Cardiogenesis Announces Binding Letter of Agreement with FDA for PMC Clinical Trial.

FOOTHILL RANCH, Calif. -- Company Expects to Submit IDE Trial Protocol to Agency by June 30 PMC Designed to Help Severe Angina Sufferers Significantly Improve Quality of Life

Cardiogenesis Corporation (OTCBB:CGCP.OB), the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, announced today it has received a Binding Letter of Agreement (LOA) from the U.S. Food and Drug Administration (FDA) regarding the trial design for its PMC system. The Company plans to submit the Investigational Device Exemption (IDE) application to the FDA by June 30 and begin this definitive trial on patients suffering from severe angina soon after approval.

Thus far, Cardiogenesis has collaborated with the FDA on a LOA to ensure key scientific and clinical issues regarding the PMC technology and trial are clearly understood and agreed to prior to commencing the study.

"The signed Letter of Agreement allows us to move a step closer to conducting this definitive PMC trial and receiving U.S. approval of the technology," stated Chairman and CEO, Michael J. Quinn. "We felt the formal Binding Letter of Agreement process was essential to first clarifying, and then agreeing with the Agency on all of the key points needing to be addressed in the trial. Based on the PMC's success to date in treating severe chronic angina in Europe, where Cardiogenesis currently has CE Mark approval, we expect that, when approved for use in the U.S., it will show similar benefits to patients here."

Following receipt of the LOA, Cardiogenesis expects to complete and submit the IDE Protocol to the FDA by June 30th. The FDA will then have 30 days to complete a review of the protocol and respond to the Company. "We've enjoyed a productive dialogue with the Agency branch and management teams throughout this process, and are optimistic that the protocol review will be straightforward and can be completed in a timely fashion," said Quinn.

As Cardiogenesis finalizes the trial's design with the Agency, it is contracting study core labs and recruiting investigative sites. The Company intends to leverage its significant international experience with the PMC system to support a successful U.S. trial.

"We feel that after experiencing the debilitating pain of angina, patients shouldn't be subjected to large, invasive surgeries. PMC is far less invasive than other therapies and can help these individuals recover their lives without the pain that has dogged them for months or years," Quinn concluded.

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 that 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, 2004, the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, 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.