Healthcare Industry News:  vascular closure 

Devices Interventional FDA

 News Release - January 5, 2006

Kensey Nash Submits ThromCat(TM) Thrombectomy System 510(k) Application to FDA

EXTON, Pa., Jan. 5 (HSMN NewsFeed) -- Kensey Nash Corporation (Nasdaq: KNSY ) today announced that it has submitted an application for 510(k) clearance for its ThromCat(TM) Thrombectomy Catheter System to the U.S. Food and Drug Administration. The ThromCat(TM) System is a thrombectomy catheter designed to remove thrombus or blood clots from a patient, with an initial indication for use in AV grafts and fistulas. The Company plans to study the utility of the device for application in additional vessels in the coming year.

The ThromCat(TM) device is a fully disposable catheter system that incorporates HeliFlex(TM) technology, an internal rotating helix that creates a powerful vacuum to draw thrombus into the catheter and macerate it, while simultaneously flushing to aid in its removal. 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 the offering of a simple and effective device.

"We are confident that the ThromCat(TM) System will have significant ease of use advantages over other mechanical thrombectomy alternatives in the marketplace," commented Joseph W. Kaufmann, President and CEO of Kensey Nash Corporation. "We have received very positive feedback from physician advisors who believe this type of device will be useful in their practices and meets a need that is not currently being fulfilled by other devices," he said.

The ThromCat(TM) System will be sold through Kensey Nash's direct U.S. endovascular sales force. "Thrombectomy is a natural extension of our recently launched TriActiv® System embolic protection platform," Mr. Kaufmann further commented. "It offers physicians another means of removing problematic clot with powerful extraction. With the expected near term commercialization of the ThromCat(TM) System and other upcoming additions to our product lines, we are achieving milestones towards our goal of providing physician customers a complete line of embolic protection and thrombus removal products," he concluded.

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", "speculates", 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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