and warrants are convertible
upon the consummation of a future private placement or at the due date at the
prices and upon the terms set forth in the agreement of the bridge financing,
which the Company intends to file with the Securities and Exchange Commission.
The Notes have not been registered under the Securities Act of 1933, as amended,
or any state securities laws and may not be offered or sold in the United States
absent registration or an applicable exemption from registration requirements.
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 Menaflex collagen meniscus implant employs proprietary
biological collagen scaffold technology to facilitate tissue growth, thereby
reinforcing and repairing the damaged meniscus of the knee. The Menaflex device
has been cleared for sale in Europe and other countries, and is marketed through
ReGen`s European subsidiary, ReGen Biologics AG. The FDA cleared the Menaflex
device to be marketed in the United States in December 2008. Visit
www.regenbio.com and www.menaflex.com for more information.
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 ReGen
management 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 2008 annual report on Form 10-K, its most recently issued
quarterly report filed on Form 10-Q 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
website maintained by the SEC at http://www.sec.gov.
ReGen Biologics, Inc.
Brion Umidi, 201-651-3515
bumidi@regenbio.com
Copyright Business Wire 2009
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