VenoStent – a clinical-stage, venture-backed, therapeutic medical device company developing bioabsorbable wraps for improving outcomes for hemodialysis patients – recently announced that they have been granted Investigational Device Exemption (IDE) from the FDA for their US clinical trial, SAVE-FistulaS, and have completed a $16 million Series A financing to fund these efforts.
Led by VC firms Good Growth Capital and IAG Capital Partners, the company has completed its Series A financing with $16M to, among other functions, fund their US Pivotal Trial and expand their manufacturing capabilities, aiming towards FDA Approval of their novel therapeutic medical device. The other investors in this financing round included TMC Venture Fund, SNR, Baylor Angel Network / Affinity Fund, Creative Ventures, Cowtown Angels, Alumni Ventures, and other notable angel investors. VenoStent has received funding from KidneyX, the National Science Foundation (NSF), the National Institute of Health (NIH), Y Combinator, Health Wildcatters, and the Texas Halo Fund.
US IDE Study
In May 2023, VenoStent was approved by the US Food and Drug Administration to begin its US IDE Study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistula Study.
There are more than 800,000 people in the United States with end-stage renal disease (ESRD) and millions more across the world. Hemodialysis access is the lifeline for patients with ESRD. But over half of the surgeries performed to initiate hemodialysis fail within a year, increasing patient mortality to levels that exceed most cancers while also decreasing quality of life. With this clinical trial, VenoStent aims to be a first-to-market device to improve hemodialysis access surgery outcomes for the hundreds of thousands of patients in the US and millions around the world who suffer from this condition.
KEY QUOTES:
“Our mission at VenoStent is to improve the quality and length of life of dialysis patients. On the heels of our very promising results in several preclinical studies and a 20-patient feasibility study that led to our Breakthrough Designation last year, this recent IDE approval is perhaps our biggest milestone to date. We now enter an exciting new epoch in our company’s development that we believe will ultimately result in FDA Approval and vastly improve the quality and length of life for patients.”
“This trial is designed to provide the highest level of clinical evidence. We’re excited to be in this position to treat the first patients in the United States with this technology, and demonstrate the safety and efficacy of our device.”
— VenoStent CEO, Tim Boire, Ph.D.
“We’re extremely pleased to be partnering with VenoStent on this critical mission. This company and technology are poised for commercial success to address a critical, unmet need.”
— Bob Crutchfield, Operating Partner at Good Growth Capital
“VenoStent’s data and traction to date is impressive and gives us a lot of confidence in their continued success. We look forward to helping them get this Breakthrough product to market and help patients that are in dire need of this innovative technology.”
— Joel Whitley, Partner at IAG Capital Partners
