VenoStent Raises $20M for SelfWrap Perivascular Wrap

VenoStent, a clinical-stage company developing a novel therapeutic device to improve dialysis outcomes, has closed a further $4 million from Norwest Venture Partners to complete its Series A financing at $20 million.

The company also gained a $3.6 million Small Business Innovation Research (SBIR) Phase II Grant by the National Institutes of Health (NIH), which will help fund its multi-center, 200-patient, randomized controlled trial (RCT) in the U.S.

Norwest General Partner Dr. Zack Scott and Investor Dr. Ehi Akhirome are joining the company as board observers.

VenoStent developed the SelfWrap bioabsorbable perivascular wrap, which goes around arteriovenous (AV) access sites during AV fistula creation surgery. The wrap aims to accelerate usability and increase durability of fistula sites for chronic kidney disease (CKD) patients needing hemodialysis. It uses the body’s healing mechanisms to mimic the arterial environment in veins.

SelfWrap was awarded U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) approval for the SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistulas Study in May 2023. The study plans to show how SelfWrap can improve outcomes for CKD patients needing dialysis.

SelfWrap was also awarded FDA breakthrough device status in May 2022 based on results from the company’s first-in-human clinical trial.

“Over half a million people in the U.S. rely on hemodialysis to survive and require an arteriovenous fistula creation surgery in order to receive the treatment. However, the AV fistula procedure has a one-year failure rate of more than 60%, which significantly impacts patients’ survival rates and quality of life,” said Norwest’s general partner Dr. Zack Scott. “VenoStent’s groundbreaking technology for AV fistula formation, SelfWrap, has the potential to significantly improve these odds. We look forward to working with the VenoStent team as it proves the efficacy of this breakthrough technology in order to improve the lives of hundreds of thousands of CKD patients.”

“Norwest’s investment is tremendous validation for VenoStent, and we are thrilled to have both Zack and Ehi joining the company’s board,” added VenoStent COO and co-founder, Geoffrey Lucks. “Zack and Ehi have extensive knowledge in our space, and their added value will match the capital and cache of Norwest dollar-for-dollar.”