WILMINGTON, Mass., Aug. 10 /PRNewswire-FirstCall/ -- CardioTech International, Inc. , a developer and manufacturer of innovative medical devices, today reported that it has signed an agreement with a Principle Investigator for the European clinical trial of its CardioPass(TM) synthetic coronary artery bypass graft.
Commenting on this key milepost in the approval process, CEO Michael Adams, responsible for Regulatory Affairs and Business Development, said, “We are pleased with our selection of a Principal Investigator who has participated in a wide range of cardiovascular clinical trials. This decision fits within our planned timeline and is an important benchmark in the commencement and completion of the clinical trial.”
CardioTech has already hired a European-based Contract Research Organization to assist in the organization, execution and completion of the clinical trial in the European Union. As previously announced, the Company is moving forward with its approved protocol to conduct a limited clinical trial of 10 patients with a post-operative follow up period of 90 days.
“With the selection of a Principal Investigator, we can now apply for Ethics Committee and Ministry of Health approvals which are needed before import licenses and other administrative paperwork can be completed. As we previously informed investors, patient enrollment for the trial is expected to begin by year end,” Mr. Adams concluded.
About CardioTech International:
CardioTech International, Inc. is a medical device company that designs, develops, manufactures and sells innovative products for the treatment of cardiovascular, orthopedic, oncology and other diseases. The Company provides its customers access to a range of proprietary and novel polymer and surface modification technologies. CardioPass(TM) is CardioTech’s proprietary, synthetic coronary artery bypass graft. (SynCAB) The Company generates revenues from sales of advanced medical devices, 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. The Company assumes no obligation to update the information contained in this press release.
For Further Information Contact: Eric Walters Sylvia Dresner Vice President & Senior Vice President Chief Financial Officer VMW Corporate & Investor Relations CardioTech International, Inc. 212-616-6161 978-657-0075 info@vmwcom.comgeneral-info@cardiotech-inc.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 Presidentof VMW Corporate & Investor Relations, +1-212-616-6161, info@vmwcom.com
Web site: http://www.cardiotech-inc.com//
