Thermedical Receives FDA 510(k) Clearance for Promising New Ablation System
10/31/2012 7:24:42 AM
Thermedical™, a medical equipment company developing new tissue-ablation therapies, has received U.S. Food & Drug Administration (FDA) clearance to market its innovative technology for the coagulation and ablation of soft tissue during percutaneous, laparoscopic and intraoperative surgical procedures.
"Receiving FDA clearance is a significant milestone for Thermedical as it will facilitate our plans to carry out a series of clinical trials to evaluate the efficacy of our system for treating large, solid tumors, including liver cancer," said Michael G. Curley, Ph.D., president of Thermedical. "We are in active discussions with leading medical centers in the United States to begin these clinical trials, and we look forward to reporting our results in the future.
"Based on our system's design features, such as the demonstrated ability to rapidly treat large volumes of tissue using a single needle, we believe the Thermedical system has the potential to treat large tumors, offering positive clinical outcomes," continued Dr. Curley.
FDA clearance of the Thermedical Ablation system was based on substantial preclinical testing carried out under multiple National Institutes of Health (NIH) Small Business Innovation Research (SBIR) Grants (CA069926 and HL063535) at the University of Colorado Denver, the University of Cincinnati Medical Center, Ohio, and the University of Louisville Medical Center, KY.
"The National Cancer Institute (NCI) is pleased to have supported the work that led to FDA clearance for this use of radiofrequency waves to treat large tumors," said Michael Weingarten, NCI SBIR director. "Our Small Business Innovation Research program is designed to advance just such early-stage development of potential cancer treatments."
According to Susan Windham-Bannister, Ph.D., president & CEO of the Massachusetts Life Sciences Center (MLSC), "We are glad to see Thermedical's progress, and commend their ongoing commitment to clinical trials to further study this breakthrough technology for the treatment of solid malignant tumors as well as a multitude of other serious medical conditions. Our Small Business Matching Grant Program is intended for just this purpose -- to support companies like Thermedical that are working on the commercialization of innovative technologies."
Thermedical was awarded a $500,000 Small Business Matching Grant in 2010 from the MLSC, the agency charged with implementing Governor Deval Patrick's 10-year, $1 billion Life Sciences Initiative.
Radiofrequency (RF) thermal ablation, in which one or more needles or catheters deliver RF waves to heat and kill tissue, is already used to treat small liver tumors. However, conventional RF may in some cases overheat tissue near the applicator and has had limited success in treating larger tumors of the size commonly found when liver cancer is first diagnosed.
Thermedical's innovative technology optimizes heat transfer and offers the potential to extend treatment to larger volumes of tissue. The company's preclinical testing demonstrates that while conventional RF ablation can treat a volume up to two centimeters in diameter, the Thermedical ablation system was able to successfully and quickly heat tissue volumes of five-to-eight centimeters in diameter. Clinical testing is planned to investigate the impact of the Thermedical technology in subjects with large tumors.
Thermedical is a privately held company founded by Massachusetts Institute of Technology (MIT) Hyperthermia Center alumni Michael G. Curley, Ph.D. and Patrick S. Hamilton, Ph.D., based in Waltham, Mass. Under a Massachusetts Life Sciences Center Small Business Matching Grant (SBMG) Award and multiple NIH SBIR Grants, the company is developing thermal-ablation systems to treat cancer and cardiac arrhythmias. The innovative ablation therapy system is designed to optimize the treatment of liver cancer patients and patients with ventricular tachycardia (VT), an abnormal rapid heart rhythm that can be potentially life threatening. Earlier this year, Thermedical was chosen to present at the 2012 NCI SBIR Investor's Forum (http://sbir.cancer.gov/investorforum/). Additional information may be found by visiting http://www.thermedical.com.
Thermedical is a trademark of Thermedical