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Tuesday, 12/28/2004 10:12:12 AM

Tuesday, December 28, 2004 10:12:12 AM

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CardioGenesis Announces FDA Approval of Advanced TMR Laser

New SolarGen 2100s - First of a Series of Products to Expand TMR Market

FOOTHILL RANCH, Calif., Dec. 28 /PRNewswire-FirstCall/ -- CardioGenesis
Corporation (OTC Bulletin Board: CGCP), the market leader in surgical products
and accessories used in angina-relieving Transmyocardial Revascularization
(TMR) and Percutaneous Myocardial Channeling (PMC) procedures, today announced
the FDA approval of the SolarGen 2100s, an advanced laser console for
performing TMR.
Chairman and CEO, Michael J. Quinn explained that "the SolarGen 2100s is
the first in a series of significant, advanced product offerings intended to
expand the TMR market. In the past 12 months, working closely with leading
cardiovascular practitioners, we have implemented a minimally invasive
initiative that will dramatically change the way TMR is performed, and how it
is viewed by patients and referring physicians. Our minimally invasive
strategy is consistent with the overriding trend in cardiovascular care ...
providing improved patient outcomes with reduced morbidity and risk."
The Company has been preparing for the launch of the advanced TMR
products, which they are naming the TMR PLUS(TM) platform. This advanced
SolarGen 2100s is an important component of the new and improved TMR platform,
as it removes many of the obstacles to performing the procedure that are
directly related to the existing TMR technology.
"The SolarGen 2100s represents a significant platform advancement in the
application of TMR in the operating room," Mr. Quinn stated. "The
substantially reduced size and footprint of the SolarGen console, the
flexibility of the power requirements, and the instantaneous system start up -
- are all important benefits of this advanced technology. It dramatically
increases the advantages of our platform to the hospital and the practitioner
in terms of clinical ease of use."
The TMR PLUS platform will include a full range of minimally invasive
delivery systems designed to reduce the morbidity associated with standard
open surgical techniques, while adding technological features to enhance the
physician's ability to visualize and treat all targeted areas of the left
ventricle. Mr. Quinn stated, "FDA approval of the SolarGen 2100s is an
important step forward for our Company. We are excited to launch this first
component of our advanced TMR PLUS platform, which we expect to be followed
shortly by the approval of the first of our minimally invasive delivery
systems. We expect this advanced TMR console to help increase the utilization
rates at TMR centers around the country, and provides us with the opportunity
to significantly grow capital revenue for the first time since the initial
approval of TMR."
Quinn emphasized that in 2005 the company is asserting itself as an
innovative cardiovascular company providing tools for improved patient
outcomes. The Company is preparing for the launch of its advanced TMR PLUS
platform, as well as the CelleratOR system for point of care preparation of
platelet rich plasma. He added, "We will continue to add to our market basket
of innovative products, focusing on devices and therapies designed to treat
advanced cardiovascular disease. 2005 is our opportunity to achieve
significant revenue growth from these new products, and those we expect to add
in the near future." Additionally, the Company recently launched a direct to
physician and direct to patient web site (www.heartofnewlife.com) regarding
TMR to help accelerate the awareness of TMR.
The company intends to highlight the advanced SolarGen 2100s TMR console,
along with its minimally invasive TMR delivery systems that are currently in
the regulatory process, and the CelleratOR system for point of care
preparation of autologous platelet rich plasma at an educational symposium in
conjunction with the STS meeting in January.

About CardioGenesis Corporation
CardioGenesis is a medical device company specializing in the treatment of
cardiovascular disease and is a leader in devices that stimulate cardiac
angiogenesis. 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. Surgical products and accessories for
the Company's minimally invasive Percutaneous Myocardial Channeling (PMC)
procedure are currently being marketed in Europe and other international
markets.
For more information on the Company and its products, please visit the
CardioGenesis company web site at www.cardiogenesis.com. or the patient and
physician website at www.heartofnewlife.com. heartofnewlife.com is a resource
for patients and physicians which provides medical information on TMR

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 Company's sales, profitability, the adoption
of its technology and products and FDA clearances are based on current
expectations and beliefs and are subject to numerous risks and uncertainties,
many of which are outside the Company's control, that could cause actual
results to differ materially. Factors that could affect the accuracy of these
forward-looking statements include, but are not limited to: any inability by
the Company to sustain profitable operations or obtain additional financing on
favorable terms if and when needed; any failure to obtain required regulatory
approvals; failure of the medical community to expand its acceptance of TMR or
PMC procedures; possible adverse governmental rulings or regulations,
including any FDA regulations or rulings; the Company's ability to comply with
international and domestic regulatory requirements; possible adverse Medicare
or other third-party reimbursement policies or adverse changes in those
policies; any inability by the Company to ship product on a timely basis; the
Company's ability to manage its growth; adverse economic developments that
could adversely affect the market for our products or our ability to raise
needed financing; actions by our competitors; and the Company's ability to
protect its intellectual property. Other factors that could cause
CardioGenesis' actual results to differ materially are discussed in the "Risk
Factors" section of the Company's Annual Report on Form 10-K for the year
ended December 31, 2003, the Company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2004, 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.

For further information, please contact: Michael J. Quinn, Chairman and
CEO, +1-714-649-5050, or Richard Lanigan, Senior VP, Marketing,
+1-714-649-5024, both of CardioGenesis Corporation.

SOURCE CardioGenesis Corporation
-0- 12/28/2004
/CONTACT: Michael J. Quinn, Chairman and CEO, +1-714-649-5050, or Richard
Lanigan, Senior VP, Marketing, +1-714-649-5024, both of CardioGenesis
Corporation/
/Web site: http://www.heartofnewlife.com /
/Web site: http://www.cardiogenesis.com /
(CGCP)

CO: CardioGenesis Corporation
ST: California
IN: HEA MTC BIO OTC
SU: PDT


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