Owego, NY – CPSI Biotech (CPSI) announced today it has been awarded a Phase II Small Business Innovation Research (SBIR) grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).  The 2 year $1.7 million Phase II project focuses on the development of a next generation cryoablation device (FrostBite™) and approach for the treatment of pancreatic cancer.

Dr. John Baust (CPSI President) commented “the overall objective of FrostBite™ is to provide a powerful ablative tool to attack pancreatic cancer, which ultimately may reduce our reliance on other traditional approaches such as chemotherapy, radiation or major surgery to treat this deadly disease.”  The potential impact of the technology is tremendous.  Speaking about the technology, Dr. P. Jay Pasricha (Professor of Medicine and Neurosciences, Division of Gastroenterology, John Hopkins School of Medicine and consultant for CPSI) commented “We are very encouraged by the potential of  FrostBite™ EUS-cryocatheter platform.  The ability to target and freeze tissues in situ under endoscopic ultrasound guidance will provide for a more precise and minimally invasive strategy to treat cancer including pancreatic, esophageal and other tumors. We are looking forward to continuing our work with CPSI to bring this technology to the clinic.”

CPSI has been actively working on the development of the FrostBite™ cryocatheter for several years.  FrostBite™ is designed to be used in conjunction with CPSI’s patented cryoengine technologies to freeze (cryoablate) cancer in situ (in place within the body), thereby destroying a tumor. This new device and approach is designed to support the growing field of natural orifice transluminal endoscopic surgery (NOTES) in which “scarless” abdominal operations can be performed with an endoscope passed through the mouth thereby enabling the introduction of surgical tools, such as CPSI’s cryoprobe, into the stomach to target various tissues via the stomach wall avoiding the need for invasive external surgical procedures. In this manner, FrostBite™ is designed to be introduced to the stomach via an endoscopic ultrasound (EUS) device and then the cryoneedle tip of the catheter passes directly through the stomach wall into a tumor in the pancreas. The use of EUS allows for the real-time visualization of the tumor and positioning of the cryoneedle prior to cryoablative treatment.

The initial development efforts behind FrostBite™ were supported, in part, by a Phase I SBIR grant awarded to CPSI by NCI in 2015.  Phase I studies demonstrated proof of concept of this new technology and treatment paradigm and yielded the development of several prototype cryocatheters.  As part of Phase I development efforts, CPSI, in conjunction with collaborators at Johns Hopkins Medical, conducted a series of studies demonstrating the successful delivery of an ultra-cold (<-170°C), highly effective lethal insult (ablative dose) within a matter of minutes.  Phase 1 studies also involved collaborative efforts with researchers from the Institute of Biomedical Technology at Binghamton University.  Successful completion of Phase I studies enabled CPSI to pursue Phase II funding.  Phase II will build upon this success and focus on further development, optimization and testing of FrostBite™ for the treatment of pancreatic cancer as well as other gastroenterological (GI) based cancers.  Speaking to the Phase II, Dr. Baust noted “this is a great opportunity to continue the development of the FrostBite™ platform for the GI-based treatment of various cancers.  This Phase II will allow for continued engineering and testing of the next generation FrostBite™ cryocatheter. This project incorporates several of CPSI’s patented technologies, including our cryoengines, dual thermal ablation and adjunctive agents (SensitICERs).  With success, FrostBite™ will provide an advanced minimally invasive approach for treating pancreatic and other cancers.”  With Phase II development initiated, CPSI is poised to embark down the commercialization path. To enable this, a start-up company (GI Cryo, Inc.) has been formed focused in the GI area to commercialize FrostBite™ and other related technologies.  To this end, Baust commented “We are actively seeking investors and partners to join our team to bring this potentially lifesaving technology platform to the market.”

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