SBIR Phase II: High Surface Area (HSA) Intraluminal Cryoablation for the Treatment of High-Risk Patients with Gallstone Disease

Award ID: 2214634

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be the development of the first minimally invasive cryoablation solution to treat high-risk patients with gallbladder disease. The current gold standard for treating gallbladder disease is surgical removal of the gallbladder. While this procedure works well for healthy patients, the use of general anesthesia has been shown to increase complications in elderly patients with underlying chronic medical conditions, leading to a $675 million cost to the US healthcare system each year. Furthermore, patients too sick for surgery have no definitive treatment options, underscoring the need for a safer alternative. Phase I efforts demonstrated the ability to safely deliver cryoablation energy via a minimally invasive catheter system to chronically defunctionalize porcine gallbladders without removal. Phase II efforts will focus on product development of the cryoablation system and optimization of clinical delivery parameters. The goal of the technology is to allow clinicians to provide their patients with the benefits of surgery, without the risk. This Small Business Innovation Research (SBIR) Phase II project proposes to continue the development of a minimally invasive cryoablation system capable of safely and effectively targeting the gallbladder. Initial testing of the cryoablation system has demonstrated the ability to uniformly generate lethal cryoablation temperatures (
NSF Program Director: Henry Ahn