WEST BRIDGEWATER, Mass., Sept. 23, 2021 /PRNewswire/ — Theromics Inc., a medical device company pioneering novel technologies for interventional radiology and drug delivery, has been awarded an STTR Phase I grant from the National Science Foundation to compile additional empirical data on HeatSYNC™, a thermal accelerant gel for optimizing and augmenting soft tissue thermal ablations. The data supported by the grant is invaluable as the Company moves toward submission of an application for an FDA Cl II 510(k) De Novo clearance.
Currently, surgical removal is the preferred treatment for most focal tumors, but it is an invasive, expensive procedure. Thermal ablation, a different treatment option, is a minimally invasive, outpatient procedure that can be performed safely at a fraction of the cost; however, incomplete ablation can result in local recurrence. Nevertheless, ablation still represents a $2B market, growing at 10% annually despite the current limitations.
Research conducted under the grant will explore the thermal behavior of the technology and how it will impact the surrounding tissue and overall ablation volume and shape.
Initial research will be conducted at the Thayer School of Engineering at Dartmouth College under Professor Paul Meany, Ph.D. Following these studies, Punit Prakesh, Ph.D. at Kansas State University, will oversee the use of this data to construct a computational model for predicting the microwave ablation patterns in a clinical setting.
"I am thrilled by the NSF STTR award, as it recognizes the potential of our novel technology to address the shortcomings of current approaches and improve outcomes for ablation procedures which could impact patients across multiple disease states and conditions," stated William KC Park, Ph.D. Principal Investigator and Chief Science Officer of Theromics. "This grant will allow us to conduct additional studies to support our 510(k) submission to the FDA."
The Company also announced an additional patent was granted by the USPTO, further strengthening an already robust patent estate in the US and abroad. The patent office has issued US Patent No. 11,076,916 Titled "Thermal accelerant compositions and methods of use." This patent covers the development and use of the Company’s HeatSYNC™ thermal accelerant in augmenting and optimizing soft tissue ablations.
Theromics has developed HeatSYNC™ gel, a novel biopolymer thermal accelerant. All standard MWV and RF systems can use HeatSYNC, and its chemical properties augment the energy generated from the system. This augmentation is controllable, customizable, and creates larger ablation volumes in a shorter treatment time by creating a 50% larger ablation zone in ½ the time of current procedures. The gel also blocks complete energy penetration, protecting critical tissue behind it. HeatSYNC is made from a naturally occurring protein and stays in position when deposited via a syringe, laparoscope, or bronchoscope. Theromics is now poised, after successful animal trials, for formal GLP testing leading to an FDA submission.
About Theromics Inc.
Theromics is developing a next-generation thermal accelerant technology for soft tissue ablation procedures and combination therapy. The Company’s proprietary HeatSYNC™ gel is based on a protein naturally found in the body and may increase cost-efficiencies and improve outcomes through more focused and patient-centric delivery. The Company will first focus on tumor ablations and then expand into additional applications, including pain and abnormal uterine bleeding. Longer-term, Theromics plans to apply its thermal technology for use as an oncolytic intratumoral drug/immunotherapy delivery platform with the potential to enhance efficacy and improve safety profiles of currently approved medicines. For more information, visit www.theromicsinc.com.
The National Science Foundation (NSF) is an independent federal agency that supports fundamental research and education across all fields of science and engineering. In fiscal year (FY) 2020, its budget is $8.3 billion. NSF funds research in all 50 states through grants to nearly 2,000 colleges, universities, and other institutions. Each year, NSF receives more than 50,000 competitive proposals for funding and makes about 12,000 new funding awards.
Ronald Murphy CEO
SOURCE Theromics Inc.