SBIR Phase I: A Novel Device Alternative to Temporary Ostomies

Savage Medical Inc., Fremont CA

Investigators

Abstract

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve the care and quality of life of colon cancer patients by reducing or eliminating the need for temporary ostomies, saving $25+ k per patient in direct surgical costs and eliminating $8.5 k per patient in annual maintenance costs; this could generate total savings of $60 k per patient treated. The proposed solution could address the need for temporary ostomy surgery; this procedure is performed 300,000+ times per year in the US. This system would reduce the risks of bowel leakage after colon resections, a problem occurring in roughly 36% of patients and generating fatal consequences in 22%. More importantly, the technology has the potential to dramatically reduce or eliminate the morbidity and mortality from ostomies and improve a patient’s quality of life. The research and development of a reliable, reversible, and cost-effective means to protect segments of bowel has broader implications and potential applications to treating a number of disease conditions, such as Crohn’s disease, ulcerative colitis, diverticulitis, ischemic bowel disease, bowel trauma, and even early colon cancer. The proposed project will develop a system to reduce diverting ostomies, which are often placed above the reconnection site to protect against leaks and their consequences. This project will develop an intraluminal fecal diversion technology using a novel anchoring mechanism that is safe, reliable, and easily reversible. The goal of this project is to optimize the design of both the device and clinical treatment algorithms for design, safety, and use; and validate the new design and protocols in subsequent animal studies. 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.