ReGen Biologics Announces New CMI Clinical Results.CMI (Computer-Managed Instruction) Using computers to organize and manage an instructional program for students. It helps create test materials, tracks the results and monitors student progress. Patients Demonstrate 3X Lower Rate of Knee Re-operation FRANKLIN LAKES, N.J. -- The latest findings from the ReGen Biologics CMI[TM] MultiCenter Clinical Trial were presented recently in Berlin, Germany. The data were presented by Richard Steadman Dr. Richard Steadman is a world-renowned knee specialist surgeon practising in Vail, Colorado and a Clinical Professor at the University of Texas Southwestern Medical Center in Dallas, Texas. , M.D. at the Joint German Congress of Orthopaedics and Trauma Surgery You can assist by [ editing it] now. meeting, the largest orthopedic congress in Europe, with over 6700 attendants in 2006. An important new finding from the CMI Multicenter Clinical Trial reveals that at four years post-surgery, CMI patients with previous meniscus meniscus /me·nis·cus/ (me-nis´kus) pl. menis´ci [L.] something of crescent shape, as the concave or convex surface of a column of liquid in a pipet or buret, or a crescent-shaped cartilage in the knee joint. injuries had a three times (3x) lower rate of re-operation on the affected knee than the control group. This result is statistically significant. Clinical data are available on 93% of patients in the trial with a minimum two-year follow-up and a mean of 59 months. Commenting on this result, Dr. Steadman affirmed, "The data on lower re-operation rates for CMI patients are very exciting, and they provide us important evidence of the long-term benefit that the CMI can have on patients with meniscus injury." Dr. Gerald Bisbee, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. noted, "This result is an example of the unique value of the database created by the conduct of the CMI Multicenter Clinical Trial." Dr. Bisbee continued, "Since the CMI trial is the only clinical trial ever conducted on an arthroscopic meniscus procedure, we expect important new findings to be published well into the future." The most recent analysis of results from the Multicenter Clinical Trial also confirms key findings previously reported. Those findings include significant amounts of new tissue growth within the injured meniscus of patients with both acute and chronic meniscus injuries. The data also demonstrate that patients with one to three prior meniscus injuries show significant improvements in Tegner activity index scores for CMI patients compared to the control group and greater patient satisfaction. These results highlight the overall importance of the CMI Multicenter Clinical Trial and the growing value of the unique data set. Data from the CMI Clinical Trial will be presented at several upcoming scientific meetings, including the Osteoarthritis osteoarthritis or osteoarthrosis or degenerative joint disease Most common joint disorder, afflicting over 80% of those who reach age 70. It does not involve excessive inflammation and may have no symptoms, especially at first. Research Society International World Congress in Prague (Czech Republic) in December 2006, the American Academy of Orthopedic Surgeons in San Diego (U.S.) in February 2007, the Arthroscopy Arthroscopy Definition Arthroscopy is the examination of a joint, specifically, the inside structures. The procedure is performed by inserting a specifically designed illuminated device into the joint through a small incision. Association of North America in San Francisco (U.S.) in April 2007 and the International Society of Arthroscopy, Florence (Italy) in May 2007. The company also expects the data to be the subject of future publications in appropriate peer-reviewed clinical journals. 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], a meniscus application of its collagen scaffold technology, 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 (1) See ISO speed. (2) (International Organization for Standardization, Geneva, Switzerland, www.iso.ch) An organization that sets international standards, founded in 1946. The U.S. member body is ANSI. 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. For Meeting Information: www.oarsi.org OsteoArthritis Research Society International www.aaos.org American Academy of Orthopedic Surgeons www.isakos.com International Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine sports medicine, branch of medicine concerned with physical fitness and with the treatment and prevention of injuries and other disorders related to sports. Knee, leg, back, and shoulder injuries; stiffness and pain in joints; tendinitis; "tennis elbow"; and www.aana.org Arthroscopy Association of North America |
|
||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion