
Nexalin Technology (NASDAQ: NXL) just reported encouraging results from a clinical study involving patients with Alzheimer's disease. And unlike most experimental Alzheimer's treatments, this one doesn't involve drugs, injections, or surgery.
Nexalin announced that its brain-stimulation technology improved sleep quality by approximately 34% in patients with mild Alzheimer's disease. The results were published in the peer-reviewed Journal of Alzheimer's Disease.
The study involved 46 patients, with 43 completing the trial. Some received Nexalin's treatment, while others received a placebo-like procedure, allowing researchers to compare results. Patients receiving Nexalin's treatment experienced substantially greater improvements in sleep quality than those in the comparison group. No serious adverse events were reported.
For a small medical technology company trying to establish itself in the Alzheimer's treatment market, these findings are encouraging.
Nexalin is developing a drug-free Alzheimer's treatment
Nexalin's technology delivers gentle electrical stimulation through electrodes placed on a patient's head. The goal is to influence brain activity without medication or invasive procedures.
Patients in the study received 30 treatment sessions over 15 days, each lasting about one hour.
Researchers measured sleep quality before and after treatment. Patients receiving Nexalin's technology saw their average sleep-quality scores improve by 34%, compared with a much smaller improvement among patients receiving the placebo-like procedure.
Sleep disturbances are common among Alzheimer's patients, often making an already difficult disease even harder for patients and their caregivers to manage. Of course, Nexalin hasn't demonstrated that its technology can cure Alzheimer's or stop the disease from progressing. The latest study focused specifically on sleep quality. But previous research involving the company's technology has also reported improvements in cognitive performance and changes in brain activity.
This latest publication is Nexalin's fourth peer-reviewed paper on its Alzheimer's research.
The next catalyst could come from the FDA
Nexalin has already completed an initial meeting with the FDA to discuss the regulatory requirements for its next-generation brain-stimulation device. The company is now preparing a U.S. pilot study that could help establish the evidence needed to pursue regulatory clearance.
Its technology has already received regulatory approvals in China, Brazil, and Israel, although it remains unapproved for use in the United States. To be sure, U.S. regulatory clearance could represent a significant commercial milestone.
Alzheimer's disease affects millions of Americans, and the market for treatments that help manage its symptoms is substantial. A device that improves sleep without requiring medication could potentially find a place alongside existing Alzheimer's treatments.
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