FOOTHILL RANCH, Calif., Nov. 14 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation , a leading developer of surgical products and accessories used in angina-relieving procedures, today announced that it has received CE MARK (Conformite Europeenne) approval for the commercial sale of the PEARL(TM) Minimally Invasive TMR delivery systems in European Union member countries. The PEARL Robotic 5.0 and Thoracoscopic 8.0 delivery systems are designed to reduce the morbidity and recovery time for patients, while providing the same improved long term survival and enduring angina benefit achieved with the standard Cardiogenesis Ho:YAG surgical system.
“We are very pleased to provide physicians and patients with Cardiogenesis’ Advanced PEARL delivery systems,” said Michael J. Quinn, Chairman and CEO. “Physicians will now be able to offer the impressive clinical benefits of TMR to patients, with reduced surgical incisions and a more rapid recovery. We believe that this minimally invasive surgical platform offers the opportunity to relaunch sole therapy surgical TMR in Europe with the leaders in advanced cardiothoracic techniques. Patients throughout Europe now have access to our advanced surgical and percutaneous devices and techniques, which have been proven to decrease morbidity rates compared to the traditional open surgical techniques.”
Quinn noted that Cardiogenesis has been busy during 2005 in initiating distribution contracts throughout the European Union countries. “We have representation now covering the majority of the European Union, with more to be added this quarter. We have already received interest from leading minimally invasive skilled surgeons throughout Europe to implement our MIS instrumentation for TMR into their practice. Our European distribution partners are prepared to immediately implement our expanded MIS product offering for TMR in their respective territories.”
Quinn went on to say, “Our progress in developing business outside the United Sates is the result of our ongoing regulatory and sales efforts in targeted international markets. By bringing our advanced tools and techniques to these developing markets, we are demonstrating our commitment to developing these significant opportunities with our distribution partners and providing the most advanced tools to their physicians and patients. Europe and the surrounding regions represents an important growth opportunity and we are committed to providing our laser myocardial revascularization therapy to patients in need around the world.”
Gary S. Allen, M.D., the Principal Investigator for the PEARL 8.0 Thoracoscopic Study in the U.S. stated, “These advanced minimally invasive tools for TMR, are necessary additions to the cardiothoracic surgeons’ armamentarium in achieving total revascularization. The Ho:YAG fiber optic platform is the only commercially available TMR system which allows for true port access laser revascularization. Patient outcomes have been superior compared to historical experiences, with many patients returning to home within 48 hours of surgery. Compared to other minimally invasive cardiac operations, port access TMR has a shorter learning curve, less contraindications, and requires fewer hospital resources. The substantially less invasive surgical profile has rapidly led to increased patient and physician acceptance, and will likely replace traditional “open” procedures as the standard of care for sole therapy TMR.”
The minimally invasive PEARL delivery systems are currently under investigation in the United States. Cardiogenesis is currently enrolling patients in a small safety and feasibility trial in support of the FDA approval process. The Company expects to complete enrollment in the study during the first quarter of 2006.
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, 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
