GI Cryo has determined that the unique GastroCS device platform, driven by a novel cryoablation technology platform in conjunction with novel FrostBite EUS compatible ablation catheter will provide a viable and safe alternative to conventional treatments, including invasive surgery, ablation, chemotherapy and radiation treatment for pancreatic cancer. Based on a growing need for new therapeutic devices to treat pancreatic cancers and cysts, coupled with the wide level of excitement from physicians regarding this innovative, patent pending technology, GI Cryo, Inc. intends to finalize the development, obtain regulatory approval and commercialize the GastroCS System technology for treatment of pancreatic cancer, cysts and pain for this incredibly mortal disease.
The GI Cryo technology is a game changing ablation platform as it offers the ability to increase the speed and effectiveness of “in situ freezing” (cryoablation), allowing for the minimally invasive, precise targeted destruction of pancreatic cancer. The GastroCS System employs the integrated, cryogen reservoir and control unit capable of generating and delivering the cryogen to the FrostBite EUS catheter, to perform cryoablation on targeted tissue providing maximum destruction while ensuring minimal trauma to the surrounding non-targeted area.
Building upon the need for new approaches to treat pancreatic cancer and the overall growing market acceptance of pancreatic ablation, GI Cryo believes that the GastroCS technology and the FrostBite catheter are poised to emerge as a leading in situ ablation technology alternative in gastroenterology.
FrostBite Technology – The FrostBite System is comprised of two main sub-systems – a cryodevice workstation (GastroCS) and cryoablation catheter (FrostBite). During the past several years, we have focused on the development of the FrostBite System utilizing the novel cryogen, Super-Critical Nitrogen (SCN) as the ablation energy source. This direction was chosen based on the research work from our life science division which studied the efficacy of cell destruction in pancreatic cancer cells and tissues and the need for an extremely fast and efficient cryogen generator.
The GastroCS workstation incorporates the computer controlled system and SCN generator and is a portable unit from where the operator, the surgeon, or the cryo-technician can control the entire procedure. The patented System uses Super-Critical Nitrogen (SCN) to freeze tissue by generating an iceball and then applies a mild resistive electrical heating for thawing, which allows the needle to be released quickly upon procedure termination. The SCN (freeze mode) and warming mode (thaw mode) are delivered to the targeted pancreatic cancer tissue using the FrostBite cryoablation catheter.
How it Works: The FrostBite cryoablation catheter is a 10F catheter similar in appearance and handling characteristics to a standard biopsy catheter, though its mode of action is quite different. An ultracold fluid (SCN) is delivered to the tip of the closed-loop catheter through an ultra-fine tubing to maximize the temperature drop of the needle in order to freeze the surrounding tissue. The SCN absorbs (extracts) heat where the catheter tip is in contact with the tissue, forming ice within seconds. Freezing of a volume of tissue 2cm in diameter typically occurs in 3 to 5 minutes. When tissue freezing is complete, the quick release thaw technology (under development) can be activated to allow for easy and rapid removal of the catheter from the tissue (Rapid Release) and the EUS-endoscope.
Technology Development Progress
Disclaimer: GI Cryo’s technologies are currently Investigational Devices and are limited by Federal Law to Investigational Use Only