Cardiogenesis (OTC:CGCP), the clinical and market leader in transmyocardial revascularization (TMR), revealed this week that it has accepted its first two patients for its feasibility study involving the cutting-edge PHOENIX System, a combination delivery system created to treat severe angina (heart pain) using both TMR and the intramyocardial delivery of stem cells simultaneously. This PHOENIX combination delivery system is CE Mark approved and has been submitted under an IDE application to the FDA.
While many individuals afflicted with coronary artery disease are able to handle surgical treatment, many have inoperable conditions. Once a patient with angina has undergone typical interventional procedures without success, such as angioplasty, and the use of medicines intended to bring additional blood to the heart, TMR is considered. It can be either used alone or in conjunction with coronary artery bypass grafting, but TMR only reduces angina; it does not cure it.
On October 7th and 8th of this year, Dr. Guillermo Reyes performed the procedures utilizing the new PHOENIX System technology in Madrid, Spain, during an investigator meeting. “Survival rates have significantly improved for persons with coronary artery disease; however as this population lives longer they can outlive the effectiveness of their prior therapy,” stated Dr. Reyes. “Clinicians are faced with an expanding population of symptomatic patients with no option for conventional treatments. Stem cell therapy with the Cardiogenesis technology has great promise as a solution for this growing clinical problem,” Dr. Reyes then added.
In a TMR procedure, a doctor uses a carbon dioxide laser to create channels inside of the left ventricle to increase blood flow to the heart, and by increasing oxygen to the walls of the heart, pain is lessened. Doctors are able to do all of this through a tiny incision in the left of the chest. While TMR has been proven to reduce angina amongst the majority of coronary artery disease patients, researchers hope that the additional injection of autologous stem cells may provide even greater angina minimization, as well as improved cardiac functioning amongst the inoperable patients.
“This is a significant milestone,” commented Cardiogenesis Executive Chairman Paul McCormick. “We will provide the early results of this feasibility study along with the pre-clinical testing being conducted at the Stem Cell Center of the Texas Heart Institute, to support our request to begin a multi-center IDE pivotal trial in the U.S. for the PHOENIX System.” Mr. McCormick believes the PHOENIX System will provide a proprietary growth opportunity for Cardiogenesis, as well as providing effective therapy for inoperable patients with coronary artery disease.
Preeminent researchers planning to participate in this study come from five medical centers across Europe and Asia, including France, India, Italy, Russia, and Spain. Cardiogenesis plans to commence clinical testing at these centers in the upcoming weeks.