Nexalin develops non-invasive devices that help reset networks in the brain associated with symptoms of anxiety and insomnia. Photo via Getty Images.

A Houston-based company is taking a medicine-free approach to target brain neurologically associated with mental illness.

Nexalin Technology’s patented, FDA-cleared frequency-based waveform targets key centers of the midbrain to support the normalization of neurochemicals through a process known as Transcranial Alternating Current Stimulation (tACS). Delivered via a non-invasive device, the treatment gently stimulates the hypothalamus and midbrain, helping to “reset networks associated with symptoms” of anxiety and insomnia. Early clinical evidence suggests this approach can promote healthier brain function and improved sleep.

Through its recently appointed scientific advisory board (SAB), Nexalin also aims to target Alzheimer’s disease with a clinical development pipeline supported by published data and internal data from studies involving its proprietary DIFS technology. Nexalin’s Gen-2 SYNC and Gen-3 Halo headset delivers the DIFS, which is a waveform that can penetrate deep brain structures implicated in cognitive decline and mental illness.

The board includes experts in neurology, neuroimaging and neurodegenerative diseases with Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer coming on board. Nexalin plans to initiate new Alzheimer’s-focused clinical studies in the Q3 2025 by incorporating cognitive testing, imaging biomarkers, and guided metrics to assess treatment efficacy and neural activation.

“I am excited to work alongside Nexalin’s leadership and fellow SAB members to help guide the next generation of non-invasive neuromodulation therapies,” Huang said in a news release. “The intersection of neuroimaging, brain stimulation, and clinical science holds enormous potential for treating neurodegenerative disease.”

Recently, Nexalin’s proprietary neurostimulation device moved forward with a clinical trial that evaluated its treatment of anxiety disorders and chronic insomnia in Brazil. The first of Nexalin’s Gen-2 15-milliamp neurostimulation devices was 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. The Nexalin Gen-2 15-milliamp neurostimulation device has also been approved in China, Brazil and Oman. Its Gen 1 device first received FDA clearance in 2003, according to the company's website.

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.

Nexalin previously raised $5 million through a

public stock offering.
FibroBiologics has opened a new 10,000-square-foot Houston lab to scale up research efforts and pave the way for in-house manufacturing. Photo via Fibrobiologics.com

Houston regenerative medicine company expands lab for future trials

new digs

A Houston regenerative medicine company has unveiled new laboratory space with the goal of expanding its pioneering science.

FibroBiologics uses fibroblasts, the body’s most common type of cell, rather than stem cells, to help grow new cells. Fibroblasts are the primary variety of cells that compose connective tissue. FibroBiologics has found in studies that fibroblasts can be even more powerful than stem cells when it comes to both regeneration and immune modulation, meaning they could be a more versatile way forward in those fields.

In 2023, FibroBiologics moved into new lab space in the UH Technology Bridge. Now, with its new space, the publicly traded company, which has more than 240 patents issued or pending, will be even better equipped to power forward with its research.

The new space includes more than 10,000 square feet of space devoted to both labs and offices. The location is large enough to also house manufacturing drug product candidates that will be used in upcoming trials. Additionally, the company reports that it plans to hire additional researchers to help staff the facility.

“This expansion marks a transformative step forward for our company and our mission,” Pete O’Heeron, FibroBiologics founder and CEO, said in a news release. “By significantly increasing the size of our lab, we are creating the space and infrastructure needed to foster greater innovation and accelerate scientific breakthroughs.”

The streamlined, in-house manufacturing process will reduce the company’s reliance on external partners and make the supply chain simpler, O’Heeron added in the release.

Hamid Khoja, the chief scientific officer for FibroBiologics, also chimed in.

“To date, our progress in developing potentially transformative therapeutic candidates for chronic diseases using fibroblasts has been remarkable,” he added in the release. “This new laboratory facility will enable further expansion and acceleration of our research and development efforts. Additionally, the expansive new space will enable us to bring in-house currently outsourced projects, expand our science team and further contribute to the increased efficiency of our R&D efforts.”

This news arrives shortly after a milestone for the company in its research about neurodegenerative disease. Last month, fibroblast treatments in an animal model study demonstrated a notable regeneration of the myelin sheath, the layer that insulates nerves and is worn down by disease.

“Confirming remyelination in a second validated animal model is an important step in our research and development efforts, offering fresh hope for patients with demyelinating diseases, including multiple sclerosis,” O’Heeron added in a separate release. “These findings advance our mission to develop transformative fibroblast-based therapies that address the root causes of chronic disease, not just their symptoms, and reflect our dedication to pushing the frontiers of regenerative medicine."

