Advertisement
(Logo: http://www.newscom.com/cgi-bin/prnh/20040202/ATSILOGO)
While the ATS 3f Aortic Bioprosthesis PMA was approved on October 30,2008, as previously indicated, a full commercial launch would commence in thefirst quarter of 2009 once these milestones were achieved. ATS Medical hasachieved these milestones and is on track with the previous guidance. The ATS3f Aortic Bioprosthesis is the Company's first entry into the $400-plusmillion U.S. tissue valve market.
Advertisement
"The FDA clearance was necessary for ATS Medical to commence a fullcommercial launch of our first tissue valve in the US. We are excited toachieve these important milestones for the Company," said Michael Dale,President and Chief Executive Officer of ATS Medical. "The tissue valve marketpresents the largest market opportunity for our Company and will importantlyprovide ATS Medical the leverage it needs to sustain high growth and enhancedprofitability in the future."
Based on the precept that 'Form Follows Function', the ATS 3f AorticBioprosthesis is a revolutionary next generation stentless pericardial aortictissue valve that is unlike any other valve. The tubular design of the ATS 3fAortic Bioprosthesis maintains the continuity of the annulus and the sinotubular junction. No other valve mimics the native valve in this manner. Bymaintaining this continuity, the ATS 3f Aortic Bioprosthesis preserves theaortic sinuses and restores native valve stress distribution and physiologicblood flow. This elegant design provides surgeons and patients with apotentially more durable solution to aortic valve replacement. With more thansix years of clinical experience confirming excellent safety and efficacy, thedemonstrated clinical benefit and recent FDA approval of the ATS 3f AorticBioprosthesis are creating excitement and product demand among US surgeons.
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 160,000 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 ATS Medical website is http://www.atsmedical.com.
Safe Harbor
This Press Release contains forward-looking statements that may includestatements regarding intent, belief or current expectations of the Company andits management. Actual results could differ materially from those projected inthe forward-looking statements as a result of a number of important factors,including the results of clinical trials, the timing of regulatory approvals,the outcome of pending litigation matters, the surgical cryoablation businessof CryoCath Technologies, Inc., regulatory actions, competition, pricingpressures, supplier actions and management of growth. For a discussion ofthese and other risks and uncertainties that could affect the Company'sactivities and results, please refer to the Company's filings with theSecurities and Exchange Commission, including its Form 10-K for the year endedDecember 31, 2007 and its most recent quarterly report on Form 10-Q.
SOURCE ATS Medical, Inc.
