WILMINGTON, MA, Jan. 25 /PRNewswire-FirstCall/ -- CardioTech International, Inc. , a manufacturer of advanced surgical devices treating cardiovascular disease, today announced that it has begun taking steps to apply to the FDA for an Investigational Device Exemption ("IDE") for CardioPass by initiating discussions with potential Principal Investigators. CardioPass is CardioTech's patented artificial coronary artery bypass graft, designed to extend the life of end-stage, no-option coronary disease patients.
IDE
CardioTech has made the strategic decision to apply for an IDE, while simultaneously pursuing the CE Mark. The Company has initiated discussions with thought-leaders in the cardiac surgical field for them to become Principal Investigators in a clinical trial. The trial will target "no- option" patients with insufficient autologous blood vessels who face imminent death from end-stage coronary artery disease. CardioTech's clinical end points are patient survivability, quality of life, freedom from angina, and graft patency.
CardioPass is a Class III (highest risk) device that requires a Pre Manufacturing Approval (PMA) from the FDA. Under the PMA process, it must first obtain an IDE before it can begin clinical trials on humans in the United States to determine the safety and efficacy of the graft.
Michael Szycher, Ph.D., Chairman and CEO, CardioTech, commented: "The start of an IDE, which begins by identifying Principal Investigators, represents a major milestone for any company developing a synthetic coronary bypass graft, which has proven to be a challenging path for over 40 years. We estimate that there are more than 100,000 'no-option' patients annually in the United States that can benefit from this technology."
CE Mark
In January 2006, CardioTech was advised by the Notified Body that it is currently in the final stages of an independent clinical review of the CardioPass dossier for "no-option" patients. A Notified Body is a European equivalent to the FDA that has the authority to grant a company the CE Mark (marketing approval) for a medical device.
S. Eric Ryan, MD, clinical consultant to CardioTech, stated: "The attainment of a positive recommendation by the 'independent clinical review' would represent a meaningful step towards the receipt of a CE Mark for CardioPass."
Broader Indications for CardioPass
CardioTech has contacted Austrian and Italian surgeons to serve as Principal Investigators in a European clinical trial which will address broader indications beyond the "no-option" patient category. For instance, CardioPass could be used in those patients requiring only one bypass.
Conference Call and Replay
Management invites you to a conference call on Wednesday, January 25, 2005 at 4:10 PM Eastern Time, to expand upon this press release, followed by a Q&A session. Topics to be addressed will be: (1) history of CardioPass technology, (2) U.S. and European regulatory approval, and (3) focus on "no- option" patients. The call can be accessed by dialing: 866 219-5268. 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 February 26, 2006 by dialing: 888 266-2081 and entering access code: 846075.
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, synthetic coronary artery bypass graft and CardioTech has partnered to develop a drug-eluting stent.
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 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 and September 30, 2005. The Company assumes no obligation to update the information contained in this press release
For more information, please contact: Michael Szycher Ph.D. CEO and Chairman 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, both of CardioTech International, Inc., +1-978-657-0075
Web site: http://www.cardiotech-inc.com//
