Worldwide, 2,000,000 new patients are diagnosed with liver cancer annually. With presently available therapies the five-year survival rate for these patients is only 10%. Between 245,000 and 280,000 in the United States die each year from Ventricular Tachycardia (VT). Thermal ablation holds promise as a treatment for both liver cancer and VT, but present thermal ablation methods are not capable of treating VT or the majority of liver tumors that are diagnosed. We founded Thermedical to develop technology capable of treating large liver tumors and VT.

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

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.

Based in Somerville, Mass., Thermedical is a privately held company founded by Dr. Curley and Patrick S. Hamilton, Ph.D. Under multiple NIH Small Business Innovation Research (SBIR) Grants, the company is developing thermal therapies for difficult-to-treat cardiac arrhythmias such as ventricular tachycardia, and for difficult-to-treat cancers, such as liver cancer.

[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] http://www.nytimes.com/2008/09/13/business/13defib.html?scp=2&sq=defibrillator&st=nyt

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NIH AWARDS THERMEDICAL $3 MILLION FOR CANCER THERAPY TESTING

SOMERVILLE, MA -- (MARKET WIRE) -- August 08, 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 million Competing Phase 2 Renewal Grant from the National Cancer 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 of malignant tumors.

"The funding from the National Cancer Institute will allow us to assess whether SERF Ablation is useful for treating solid tissue in general, and to pursue investigation for ablation of liver cancer in particular," said Michael G. Curley, Ph.D., founder of Thermedical and principal investigator on the project.

"Physicians have continuously called for techniques that can reliably heat large volumes of tissue in an effort to improve the outcomes for liver cancer patients," continued Dr. Curley. "In our previously funded Phase 2 Grant, we demonstrated that SERF ablation can heat 8-cm volumes of tissue in less than five minutes. The next phase of research is designed to evaluate whether, by ablating large tissue volumes, SERF Ablation can provide effective ablation of liver cancer."

According to the American Cancer Society, more than 145,000 new cases of colorectal cancer are diagnosed each year in the United States and half of these will develop metastases to the liver. Liver cancer is the third leading cause of cancer-related deaths worldwide, and the prognosis for liver cancer patients is poor -- 90 percent die within five years of diagnosis.

SERF Ablation uses radiofrequency (RF) electrical energy to overheat, and as a result, kill solid tumor tissue. The energy is delivered by a needle that simultaneously injects warm saline into the tumor. The saline alters the physics of energy delivery through the tissue, potentially allowing treatment of much larger tumors than can presently be treated using RF alone.

The proceeds from the grant will initially be used to apply for U.S. Food & Drug Administration (FDA) clearance for ablation of solid tissue in 2007. A multi-institutional clinical trial for ablation of liver cancer will follow, led by Steven Curley, M.D. (no relation), professor of surgery and chief, gastrointestinal tumor surgery, M.D. Anderson Cancer Center, Houston. The trial will also be carried out by Kelly M. McMasters, M.D., chair, Department of Surgery, University of Louisville, Louisville, Ky., as well as Syed A. Ahmad, M.D., assistant professor of surgery, University of Cincinnati College of Medicine, Cincinnati, and Carlton C. Barnett, Jr., M.D., assistant professor of surgical oncology, University of Texas Southwestern Medical Center, Dallas.

Based in Somerville, Mass., Thermedical is a privately held company that is currently a division of E.P. Limited, founded by Dr. Curley and Patrick S. Hamilton, Ph.D. Under multiple NIH Small Business Innovation Research (SBIR) grants, the company is developing thermal therapies for difficult-to-treat cancers, such as liver cancer, and for difficult-to-treat cardiac arrhythmias such as ventricular tachycardia.

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NIH AWARDS THERMEDICAL $3 MILLION FOR CANCER THERAPY TESTING

Company to Test Radiofrequency Electrical Energy to Overheat and Kill Solid, Malignant Tumors