• About Us
  • Our Products
  • Patients
  • Surgeons
  • Investors
  • Contact Us
Press Releases

Home > About Us > Press Releases

Press Releases

Back to previous page

Recent Article Validates Tools Used by ReGen Biologics to Measure Meniscus Performance


FRANKLIN LAKES, NJ -- May 25, 2005 -- ReGen Biologics, Inc. (OTC:RGBI) recognizes an important peer reviewed journal article which provides scientific validity for two important measures of patient status post-meniscus surgery.  A torn meniscus is a common ailment, leading to approximately one million surgeries in the United States in 2005.  Approximately 85% of these patients will undergo a partial meniscectomy, a procedure to remove the torn or damaged meniscus tissue, leaving them with less than original meniscus volume.

ReGen has conducted the largest clinical trial ever on the meniscus, the CMI™ Multicenter Clinical Trial, and has the largest longitudinal database involving the meniscus and the effects of arthroscopic surgery on the meniscus.  The clinical trial highlights the role played by functional and activity scores that measure performance of the meniscus.

The recently published article provides important validation of two methods for measuring the performance of the knee, both of which were used in the ReGen clinical trial.  The authors successfully demonstrated the validity, reliability, and responsiveness of the Lysholm Knee Score and Tegner Activity Scale, which are important in measuring the meniscus performance and are necessary to determine the value of certain procedures or products such as the ReGen CMI.  Publication of these findings confirms the appropriateness of the ReGen trial design and provides support that the clinical benefit of a product such as the CMI can be measured.

The article, "Reliability, Validity, and Responsiveness of the Lysholm Knee Score and Tegner Activity Scale for Patients with Meniscal Injury of the Knee", adds to the base of knowledge being built regarding the effectiveness of various treatments for meniscus injuries.  The article was published in the April issue of The Journal of Bone and Joint Surgery.

The investigation that served as the basis for the article was performed at the Steadman Hawkins Research Foundation in Vail, Colorado.  Data used in this validation study include, in part, data from the CMI™ Multicenter Clinical Trial conducted by ReGen Biologics.

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.

About Steadman Hawkins Foundation:
Please visit www.steadman-hawkins.com.

About The Journal of Bone and Joint Surgery:
Please visit www.ejbjs.org.

Contacts:
ReGen Biologics, Inc.
Brion Umidi
Chief Financial Officer
(201) 651-3515
bumidi@regenbio.com

Cameron Associates
Al Palombo
Investor Relations
(212) 554-5488
al@cameronassoc.com

NeboWeb Content Management System Tracking