EXTON, Pa., Feb. 24 /PRNewswire-FirstCall/ -- Kensey Nash Corporation announced today that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company’s unique biomaterials technology for treating articular cartilage defects of the knee. The clinical trial will utilize the Company’s Cartilage Repair Device, which consists of a proprietary bi-phasic, bioresorbable implant designed to treat chondral lesions.
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. Worldwide, physicians perform approximately one million procedures each year to repair damaged articular 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 partial or total knee replacement. The Company believes that an 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 performed each year.
“Our cartilage repair product team has made great progress in the development of this device over the past few years. Significant preclinical research has been conducted with some of the premier academic institutions in the U.S.,” stated Douglas G. Evans, COO of Kensey Nash Corporation. “Our IDE submission for this clinical trial represents an important accomplishment towards achieving full commercialization of this proprietary product and technology,” he concluded.
The Company’s Cartilage Repair Device (CRD) is a composite of several bioresorbable 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 in the knee or other articulating joints. The Company’s Cartilage Repair implant is housed in an insertion tool, which facilitates arthroscopic insertion, allowing the surgeon to avoid 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 color-coded instruments to estimate implant size and prepare the defect site for the delivery of this proprietary bi-phasic implant.
“We believe that our product development team has created a sophisticated solution for the treatment of focal articular cartilage defects,” commented Russell T. Kronengold, Ph.D., VP of Biomaterials R&D of Kensey Nash Corporation. “We believe that the CRD provides the requisite biomechanical and biological properties that promote successful osteochondral repair. The KNC approach utilizes well established biomaterials that have a proven safety record,” he added.
The Company has established an advisory board of leading clinicians and researchers to counsel on the clinical application of the device, and the design and execution of the upcoming human clinical trial.
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, including the financial forecasts for the third quarter of fiscal 2009 and the full year fiscal 2009. 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.
CONTACT: Joseph W. Kaufmann, President and Chief Executive Officer of
Kensey Nash Corporation, +1-484-713-2100
