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ReGen Biologics, Inc. (RGBI) Clarifies Recent Press about the Menaflex Device


8/5/2009 6:15:24 AM

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HACKENSACK, N.J., Aug 5 /PRNewswire/ -- ReGen Biologics, a Hackensack, NJ based orthopedic products company seeks to clarify several statements regarding its Menaflex collagen meniscus implant that were made in a press release that was issued on Tuesday, August 4, by a party unaffiliated with the company. ReGen was unaware of the press release until it surfaced yesterday in media reports and on the Internet. The statements made in the release do not represent the views of the company regarding the use of the Menaflex device. ReGen's Menaflex(TM) device is a resorbable collagen scaffold used in arthroscopic surgery to address the most common form of knee injury, a torn medial meniscus. The device is inserted after a partial meniscectomy to reinforce and repair the damaged meniscus by providing a scaffold that is replaced by the patient's own tissue.

The press release discusses use of the Menaflex device with protein rich plasma and potential use as a carrier for stem cells. Both of these uses are outside of the indications for use of the device that were cleared by the FDA. While surgeons may use a device outside of FDA cleared indications, based upon professional judgment, this sort of "off label" use is not condoned or promoted in any way by ReGen. The company is committed to ensuring that its products are used for their FDA cleared indications and in accordance with best medical practices.

Surgeon acceptance of the Menaflex device has been excellent and is reflected by the fact that in the past few months the company has trained over 120 surgeons in the proper use of the device. The surgeon training course provides background information about the product, hands-on experience in the proper surgical technique and discussion of patient selection in accordance with the FDA cleared indications for use. ReGen's extensive surgeon training program is designed to prepare surgeons to use the Menaflex device safely and effectively.

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 Menaflex(TM) collagen meniscus implant employs proprietary collagen scaffold technology to facilitate tissue growth, thereby reinforcing and repairing the damaged meniscus of the knee. The Menaflex device has been approved for sale in Europe and other countries, and is marketed through ReGen's European subsidiary, ReGen Biologics AG. The FDA cleared the Menaflex device to be marketed in the United States in December 2008. Visit www.regenbio.com and www.menaflex.com for more information.

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