ReGen Biologics Inc (fka RGBOQ)

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ReGen Biologics Provides Update on 510(k) Regulatory Submission

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August 07, 2006 08:30 AM US Eastern Timezone

FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--Aug. 7, 2006--In relation to correspondence received from the FDA, ReGen Biologics, Inc. (OTC: RGBI) provided an update today regarding the 510(k) submission for its collagen scaffold device.

In a letter, the FDA indicated that the device is not substantially equivalent (NSE) to existing Class II devices already in receipt of FDA clearance. The Company has submitted an appeal, believing that it has clearly demonstrated the safety and substantial equivalence of its device. The appeal serves to reopen the 510(k) file for a supervisory review and a potential reversal of the NSE decision. The Company intends to vigorously pursue the appeal and all alternatives available to ensure that the device is cleared for marketing in the United States through the least burdensome regulatory pathway.

"While we are disappointed with this initial decision from the FDA, we continue to believe that the collagen scaffold device should be regulated as a Class II device," stated Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer of ReGen Biologics. "The evidence demonstrated by extensive data on over 300 patients, as well as our marketing experience in Europe, provides a strong rationale for this product being made available to surgeons and patients in the U.S. In the interest of the patient population that may be eligible for this device, as well as our shareholders, we are moving aggressively toward a successful completion of the NSE appeal process. There remain several additional avenues available to us for achieving FDA marketing clearance, including the completion of our original Pre-Market Approval (PMA) application," Bisbee concluded.

The collagen scaffold 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 a million partial meniscectomy patients per year in the U.S. alone, the availability of this product for use in the meniscus represents a significant treatment alternative for surgeons and patients.

The Company will provide further information regarding the status of the 510(k) submission as soon as it has more definitive information with regard to its appeal.

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. The Company's first approved product using its collagen scaffold technology is the CMI(TM), which is cleared for sale in Europe and marketed through the Company'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

Contacts
ReGen Biologics, Inc.
Brion Umidi, 201-651-3515
[e-mail]

or

Investor Relations:
Cameron Associates
Al Palombo, 212-554-5488
[e-mail]