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ATS Medical Announces Record Quarterly Revenue and Gross Profit

As announced previously, the Food and Drug Administration (FDA) has

asked ATS to provide additional information and clarification in

support of its PMA for the ATS 3f Aortic Bioprosthesis. The Company

submitted answers to the FDA in March 2008. Management continues to

expect that the ATS 3f Aortic Bioprosthesis will be approved in the

second half of 2008.

-- ATS 3f Enable(TM) Aortic Bioprosthesis: Enrollment continues to

progress with excellent clinical results in the Company's European

clinical trial of its Enable sutureless tissue valve designed to

provide a less invasive approach for aortic valve replacement. The

Company recently implanted the 50th patient in this pivotal trial and

expects to reach enrollment of 100 patients around mid year. The first

regulatory approval for commercialization is expected in mid 2009.

Mechanical Valves

-- ATS Open Pivot AP360(TM) Mechanical Heart Valve: The Company commenced

a limited launch of its ATS AP360 Heart Valve in the first quarter.

The AP360 is the Company's most competitive Open Pivot product, with

the same hemodynamic features as its existing supra annular AP valve

but with a revised cuff design to enable easier suturing. Initial

physician response has been excellent and the company expects to see

measurable revenue growth from this new offering in the second quarter.

Repair Products

-- ATS Simulus(R) Semi-Rigid and Adjustable Flexible Rings: Initial launch

and implants have been completed; surgeon feedback has been very

positive and contributed to revenue growth of 28.0% in the first

quarter of 2008 compared to Q4 2007 and 70.4% compared to the first

quarter of 2007. The ATS Simulus Flexible rings and bands are fast

becoming the annuloplasty device of choice among surgeons performing

SOURCE ATS Medical, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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