3 Houston health tech innovators to know this week

who's who

This week's roundup of Houston innovators includes Matthew Kuhn of Taurus Vascular, Tim Boire of VenoStent, and Howard Berman of Coya Therapeutics. Photos courtesy

Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes three health tech innovators celebrating milestones for each of their companies.

Matthew Kuhn, co-founder and CEO of Taurus Vascular

Taurus Vascular is one step closer to stopping abdominal aortic aneurysms for good. Photo courtesy of TNVC

A Houston biotech company has won the Texas A&M New Ventures Competition (TNVC). Taurus Vascular took home $30,000 for its first-place victory.

Taurus Vascular is working on a new solution to stopping abdominal aortic aneurysms (AAA) before they rupture and become potentially fatal. The company arose out of the TMC Innovation Biodesign Program. Fellows Matthew Kuhn and Melanie Lowther had a year to bring a company to fruition. The highly qualified team can boast of Kuhn’s more than 40 patents and Lowther’s former role as director of entrepreneurship and innovation at Texas Children’s Hospital.

The competition’s intense process included presenting to commercialization experts across several rounds. In fact, vetting takes four months and includes coaching to help competitors thrive in their pitches. Read more.

Tim Boire, CEO and co-founder of VenoStent

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. Read more.

Howard Berman, CEO and co-founder of Coya Therapeutics

Coya Therapeutics announced an expanded research collaboration with the Houston Methodist Research Institute, as well as funding from the Johnson Center. Photo via LinkedIn

A clinical-stage Houston biotech company has expanded its collaboration with Houston Methodist Research Institute, or HMRI.

Coya Therapeutics is already sufficiently established to be publicly traded since late 2022, but there’s always room to grow. With the help of a new sponsored research agreement, Coya will work on multiple initiatives. Coya is led by co-founder and CEO Howard Berman, who was inspired by his father’s dementia diagnosis.

"I was interested in what I could do for my dad," Berman said on the Houston Innovators Podcast, explaining that he met with renowned Houston Methodist researcher and neurologist, Dr. Stanley Appel, who showed him that he was not only working on treatments that could help Berman’s now-deceased father, but that he’d been able to stop the progression of ALS. Read more.

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VenoStent's innovative medical device is officially enrolling subjects in a clinical trial. Image courtesy of VenoStent

Houston startup with unique vascular innovation enrolls subjects in new trial

medical device momentum

A Houston-based company has enrolled the initial subjects in a first-of-its-kind trial.

VenoStent was created to improve vascular surgery outcomes for patients undergoing arteriovenous fistula (AVF) creation surgery.

“When a vein is connected to an artery, as in AVF creation, the vein experiences a 10x increase in pressure and flow that is traumatizing to veins. Many fail to become usable for dialysis,” Geoffrey Lucks, VenoStent COO and co-founder, says in a news release.

Enter VenoStent’s SelfWrap Bioabsorbable Perivascular Wrap, better known as simply SelfWrap. In May 2023, SelfWrap gained FDA approval to begin its US IDE Study, SAVE-FistulaS: The SelfWrap-Assisted ArterioVEnous Fistula Study.

Roughly half a million Americans need hemodialysis just to survive another day. Nearly all of those patients require a vascular access creation surgery, but the procedure has a 50-percent failure rate in its first year. VenoStent and SelfWrap are aimed at improving those odds. It works by using the body’s own healing mechanism.

SelfWrap is a flexible, bioabsorbable vascular wrap that helps to recreate the arterial environment in veins. Over time, the body replaces the SelfWrap with venous tissue.

The company has begun to enroll patients for what will eventually be a 200-subject study. Some of those people have radiocephalic fistulas, others have brachiocephalic ones. This is important, because it will likely prove that the technology works for most types of AVFs. The sites for this clinical trial are at the Surgical Specialists of Charlotte, P.A. in Charlotte, NC, and the Cardiothoracic and Vascular Surgeons in Austin.

