How a Houston company is fighting anxiety, insomnia & Alzheimer’s through waveforms

mental health

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.
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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.

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

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Pharma giant considers Houston for $1B manufacturing campus

in the works

Another pharmaceutical giant is considering Houston’s Generation Park for a manufacturing hub.

According to a recent filing with the Texas Jobs, Energy, Technology and Innovation (JETI) program, Bristol Myers Squibb Co. is considering the northeast Houston management district for a new $1 billion multi-modal pharmaceutical manufacturing campus.

If approved, the campus, known as Project Argonaut, could create 489 jobs in Texas by 2031. Jobs would include operations technicians, engineering roles, administrative and management roles, production specialists, maintenance support, and quality control/assurance. The company predicts annual average wages for these positions to be around $96,000, according to the filing.

The project currently includes the 600,000-square-foot facility, but according to the filing, Bristol Myers Squibb “envisions this site growing in scale and capability well beyond its opening configuration."

The Texas JETI program offers companies temporary school property tax limitations in exchange for major capital investment and job creation. E.R. Squibb & Sons LLC applied for a 10-year tax abatement agreement in the Sheldon Independent School District.

The agreement promises a $ 1 billion investment. Construction would begin in 2027 and wrap in 2029.

“The proposed project reflects [Bristol Myers Squibb Co.’s] enduring commitment to bringing innovative medicines to patients and ensuring the long-term supply reliability they depend on,” the filing says. “The proposed project is purpose-built to support and manufacture medicines spanning multiple therapeutic areas and modalities, positioning the site as a long-term launch and commercial campus for decades to come. These medicines will provide therapies to the [Bristol Myers Squibb Co.’s] patients located in markets both nationally and internationally.”

The Fortune 100 company is considering 16 other cities for the new manufacturing facility in the Central and Eastern markets in the U.S. According to the Houston Chronicle, Bristol Myers Squibb Co is still in the “evaluation process” for its potential manufacturing site.

Last fall, Eli Lilly and Co. selected Generation Park for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.

Houston health tech co. lands NIH grant for AI cancer prediction tool

fresh funding

Houston-based CellChorus and Stanford Medicine were recently awarded a Phase I Small Business Innovation Research grant for the company's AI platform to test how certain cancer patients will respond to therapies.

The funding comes from the National Cancer Institute of the National Institutes of Health. According to a filing, the grant totaled just under $400,000.

CellChorus, which spun out from the University of Houston’s Technology Bridge, has developed TIMING (Time-lapse Imaging Microscopy In Nanowell Grids), which analyzes the behavior of thousands of individual immune cells over time and can identify early indicators of treatment success or failure.

The company will work with Stanford's Dr. David Miklos and Dr. Saurabh Dahiya, who have built the Bone Marrow Transplantation and Cell Therapy Biobank. The biobank manages and stores biological samples from patients treated at their clinic and in clinical trials.

"Predicting which patients will achieve durable responses after CAR-T therapy remains one of the most important challenges in the field,” Miklos said in a news release. “We aim to uncover functional cellular signatures that can guide treatment decisions and improve patient outcomes.”

The project will specifically profile cells from patients with relapsed/refractory large B-cell lymphoma (r/rLBCL). According to CellChorus, only about half of r/rLBCL patients who receive CAR-T therapy "achieve a durable, long-term remission." Others do not respond to therapy or experience relapse.

“The sooner we know whether a cancer therapy is working, the better. To maximize patient benefit, we need technology that can provide a robust and early prediction of response to therapy. The technology needs to be scalable, cost-efficient, and capable of rapid turnaround times,” Rebecca Berdeaux, chief scientific officer of CellChorus, added in the release. “We are excited to work with Drs. David Miklos and Saurabh Dahiya and their colleagues on this very important project.”

CellChorus has previously received SBIR grants from federal agencies, including a $2.5 million award in 2024 from its National Center for Advancing Translational Sciences (NCATS) and a $2.3 million SBIR Fast-Track award from the National Institute of General Medical Sciences in 2023.

Houston museum showcases America's founding documents in rare exhibit

Experience History

As the United States prepares to celebrate its 250th birthday, Houstonians have a chance to see rare documents from the founding of the nation. Freedom Plane National Tour: Documents That Forged a Nation, presented by the National Archives Foundation, will be on display at the Houston Museum of Natural Science through Monday, May 25.

The collection includes a rare engraving of the original Declaration of Independence; official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton; a draft of the Bill of Rights; the Treaty of Paris, the documented that recognized America's independence from Great Britain; and the tally of votes approving the Constitution.

The National Archives specifically chose Houston as one of only eight cities in the country to host the exhibit as a means to help the documents reach a wider audience outside of the main hub of semiquincentennial events in New England and the Washington, D.C. area.

"One of the things we decided when we put the tour together because we wanted to be off the East Coast," said Patrick Madden, CEO of the National Archives Foundation, who was onsite for the exhibit's opening in Houston. "There's a lot of 250th celebration stuff happening in the original 13 colonies. How do we get it to major markets where larger numbers of people can see it? So in the case of Houston, obviously, [is a] major market in this part of the country, but also we've partnered with the museum twice before with National Archives exhibits, so we knew that they would be up to the task of handling the exhibit and the crowds."

The star of the collection is a rare engraving of the original Declaration of Independence. Secretary of State and future president John Quincy Adams commissioned 200 exact replicas of the document from engraver William J. Stone in 1823. Less than 50 now remain. Madden joyfully pointed out that there are errors in this document, a potent reminder that the men who forged a nation made mistakes.

"There's a couple of typos in it where they had to make corrections," said Madden. "So even the founders, you know, they're all human. That resonates because here these people are making this move against the most powerful nation in the world and putting their lives on the line for a country based on ideas."

Other impressive parts of the collection include official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton, as well as one of the drafts of the Bill of Rights. Many states would not ratify the Constitution until certain rights were included in the document, leading to Washington going on a national tour assuring state leaders enshrining protections was first on the list. The draft copy on display specifically shows the First Amendment in progress.

Houston is the fourth stop on the exhibition's tour, which will take the documents to Denver, Miami, Dearborn, and Seattle through the summer. Freedom Plane is just one part of a larger patriotic celebration at the HMNS, which includes a film series celebrating American science and culture and general Americana decoration throughout the main hall.

Admission to Freedom Plane is free to the public, but separate from general admission to the museum. Space is limited, and passes are available on a first-come, first-serve basis. Non-members should expect long waits or the possibility that the day's passes are sold out. Only museum members can reserve passes for specific times. Flash photography is prohibited due to the fragile nature of the documents.

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This article originally appeared on CultureMap.com.

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