Cardiogenesis Corporation Makes Pre-IDE Submission for PHOENIX Combination Delivery...

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Thu Jul 30, 2009 7:30am EDT

Cardiogenesis Corporation Makes Pre-IDE Submission for PHOENIX Combination
Delivery System





IRVINE, Calif., July 30 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation
(Pink Sheets: CGCP), a market leader in laser transmyocardial
revascularization (TMR), today announced that it has submitted a pre-IDE
(Investigational Device Exemption) to the Food and Drug Administration to
initiate a feasibility trial for its PHOENIX System in patients with
refractory angina.  The PHOENIX Combination Delivery System combines
intramyocardial laser channeling with the delivery of a biologic substance. 
The PHOENIX received a CE MARK in 2006 and there have been over 50 clinical
cases completed to date outside of the U.S.

"The early clinical results achieved with TMR plus biologics suggest the
potential of this combination therapy; to not only mitigate the debilitating
effects of refractory angina, but potentially to improve cardiac function as
well," said Paul McCormick, Executive Chairman.  "Animal work by Dr. Patel
demonstrated that the pre-treatment of myocardium with TMR enhanced cell
viability and uptake when delivered with the Cardiogenesis PHOENIX combination
delivery system, compared to cell therapy alone.  This submission is an
important step towards initiating the feasibility trial in the United States."

The company plans to evaluate the therapeutic effect of delivering Platelet
Rich Plasma (PRP) in combination with TMR.  PRP is derived from the patient's
own circulating blood and is well documented in clinical applications for its
angiogenic effect and accelerated wound healing response.

Center for Biologics Evaluation and Research (CBER) is the lead reviewing
center for the PHOENIX application.  The company expects to meet with CBER
during the next 60 days to identify any additional information required to
begin the feasibility trial.

About Cardiogenesis Corporation
Cardiogenesis is a medical device company specializing in the therapies for
the treatment of chronic cardiac ischemia.  The company's market leading
Holmium:YAG laser system and disposable fiber-optic accessories are used to
perform a FDA-cleared surgical procedure known as Transmyocardial
Revascularization (TMR) to treat patients suffering from angina. Surgical
products and accessories for the Cardiogenesis TMR procedure, which are
marketed in the U.S. and around the world, have been shown to reduce angina
and improve the quality of life in patients with coronary artery disease.

For more information on the company and its products, please visit the
Cardiogenesis company website at http://www.cardiogenesis.com or the direct to
patient website at http://www.heartofnewlife.com.

With the exception of historical information, the statements set forth above
include forward-looking statements. Any forward-looking statements in this
news release related to the possible effectiveness of the company's PHOENIX
delivery system or other technologies and the planned clinical trials, are
based on current expectations and beliefs and are subject to numerous risks
and uncertainties, which are discussed in the "Risk Factors" section of the
company's Annual Report on Form 10-K for the year ended December 31, 2008 and
the company's other recent SEC filings. The company disclaims any obligation
to update any forward-looking statements as a result of developments occurring
after the date of this press release.

http://www.cardiogenesis.com



SOURCE  Cardiogenesis Corporation

Paul McCormick, Executive Chairman of Cardiogenesis Corporation,
+1-949-420-1808
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