October 28, 2008 – Thermedical said yesterday it received a $3.6 million competing phase two renewal grant from the National Heart, Lung and Blood Institute, which will fund continued development and testing of the company’s Saline Enhanced Radiofrequency Ablation (SERF) system, which is designed for use in ablation treatment for ventricular tachycardia (VT).
“The funding from the National Heart Lung and Blood Institute will allow us to assess whether SERF Ablation is useful for treating the arrhythmogenic tracks that are left within infarct scars following a myocardial infarction, or heart attack,” said Michael G. Curley, Ph.D., founder of Thermedical and principal investigator on the project. “Physicians feel these tracks are critical to the occurrence of VT and can lead to sudden cardiac death.”
In Thermedical’s previously funded phase two grant, the company documented for the first time that remnant healthy myocardium within infarct scar (the channels thought responsible for a portion of the VT circuit) has been ablated throughout the scar’s depth. The practical implication of these results is that SERF Ablation should eliminate the VT circuits associated with the infarct scar.
VT contributes to the 300,000 patients who die from sudden cardiac death in the U.S. annually. The primary prevention for sudden cardiac death from VT is the use of an implantable cardioverter defibrillator (ICD). This is an expensive therapy, costing about $70,000 per patient.
SERF Ablation uses radiofrequency (RF) electrical energy to overheat, and as a result, kill myocardial tissue. The energy is delivered by a catheter-delivered needle that simultaneously injects warm saline into the tissue. The saline alters the physics of energy delivery through the tissue, potentially allowing treatment of much larger volumes than can presently be treated using RF alone.
The proceeds from the grant will be used to gather the data needed to apply for FDA investigational device exemption for clinical trials for ablation of myocardial infarct scars. These data will be gathered in a multi-institutional, pre-clinical trial led by Douglas L. Packer, M.D., professor in medicine, Mayo Clinic. The trial will also be carried out by David J. Wilber, M.D., director, division of cardiology, Loyola Stritch School of Medicine, David J. Callans, M.D., associate director of Electrophysiology and Francis E. Marchlinski, M.D., Director of Electrophysiology at the University of Pennsylvania School of Medicine, and Roy M. John, M.D. director, experimental arrhythmia research and Laurence Epstein, M.D., director, electrophysiology and pacing laboratory, Brigham and Women’s Hospital.
For more information: www.thermedical.com