VenoStent, Inc., a clinical-stage medical device company developing a novel therapeutic device for improving dialysis patient outcomes, announced today that it closed an additional $4 million from Norwest Venture Partners to round out its Series A financing at $20 million with Good Growth Capital and IAG Capital Partners co-leading the deal. In addition, the company was awarded 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 US.
Norwest General Partner Dr. Zack Scott and Investor Dr. Ehi Akhirome are joining the company as board observers. Dr. Scott and Dr. Akhirome bring deep medtech expertise from previous experience as a surgeon and physician scientist, respectively.
“2024 has been a momentous year for VenoStent so far. In the span of a few months, we initiated our first clinical sites, enrolled the first patients in our large RCT and closed our Series A with Norwest,” said Tim Boire, Ph.D., VenoStent CEO and co-founder. “We also received the NIH grant, which enables us to execute our trial with the highest degree of quality and rigor to make it as scientifically robust and impactful to patients as possible. Each of these are major company milestones that collectively represent many years of intensive and fruitful R&D and collaboration. These recent milestones will propel our company forward to an exciting next phase.”
As a clinical-stage therapeutic medical device company, VenoStent has developed a bioabsorbable perivascular wrap, SelfWrap, that goes around arteriovenous (AV) access sites at the time of AV fistula creation surgery. The bioabsorable wrap is intended to accelerate the usability and increase the durability of the fistula sites for chronic kidney disease (CKD) patients requiring hemodialysis. SelfWrap uses the body’s own healing mechanisms to mimic the arterial environment in veins, which experience a 10x increase in pressure and flow during AV creation and causes the veins to become unusable in dialysis.
In May 2023, SelfWrap was approved by the U.S. Food and Drug Administration to begin its U.S. Investigational Device Exemption (IDE) study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistulas Study. The study is designed to show how SelfWrap can improve clinical outcomes for CKD patients requiring hemodialysis. Based on the compelling results from the company’s first-in-human clinical trial, the FDA granted SelfWrap a Breakthrough Device Designation in May 2022.
“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 Dr. 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,” said 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.”