Healthcare Industry News: collagen scaffold
News Release - September 25, 2007
ReGen Biologics Receives NSE Letter from FDA, Proceeding with Next Steps to Gain U.S. Market Clearance
Company to Host Investor Update Conference CallHACKENSACK, N.J.--(HSMN NewsFeed)--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.
Source: ReGen Biologics
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