Fistula Solution

Executive Summary

Fistula Solution is a Miami-based medical device startup (founded 2017) that aims to become the global leader in complex wound care devices. The company currently provides standard-of-care devices for enteric fistulas and high-output ostomy stomas, addressing critical needs in post-surgical and chronic wound management. In addition to its marketed products, Fistula Solution is developing innovative solutions for rectovaginal fistulas, surgical drain wounds, necrotizing soft tissue infections, and other ostomy complications—areas with limited effective options. By targeting high-acuity, underserved indications, the company seeks to improve patient outcomes and reduce healthcare costs associated with prolonged wound healing and hospital stays. Despite being privately held with no disclosed funding or revenue data, its focus on niche, high-need applications positions it for potential growth in the wound care market, which is expanding due to aging populations and rising surgical volumes.

Upcoming Catalysts (preview)

• Q4 2026FDA 510(k) clearance for rectovaginal fistula device60% success
• Q2 2026Partnership with major hospital system for clinical trial50% success
• Q3 2026Series A funding round announcement70% success