CardioTech Receives FDA Approval For Export Of Second Graft Size For CardioPass Clinical Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices
Article Date: 14 Jul 2008 - 3:00 PDT

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CardioTech International, Inc. (AMEX: CTE), a leading developer and manufacturer of advanced biomaterials for a broad range of medical devices, announced that it has received the necessary U.S. Food and Drug Administration ("FDA") approval to export its 4mm graft in further support of the ongoing European clinical trial of CardioPass™ , the Company's proprietary synthetic coronary bypass graft.

Commenting on today's announcement, Michael Adams, CEO and President, said, "We are pleased with the FDA's timely review and approval of our request to export the 4mm graft for use in our CardioPass™ European clinical trial. This important milestone provides a second graft size available for use in the trial and expands the potential patient population available for treatment. In concert with our team of clinical and regulatory professionals in Europe, we believe we are now poised to move towards the completion of our clinical 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

Through its newly formed AdvanSource Biomaterials Corporation subsidiary, CardioTech develops advanced polymer materials which provide critical characteristics in the design and development of medical devices. The Company's biomaterials are used in devices that are designed for treating a broad range of anatomical sites and 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 license fee income. CardioTech is conducting a clinical trial for regulatory approval in Europe for its CardioPass™ synthetic coronary bypass graft. More information about CardioTech is available at its new website: http://www.advbiomaterials.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 for the fiscal year ended March 31, 2008. 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