What You Should Know:
– VenoStent, Inc., a medical device company pioneering a new approach to improve dialysis patient outcomes, announced the successful completion of its Series A funding round. The round closed at $20M, with Norwest Venture Partners contributing an additional $4M to join Good Growth Capital and IAG Capital Partners as co-leads.
– VenoStent also welcomes Dr. Zack Scott, Norwest General Partner, and Dr. Ehi Akhirome, Norwest Investor, to its board of observers
Funding to Fuel Pivotal Clinical Trial
This funding boost, coupled with a $3.6 million Small Business Innovation Research (SBIR) Phase II Grant awarded by the National Institutes of Health (NIH), will empower VenoStent to advance its groundbreaking technology:
- SelfWrap: This bioabsorbable wrap represents a novel approach to improving the durability and usability of arteriovenous fistulas (AVFs). AVFs are surgically created connections between arteries and veins, enabling life-saving hemodialysis for chronic kidney disease (CKD) patients.
- Multi-Center Trial: The NIH grant will support a multi-center, randomized controlled trial (RCT) involving 200 patients across the US. This pivotal trial, known as SAVE-FistulaS (SelfWrap-Assisted Arteriovenous Fistulas Study), is designed to demonstrate SelfWrap’s effectiveness in enhancing clinical outcomes for CKD patients undergoing hemodialysis.
Building on Early Success
VenoStent’s SelfWrap technology has garnered significant recognition:
- Breakthrough Device Designation: In May 2022, the U.S. Food and Drug Administration (FDA) granted SelfWrap Breakthrough Device Designation based on promising results from the company’s first-in-human clinical trial.
- Investigational Device Exemption (IDE) Approval: Building on this momentum, VenoStent received FDA approval in May 2023 to initiate its U.S. IDE study, SAVE-FistulaS.
A Decade of Innovation for Improved Patient Lives
VenoStent’s bioabsorbable wrap, SelfWrap, is the culmination of over a decade of dedicated development. Designed to optimize mechanical support and promote outward vein growth, SelfWrap holds the potential to significantly improve:
- Hemodialysis Access: SelfWrap aims to enhance the usability and durability of AVFs, simplifying access for hemodialysis procedures.
- Patient Quality of Life: Improved AVF function can translate into a better quality of life and potentially a longer lifespan for ESRD (End-Stage Renal Disease) 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.”