CardioTech Receives Approval For A Second Graft Size For CardioPass Clinical Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices
Article Date: 09 May 2008 - 2:00 PDT

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CardioTech International, Inc. (AMEX: CTE), a developer and manufacturer of advanced medical devices and materials for the treatment of a broad range of disease states, announced that it has received the necessary Ministry of Health approval to add a 4mm graft for the clinical trial of CardioPass™ , the Company's proprietary synthetic coronary bypass graft. Until now, the trial was only approved for a 5mm graft.

Commenting on today's announcement, CardioTech CEO and President Michael F. Adams said, "Adding a second graft size for the 10-patient clinical trial offers the surgeons an important new option and a larger potential pool of patients to be reviewed for graft implant eligibility for the trial. We now have two sites for the trial that will be able to have both CardioPass™ sizes for use in the trial. "

Approval by the Notified Body for a CE Mark would allow CardioPass™ to be marketed and sold in all European Union countries as well as other countries worldwide that accept this approval for registration within those countries.

CardioPass™ Synthetic Graft for Coronary Artery Bypass

CardioPass™ is designed to be 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™ is made from ChronoFlex®, the Company's proprietary biodurable medical-grade polymer and engineered to be pulsatile, biostable, torque-resistant and suturable. Once it is implanted, the graft's polymer construction allows it to incorporate the patient's own cells and tissue, so that the inner surface mimics the normal environment for blood contact. ChronoFlex® has also been specially formulated to be flexible, enabling CardioPass™ to pulse like a human vein would as it carries blood to the heart.

About CardioTech International

CardioTech is a developer of advanced polymer materials and manufacturer of medical products for the treatment and diagnosis of a broad range of disease states. The Company's business model leverages its proprietary materials science technology and manufacturing expertise in order to expand its product sales and royalty and development fee income. CardioTech is conducting its first clinical trial for regulatory approval in Europe for its CardioPass synthetic coronary bypass graft. More information about CardioTech is available at its website: http://www.cardiotech-inc.com.

Forward-Looking Statements

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 risks and uncertainties. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause results to differ materially from the forward-looking statements. For further information on such risks and uncertainties, you are encouraged to review CardioTech's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K/A for the fiscal year ended March 31, 2007 and its Quarterly Reports on Form 10-Q for the periods ended June 30, 2007, September 30, 2007 and December 31, 2007. CardioTech assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.

CardioTech International