“While it’s ambitious and sets a high bar for FDA Approval, we owe it to the chronic kidney disease (CKD) patient community to provide the highest level of clinical evidence,” Timothy Boire, CEO and cofounder, says in the release. “We’re confident based on years of preclinical and clinical data that we’ll demonstrate superiority to standard of care with this breakthrough technology.”

VenoStent recently completed a $16 million Series A, financed by Good Growth Capital and IAG Capital. This is the first-ever randomized controlled trial of a medical device designed to improve outcomes from arteriovenous fistula (AVF) creation surgery in the United States.

This week's roundup of Houston innovators includes Jeremy Pitts of Activate Houston, Tim Boire of VenoStent, and Kevin Knobloch of Greentown Labs. Photos courtesy

3 Houston innovators to know this week

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from medical device to climatetech — recently making headlines in Houston innovation.

Jeremy Pitts, managing director for Activate Houston

Jeremy Pitts has been named the inaugural Houston managing director for Activate. Photo via LinkedIn

Activate named Jeremy Pitts as the Houston managing director this month. The nonprofit, which announced its new Houston program earlier this year, was founded in Berkeley, California, in 2015 to bridge the gap between the federal and public sectors to deploy capital and resources into the innovators creating transformative products.

For Activate Houston, the challenge is to focus on finding and supporting innovators within the energy sector.

"There are so many reasons to be excited about the energy transition and overall innovation ecosystem in Houston — the region's leadership in energy and desire to maintain that leadership through the energy transition, the many corporations leading the charge to be part of that change who are speaking with their actions and not just their words, the incredible access to talent, the region's diversity, the list goes on and on," Pitts tells InnovationMap. Read more.

Tim Boire, CEO and co-founder of VenoStent

Tim Boire shares his company's roadmap on this week's episode of the Houston Innovators Podcast. Photo via LinkedIn

Commercializing a health tech innovation is a long game — fraught with regulatory obstacles, cyclical rounds of funding, and continuous improvement — all fueled by the desire to enhance treatment and save lives.

That's Tim Boire's plan. And it's a thorough one at that. On this week's episode of the Houston Innovators Podcast, Boire — president and CEO of VenoStent, a medical device startup that’s designing a unique material for hemodialysis patients — shares his roadmap for his company.

"We believe we can be pioneers of a paradigm shift in vascular surgery — to not just treat problems after they've already occurred, but actually prevent them from occurring in the first place," he says in the episode. Read more.

Kevin Knobloch , CEO of Greentown Labs

Kevin Knobloch will lead Greentown Labs as CEO. Photo via LinkedIn

While not based in Houston, Kevin Knobloch, who served as chief of staff of the United States Department of Energy in President Barack Obama’s second term, is definitely going to be someone to know in the innovation ecosystem. He will be CEO of Greentown Labs, effective September 5. In his role, Knobloch will oversee both Greentown locations in Houston and Somerville, Massachusetts, outside of Boston.

“I’m honored and thrilled to have the opportunity to once again pass the leadership baton,” Greentown Co-Founder Jason Hanna says, who has been serving as interim CEO. “Especially so given Kevin’s incredible record of climate leadership. I’m excited for the future of this organization and the impact he can make as Greentown enters the second decade of its climate mission.” Read more.

Tim Boire, CEO and co-founder of VenoStent, shares his company's roadmap on this week's episode of the Houston Innovators Podcast. Photo via LinkedIn

This Houston medical device innovator plans to lead a 'paradigm shift' in vascular surgery

HOUSTON INNOVATORS PODCAST EPISODE 199

Commercializing a health tech innovation is a long game — fraught with regulatory obstacles, cyclical rounds of funding, and continuous improvement — all fueled by the desire to enhance treatment and save lives.

That's Tim Boire's plan. And it's a thorough one at that. On this week's episode of the Houston Innovators Podcast, Boire — president and CEO of VenoStent, a medical device startup that’s designing a unique material for hemodialysis patients — shares his roadmap for his company.

