Healthcare Industry News:  ASPIRE study 

Devices FDA

 News Release - January 12, 2006

Kensey Nash Submits QuickCat(TM) Extraction Catheter 510(k) Application to FDA

EXTON, Pa., Jan. 12 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has submitted an application for 510(k) clearance for its QuickCat(TM) Extraction Catheter to the U.S. Food and Drug Administration. The QuickCat(TM) Catheter is an aspiration thrombectomy device designed to remove fresh soft emboli and thrombi (blood clots) from vessels in the arterial system.

The QuickCat(TM) Extraction Catheter is a fully disposable catheter system that uses a straightforward aspiration system to quickly draw thrombus into the catheter to remove it. The QuickCat(TM) Catheter will be sold through Kensey Nash's direct U.S. endovascular sales force.

The QuickCat(TM) Catheter will be a complementary offering to Kensey Nash's ThromCat(TM) Thrombectomy Catheter System, a more powerful mechanical device with Heliflex(TM) technology, designed to remove more organized thrombus. According to industry sources, the current market for thrombectomy catheter systems approximates $100 million worldwide, including the coronary market. The Company believes that the worldwide market could expand with products that are not only effective, but easy to use.

"We are endeavoring to offer our physician customers with a full product line of embolic protection and thrombus extraction products," commented Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "By the end of our fiscal year, we are expecting to offer the new TriActiv® FX(TM) Embolic Protection System, the ThromCat(TM) Thrombectomy Catheter System, and now the QuickCat(TM) Extraction Catheter. In addition, we expect to complete our pilot trials on our TriActiv® ProGuard(TM) Embolic Protection System in the carotid anatomy, which will be followed by the commencement of a larger pivotal trial for carotid embolic protection."

"All of these activities make it an exciting time for our company, and I am very proud of what our product development, clinical, regulatory and manufacturing teams have accomplished," Mr. Kaufmann continued. "We will now look forward with anticipation to the upcoming American College of Cardiology (ACC) conference in March 2006, where the TriActiv® FX(TM) data from the ASPIRE study will be announced and launch activities for our new endovascular products will begin."

About Kensey Nash Corporation. Kensey Nash Corporation is a leading developer and manufacturer of absorbable biomaterials-based products with applications in the cardiology, orthopaedics, spine, drug and biologics delivery, periodontal/dental, surgical and wound care markets. The Company was 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. The TriActiv® System, a novel embolic protection system, is cleared for sale in the U.S. TriActiv® FX(TM) System, the second generation of the TriActiv® System, is approved for sale in the European Union and has been studied in a clinical trial to gain regulatory clearance in the U.S.

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 tried to identify these forward-looking statements by using words such as "expects," "anticipates," "estimates," "plans," "will," "forecasts," 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, demand for and the Company's ability to develop and manufacture biomaterial products, additional regulatory approvals, and competition from other technologies in the marketplace. For a more detailed discussion of these and other factors, please see the Company's SEC 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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