Venova Medical

Executive Summary

Venova Medical is a privately held medical device company developing the Velocity Percutaneous Arterio-Venous Fistula (pAVF) System, a minimally invasive solution for creating vascular access in hemodialysis patients. Traditional surgical arteriovenous fistulas (AVFs) suffer from high failure rates and complications, often delaying or preventing effective dialysis. Venova's technology aims to overcome these barriers by enabling a reproducible, less traumatic procedure that can be performed in an outpatient setting. The Velocity system leverages a novel catheter-based approach to create a functional AVF without open surgery, potentially reducing recovery time, infection risk, and the need for revisions. With an estimated total addressable market of over 500,000 end-stage renal disease patients annually in the U.S. alone, Venova is well-positioned to address a critical unmet need. The company has a strong intellectual property portfolio and is backed by experienced management. While still in the development stage, early clinical data suggest promising safety and efficacy, positioning Venova as a potential disruptor in the $4 billion vascular access market.

Upcoming Catalysts (preview)

• Q2 2026FDA IDE Approval for Pivotal Trial75% success
• Q4 2026Completion of First-in-Human Study Enrollment80% success
• Q1 2027Presentation of Interim Clinical Data at Major Conference65% success