Thermedical
Company Background
Michael Curley, Ph.D., and Patrick Hamilton, Ph.D., incorporated Thermedical in Delaware in 2008 to develop, manufacture, and sell thermal therapy devices. They have been collaborating since they met at the Massachusetts Institute of Technology’s Hyperthermia Center, and they have a unique and detailed understanding of biologic heat transfer. The company has seven employees.
Technology Overview
Thermedical’s first product, SERF Ablation therapy for liver cancer, has a 510(k) application pending with the FDA. Thermedical is taking a revolutionary approach to tumor thermal ablation by altering the physics of heat transfer in tissue. SERF Ablation transports thermal energy deep into tissue using convection of warm saline, which carries the heat through the extracellular space. The tissue is transformed from having the insulating properties of wood to conducting heat as efficiently as bronze. Radiofrequency (RF) energy then heats the transformed tissue, and can thereby treat 100 times the volume of tissue that conventional RF can heat. Thermedical has demonstrated that SERF Ablation can treat an 8-cm diameter liver tumor in five minutes.
Market Potential
SERF Ablation for Liver Cancer will extend a treatment therapy for small tumors—RF Ablation—to the 80 percent of patients with tumors larger than 3 cm. The 1.3 million patients annually diagnosed with these large tumors have no cure available to them and live less than one year. This market is significant, with $1.8 billion spent annually on palliative therapies for these patients.
The markets for follow-on products are even more substantial. SERF Ablation will be curative for Ventricular Tachycardia (VT), and will be a disruptive technology for the $7 billion Implantable Cardioverter Defibrillator market. SERF Ablation for fibroids is an alternative to hysterectomy and may restore fertility in the 300,000 women who present with fibroids annually in the U.S.
Competitive Advantage
Thermedical’s competitive advantage is their expertise on biologic heat transfer and their techniques for increasing heat transfer in tissue. Tissue does not conduct heat well, so existing ablation systems overheat tissue near the energy applicators. These products create hot-spots, islands of therapy in a sea of untreated tissue. SERF Ablation addresses the source of the problem. Warm saline transport increases the heat transfer capacity of tissue by a factor of more than 20, and can quickly and uniformly heat very large volumes of tissue — up to 8 cm diameter — using a single RF applicator. SERF Ablation is uniquely capable of treating conditions that require ablation of large volumes of tissue.
Financial Overview
Thermedical has been funded through NCI and NHLBI grants ($9.0 million) and a grant from the Massachusetts Life Sciences Center ($500,000). With these funds the company has brought SERF Ablation to a 510(k) application. Thermedical has just received its Series A investment from Dr. Samuel H. Maslak, the founder and former CEO of Acuson, the pioneering developer of modern ultrasound imaging systems, acquired by Siemens in 2001. These funds will be used for expanded regulatory clearances. Thermedical seeks funds for human clinical trials of their liver cancer ablation system.
Intellectual Property
Thermedical’s technique is protected by U.S. Patent #6,328,735. The company has filed four additional patents and two trademarks.
Commercialization Strategy
Thermedical will sell direct in the U.S., building a strong training program to ensure that physicians understand the technology. The company will use this approach in Europe for product introduction, but will shift to distributors once the product is established. Thermedical plans to use distributors in the rest of the world.
Pipeline Products
New SERF Ablation therapies will be built around the company’s SERF Ablation system, which can be used to treat a variety of conditions using therapy-specific applicators. The SERF Ablation system and needle for treating liver cancer are undergoing FDA 510(k) review. The company has also completed a preclinical prototype of their VT ablation catheter, which is undergoing successful preclinical testing. The gynecological application for treating fibroids is in design development. Clinical collaborators for all three applications are enthusiastic about bringing these new tools into the clinic.
Management Team
Michael Curley, Ph.D., President, is the inventor of SERF Ablation Therapy. Dr. Curley previously founded Acuson’s Interventional Devices Business Unit and was its Vice President and General Manager with full profit and loss responsibility. He invented the AcuNav™ Diagnostic Ultrasound Catheter and led its successful introduction to the electrophysiology and interventional cardiology markets; the AcuNav has accumulated more than $1.0 billion in sales to date. His graduate research focused on thermal therapy for cancer. He holds S.B., S.M, and Ph.D. degrees from MIT.
Katharine M. Stohlman, Chief Operating Officer and VP Regulatory and Clinical Affairs was VP of QA and Regulatory Affairs for Viacor, Inc., from 2002 to 2011 and held operational management positions with HP Medical Products Group from 1983 to 2002, with direct reports of more than 200 employees. She holds an S.B. from MIT and an MBA from Harvard Business School.
Patrick S. Hamilton, Ph.D., Founder and VP Engineering, has considerable experience designing and implementing hardware and software for diagnostic and therapeutic medical systems. Dr. Hamilton holds an S.B. from MIT and M.S. and Ph.D. degrees from the University of Wisconsin.
