CardioTech
International, Inc. (Amex: CTE), 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: cardiotech-inc/.
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.
CardioTech International, Inc.
cardiotech-inc/