"We believe we can be pioneers of a paradigm shift in vascular surgery — to not just treat problems after they've already occurred, but actually prevent them from occurring in the first place," he says in the episode.

VenoStent's most recent hurdle cleared is closing a $16 million series A round of venture funding. Two Charleston, South Carolina-based firms — Good Growth Capital and IAG Capital Partners — led the round. The TMC Venture Fund also contributed.

Now, VenoStent is headed for a 200-patient trial in the United States, with an ultimate goal of product launch in 2026. The company's unique medical device is a bioabsorbable wrap that reduces vein collapse by providing mechanical support and promoting outward vein growth.

Boire had the idea for VenoStend when he was completing his PhD at Vanderbilt University. He completed the program, and then joined the HealthWildcatters accelerator in 2017 in Dallas. After that, Boire and his co-founder, Geoff Lucks, decided to take the leap and move to Houston to join JLABS at TMC. The rest, as they say, is history.

“Houston’s been a great place to hire,” Boire says. “We've been I think very fortunate to find our employees who are stellar, true believers in the technology — amazing engineers, and amazing people.”

And, of course, Boire has a plan to continue this hiring success. He says the goal is to grow to a team of 16 by the end of the year. Marketing and sales roles will likely be filled in 2025 ahead of product launch.

“When we think about what our mission is at VenoStent, it’s to ultimately improve patient care — and we are very passionate about this specific problem that patients experience and go through,” Boire says.

“That's what drives everything we're doing as a company to improve quality and length of life for patients who have chronic kidney disease that progresses to a point where they need dialysis to sustain life," he continues. "We believe that we can become the standard care for vascular surgery starting with hemodialysis access."

As VenoStent's trials and growth goes according to plan, Boire says this product can be used for other implications.

Boire shares more on his grand plan, plus how he weathered the storm that is fundraising at a time where so much venture capital activity has slowed. Listen to the interview here — or wherever you stream your podcasts — and subscribe for weekly episodes.

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

A Houston tech startup launches a crowdfunding campaign — and more local innovation news. Photo courtesy of The Postage

Roundup: Houston startups announce new partnerships, crowdfunding campaigns, and more

Short stories

The Houston innovation ecosystem has been bursting at the seams with news from innovative tech companies and disruptive Houston startups as we fly through the final quarter of 2021.

In this roundup of short stories within Houston innovation, a Texas energy tech company gets selected for a prestigious program, a med device company heads to clinical trials, a startup launches a crowdfunding campaign, and more.

The Postage launches crowdfunding campaign

The Postage is looking for financial support with its new campaign. Photo courtesy of The Postage

The Postage, a Houston-based, full-service digital platform to help organize affairs to make after-life planning a smoother process for families, has announced the launch of a crowdfunding campaign through MicroVentures.

"This crowdfunding offering is selling crowd notes to raise maximum offering proceeds of $500,000 with a minimum investment of $100," according to a news release. "We currently anticipate closing this offering on April 4, 2022."

More information on this offering can be found at: https://invest.microventures.com/offerings/the-postage.

Emily Cisek co-founded the company after she experienced an overwhelming experience following a death in her family.

"I just knew there had to be a better way, and that's why I started The Postage," Cisek says on an episode of the Houston Innovators Podcast. "My background had historically been in bringing offline businesses online, and I started doing some research on how I could make this space better. At the time, there really wasn't anything out there."

Texas company selected for Chevron Technology Ventures Catalyst Program

This Texas company has joined CTV's startup program. Photo via Getty Images

SeebeckCell Technologies, while based in Arlington, Texas, is no stranger to the Houston innovation ecosystem. The startup was in the first class of the Rice Alliance Clean Energy Accelerator, participated in the MassChallenge Texas Houston cohort, and is a member at Greentown Houston. The company announced earlier this month a new Houston association as it was invited to participate in the Chevron Technology Ventures Catalyst Program to develop further their technology platform designed to recover industrial waste heat energy, increasing energy consumption efficiency, and eliminating battery replacement in IoT applications, according to a news release.

