Message #28 From:
NewsBot Date: November 7, 2006 05:30:00 AM
RGBI News ReGen Biologics Announces New CMI Clinical Results
FRANKLIN LAKES, N.J.--(BUSINESS WIRE)--The latest findings from the ReGen BiologicsCMI™
MultiCenter Clinical Trial were presented recently in Berlin, Germany.
The data were presented by Richard Steadman, M.D. at the Joint German
Congress of Orthopaedics and Trauma Surgery 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
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 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 Research Society International
World Congress in Prague (Czech Republic) inDecember 2006, the
American Academy of Orthopedic Surgeons in San Diego (U.S.) in February
2007, the Arthroscopy 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™,
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 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.
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
www.aana.org Arthroscopy Association
of North America