EXTON, Pa., June 23 /PRNewswire-FirstCall/ -- Kensey Nash Corporation (Nasdaq: KNSY - News) today announced that the ThromCat® XT Thrombectomy Catheter System has been granted CE Marking approval which allows for the sale of the product throughout the European Economic Area (EEA). The ThromCat XT System, a mechanical thrombectomy catheter designed to remove thrombus (blood clots) from a patient, is indicated for use in both the coronary and peripheral vasculature. The CE Mark approval meets the criteria established for a milestone payment of $1.5 million under the Company’s Development and Regulatory Services Agreement with The Spectranetics Corporation (Spectranetics). The milestone payment to Kensey Nash Corporation will be recorded as deferred revenue and will be recognized into revenue over the remaining period of the Agreement.
“We are pleased to announce the achievement of this important milestone and to provide Spectranetics with this next generation thrombectomy device,” commented Joseph W. Kaufmann, Chief Executive Officer of Kensey Nash Corporation. “Our product development team has integrated several new features into the original ThromCat System. This version of the device offers more effective thrombus removal technology within an even easier to use system, thereby allowing physicians a faster and more effective method for removing coronary and peripheral thrombus,” he concluded.
The ThromCat XT Thrombectomy Catheter System
The ThromCat XT System is based upon the same design principles as the original ThromCat product, which utilizes a high-speed rotary helix within a flexible atraumatic 7F extraction catheter to safely and effectively remove thrombus. The ThromCat XT extends the capability of this innovative first generation disposable device by incorporating an advanced extraction helix technology that improves the product’s performance, particularly when used in more advanced thrombus. The ease-of-use of the ThromCat XT System is enhanced by further simplifying the setup procedure of the original device, resulting in an even shorter set up time. In addition, the device incorporates a new catheter jacket technology to allow use in more challenging anatomy, thereby extending the utility of this powerful and disposable 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 in the cardiovascular markets and the orthopaedic markets of sports medicine, spine, and extremities. Most of the products are based on the Company’s significant expertise in the design, development, manufacturing and processing of resorbable biomaterials, which has led to partnerships to commercialize technologies. Kensey Nash has also developed and commercialized a series of innovative endovascular products and completed the sale of these product lines to The Spectranetics Corporation in May 2008. Although the Company sold this portfolio of products to Spectranetics, the Company still participates directly in the future success of these products through a Manufacturing and Licensing Agreement and a Development and Regulatory Services Agreement. The Company is known as a pioneer in the field of biomaterials and 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,” 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), Spectranetics’ success in selling the QuickCat, ThromCat and SafeCross products, the Company’s success in distributing its products into the marketplace, the Company’s dependence on major customers and partners (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, the Company’s success in its research and development efforts in its cartilage repair and extracellular matrix technologies programs and competition from other technologies, among other important risks. 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.
