FOOTHILL RANCH, Calif., June 20 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation , a leading developer of surgical products and accessories used in angina-relieving procedures, announced today it has received approval from Health Canada to sell the Company's advanced TMR PLUS platform, including the Solargen 2100s console and the minimally invasive PEARL surgical delivery systems, in that country. To distribute the systems, Cardiogenesis entered into a distribution agreement with Minogue Medical for the Canadian market.
"The recent comprehensive approval by Health Canada of our advanced TMR PLUS system components makes the Canadian market the first with access to the full range of laser myocardial revascularization devices," commented Michael J. Quinn, Chairman and CEO. "Patients throughout Canada now have access to all of our minimally invasive surgical and percutaneous devices and techniques, which have been shown to decrease procedural morbidity compared to the traditional open surgical techniques."
Cardiogenesis reported that it is currently implementing a new TMR program at the Canadian Surgical Technologies and Advanced Robotics (CSTAR) Center. The company expects that CSTAR will be the first medical facility in Canada to use the minimally invasive PEARL robotic delivery system for TMR. Located in London, Ontario, the Center is a leader in developing and implementing next generation minimally invasive surgical and interventional techniques and technologies.
To distribute the newly-approved platform, Cardiogenesis contracted with Minogue Medical, a leading surgical supply company. Minogue Medical will exclusively distribute TMR PLUS, including the Solargen 2100s console and the PEARL surgery delivery systems throughout the country.
"Canada will be a growth market for Cardiogenesis, now that our full range of TMR PLUS and PMC products are available for sale there," stated Quinn. "We were drawn to Minogue Medical because of their fine reputation and established ability to educate, sell and support the platform across the country."
Quinn went on to say, "Our progress in developing the Canadian market is the result of our ongoing regulatory and sales efforts in targeted international markets. We have already been approved to utilize the TMR and PMC procedures in Europe, and Canada represents a tremendous opportunity to accelerate our sales and profitability in providing our laser myocardial therapy to patients in need around the world."
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.
Media Contact: Justin Perras/Richard Dukas Dukas Public Relations P: (212) 704-7385 E: justin@dukaspr.com/richard@dukaspr.com Investor Contact: Christine Ocampo, Vice President, Chief Financial Officer Cardiogenesis Corporation P: (714) 649-5000 E: cocampo@cardiogenesis.com
Cardiogenesis CorporationCONTACT: Media, Justin Perras, justin@dukaspr.com, or Richard Dukas,richard@dukaspr.com, both of Dukas Public Relations, +1-212-704-7385, forCardiogenesis Corporation; or Investors, Christine Ocampo, Vice President,Chief Financial Officer of Cardiogenesis Corporation, +1-714-649-5000,cocampo@cardiogenesis.com