Daniel Barvin has a neurodegenerative disease in his near future. He joined Houston-based Coya Therapeutics to help fight for a cure to the aggressively deadly ALS. Photo via Getty Images

How this Houston innovator is using his personal connection to ALS fuel his fight for a cure

guest column

We can never predict how our lives will turn out, but then maybe some of us can. Genetic testing showed that I, like my grandfather, aunt, uncle and father before me, would most likely die of amyotrophic lateral sclerosis, more commonly known as ALS, and/or frontotemporal degeneration (FTD) in my 40s.

Being 36, it’s possible that fear could have overtaken my life, but instead I chose to fight for every chance to change not only my life, but the lives of millions who are suffering or may one day suffer from neurodegenerative disease.

ALS is a rare disease that robs one of their ability to control their muscles, leading them to lose their ability to walk, talk and eventually breathe. Eighty percent of cases are sporadic (of unknown origin) and 20 percent have known genetic causes.

When I learned that I carried the C9ORF72 genetic variant, a causative genetic variant for ALS/FTD) my first instincts were to help others understand their status and where they could turn for help. I saw a vacuum for resources and understanding in the genetic ALS space and I knew that thousands were suffering in darkness.

Through the efforts of many, we created the first ever nonprofit – Genetic ALS & FTD: End the Legacy – focused on fighting for the genetic ALS and FTD communities. After making great strides to fight for our rights and access to care, I was asked if I could help my current CEO, Howard Berman, commercialize Dr. Stanley Appel’s regulatory T Cell (Treg) therapy for ALS.

I joined Coya Therapeutics in 2021 as the first employee, working to build a company that would one day bring life changing therapies to patients. Coya’s therapies are based on Dr. Appel’s discovery that neurodegenerative diseases drive an inflammatory response. As inflammation rises, it damages regulatory T cells, and when Tregs are damaged, inflammation becomes a persistent condition driving degeneration and eventually death.

It was at that point that my life changed from the advocacy world to the therapeutic world. Now over three years later, we are closer than ever to making a paradigm change for how patients with ALS and other neurodegenerative diseases are treated.

At Coya, we believe that combination biologics are the future of treating neurodegenerative diseases. COYA 302 is our lead asset, which has shown promising results in a proof-of-concept study released in March of 2023. We are currently working towards a double-blind, placebo-controlled trial for COYA 302 in ALS set to kick off later this year.

I never wanted to live a life so damned by disease, but when put between a rock and a hard place, the only choice is to fight. I don’t know how my life will end, but I hope that my children will know that I faced a great challenge head on with pride and resilience.

In the end, it is the combination of both the worlds I work in that lead to better outcomes for patients, raising awareness and lifesaving research. This ALS Awareness Month, please join us and our partners like the ALS Association, End the Legacy, and I AM ALS in raising awareness about these conditions, their risks, and treatment options.

------

Daniel Barvin is the vice president of operations and patient advocacy at Coya Therapeutics.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Houston-area lab grows with focus on mobile diagnostics and predictive medicine

mobile medicine

When it comes to healthcare, access can be a matter of life and death. And for patients in skilled nursing facilities, assisted living or even their own homes, the ability to get timely diagnostic testing is not just a convenience, it’s a necessity.

That’s the problem Principle Health Systems (PHS) set out to solve.

Founded in 2016 in Clear Lake, Texas, PHS began as a conventional laboratory but quickly pivoted to mobile diagnostics, offering everything from core blood work and genetic testing to advanced imaging like ultrasounds, echocardiograms, and X-rays.

“We were approached by a group in a local skilled nursing facility to provide services, and we determined pretty quickly there was a massive need in this area,” says James Dieter, founder, chairman and CEO of PHS. “Turnaround time is imperative. These facilities have an incredibly sick population, and of course, they lack mobility to get the care that they need.”

What makes PHS unique is not only what they do, but where they do it. While they operate one of the largest labs serving skilled nursing facilities in the state, their mobile teams go wherever patients are, whether that’s a nursing home, a private residence or even a correctional facility.

Diagnostics, Dieter says, are at the heart of medical decision-making.

“Seventy to 80 percent of all medical decisions are made from diagnostic results in lab and imaging,” he says. “The diagnostic drives the doctor’s or the provider’s next move. When we recognized a massive slowdown in lab results, we had to innovate to do it faster.”

Innovation at PHS isn’t just about speed; it’s about accessibility and precision.

Chris Light, COO, explains: “For stat testing, we use bedside point-of-care instruments. Our phlebotomists take those into the facilities, test at the bedside, and get results within minutes, rather than waiting days for results to come back from a core lab.”

Scaling a mobile operation across multiple states isn’t simple, but PHS has expanded into nine states, including Texas, Oklahoma, Kansas, Missouri and Arizona. Their model relies on licensed mobile phlebotomists, X-ray technologists and sonographers, all trained to provide high-level care outside traditional hospital settings.