"SeebeckCell is excited to be supported by Chevron, a technology leader in the energy market," says Ali Farzbod, co-founder and CEO of Seebeckcell Technologies, in the release. "This is inspiring hope in the scientific community as we see Chevron continue to back commercializing academically developed technologies that provide potential solutions for addressing climate change. Through collaboration and partnership, we're able to grow our startup and we're grateful for participating in the Rice Alliance Clean Energy Accelerator that helped connect us with Chevron."

SeebeckCell Technologies is helping petroleum and gas industries and emerging markets solve energy waste with an innovative liquid based thermoelectric generator.

VenoStent heads to clinical trials

VenoStent

VenoStent has reached the clinical trials stage. Photo via venostent.com

VenoStent Inc. has announced successful enrollment in its initial feasibility clinical trial. The med device startup is a tissue engineering company that's developing smart polymer wraps to transform the efficacy of the vascular surgery industry, which sees five million operations each year.

"We are very pleased to announce that we have successfully enrolled twenty end-stage renal disease patients in our initial feasibility study taking place in Asuncion, Paraguay," says Tim Boire, CEO., in a news release "After years of development, we are confident that our bioabsorbable wrap technology can have a positive impact on the lives of patients that require hemodialysis to sustain life. This is a major milestone toward our mission to improve the quality and length of life for end-stage renal disease patients, as well as others needing vascular surgery."

VenoStent is an alum of TMC Innovation's accelerator and has been named a most promising company by Rice Alliance.

Cart.com announces latest partnership

Cart.com has a new partner, which has increased access to tools for its clients. Photo via cart.com

Houston-based Cart.com, an end-to-end ecommerce services provider and Amazon competitor, has announced yet another new partnership. The company has teamed up with Extend, which provides modern extended warranties and product protection plans. The partnership means that Cart.com merchants have access to a new revenue stream and new ways to increase customer satisfaction by leveraging Extend's platform and technology-enabled proprietary insurance stack.

"Like Cart.com, Extend is fixing the fractured ecommerce ecosystem by providing a truly innovative, effortless, and easy-to-understand service for both merchants and their customers," says Omair Tariq, Cart.com co-founder and CEO, in a news release. "By creating seamless solutions to serve brands, we empower them to focus completely on their customers. The partnership with Extend fits squarely in this view; anyone who has wrangled with extended warranty claims in the past understands the friction involved. Extend is rewriting the rules for product protection and customer service while Cart.com takes care of everything from the factory floor to the customer door. Through this partnership with Extend, we're now seamlessly covering the post-purchase experience too."

Extend launched in 2019 — a time when only the top 1 percent of merchants could offer extended warranties and protection plans to help their customers, according to the release. Now, Extend is valued at $1.6 billion, has raised over $315 million in venture capital, is on track to sell more than three million protection plans in 2021.

"The relationship between an ecommerce company and its customer doesn't end with the sale," says Woodrow Levin, co-founder and CEO of Extend, in the release. "Our technology will allow Cart.com's clients to continue to engage customers after they make a purchase, unlocking opportunities to increase brand loyalty, open new revenue channels, and create lasting customer relationships. Together, we're empowering clients to deliver a better experience for customers and we are excited to continue to build on that vision."

Campus Concierge rebrands to Clutch with revamped website

A Houston startup has just flipped a switch. Image via thatsclutch.com

Campus Concierge is now Clutch, the Houston-based startup announced on its Facebook page last month. The new name also came with a revamped website.

Madison Long and Simone May had the idea for the company when they were undergraduate students at Purdue University and their only option for scoping out basic services — like getting their hair done or hiring a DJ for an event or a photographer for graduation photos — was to ask around among older students. Launched earlier this year, the platform is a marketplace to connect students who have skills or services with potential clients in a safe way. The company, which was a member of DivInc's inaugural Houston accelerator, launched on three college campuses this year — Texas Southern University, Rice University, and Prairie View A&M.

