FOOTHILL RANCH, Calif., Jan. 19 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation , 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 approval from the U.S. Food and Drug Administration (FDA) on the clinical trial protocol for the PMC procedure. The protocol is approved under an Investigational Device Exemption (IDE).
“This has been an extremely time consuming exercise that has taken nine months to complete, much longer than we initially anticipated,” stated Chairman and CEO, Michael J. Quinn. “With the approved protocol, we can now enter into serious discussions with potential strategic partners in the interventional cardiology arena.”
Prior to receiving the protocol approval, the Company entered into a binding Letter of Agreement with the FDA to ensure that key scientific and clinical issues regarding the PMC technology and trial are clearly understood and agreed to prior to commencing the study. Quinn commented, “We felt the formal binding 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. As a result of working closely with the FDA, we now have a document which will consider both the safety and efficacy of this much needed percutaneous technology.”
“This completes the migration of our technology along the continuum of care spectrum from surgical, to the minimally invasive and robotic platforms that are currently under FDA review, and finally to the percutaneous procedure. We are approaching 30,000 TMR procedures worldwide. The knowledge we have gained from this experience is invaluable in moving forward with the FDA on this platform.”
Following receipt of the protocol approval, the company plans to continue its search for a strategic partner and begin the U.S. trial this year.
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; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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 September 30, 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.
Cardiogenesis Corporation
CONTACT: Michael J. Quinn, Chairman and CEO, +1-714-649-5050, or ChristineG. Ocampo, Sr. VP, CFO, +1-714-649-5066, both of Cardiogenesis Corporation
