Clinical study paper on TMR therapy with autologous stem cells presented

Sep 14 2009

PLC Systems Inc. (OTC Bulletin Board: PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that a paper on a clinical study utilizing its Transmyocardial Laser Revascularization (TMR) therapy in conjunction with autologous stem cells was presented at ESC Congress 2009, the annual meeting of the European Society of Cardiology, in Barcelona, Spain.

This study is designed to examine the safety and feasibility of transplanting stem cells during TMR used in combination with coronary bypass grafting in patients with end-stage heart failure. According to the initial results of the study, this procedure was effective in improving cardiac function, as assessed by echocardiography and magnetic resonance imaging prior to therapy and post surgery, as well as three, six and twelve months afterwards. In addition, the treatment thus far has proven feasible and safe; no intra- or post-operative major adverse cardiac events occurred in the patients enrolled in the study.

This investigator-sponsored study, called INSTEM, is on-going in Germany under the leadership of Dr. Hans-Michael Klein, Associate Professor in the Department of Thoracic and Cardiovascular Surgery at Dusseldorf Medical School in Germany, who presented the initial results at a session on Saturday, August 29th.

Mark R. Tauscher, president and chief executive officer of PLC Systems, said, "We have been monitoring the work of Dr. Klein and others in utilizing our TMR therapy in conjunction with stem cells for some time, and thus we are quite pleased to see the positive initial results of his clinical study presented to an important audience like ESC. Should such a therapy be proven effective, it would provide a new avenue of treatment for heart failure patients, who number approximately 5 million in the U.S. alone and millions more worldwide."

"The combination of CD133+ stem cell transplantation and surgical myocardial revascularization promises to be a new and enhanced causal therapy of severe ischemic cardiomyopathy," stated Dr. Klein. "Although the follow-up has not yet been completed, we can strongly suppose that this procedure significantly augments improvement in left ventricle function."

http://www.plcmed.com/