SBIR Phase I: Treatment of Type 2 Diabetes through Cryoablation of the Duodenum

This Small Business Innovation Research Phase (SBIR) I project is a novel procedural treatment for the 5-10 million people in the U.S. with medical refractory Type 2 Diabetes. Current treatments require self-management of insulin injections and/or medication, frequent visits to specialists, and a controlled diet. Patients can fail to achieve optimal glycemic control due to the individual medication dosing requirements, safety, and tolerance limits. Poorly managed patients can suffer from adverse events including heart attack, stroke, nerve damage, blindness, and early death. This Duodenal Cryoablation system aims to provide an outpatient, minimally invasive procedure for controlled ablation of the duodenum utilizing a standard, cost-effective endoscopic approach. If successful, the novel therapy will decrease or eliminate insulin and/or medical therapies in patients suffering from medical refractory Type 2 Diabetes. This SBIR Phase I project aims to develop a novel cryoablation system that delivers a highly controlled and targeted cryoablative agent for freezing the duodenum. The system is based on emerging evidence of duodenum remodeling upon ablation resulting in restoration of glucose control and regulation. The technical engineering milestones include managing high pressures of the cryogenic fluid within extreme dimensions including small luminal diameters and long length, within a unique and tortuous path. A key objective is to produce a system ensuring consistent cryogenic fluid delivery down a small diameter, insulated, long length lumen to a set of sprayers placed in the duodenum. A second objective is the development of a method of consistent cryogenic fluid distribution through the sprayers to the target tissue. The final objective is the development of bench methods and testing capabilities validating consistent cryogenic fluid delivery. The design will be tested in preclinical models and the harvested tissue evaluated via histopathological analysis for ablation efficacy. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.