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(TM) 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.
SOURCE: ReGen Biologics, Inc.
ReGen Biologics, Inc. Brion Umidi, 201-651-3515 bumidi@regenbio.com

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