WILMINGTON, Mass., March 8 /PRNewswire-FirstCall/ -- CardioTech International, Inc. today announced that it has received an official response to its submission for CE-Mark approval for its CardioPass Artificial Coronary Artery Graft for the indication for use with “no-option” patients. After a thorough review of the medical necessity of such a graft and CardioTech’s technical dossier, CardioTech’s notified body has requested CardioTech to acquire additional limited clinical data, with a more defined and broader indication, in an abbreviated trial. A CE-Mark approval allows for the marketing and sale of a product throughout Europe and many other international countries which recognize this standard, excluding the United States and Japan.
Based on this response, CardioTech is now in the process of planning a limited European clinical trial. The Company plans to expand the initial indication for use of the CardioPass graft from “no option” patients to patients who present with suboptimal (diseased or inferior) vessels discovered while undergoing surgery. CardioTech believes that up to 15% of the 600,000 patients annually undergoing bypass surgery worldwide have suboptimal vessels.
The expanded indications would allow surgeons to determine during the bypass operation if the patient has the required native vessels of sufficient quality to complete the revascularization. Currently, when a surgeon is unable to identify such native vessels during the restricted time that the patient can reasonably be kept on bypass, the surgeon is often forced to complete the operation utilizing suboptimal vessels. The clinical availability of the CardioPass graft would offer the surgeon the ability to intraoperatively choose to utilize the CardioPass to complete the needed revascularization.
Michael Szycher, Ph.D., Chairman and CEO, CardioTech, stated, “We regard this response by the notified body as an important, positive milestone to obtaining marketing approval in Europe for the CardioPass graft. We believe that CardioTech is the only company that is actively seeking regulatory approval for a synthetic coronary artificial bypass graft to address the growing, unmet need for today’s bypass patients who have advanced coronary disease.”
Data collected during this European trial may also be used to support the application to obtain an Investigational Device Exemption (IDE) in the United States is granted by the FDA to allow clinical trials in the United States. CardioTech will be working with the broad depth of clinical, surgical, and regulatory experts available to the company to construct and perform this trial in accordance with Good Clinical Practice (GCP) standards.
Conference Call and Replay
Management invites you to a conference call on Wednesday, March 8, 2006 at 4:10 PM Eastern Time, to expand upon this press release, followed by a Q&A session. The call can be accessed by dialing: 866 244 4635. Participants are asked to call the assigned number approximately 5 minutes before the conference call begins. A replay of the conference call will be available approximately three hours after the call through April 7, 2006 by dialing: 888-266-2081 and entering access code: 870836.
About CardioTech
CardioTech International, Inc. is a medical device company that develops, manufactures and sells advanced products to surgically treat cardiovascular disease. CardioTech is currently developing new products that address annual worldwide markets exceeding $1 billion. CardioPass is CardioTech’s proprietary, synthetic coronary artery bypass graft and CardioTech has partnered to develop a drug-eluting stent with CorNova.
CardioTech’s corporate headquarters are located in Wilmington, Massachusetts, with operations in California and Minnesota. CardioTech 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 clinical risks and 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. The Company assumes no obligation to update the information contained in this press release.
For more information, please contact: CardioTech International, Inc. Michael Szycher Ph.D. CEO and Chairman Eric G. Walters Vice President and CFO 978-657-0075 Catalyst Financial Resources, LLC Tom O’Brien 716-830-6611
CardioTech International, Inc.
CONTACT: Michael Szycher Ph.D., CEO and Chairman, or Eric G. Walters, VicePresident and CFO, both of CardioTech International, Inc., +1-978-657-0075; or Tom O’Brien of Catalyst Financial Resources, LLC, +1-716-830-6611
Web site: http://www.cardiotech-inc.com//
