Healthcare Industry News: collagen scaffold
News Release - July 7, 2008
ReGen Biologics Announces JBJS Publication of Successful Clinical Trial Results for its Meniscus Product
HACKENSACK, N.J.--(HSMN NewsFeed)--ReGen Biologics (OTC: RGBI) announced today the publication of results of its Menaflex™ Collagen Meniscus Implant Clinical Trial in the July 2008 issue of The Journal of Bone and Joint Surgery (“JBJS”) American Volume.The article provides peer reviewed documentation of long-term clinical results demonstrated in patients participating in ReGen’s Multicenter Clinical Trial. The trial compared outcomes of a partial meniscectomy procedure, the current standard of care for meniscus injuries, to treatment with the Company’s Menaflex collagen meniscus implant. The Menaflex product is referred to as the Collagen Meniscus Implant or CMI® in the JBJS publication.
The authors found that the Menaflex implant resulted in a statistically significant increase in new tissue within the meniscus for patients with both acute and chronic meniscus injuries. Findings further indicated that patients with one to three prior meniscus injuries (chronic group) regained significantly more pre-injury activity, and had fewer meniscus-related reoperations than the control group, evidencing the potential to slow the progression of degenerative joint changes in those patients.
The list of co-authors are: William G. Rodkey, D.V.M. (Vail, CO), Kenneth E. DeHaven, M.D. (Rochester, NY), William H. Montgomery, III, M.D. (San Francisco, CA), Champ L. Baker, Jr., M.D. (Columbus, GA), Charles L. Beck, Jr., M.D. (Salt Lake City, UT), Scott E. Hormel, M.D. (Seattle, WA), J. Richard Steadman, M.D. (Vail, CO), Brian J. Cole, M.D. (Chicago, IL), and Karen K. Briggs, MPH (Vail, CO).
To download an abstract of the article and for more information, please visit the Company’s website at www.regenbio.com or the JBJS website at www.ejbjs.org. The complete article will be available for download from the ReGen site shortly.
“We are delighted that these important clinical data have been published by JBJS, a prestigious peer-reviewed professional journal, and we congratulate the authors,” commented Gerald E. Bisbee, Jr., Ph.D., Chairman and CEO of ReGen Biologics. “The article will allow clinicians around the world the opportunity to become familiar with the performance of the Menaflex product.”
The Menaflex procedure provides the only clinically proven option to address the partial loss of meniscus tissue in patients undergoing partial meniscectomy. The Company estimates greater than 1.5 million partial meniscectomy procedures are performed annually to remove damaged meniscus tissue.
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. ReGen’s first approved product using its collagen scaffold technology is the Menaflex collagen meniscus implant, which is cleared for sale in Europe and other countries and marketed through ReGen’s European subsidiary, ReGen Biologics AG. The CMI® name was used during the research and development phase of the Company’s collagen meniscus implant device, and it will continue to be seen in numerous scientific publications and clinical references. ReGen continues to work to obtain FDA clearance of the Menaflex device in the United States.
For more information on ReGen, visit www.regenbio.com. For more information on the Menaflex collagen meniscus implant visit www.menaflex.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 2007 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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