NEWS

NIH AWARDS THERMEDICAL™ $3.6 MILLION TO TEST FOR PREVENTION OF SUDDEN CARDIAC DEATH

 

Company to Test Radiofrequency Electrical Energy to Treat Myocardial
Infarctions to Prevent Ventricular Tachycardia

 

SOMERVILLE, Mass., October 27, 2006 – Thermedical™, a privately held company currently developing a proprietary ablation therapy for the treatment of cancer, announced today that it has received a $3.6 million Competing Phase 2 Renewal Grant from the National Heart, Lung and Blood Institute. The three-year grant 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 2 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. 

 

“These results not only show that SERF Ablation™ could be a successful and efficient therapy to improve the quality of life of patients with ICDs; the results also hold the hope that, since nearly all of the scar-related VT circuits are ablated, SERF Ablation™ could be used as a primary therapy for VT,” continued Dr. Curley.

 

VT contributes to the 300,000 patients who die from Sudden Cardiac Death in the United States annual [1]. The primary prevention for Sudden Cardiac Death from VT is the use of an Implantable Cardioverter Defibrillator (ICD). This is an expensive therapy, costing over $70,000 per patient [2]. In 2005 the United States spent nearly $4.3B on ICD therapy for VT [3]. 

 

“If our development is successful, SERF Ablation™ would be a low-cost alternative to ICD therapy and could save the US healthcare system approximately 75 percent of the cost of treating patients with VT,” said Dr. Curley. 

 

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 U.S. Food & Drug Administration (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.

SERF™ Ablation is a trademark of THERMEDICAL

[1] Trappe, HJ, P Pfitzner, HG Fieguth, et al. (1994) PACE, 17:2172 

[2] Groeneveld PW, Matta MA, Suh JJ, Heidenreich PA, Shea JA (2006), “Costs and quality-of-life effects of implantable cardioverter- defibrillators,” Am J Cardiol., 98(10):1409-15.

[3] Defibrillators are livesavers but risks give pause, New York Times, Sept 12,2008

The Thermedical® Ablation System is 510(k) cleared for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.  Use of the Thermedical Ablation System for any specific soft tissue indication has not been evaluated or approved by the US FDA.

Use of the Thermedical Ablation System for the treatment of VT is investigational and is not approved for use or sale in any market.

150 Bear Hill Road,  Waltham, MA 02451-1036
781.373.3688

©Copyright Thermedical, Inc. 2011-2015. All Rights Reserved. | Copyright and Trademark Notice 
Thermedical® and Durablate™ are trademarks of Thermedical, Inc. registered in the United States and Internationally.