Fistula Solution
Fistula Solution’s vision is to be the global performance leader in complex wound care devices. Its current devices are the standard of care for enteric fistulas, and its SBIR Direct Phase II project will deliver a novel post-surgical ostomy incision management device.
Over 100,000 patients of all ages undergo ostomy surgery in the U.S. annually due to a variety of pathophysiologic conditions, including colorectal cancer, inflammatory bowel disease, bowel obstruction, diverticulitis, and many other medical conditions. A life-saving procedure, ostomy surgery allows bodily waste to pass through a surgically created opening called a stoma on the abdomen into a prosthetic known as a ‘pouch’ or ‘ostomy bag’ on the outside of the body. Unfortunately, current pouch designs offer little therapeutic benefit for post-surgery edema (swelling) and may not maintain a tight seal, allowing leakage of intestinal fluid and waste. Resulting stoma complications include mucocutaneous (skin/stoma) separation, stoma retraction, and moisture-associated skin damage. Up to 70% of ostomy patients endure these complications, with 29% of these patients requiring hospital readmissions at an additional cost of $78,000 per patient.
To decrease the risk of complications, Fistula Solution has developed the LimpetTM, a new device designed as an alternative to conventional pouches used to collect waste from the stoma. The company's goal is to deliver a new post-surgical standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions, and save healthcare costs.
