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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Rice University lands $18M to revolutionize lymphatic disease detection

fresh funding

An arm of the U.S. Department of Health and Human Services has awarded $18 million to scientists at Rice University for research that has the potential to revolutionize how lymphatic diseases are detected and help increase survivability.

The lymphatic system is the network of vessels all over the body that help eliminate waste, absorb fat and maintain fluid balance. Diseases in this system are often difficult to detect early due to the small size of the vessels and the invasiveness of biopsy testing. Though survival rates of lymph disease have skyrocketed in the United States over the last five years, it still claims around 200,000 people in the country annually.

Early detection of complex lymphatic anomalies (CLAs) and lymphedema is essential in increasing successful treatment rates. That’s where Rice University’s SynthX Center, directed by Han Xiao and Lei Li, an assistant professor of electrical and computer engineering, comes in.

Aided by researchers from Texas Children’s Hospital, Baylor College of Medicine, the University of Texas at Dallas and the University of Texas Southwestern Medical Center, the center is pioneering two technologies: the Visual Imaging System for Tracing and Analyzing Lymphatics with Photoacoustics (VISTA-LYMPH) and Digital Plasmonic Nanobubble Detection for Protein (DIAMOND-P).

Simply put, VISTA-LYMPH uses photoacoustic tomography (PAT), a combination of light and sound, to more accurately map the tiny vessels of the lymphatic system. The process is more effective than diagnostic tools that use only light or sound, independent of one another. The research award is through the Advanced Research Projects Agency for Health (ARPA-H) Lymphatic Imaging, Genomics and pHenotyping Technologies (LIGHT) program, part of the U.S. HHS, which saw the potential of VISTA-LYMPH in animal tests that produced finely detailed diagnostic maps.

“Thanks to ARPA-H’s award, we will build the most advanced PAT system to image the body’s lymphatic network with unprecedented resolution and speed, enabling earlier and more accurate diagnosis,” Li said in a news release.

Meanwhile, DIAMOND-P could replace the older, less exact immunoassay. It uses laser-heated vapors of plasmonic nanoparticles to detect viruses without having to separate or amplify, and at room temperature, greatly simplifying the process. This is an important part of greater diagnosis because even with VISTA-LYMPH’s greater imaging accuracy, many lymphatic diseases still do not appear. Detecting biological markers is still necessary.

According to Rice, the efforts will help address lymphatic disorders, including Gorham-Stout disease, kaposiform lymphangiomatosis and generalized lymphatic anomaly. They also could help manage conditions associated with lymphatic dysfunction, including cancer metastasis, cardiovascular disease and neurodegeneration.

“By validating VISTA-LYMPH and DIAMOND-P in both preclinical and clinical settings, the team aims to establish a comprehensive diagnostic pipeline for lymphatic diseases and potentially beyond,” Xiao added in the release.

The ARPA-H award funds the project for up to five years.

Houston doctor wins NIH grant to test virtual reality for ICU delirium

Virtual healing

Think of it like a reverse version of The Matrix. A person wakes up in a hospital bed and gets plugged into a virtual reality game world in order to heal.

While it may sound far-fetched, Dr. Hina Faisal, a Houston Methodist critical care specialist in the Department of Surgery, was recently awarded a $242,000 grant from the National Institute of Health to test the effects of VR games on patients coming out of major surgery in the intensive care unit (ICU).

The five-year study will focus on older patients using mental stimulation techniques to reduce incidences of delirium. The award comes courtesy of the National Institute on Aging K76 Paul B. Beeson Emerging Leaders Career Development Award in Aging.

“As the population of older adults continues to grow, the need for effective, scalable interventions to prevent postoperative complications like delirium is more important than ever,” Faisal said in a news release.

ICU delirium is a serious condition that can lead to major complications and even death. Roughly 87 percent of patients who undergo major surgery involving intubation will experience some form of delirium coming out of anesthesia. Causes can range from infection to drug reactions. While many cases are mild, prolonged ICU delirium may prevent a patient from following medical advice or even cause them to hurt themselves.

Using VR games to treat delirium is a rapidly emerging and exciting branch of medicine. Studies show that VR games can help promote mental activity, memory and cognitive function. However, the full benefits are currently unknown as studies have been hampered by small patient populations.

Faisal believes that half of all ICU delirium cases are preventable through VR treatment. Currently, a general lack of knowledge and resources has been holding back the advancement of the treatment.

Hopefully, the work of Faisal in one of the busiest medical cities in the world can alleviate that problem as she spends the next half-decade plugging patients into games to aid in their healing.