VenoStent has raised additional funding. Image courtesy of VenoStent

A clinical-stage Houston health tech company with a novel therapeutic device has raised venture capital funding and secured a grant from the National Institutes of Health.

VenoStent Inc., which is currently in clinical trials with its bioabsorbable perivascular wrap, announced the closing of a $20 million series A round co-led by Good Growth Capital and IAG Capital Partners. The two Charleston, South Carolina-based firms also led VenoStent's 2023 series A round that closed last year at $16 million.

Additionally, the company secured a $3.6 million Small Business Innovation Research (SBIR) Phase II Grant from NIH, which will help fund its multi-center, 200-patient, randomized controlled trial in the United States.

Tim Boire, VenoStent CEO and co-founder, describes 2024 so far as "a momentous year" so far for his company.

"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," Boire says in a news release. "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," he continues. "These recent milestones will propel our company forward to an exciting next phase."

Tim Boire is the CEO and co-founder of VenoStent. Photo via LinkedIn

The company's innovation, the SelfWrap, goes around arteriovenous (AV) access sites at the time of AV fistula creation surgery. The device is intended "to accelerate the usability and increase the durability of the fistula sites for chronic kidney disease (CKD) patients requiring hemodialysis," reads the release, "mimicking 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."

Along with the investment, VenoStent announced two new board observers. Norwest General Partner Dr. Zack Scott and Investor Dr. Ehi Akhirome are bringing their expertise to the growing company.

"Norwest's investment is tremendous validation for VenoStent, and we are thrilled to have both Zack and Ehi joining the company's board," VenoStent COO and Co-Founder Geoffrey Lucks adds in the release. "Zack and Ehi have extensive knowledge in our space, and their added value will match the capital and cache of Norwest dollar-for-dollar."

Last year at the same time VenoStent announced its last funding round, the SelfWrap was approved by the U.S. Food and Drug Administration to begin its U.S. Investigational Device Exemption (IDE) study.

"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 percent, which significantly impacts patients' survival rates and quality of life," Scott says in the release. "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."

Last summer, Boire told InnovationMap on the Houston Innovators Podcast that he's looking to launch the product in 2026.

A Houston startup based out of the TMC Innovation Factory has announced funding and upcoming trials. Photo courtesy of TMC

Houston health tech startup secures $16M series A, prepares for first U.S. clinical trials

money moves

Fueled by fresh funding in the bank, a medical device startup has announced upcoming trials.

VenoStent, Inc., a company developing an innovative tool to improve outcomes for hemodialysis patients, has closed $16 million in a series A round of financing. Two Charleston, South Carolina-based firms — Good Growth Capital and IAG Capital Partners — led the round.

The company also announced it received Investigational Device Exemption from the FDA for its United States clinical trial, SAVE-FistulaS.

“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," Tim Boire, CEO of VenoStent, says in a news release. "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."

VenoStent's novel therapeutic medical device is a bioabsorbable wrap. Image courtesy of VenoStent

VenoStent's series A will fund the trial, expand manufacturing capabilities, and more. The company is targeting the more than 800,000 people in the U.S. with end-stage renal disease. Currently, more than half of the surgeries performed to initiate hemodialysis fail within a year. VenoStent's novel therapeutic medical device is a bioabsorbable wrap that reduces vein collapse by providing mechanical support and promoting outward vein growth.

“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,” continues Boire in the release.

Per the release, the company is aiming for FDA Approval and be the first-to-market device to improve hemodialysis access surgery.

“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,” says Bob Crutchfield, operating partner at Good Growth Capital, in the release.

The TMC Venture Fund also contributed to the series A investment round, along with SNR, Baylor Angel Network / Affinity Fund, Creative Ventures, Cowtown Angels, Alumni Ventures, and other notable angel investors. Past investors in VenoStent include KidneyX, National Science Foundation, National Institute of Health, Y Combinator, Health Wildcatters, and the 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,” says Joel Whitley, partner at IAG Capital Partners, in the release.

Tim Boire is the CEO of VenoStent. Photo via LinkedIn

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Axiom Space-tested cancer drug advances to clinical trials

mission critical

A cancer-fighting drug tested aboard several Axiom Space missions is moving forward to clinical trials.

Rebecsinib, which targets a cancer cloning and immune evasion gene, ADAR1, has received FDA approval to enter clinical trials under active Investigational New Drug (IND) status, according to a news release. The drug was tested aboard Axiom Mission 2 (Ax-2) and Axiom Mission 3 (Ax-3). It was developed by Aspera Biomedicine, led by Dr. Catriona Jamieson, director of the UC San Diego Sanford Stem Cell Institute (SSCI).

The San Diego-based Aspera team and Houston-based Axiom partnered to allow Rebecsinib to be tested in microgravity. Tumors have been shown to grow more rapidly in microgravity and even mimic how aggressive cancers can develop in patients.

“In terms of tumor growth, we see a doubling in growth of these little mini-tumors in just 10 days,” Jamieson explained in the release.

Rebecsinib took part in the patient-derived tumor organoid testing aboard the International Space Station. Similar testing is planned to continue on Axiom Station, the company's commercial space station that's currently under development.

Additionally, the drug will be tested aboard Ax-4 under its active IND status, which was targeted to launch June 25.

“We anticipate that this monumental mission will inform the expanded development of the first ADAR1 inhibitory cancer stem cell targeting drug for a broad array of cancers," Jamieson added.

According to Axiom, the milestone represents the potential for commercial space collaborations.

“We’re proud to work with Aspera Biomedicines and the UC San Diego Sanford Stem Cell Institute, as together we have achieved a historic milestone, and we’re even more excited for what’s to come,” Tejpaul Bhatia, the new CEO of Axiom Space, said in the release. “This is how we crack the code of the space economy – uniting public and private partners to turn microgravity into a launchpad for breakthroughs.”