Focus Area

GI Cryo, Inc. is a startup company focused on the final development and commercialization of a novel catheter-based, ultrasound guided, endoscopic cryoablation technology platform.  The GastroCS System (GastroCS cryoablation console and FrostBite EUS Cryocatheter) has robust intellectual property backing to which GI Cryo has obtained an exclusive license for the use within gastroenterological arena. As related to this initiative, GI Cryo is looking to develop the technology for indication specific use in the GI area, initially focusing on pancreatic cancer.indications

Pancreatic cancer strikes millions of individuals annually worldwide.  With a 5 year survival rate of less than 5%, today a diagnosis of pancreatic cancer is essentially a death sentence (6-12 month life expectancy) due to no truly effective treatment options.  In the United States alone it is estimated by the American Cancer Society that >48,000 new cases will be diagnosed in 2015 with over 40,000 deaths, ranking pancreatic cancer as the 4th leading cause of cancer related deaths in the US.  Worldwide, an estimated 330,000 individuals were diagnosed in 2014. Based on current trends and prognoses of continued increases in incidence, it has recently been projected that pancreatic cancer will become the 2nd leading cause of cancer-related deaths in the US by 2030, overtaking both colon and breast cancer and falling below only lung cancer. As such, it is clear that there is a significant need and urgency for the development of new treatments.

Endoscopic Approach – The procedure for conducting Endoscopic Ultrasound (EUS) Guided Cryoablation of Pancreatic Cancer is designed to be quick and minimally invasive.  The procedure involves inserting an EUS probe down the esophagus of a patient into the stomach.  With the EUS transducer placed on the wall of the stomach near the pancreas, the FrostBite needle tip would be passed through the wall of the stomach and into the center of the target area (lesion) within the pancreas.  The proper placement of the ablation needle is achieved using ultrasound visualization.  Once in position, the freezing process is activated to EUS Frostbitedestroy the targeted tissue.  The freezing process can be visualized in real-time using EUS ultrasound given that frozen tissue appears as a black mass on the ultrasound image, allowing the physician to actively monitor the ablation process.  Once the target is frozen, the probe can be repositioned and another ablation commenced if desired.  When the ablation is completed, the FrostBite needle is retracted from the tissue into the EUS device and then the EUS device is removed from the patient.  As the FrostBite needle tip is less than 1.5 mm in diameter, the hole created within the wall of the stomach self-seals (closes) upon needle removal, so no stitching or surgical closing of the penetration site will be necessary. Learn more about Endoscopic Cryoablation.

The strategy for approaching the pancreas through the stomach wall is a new approach for treating pancreatic cancer.  Preliminary studies support the position that this approach will provide a highly effective, minimally invasive treatment option yielding a reduction in morbidity, hospital stay term, procedural cost, and postsurgical complications compared to traditional open surgical approaches.  Endoscopic ultrasound guided treatment of pancreatic cancer is now being explored and published on by clinicians from institutions including  Johns Hopkins Medical School, Cornell Weill, University of Washington and MD Anderson.

Disclaimer: GI Cryo’s technologies are currently Investigational Devices and are limited by Federal Law to Investigational Use Only