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.

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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Houston team develops innovative soft skeleton for kids with cerebral palsy

health tech

A team from the NSF University of Houston Building Reliable Advances and Innovation in Neurotechnology (UH BRAIN) Center and TIRR Memorial Hermann has introduced the MyoStep soft exoskeleton for children with cerebral palsy, according to a news release from UH.

The soft skeleton aims to address motor impairments caused by cerebral palsy that impact children’s ability to participate in physical activities, self-care and academics.

“The MyoStep project represents a significant advancement in the field of pediatric mobility aids, particularly for children with cerebral palsy,” Jose Luis Contreras-Vidal, director of UH BRAIN and the Hugh Roy and Lillie Cranz Cullen Distinguished Professor of Electrical and Computer Engineering, said in a news release.

The next-generation lightweight, soft exoskeleton was funded by the IEEE Electron Devices Society (EDS) Award.

The MyoStep is made to be lightweight and discreetly fit under clothes. It includes a wireless sensor network embedded inside the smart and flexible fabrics that is the backbone of the suit and collects and sends real-time data about the user’s movements It also includes safety features with temperature monitoring and emergency shut-off mechanisms.

“By integrating cutting-edge technologies such as artificial muscles, smart fabrics, and a comprehensive sensor network, MyoStep offers a promising solution to the challenges faced by existing exoskeletons,” Contreras-Vidal said in a news release.

Cerebral palsy is a neurological disorder that impacts motor skills. It occurs in one to four out of every 1,000 births worldwide.

“What makes the MyoStep project so compelling is that it’s not just about the technology: it’s about restoring confidence, function, and hope,” Dr. Gerard Francisco, a clinical partner on the technology, The Wulfe Family Chair of Physical Medicine and Rehabilitation at UTHealth Houston and medical officer at TIRR Memorial Hermann, said in a news release. “This kind of innovation has the potential to dramatically improve quality of life, helping children move through the world with greater ease and dignity.”

Houston universities launch summer 2025 accelerators for student ventures

summer session

OwlSpark, a startup and small business accelerator for Rice University-affiliated ventures, has named the latest 11 companies to its program that focus on challenges across technology, health care, consumer products and other sectors. The program is hosted in tandem with the University of Houston’s RED Labs and will take place at the Ion.

The early-stage accelerator runs for 12 weeks and culminates at The Bayou Startup Showcase on July 31.

According to a news release from Rice, “the accelerator cultivates a vibrant environment where founders are empowered to build, test, and scale their ideas in a setting built for entrepreneurship.”

The program is divided into two tracks: one for high-growth tech startups and another for small businesses.

The latest OwlSpark class includes:

  • Web and mobile platform EasilyBEE, which boosts family and community engagement in K-12 schools
  • Diagnos, a wearable-integrated wellness platform that monitors health and prevents injuries in college athletes
  • Johnnie, an AI-powered records management software for rural and midsize first responder agencies
  • JustKindHumility, which offers faith-based travel journals
  • Klix, whichautomates early-stage clinical trial management from document screening to AI-driven patient outreach and eligibility checks
  • Lizzy’s Gourmet Gains, which offers high-protein, flavor-forward dips and dressings
  • NextStep, an AI-powered multilingual assistant helping underserved communities navigate resources for health care
  • A catheter-integrated sensor device PeriShield, which detects early infection in peritoneal dialysis patients
  • Right Design, which connects creatives with vetted employers, mentors and projects via job matching and commissions
  • UCoreAlly, which provides business support for biotech startups in marketing, business development, customer support, human resources and accounting
  • Ultrasound-based ablation system VentriTech that treats ventricular arrhythmias

The Owl Spark accelerator has supported 229 founders and launched 104 ventures with participants raising more than $116 million in funding since 2013, according to Rice.

UH also shared the 9 teams that will participate in RED Labs' latest cohort.

The latest RED Labs class includes:

  • BLEED, an art agency that helps artists commercialize their work by connecting art collectors to original artwork and artists
  • Brain Haven, which is developing nasal inhalers designed to stimulate the emotional and memory processing centers to preserve neuroplasticity and delay cognitive decline
  • Candi Wands Automated Cotton Candy, which has developed a continuously operating cotton candy machine to help entertainment venues boost passive revenue
  • ChériCollectible, a series of in-person events where Gen Z and collectors can buy, sell, and trade modern collectibles
  • JobRadar, a job board that uses AI to analyze and categorize positions in real-time and then apply candidates instantly
  • Stage Select LLC, a supplementary talent booking service that partners with multi-stage venues to help fill gaps in programming and increase profitability by finding and booking local talent for their "second stage."
  • P-LEGS, a pediatric lower-limb exoskeleton that reduces physical strain on therapists while delivering customizable gait training.
  • Roll ‘N’ Reel Photo Booth, an interactive event-based equipment rental business
  • Stayzy, which automates guest communication and handles maintenance issues with an AI-powered software for short-term rental companies that manage 20-plus rentals