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ATS Medical Provides Update on First Generation Tissue Valve Approval

Thursday, January 31, 2008 General News
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MINNEAPOLIS, Jan. 31 ATS Medical, Inc.(Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgeryproducts and services, today announced it has received a request foradditional information and clarification from the US Food and DrugAdministration (FDA) regarding its PMA approval application for its ATS 3f(R)Aortic Bioprosthesis. Additionally, the Company announced the same valve hasbeen approved by the Canadian regulatory authorities for sale in Canada.
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"We look forward to working closely with the FDA to provide theinformation requested and answer conclusively their questions during the firstquarter," commented Michael Dale, President and CEO of ATS Medical. "Based onthe nature of the questions received, we remain confident that the ATS 3f(R)Aortic Bioprosthesis will receive PMA approval but the approval may not occuruntil the second half of 2008."
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The PMA for the ATS 3f(R) Aortic Bioprosthesis is supported by data from405 patients implanted with the heart valve and included over 900 patientyears of follow-up data. The clinical results for the ATS 3f(R) AorticBioprosthesis met all the FDA Objective Performance Criteria (OPC) used forassessing clinical data.

The FDA's request for additional information was primarily related to thein-vitro testing submitted in the original IDE application. The Company isconfident it can provide information and analysis to assure FDA that thein-vitro data meets all FDA and international valve testing standards and thatthe ATS 3f(R) Aortic Bioprosthesis is safe and effective.

The valve is currently approved for sale in Europe and marketing willbegin in Canada in the near future.

Financial Outlook

Additionally, the Company provided an update to its previously issuedfinancial guidance for 2008 and its reporting timeline for 2007 year-endresults.

The Company anticipates it will release preliminary sales data for thefourth quarter and full year 2007 on February 4th and report full year2007 operating results on February 25, 2008. The Company expects that itsfull year 2007 revenue will be within its originally provided guidance of$49 million to $50 million.

For the full year 2008, the Company is revising its full year revenueestimate to between $60 to $64 million as compared to its previous revenueguidance of $65 to $70 million. The revised guidance includes approximately$2.0 to $3.0 million of worldwide revenue from the company's tissue valves.

"The delay in our ability to market the tissue value in the U.S. isexpected to result in a modest reduction in our growth expectations for2008. However we still expect to report revenue growth of approximately25% for 2008," commented Mr. Dale. "Additionally, we continue to believe thestrong growth of our mechanical valve, heart valve repair and surgicalablation franchises will enable us to be profitable in the fourth quarter of2008 and will provide cash flow adequate to fund the business until we arecash flow positive."

About ATS Medical

ATS Medical, Inc. provides innovative products and services focused oncardiac surgery. The company, global in scope, is headquartered inMinneapolis, Minnesota. More than 145,000 ATS Open Pivot(R) Heart Valves,which utilize a unique pivot design resulting in exceptional performance andlow risk profile, have been implanted in patients worldwide. The ATS 3f(R)brand encompasses multiple tissue heart valve product offerings at varyingsteps from market introductions to clinical trials to development projectsthat incorporate less invasive valve replacement technology. ATS Medical'sfocus on serving the cardiac surgery community is further strengthened byofferings that include ATS Simulus(R) annuloplasty products for heart valverepair, and ATS CryoMaze(TM) surgical ablation products. The
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