"Building community is so critical given the fact that it's nerve-wracking any time to ask someone for help — especially now that you are coming back to school after a year of being virtual," Long, CEO and co-founder of Clutch, previously told InnovationMap.

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Houston-founded startup raises $1.2M and moves headquarters to Detroit

moving forward

Houston-founded ChurchSpace, known as the Airbnb for churches, has formed an official partnership with the City of Detroit and will relocate its headquarters.

The announcements come as the company successfully closed a $1.2 million oversubscribed funding round. The round was led by California-based Black Ops Ventures, with participation from Michigan Rise and Dug Song of Minor Capital, who is also the founder of the Song Foundation, another Michigan-based organization.

"This raise is more than a business milestone—it's a testament to what happens when strategy meets faith. In today's climate, raising capital takes grit and resilience—especially without deep networks or traditional access. By God's grace, doors have opened, and our mission is clearer than ever. Now, with capital in hand, we're building boldly toward a future where the Church isn't just surviving—but leading community transformation," Emmanuel Brown, co-founder and CEO of ChurchSpace, said in a statement.

In Detroit, ChurchSpace plans to activate underutilized church campuses as micro-logistics spaces for food distribution and retail partnerships, as well as last-mile delivery centers. To kick off its relocation, ChurchSpace will host a Detroit Pastor Meetup on July 19.

"We welcome ChurchSpace's investment in Detroit and the jobs and innovation it will bring," Detroit Mayor Mike Duggan added in the release. "Our faith community has long been a critical backbone of our neighborhoods. Through ChurchSpace's groundbreaking work, they will continue to be anchors of opportunity and resilience in our city's future."

ChurchSpace was originally founded to convert underutilized church real estate into event, meeting and commercial kitchen space to boost revenue and relieve financial burden while remaining compliant with IRS regulations for non-profits. The company participated in the inaugural cohort of the AWS Impact Accelerator for Black Founders, which included a pre-seed fundraising campaign and a $125,000 equity injection from Amazon in 2022. It was also one of two Houston companies to receive $100,000 as part of the Google for Startups Black Founders Fund that same year.

The company reports that its platform in Texas has generated up to $100,000 annually in new revenue that was reinvested into church ministries, food programs and community initiatives.

"What we built in Houston was more than technology—it was transformation. We expanded our purpose and packaged proven strategies to help churches thrive, transform communities, and even combat food insecurity," Day Edwards, co-founder and president of ChurchSpace, added in the statement. "Now, with prayer and the support of our team and investors, we're bringing that same impact to Detroit—to help churches, communities, and small businesses redefine pulpits and rediscover communal possibilities."

Houston space tech co. lands millions and more innovation news to know

Trending News

Editor's note: It's time to recap the top innovation news for the first half of May 2025. Our five most-read stories from May 1-15 include updates from Intuitive Machines and The Ion. Plus, driverless trucks hit the road from Houston to Dallas. Get all of the details below.

1. Houston space tech leader lands up to $10 million for Earth re-entry vehicle and lab

The Texas Space Commission has selected Houston's Intuitive Machines to develop a vehicle that will return lunar samples to Earth, along with an orbital fabrication lab. Photo courtesy Intuitive Machines.

Houston-based space technology, infrastructure, and services company Intuitive Machines has been awarded a state grant of up to $10 million to help develop an Earth re-entry vehicle and in-space biomanufacturing lab. The Texas Space Commission approved the grant, which is coming from the state’s Space Exploration and Research Fund. Intuitive Machines says the money will support its “critical risk-reduction platform” for returning lunar samples to Earth. The funding will go toward an early 12-month phase of the project. Continue reading.

2. 9 can't-miss Houston business and innovation events for May

Don't miss these May events — from an investor activation series to a crawfish cook-off. Photo courtesy Greentown Labs.

There's a lot to learn this month at events around Houston. Hear from AI and energy experts or gain insights into how to tap into funding at informative panels or sessions. Continue reading.

