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

making waves

Nexalin Technology is launching a Phase II clinical trial of its neurostimulation device for adult patients suffering from anxiety and insomnia. File image.

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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A new medical device created in Houston is revolutionizing opioid withdrawal treatment. Photo via sparkbiomedical.com

Houston med-tech companies partner on wearable device for opioid withdrawal

treating addiction

Houston-based Spark Biomedical has created a revolutionary wearable device that provides unprecedented levels of opioid withdrawal relief.

The device known as the Sparrow Therapy System is worn over the ear for five to seven days and sends mild electrical signals to trigger cranial nerves that sit near the skin's surface.

Once activated, the nerves release endorphins that the body has stopped producing on its own during opioid use. The endorphins satisfy the opioid receptors and in turn reduce or prevent the intense symptoms that often come along with opioid withdrawal. According to Spark BioMed CEO Daniel Powell, the technology also helps patients better control their "flight or fight mechanisms," allowing them to make clearer, more logical decisions as they come off of the drug.

"If you ask 100 people who've gone through opioid withdrawal, I would bet 99 of them will tell you they thought they were going to die," Powell says. "Giving them the ability to manage that is huge. It's the first step towards addiction recovery. It's not solving the addiction, but it is an absolute barrier to move forward."

The product was approved by the FDA in January of 2020, after clinical trials showed that the Sparrow could meaningfully reduce withdrawal symptoms in the first hour of use. According to Powell, roughly a third of patients in the trial were completely out of withdrawal and patients' Clinical Opioid Withdrawal Scales scores reduced by more than 53 percent across the board.

Spark, which won Venture Houston's inaugural pitch competition earlier this year, partnered with Houston-based Velentium (which also happened to grow 93 percent last year after partnering with General Motors on Project V) to bring the product from concept to commercial physician prescribed product. "We needed a more sophisticated design house to help us finish it," Powell says.

The up-and-comers were connected through one of Spark's investors. Powell, in a previous career, had also sold a neurostimulator that Velentium CTO Randy Armstrong had invented.

"You're seeing more and more Houston centric medical innovation than we've ever seen before," says Velentium CEO Dan Purvis. "And the cool thing about that is there ends up being a camaraderie amongst entrepreneurs, medical researchers and scientists."

And though the release of Sparrow marks a huge milestone, neither Spark of Velentium are stopping there. Moving forward, Spark aims to conduct a massive study on how a similar technology, dubbed the Roo, can aid infants born to opioid-dependent mothers wean from the drug.

The company also aims to create a next generation Sparrow with the help of Velentium, and will look at long-term uses of the product. Powell says that Spark will look to determine if the product can prevent relapses and help to cure addiction when worn daily or regularly.

"Our big, crazy, ambitious goal is can we actually help people recover from addiction," Powell says. "We're really not addressing psychology, that's going to be in cognitive behavioral therapy. But if we can remove the neurological results of drug use, we think we can make at least start to stack the deck in the favor of the patient versus having the deck stacked completely against them all the time."

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UH lands $4M NIH grant to study early signs of autoimmune disease

NIH funding

The University of Houston recently received a $4 million National Institutes of Health grant to support a 10-year longitudinal study to identify the earliest biological markers of autoimmune disease.

Led by Chandra Mohan, the Hugh Roy and Lillie Cranz Cullen Endowed Professor of Biomedical Engineering, the study aims to examine what causes Systemic Autoimmune Rheumatic Diseases (SARDs) and to identify targets for future treatments. The study will be carried out in collaboration with Dr. Karen Costenbader at Harvard Medical School, Boston.

SARDs include conditions like rheumatoid arthritis, systemic lupus erythematosus, Sjögren’s syndrome and systemic sclerosis—all are considered chronic diseases currently without a cure. Autoimmune diseases affect over 30 million people globally, according to UH.

SARDs occur when the body’s immune system attacks healthy, non-threatening tissues and organs. According to UH, in these diseases, the body often attacks nuclear antigens, creating anti-nuclear autoantibodies, which can be early detection signs for SARDs in more than 50 percent of patients, Mohan says.

Researchers will study blood samples and environmental exposure over the 10 years to better understand anti-nuclear autoantibodies.

“Collectively, these studies will help identify the genetic, environmental and cellular factors that are operative at the two steps of SARD development, namely the emergence of anti-nuclear autoantibodies and disease onset,” Mohan said in a news release. “ More importantly, these studies will highlight functional molecular pathways and mechanisms that may be operative at each step."

Mohan predicts that looking at SARDs’ shared characteristics, rather than each disease individually, could help identify more treatment methods.

“Individual SARDs have been examined in silos without an attempt to discern shared underlying features at the molecular level,” he added in the release. “Current understanding of the initial (and likely shared) origins of SARDs is only rudimentary but urgently needed to develop means for prevention and treatment.”

