VenoStent

Executive Summary

VenoStent is a clinical-stage medical device company developing SelfWrap, a bioabsorbable vascular wrap designed to reduce the high failure rate of arteriovenous (AV) access sites in hemodialysis patients with end-stage renal disease. The company leverages a proprietary 3D-printing platform to create patient-conforming devices, aiming to improve surgical outcomes and reduce complications such as stenosis and thrombosis. Founded in 2017 and headquartered in Houston, Texas, VenoStent addresses a significant unmet need in the $2B+ AV access market, where current solutions like synthetic grafts and vein transpositions have suboptimal patency rates. VenoStent is advancing SelfWrap through clinical trials, with data expected to support regulatory clearance and commercialization. The product's bioabsorbable nature eliminates the need for permanent implants, potentially reducing long-term complications. If successful, SelfWrap could become the standard of care for dialysis access creation, offering a safer, more effective alternative to existing therapies. The company is well-positioned to capture value in the growing end-stage renal disease population, with a strong IP portfolio and manufacturing scalability through its 3D-printing platform.

Upcoming Catalysts (preview)

• Q3 2026Pivotal Trial Enrollment Completion80% success
• Q4 202612-Month Patency Data Readout75% success
• TBDFDA 510(k) Submission60% success