3. Autonomous truck company rolls out driverless Houston-Dallas route

Aurora began regular driverless deliveries between Houston and Dallas on April 27. Photo courtesy Aurora.

Houston is helping drive the evolution of self-driving freight trucks. In October, Aurora opened a more than 90,000-square-foot terminal at a Fallbrook Drive logistics hub in northwest Houston to support the launch of its first “lane” for driverless trucks—a Houston-to-Dallas route on the Interstate 45 corridor. Aurora opened its Dallas-area terminal in April and the company began regular driverless customer deliveries between the two Texas cities on April 27. Continue reading.

4. Texas-based 'DoorDash for laundry' startup tumbles into Houston market

The service has been a smash success in Austin. Courtesy photo

Laundry may seem like an endless task that piles up, but a new service offers a solution to overwhelmed Houston families. NoScrubs, an Austin-based home laundry pickup service has just expanded to Houston. Described by the company as "DoorDash — but for laundry," they wash customer's clothes at local laundromats and return them the same day, folded and ready to be put away. The service took off like gangbusters in Austin, making an expansion to the state's largest city an obvious choice. Continue reading.

5. New energy innovation and coworking spaces open at the Ion

The Oxy Innovation Center has opened at the Ion and Industrious' coworking space launches soon. Photo courtesy of The Ion

Houston-based Occidental officially opened its new Oxy Innovation Center with a ribbon cutting at the Ion. The opening reflects Oxy and the Ion's "shared commitment to advancing technology and accelerating a lower-carbon future," according to an announcement from the Ion. Oxy, which was named a corporate partner of the Ion in 2023, now has nearly 6,500 square feet on the fourth floor of the Ion. Rice University and the Rice Real Estate Company announced the lease of the additional space last year, along with agreements with Fathom Fund and Activate. Continue reading.

Houston healthtech leader launches clinical trial for innovative anxiety-treating device

making waves

Houston-based Nexalin Technology’s proprietary neurostimulation device will move forward with a new clinical trial evaluating its treatment of anxiety disorders and chronic insomnia in Brazil.

The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices have been shipped to São Paulo, Brazil, and the study will be conducted at the Instituto de Psiquiatria university hospital (IPq-HCFMUSP). The shipments aim to support the launch of a Phase II clinical trial in adult patients suffering from anxiety and insomnia, according to a news release.

“Brazil is an important emerging market for mental health innovation, and this collaboration marks our first IRB-approved study in the region,” Mike White, CEO of Nexalin, said in the release.

The study will be led by Dr. Andre Russowsky Brunoni, who specializes in neuromodulation and interventional psychiatry. He currently serves as director of the interventional psychiatry division at IPq-HCFMUSP and this summer will join UT Southwestern in Dallas and its Peter O’Donnell Jr. Brain Institute as a professor of psychiatry.

The Phase II study plans to enroll 30 adults in São Paulo and assess the efficacy of Nexalin’s non-invasive deep intracranial frequency stimulation (DIFS™) of the brain in reducing anxiety symptoms and improving sleep quality, according to the company. Using the Hamilton Anxiety Rating Scale (HAM-A), the trial’s goal is a reduction in anxiety symptoms, and assessments of sleep onset latency, total sleep time, overall sleep quality, depressive symptoms and clinical impression of improvement. The company plans to share results in a peer-reviewed scientific journal.

“Anxiety and insomnia are very common conditions that often occur together and cause significant distress,” Brunoni added in the news release. “In this study, we are testing a new, non-invasive brain stimulation technology that has shown promising results in recent research. Our goal is to offer a safe, painless, and accessible alternative to improve people’s well being and sleep quality.”

The Nexalin Gen-2 15-milliamp neurostimulation device has been approved in China, Brazil, and Oman.

The company also enrolled the first patients in its clinical trial at the University of California, San Diego, in collaboration with the VA San Diego Healthcare System for its Nexalin HALO, which looks to treat mild traumatic brain injury and post-traumatic stress disorder in military personnel and the civilian population. It also recently raised $5 million through a public stock offering. Read more here.

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