The financial impact for patients is significant. Instead of ambulance rides and ER visits costing thousands, PHS services often cost just a fraction, sometimes only tens or hundreds of dollars.

“Traditionally, without mobile diagnostics, the patient would be loaded into a transportation vehicle, typically an ambulance, and taken to a hospital,” Dieter says. “Our approach is a fraction of the cost but brings care directly to the patients.”

The company has also embraced predictive and personalized medicine, offering genetic tests that guide medication decisions and laboratory tests that predict cognitive decline from conditions like Alzheimer's and Parkinson’s.

“We actively look for complementary services to improve patient outcomes,” Dieter says. “Precision medicine and predictive testing have been a great value-add for our providers.”

Looking to the future, PHS sees mobile healthcare as part of a larger trend toward home-based care.

“There’s an aging population that still lives at home with caretakers,” Dieter explains. “We go into the home every day, whether it’s an apartment, a standalone home, or assisted living. The goal is to meet patients where they are and reduce the need for hospitalization.”

Light highlighted another layer of innovation: predictive guidance.

“We host a lot of data, and labs and imaging drive most treatment decisions,” Light says. “We’re exploring how to deploy diagnostics immediately based on results, eliminating hours of delay and keeping patients healthier longer.”

Ultimately, innovation at PHS isn’t just about technology; it’s about equity.

“There’s an 11-year life expectancy gap between major metro areas and rural Texas,” Dieter says. “Our innovation has been leveling the field, so everyone has access to high-quality diagnostics and care, regardless of where they live.”

Aegis Aerospace appoints Houston space leader as new president

moving up

Houston-based Aegis Aerospace's current chief strategy officer, Matt Ondler, will take on the additional role of president on Jan. 1. Ondler will succeed Bill Hollister, who is retiring.

“Matt's vision, experience, and understanding of our evolving markets position us to build on our foundation and pursue new frontiers,” Stephanie Murphy, CEO of Aegis Aerospace, said in a news release.

Hollister guided Aegis Aerospace through expansion and innovation in his three years as president, and will continue to serve in the role of chief technology officer (CTO) for six months and focus on the company's technical and intellectual property frameworks.

"Bill has played an instrumental role in shaping the success and growth of our company, and his contributions leave an indelible mark on both our culture and our achievements," Murphy said in a news release.

Ondler has a background in space hardware development and strategic leadership in government and commercial sectors. Ondler founded subsea robots and software company Houston Mechatronics, Inc., now known as Nauticus Robotics, and also served as president, CTO and CSO during a five-year tenure at Axiom Space. He held various roles in his 25 years at NASA and was also named to the Texas Aerospace Research and Space Economy Consortium Executive Committee last year.

"I am confident that with Matt at the helm as president and Bill supporting us as CTO, we will continue to build on our strong foundation and further elevate our impact in the space industry," Murphy said in a news release. "Matt's vision, experience, and understanding of our evolving markets position us to build on our foundation and pursue new frontiers."

Rice University launches new center to study roots of Alzheimer’s and Parkinson’s

neuro research

Rice University launched its new Amyloid Mechanism and Disease Center last month, which aims to uncover the molecular origins of Alzheimer’s, Parkinson’s and other amyloid-related diseases.

The center will bring together Rice faculty in chemistry, biophysics, cell biology and biochemistry to study how protein aggregates called amyloids form, spread and harm brain cells. It will serve as the neuroscience branch of the Rice Brain Institute, which was also recently established.

The team will work to ultimately increase its understanding of amyloid processes and will collaborate with the Texas Medical Center to turn lab discoveries into real progress for patients. It will hold its launch event on Jan. 21, 2026, and hopes to eventually be a launchpad for future external research funding.

The new hub will be led by Pernilla Wittung-Stafshed, a Rice biophysicist and the Charles W. Duncan Jr.-Welch Chair in Chemistry.

“To make a real difference, we have to go all the way and find a cure,” Wittung-Stafshede said in a news release. “At Rice, with the Amyloid Mechanism and Disease Center as a catalyst, we have the people and ideas to open new doors toward solutions.”

Wittung-Stafshede, who was recruited to Rice through a Cancer Prevention and Research Institute of Texas grant this summer, has led pioneering work on how metal-binding proteins impact neurodegenerative disorders, including Alzheimer’s and Parkinson’s diseases. Her most recent study, published in Advanced Science, suggests a new way of understanding how amyloids may harm cells and consume the brain’s energy molecule, ATP.

According to Alzheimer’s Disease International, neurodegenerative disease cases could reach around 78 million by 2030 and 139 million by 2050. Wittung-Stafshede’s father died of dementia several years ago.

“This is close to my heart,” Wittung-Stafshede added in the news release. “Neurodegenerative diseases such as dementia, Alzheimer’s and Parkinson’s are on the rise as people live longer, and age is the largest risk factor. It affects everyone.”