WILMINGTON, Mass., May 10 /PRNewswire-FirstCall/ -- CardioTech International, Inc. , a developer and manufacturer of medical devices treating advanced cardiovascular disease, today announced that it has received written acknowledgement from its Notified Body in Europe that its clinical trial plan has been accepted. Following the clinical trial, the analyzed data will be submitted by CardioTech to the Notified Body in support of its CE Mark application.
The planned 10 patient clinical trial protocol allows surgeons to intraoperatively decide to use the CardioPass synthetic coronary artery bypass ("SynCAB") instead of autologous vessels. CardioTech estimates that of the 600,000 coronary bypass operations performed worldwide, about 15% of veins are found to be suboptimal. Patients will be followed for 90 days and assessed for graft patency and quality of life measures.
Michael Szycher, Ph.D., Chairman and CEO stated: "We are pleased that we have received a definitive indication that our plan for a clinical trial in Europe is consistent with the Notified Body's requirements. This planned trial brings us a step closer to fulfilling the unmet need of providing patients with a suitable alternative to an autologous vessel."
Michael Adams, Vice President of Regulatory Affairs and Business Development commented: "We are excited about the opportunity to conduct this clinical trial. Potential clinical trial sites have been identified and we will be working closely with them as we prepare to commence the study."
About CardioTech
CardioTech International, Inc. is a medical device company that develops, manufactures and sells advanced products to surgically treat cardiovascular disease. The company is currently developing new products that address annual worldwide markets exceeding $1 billion. CardioPass is the Company's proprietary SynCAB and CardioTech has partnered to develop a drug-eluting stent.
The company's corporate headquarters are located in Wilmington, Massachusetts, with operations in California and Minnesota. The company generates revenues from sales of advanced medical devices and disposables used during cardiopulmonary bypass procedures, as well as from contracted product design and development services. More information can be found about CardioTech at its website: http://www.cardiotech-inc.com.
CardioTech believes that this press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to regulatory risks and clinical uncertainties. Such statements are based on management's current expectations and are subject to facts that could cause results to differ materially from the forward-looking statements. For further information you are encouraged to review CardioTech's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the period ended March 31, 2005, and Quarterly Reports on Form 10-Q for the periods ended June 30, 2005, September 30, 2005 and December 31, 2005. The Company assumes no obligation to update the information contained in this press release.
For more information, please contact: CardioTech International Inc. Catalyst Financial Resources, LLC Michael Szycher Ph.D. Tom O'Brien CEO and Chairman 716-830-6611 Eric G. Walters Vice President and CFO 978-657-0075
CardioTech International, Inc.CONTACT: Michael Szycher Ph.D., CEO and Chairman, or Eric G. Walters, VicePresident and CFO, +1-978-657-0075, both of CardioTech International, Inc.;or Tom O'Brien of Catalyst Financial Resources, LLC, +1-716-830-6611
Web site: http://www.cardiotech-inc.com//
