Healthcare Industry News:  joint replacement 

Devices Orthopaedic FDA

 News Release - September 27, 2006

Kensey Nash Announces 510(K) Clearance for Proprietary Bone Void Filler

Articular Cartilage Device Set For Further Study

EXTON, Pa., Sept. 27 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) announced today that it has received FDA clearance for a proprietary bone void filler product, an important milestone for the Company's broader cartilage regeneration research program. The recently cleared device, OrthoFill(TM) Bone Void Filler, is indicated to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery (including surgically created osseous defects for the harvest of the bone) and are not intrinsic to the stability of the bony structure. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.

The OrthoFill(TM) product is a composite of several bioresorbable biomaterials, utilizing both the Company's proprietary collagen technology, as well as its synthetic polymer Porous Tissue Matrix(TM) (PTM) technology with mineral. This design creates an architecture optimized for certain types of bone void filling applications seen in sports medicine injuries. The bone void filler device utilizes a similar material composite as the Company's proprietary tissue engineering implant designed to repair damaged articular cartilage in the knee or other articulating joints. The Company is continuing development of its cartilage repair matrix to heal articular cartilage defects.

"We have had promising results with our product development efforts aimed at creating a sophisticated solution for articular cartilage repair," commented Doug Evans, Chief Operating Officer of Kensey Nash Corporation. "Having this unique composite material cleared for human use in treating bone voids is an important step in our broader development program. We intend to continue to advance this research internally and ultimately partner the whole technology platform at the appropriate time. To progress the program, we are planning a series of important pre-clinical cartilage studies, expected to commence in early 2007," he added.

Articular cartilage injury is commonly encountered in people with active lifestyles. Unlike other tissue types, cartilage possesses a limited capacity to heal. Surgical treatment options available today usually generate a repair tissue that is insufficient in absorbing or distributing loads and is prone to failure. U.S. physicians perform over 500,000 procedures each year to repair damaged cartilage in the knee and a majority of these are repeat procedures illustrating the ineffectiveness of current therapeutic approaches. Over time, debilitating osteoarthritis may develop in the afflicted joint ultimately requiring knee replacement or other invasive treatment. Therefore, early and successful treatment of traumatized articular cartilage may prevent the long-term onset of osteoarthritis and, consequently, reduce the number of radical knee joint replacement surgeries of which 250,000 are performed annually.

About Kensey Nash Corporation. Kensey Nash Corporation is a leading medical technology company providing innovative solutions and technologies for a wide range of medical procedures. The Company provides an extensive range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets. Many of the products are based on the Company's significant expertise in the design, development, manufacturing and processing of absorbable biomaterials, which has led to partnerships to commercialize technologies. Kensey Nash has also commercialized a series of innovative embolic protection and thrombus removal products through its own direct endovascular sales force. The Company is known as a pioneer in the field of arterial puncture closure, as the inventor and developer of the Angio-Seal(TM) Vascular Closure Device, which is licensed to St. Jude Medical, Inc.

Cautionary Note for Forward-Looking Statements. This press release contains forward-looking statements that reflect the Company's current expectations about its prospects and opportunities. The Company has tried to identify these forward-looking statements by using words such as "expect," "anticipate," "estimate," "plan," "will," "forecast," "believe," "guidance," "projection" or similar expressions, but these words are not the exclusive means for identifying such statements. The Company cautions that a number of risks, uncertainties, and other important factors could cause the Company's actual results to differ materially from those in the forward-looking statements. For a detailed discussion of these factors, please see the Company's SEC filings, including the disclosure under "Risk Factors" in those filings. Except as expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason.


Source: Kensey Nash

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