Clinical TMR + stem cell delivery tests basis for Cardiogenesis' U.S. strategy
June 13, 2008 -- A presentation given this week at the 10th annual meeting of the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) by Cardiogenesis Corp. (Irvine, Calif.) describes the use of Phoenix, its Holmium YAG Laser delivery system that combines transmyocardial revascularization (TMR) with autologous bone marrow-derived stem cells. The company intends to use global clinical experience to support its clinical and regulatory strategy in the U.S.
June 13, 2008 -- A presentation given this week at the 10th annual meeting of the International Society of Minimally Invasive Cardiothoracic Surgeons (ISMICS) by Cardiogenesis Corp. (Irvine, Calif.) describes the use of the Phoenix delivery system that combines transmyocardial revascularization (TMR) with autologous bone marrow derived stem cells. Phoenix is a Holmium YAG Laser system manufactured by Cardiogenesis (Pink Sheets: CGCP), which is known for developing surgical products for cardiac revascularization.
Guillermo Reyes, M.D. of La Princesa Hospital (Madrid, Spain) made the presentation, titled "Transmyocardial Revascularization Combined with Concentrated Autologous Stem Cells.". It reports a study of 9 patients with diffuse coronary artery disease and medically refractory class III/IV angina that were treated by the application of TMR in combination with bone marrow derived stem cells in targeted ischemic heart muscle. At an average follow up of 6 months:
-- All patients experienced at least a two class reduction in angina;
-- 7 patients were angina free;
-- Sublingual nitrate use pre procedure was 37 per patient per month compared to 4 per month at follow up (p=0.03);
-- and there were no perioperative adverse events including no arrhythmias.
The hypothesis for the study is an enhanced cell uptake and angiogenic effect when delivering concentrated bone marrow derived stem cells to the stimulated tissue border zone surrounding the TMR channels at the time of surgery.
"These initial clinical results utilizing the Phoenix delivery system are very promising," stated Richard Lanigan, President of Cardiogenesis, "and they build upon the growing body of evidence that our Holmium YAG TMR system has a favorable impact on cell retention and survival in cardiac tissue as described by Dr. Amit Patel in a recent animal study published in Cell Transplantation. Our corporate focus is to build on this early work and provide clinicians effective tools to treat the large patient population suffering from refractory angina, be it as sole therapy or concomitant with coronary bypass."
The Phoenix system was CE Mark approved in November 2006 and has been used in over 40 procedures at cardiac centers outside the U.S. It is not currently FDA approved. The company intends to utilize the clinical experience outside the U.S. to support its clinical and regulatory strategy in the U.S.