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ATS Medical Provides Update on First Generation Tissue Valve Approval
Date:1/31/2008
formation and analysis to assure FDA that the in-vitro data meets all FDA and international valve testing standards and that the ATS 3f(R) Aortic Bioprosthesis is safe and effective.
The valve is currently approved for sale in Europe and marketing will begin in Canada in the near future.
Financial Outlook
Additionally, the Company provided an update to its previously issued financial guidance for 2008 and its reporting timeline for 2007 year-end results.
The Company anticipates it will release preliminary sales data for the fourth quarter and full year 2007 on February 4th and report full year 2007 operating results on February 25, 2008. The Company expects that its full 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 revenue estimate to between $60 to $64 million as compared to its previous revenue guidance 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. is expected to result in a modest reduction in our growth expectations for 2008. However we still expect to report revenue growth of approximately 25% for 2008," commented Mr. Dale. "Additionally, we continue to believe the strong growth of our mechanical valve, heart valve repair and surgical ablation franchises will enable us to be profitable in the fourth quarter of 2008 and will provide cash flow adequate to fund the business until we are cash flow positive."
About ATS Medical
ATS Medical, Inc. provides innovative products and services focused on
cardiac surgery. The company, global in scope, is headquartered in
Minneapolis, Minnesota. More than 145,000 ATS Open Pivot(R) Heart Valves,
which utilize a unique pivot design resulting in exceptional performance
and low risk profile, have been im
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| SOURCE ATS Medical, Inc. Copyright©2008 PR Newswire. All rights reserved |
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