WILMINGTON, Mass., Dec. 13 /PRNewswire-FirstCall/ -- CardioTech International, Inc. , a developer and manufacturer of advanced medical device materials and products for the treatment of cardiovascular and other diseases, today reported that it has received official approval from the Ministry of Health of the European Union country where a clinical trial of CardioPass(TM), the Company's proprietary synthetic coronary bypass graft, can now begin. The lead investigator and his medical team have started to identify potential candidates for the first human clinical trial of CardioPass(TM) in Europe.
Commenting on today's announcement, CardioTech CEO and President Michael Adams said: "After a rigorous review of our protocol, Ministry of Health approval is the final clinical milestone in our preparations for the 10-patient clinical trial in the European Union. We are applying for an export certificate from the FDA which we anticipate receiving early next year, paving the way for trial surgeries to begin in the first calendar quarter of 2007. We are very pleased that our timetable for the trial has proceeded on schedule."
Following clinical trial regulations, CardioTech will not comment further on the trial until the Notified Body makes its determination based on a the research data on the 10 patients who will be followed up for 90 days after their surgeries. This process is expected to take approximately nine months. Approval by the Notified Body for a CE Mark would allow CardioPass(TM) to be marketed and sold in all European Union countries.
CardioPass(TM): Synthetic Graft for Coronary Artery Bypass
CardioTech's science and technology team has developed CardioPass(TM) as an effective alternative for patients who have undergone repeat procedures or have insufficient native vessels for bypass. Repeat surgeries account for up to 20 percent of all bypass procedures. CardioPass(TM) is made from ChronoFlex(R), the Company's proprietary biodurable medical-grade polymer. Once it is implanted, the graft is designed to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex(R) has also been specially formulated to be flexible, enabling CardioPass(TM) to pulse like a human vein would as it carries blood to the heart.
About CardioTech International:
CardioTech International, Inc. is a medical device company that designs, develops, manufactures and sells innovative products and materials for the treatment of cardiovascular, orthopedic, oncology, urology and other diseases. The Company's strategic goal is to incorporate its proprietary polymer technology into a wide range of breakthrough medical applications. CardioPass(TM) is CardioTech's proprietary, synthetic coronary artery bypass graft. (SynCAB) The Company generates revenues from sales of advanced medical devices and materials, as well as from contracted product design and development services. More information about CardioTech is available at its website: http://www.cardiotech-inc.com.
CardioTech International 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 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, including its Annual Report on Form 10-K for the period ended March 31, 2006 and its Quarterly Reports on Form 10-Q for the periods ended June 30, 2006 and September 30, 2006. The Company assumes no obligation to update the information contained in this press release.
For Further Information Contact: Eric Walters Vice President & Chief Financial Officer CardioTech International, Inc. 978-657-0075 general-info@cardiotech-inc.com Sylvia Dresner Senior Vice President VMW Corporate & Investor Relations 212-616-6161 info@vmw.com
CardioTech International, Inc.CONTACT: Eric Walters, Vice President & Chief Financial Officer ofCardioTech International, Inc., +1-978-657-0075, general-info@cardiotech-inc.com; OR Sylvia Dresner, Senior Vice President of VMW Corporate &Investor Relations, +1-212-616-6161, info@vmw.com
Web site: http://www.cardiotech-inc.com//