Earlier this year, UH also received an $11 million NIH grant to conduct a first-of-its-kind study of early language development in children ages 18 to 24 months. Read more here.

New Texas Stock Exchange officially begins trading in Dallas

Welcome to Y'all Street

Two-step aside, New York Stock Exchange and Nasdaq. The Dallas-based Texas Stock Exchange, nicknamed Y’all Street, just kicked off live trading with five stocks — and lots of Lone Star ambition.

“The Texas Stock Exchange aims to revitalize competition for [stock] issuers, establish the premier venue for listings, and create a world-class trading platform for all market participants,” the exchange says in a fact sheet.

The exchange — whose Texas-influenced nickname is a nod to New York City’s Wall Street — has collected at least $275 million in investments. The roughly 90 financial backers of TXSE include Bank of America, BlackRock, Charles Schwab, Citadel Securities, Dell Family Office, Fortress, Goldman Sachs, and JPMorgan Chase.

Representatives of TXSE couldn’t be reached for comment. On its website, the exchange calls itself “the most well-capitalized equities exchange to ever be approved” by the U.S. Securities and Exchange Commission (SEC).

Not to be outdone, NYSE has launched Dallas-based NYSE Texas and Nasdaq has expanded its presence in Dallas.

Y’all Street adds to Dallas-Fort Worth’s rising status as a major hub for financial services, with The Wall Street Journal naming North Texas the country’s second biggest financial hub after New York City.

“A homegrown national exchange means more jobs, more investment, and more growth opportunities for businesses and communities across the Lone Star State,” Gabriela von zur Muehlen, senior vice president and chief policy officer at the Texas Association of Business, told The Texas Tribune.

Bulent Temel, an associate professor of practice in economics at the University of Texas at San Antonio, told Texas Standard that TXSE “is going to boost the credibility of the Texas economy.”

Texas’ estimated gross domestic product (GDP), a yardstick for the size of an economy, climbed to a record-setting $2.9 trillion in 2025, making it the state with the second highest GDP after California. DFW’s estimated GDP in 2023 stood at $744.6 billion, eclipsing the GDP of many countries.

“The center of gravity for American capitalism is now headquartered in the Boom Belt,” Abbott proclaimed in April, referring to an 11-state region (including Texas) in the South and Southeast that’s seeing tremendous economic and population growth. “The Texas Stock Exchange is the natural extension of that capitalism. It ensures that capital markets will reflect the quadrant that is driving American growth.”

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This article originally appeared on CultureMap.com.

Orion vehicle manager reflects on Artemis II, looks to 2028 moon mission

Q&A

Humanity is finally headed back to the moon after more than half a century. This year's launch of the Artemis II mission in the Orion spacecraft put four crew members in lunar orbit and tested the new ship developed by Lockheed Martin.

Everything went smoothly, safely returning astronauts home, but there is always room to improve. InnovationMap chatted via email with Orion vehicle manager Branelle Rodriguez, shortly after a talk at The Ion, for insight on how Orion might perform in the future as the next lunar landing approaches in early 2028.

InnovationMap: How satisfied are you with the way Orion operated on this past mission?

Branelle Rodriguez: Orion performed exceptionally well during Artemis II, successfully demonstrating critical spacecraft capabilities, including life support systems, displays and controls, and executing manual piloting operations. Artemis II brought humans back to the moon, achieving key exploration and scientific imagery, while validating systems essential for future Artemis missions.

IM: What is the most important thing you learned about improving Orion for the next mission?

BR: The Artemis II mission provided invaluable insights into crew operations and spacecraft performance in a deep-space environment. With every mission, NASA applies lessons learned to continuously improve Orion’s operations, validate design and ensure mission readiness. Artemis II offered our first opportunity to evaluate several new systems and gain a deeper understanding of what it is like for astronauts to live and work inside the spacecraft. The operational, technical and human factors data collected are being integrated across the program to refine future missions, reduce risk and enhance overall mission success.

IM: How has Orion helped the mission to explore space?

BR: Orion is one of NASA’s foundational elements for human deep space exploration—not only supporting the mission but serving as a core component of it. It is currently the only spacecraft capable of carrying crew on deep space missions and returning them safely to Earth from the high speeds required from the vicinity of the moon. No other spacecraft has the technology to endure the extremes that come with human deep-space travel, such as advanced environmental and life support, navigation, communications, radiation shielding, and the world’s largest ablative heat shield to protect the astronauts during reentry into Earth’s atmosphere. Orion has already taken astronauts to explore space farther than ever before—252,756 miles from Earth— and will carry crews to the moon on future missions to explore the lunar South Pole region. The astronauts’ observations, samples, and data collected on these future missions will expand our understanding of our solar system and home planet.

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This conversation has been edited for brevity and clarity.

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