EXTON, Pa., May 26 /PRNewswire-FirstCall/ -- Kensey Nash Corporation (Nasdaq: KNSY) announced that its cartilage repair device has been highlighted in two podium presentations at the 8th World Congress of the International Cartilage Repair Society (ICRS) Meeting held in Miami, FL on May 23-26, 2009. The pre-clinical findings demonstrate the potential for Kensey Nash's proprietary tissue engineering implant to repair damaged articular cartilage.
These presentations detailed two studies, which have been designed to evaluate the safety and performance of the Kensey Nash Cartilage Repair Device (CRD) in a simulated clinical application prior to initiating a formal clinical investigation, which is ultimately necessary for U.S. FDA marketing approval. The first study, being performed with the
"The results on our cartilage repair device are encouraging," commented Russell T. Kronengold, Ph.D., VP of Biomaterials R&D of Kensey Nash Corporation. "The tissue repaired within the defect and its integration with healthy adjacent tissue is favorable when compared to that observed in various previous efforts to repair articular cartilage. These pre-clinical results support our belief that we have created a sophisticated solution for the treatment of focal articular cartilage defects by providing a device with the requisite biomechanical and biological properties for promoting osteochondral repair," he concluded.
The CRD is a composite of several resorbable biomaterials, utilizing the Company's proprietary collagen technology, and beta-tricalcium phosphate mineral suspended in a synthetic polymer Porous Tissue Matrix (PTM). This device architecture is designed to repair damaged articular cartilage. The Company's Cartilage Repair implant is housed in an insertion tool, which facilitates arthroscopic insertion, allowing the surgeon to avoid invasive open procedures. The design also allows implants to be cut to length and easily hydrated with autologous blood products. The Company has also developed a full complement of specialized instruments to prepare the defect site for delivery of this proprietary bi-phasic implant. The Company is currently in discussion with FDA regarding the initiation of a US clinical trial for the device.
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 sports medicine, spine, and endovascular 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. 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," "would," "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 including, without limitation, current economic conditions, foreign currency fluctuations, risks associated with the Company's continued research and development efforts with respect to the endovascular products (including the risk that those efforts will not be successful and that some of the associated milestone payments will not be received) and Spectranetics' success in selling the ThromCat(TM) and SafeCross(TM) products, as well as the Company's success in distributing its products into the marketplace, the Company's dependence on four major customers (St. Jude Medical, Arthrex, Orthovita and Spectranetics) and their success in selling Kensey Nash related products in the marketplace, the impact of product recalls and other manufacturing issues, and competition from other technologies. For a detailed discussion of factors that could affect the Company's future operating results, 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 Corporation|
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