VenoStent Completes $16M Series A Financing, Receives IDE Approval from FDA to Begin US Trial

Breakthrough medical device has shown promise to improve outcomes in dialysis patients

HOUSTON, TX / ACCESSWIRE / July 31, 2023 / VenoStent, Inc., a clinical-stage, venture-backed, therapeutic medical device company developing bioabsorbable wraps to improve outcomes for hemodialysis patients, has announced that they have been granted Investigational Device Exemption (IDE) from the FDA for their US clinical trial, SAVE-FistulaS, and have completed a $16M Series A financing to fund these efforts.

"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" explains VenoStent CEO, Tim Boire, Ph.D.

$16M Series A Initial Close

Led by seasoned venture capital 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.

"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," said Bob Crutchfield, Operating Partner at Good Growth Capital.

Other investors in this round of financing 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 in the past from KidneyX, National Science Foundation (NSF), National Institute of Health (NIH), Y Combinator, Health Wildcatters, and Texas Halo Fund.

"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," said Joel Whitley, Partner at IAG Capital Partners.

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 over 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. Unfortunately, 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.

"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." explains CEO Tim Boire.

About VenoStent

VenoStent, Inc. (www.venostent.com) is a privately held, therapeutic medical device company developing a bioabsorbable wrap, SelfWrap, to transform outcomes in vascular surgery, starting with hemodialysis access. The device is intended to improve the usability and durability of arteriovenous fistulas (AVFs), the artery-vein connections that are surgically created in the arms of chronic kidney disease patients to enable life-saving dialysis treatments. SelfWrap has been finely-tuned through a decade of development to provide optimal mechanical support, improving hemodynamics and outward vein growth, and ultimately leading to improved quality and length of life for ESRD patients.

Forward-Looking Statements

This release contains forward-looking statements, which represent estimates and assumptions with respect to certain future events, which are subject to significant risks and uncertainties. Products discussed in this release are in the investigational stage and have not yet been approved, nor are they available, for sale in the US or any other country.

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SOURCE: VenoStent