SBIR Phase II: 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 II project is to improve the care and quality of life of colon cancer patients while reducing healthcare costs. The development of a reliable, reversible, and cost-effective means to protect segments of bowel has potential applications to treating a number of common disease conditions such as colon cancer, Crohn’s disease, ulcerative colitis, diverticulitis, ischemic bowel disease, and abdominal trauma. There are more than 120,000 temporary ostomies (surgical openings) performed each year in the US, and a majority of these can be eliminated with the development of the funded technology, addressing a $6.4 Billion total market opportunity. This funded device will initially target the over 40,000 individuals who have low bowel resections, the majority for rectal cancer. This represents an initial market size of $200 million in US. The overall impact with full market penetration in just the US rectal resection market is $2.4 billion in savings. This Small Business Innovation Research (SBIR) Phase II project advances the development of a novel technology to protect segments of bowel. Colorectal cancer is the third most common cancer with about 30-40% of cases involving the rectum. Rectal cancer is typically treated with surgical resection. However, anastomotic leaks can occur in up 10-18% of patients after resection, with an associated high mortality due to severe abdominal sepsis. Currently, diverting ostomies are typically placed above the anastomosis to mitigate the severe consequences of an anastomotic leak, but temporary ostomies themselves are highly morbid, have significant risk of mortality, are expensive to the healthcare system, and drastically impact patient’s quality of life. The funded technology is a medical device that provides temporary, minimally invasive protection of bowel during the healing process, avoiding the need for a diverting ostomy. This project will perform design verification testing, end user testing, and large animal validation testing required for human study approval. The goal of this project is to have a fully validated (both benchtop and animal testing completed), clinically ready medical device ready for further development. 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.