Nexalin Advances Pivotal Insomnia Clinical Trial

Written by Emily J. Thompson, Senior Investment Analyst

Source: Benzinga

Updated: Feb 24 2026

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Source: Benzinga

Trial Overview: Nexalin is collaborating with Lindus Health to conduct a pivotal clinical trial in the U.S. aimed at enrolling at least 150 participants suffering from moderate to severe insomnia, with a randomized, triple-blinded, sham-controlled design that includes a four-week treatment period followed by a four-week follow-up to assess response durability.
Remote Treatment Innovation: The trial is structured as fully decentralized, allowing participants to complete treatments and assessments remotely through Nexalin's newly launched NeuroCare virtual clinic and advanced Electronic Data Capture system, thereby eliminating traditional site visit requirements and expanding access to a broader patient population.
FDA Submission Support: This pivotal study is designed to support Nexalin's planned de novo insomnia submission to the U.S. FDA, representing a key milestone in the company's global strategy to expand its Deep Intracranial Frequency Stimulation platform into high-prevalence neuropsychiatric indications, further validating the broader potential of its technology.
Market Positioning: CEO Mark White emphasized that successful execution of this study will position Nexalin for regulatory clearance in a high-demand market, as insomnia affects approximately 30 million adults in the U.S., with the global insomnia therapeutics market representing a multi-billion-dollar annual opportunity that continues to grow with increasing awareness and diagnosis.

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Nexalin Technology, Inc. is engaged in designing and developing neurostimulation products for the mental health epidemic. The Company has developed an easy-to-administer medical device (Generation 1 or Gen-1) that utilizes bioelectronic medical technology to treat anxiety, depression and insomnia, without the need for drugs or psychotherapy. Its original Gen-1 devices are cranial electrotherapy stimulation (CES) devices that emit a waveform at 4 milliamps during treatment. It has also designed and developed a new advanced waveform technology to be emitted at 15 milliamps through new and improved medical devices referred to as (Generation 2 or Gen-2) and (Gen-3). Gen-2 is a clinical use device with a modern enclosure to emit the new 15 milliamp advanced waveform. Gen-3 is a new patient headset that will be prescribed by licensed medical professionals in a virtual clinic setting like existing telehealth platforms. Its products are non-invasive and undetectable to the human body.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Nexalin Advances HALO Clarity Clinical Trial for Insomnia Treatment

Feb 24 2026NASDAQ.COM

Clinical Trial Launch: Nexalin Technology is advancing its HALO Clarity program by initiating a pivotal clinical trial aimed at supporting a de novo submission to the U.S. FDA for moderate to severe insomnia treatment, which is expected to provide a competitive edge in the multi-billion-dollar insomnia market.
Technological Innovation: The company positions its non-drug Deep Intracranial Frequency Stimulation (DIFS) technology as a potential alternative to address insomnia affecting approximately 30 million adults in the U.S., particularly as many patients express dissatisfaction with current treatment options due to concerns about dependency and tolerability.
Trial Design: The HALO Clarity study is a randomized, triple-blinded, sham-controlled trial designed to enroll at least 150 adults, utilizing a fully decentralized model that allows participants to complete treatments and assessments remotely through Nexalin's NeuroCare virtual clinic, thereby broadening patient access.
Strategic Implications: This trial builds on previously published clinical data demonstrating significant improvements in sleep parameters, marking a major milestone in Nexalin's strategy to expand its DIFS platform into high-prevalence neuropsychiatric conditions, with results expected to form the foundation for the company's planned FDA submission.

Nexalin Advances Drug-Free Insomnia Treatment Clinical Trial

Feb 24 2026Newsfilter

Clinical Trial Design: Nexalin, in collaboration with Lindus Health, plans to recruit 150 participants in a triple-blinded, sham-controlled clinical trial in the U.S. to support its drug-free insomnia treatment submission to the FDA, marking a strategic expansion into neuropsychiatric indications.
Technological Innovation: HALO™ Clarity leverages Nexalin's proprietary 15 mA DIFS™ technology to target deeper brain structures, offering a non-pharmacological treatment option that addresses the urgent needs of 30 million insomnia sufferers in the U.S., presenting significant market potential.
Research Execution Model: The trial is structured as a fully decentralized study, allowing participants to complete treatments and assessments remotely through Nexalin's newly launched NeuroCare virtual clinic, aimed at increasing patient accessibility while reducing barriers to traditional clinical trial participation.
Market Opportunity: The global insomnia therapeutics market represents a multi-billion-dollar annual opportunity, and as awareness and diagnosis increase, Nexalin's research not only enhances the market recognition of its technology but also potentially accelerates the regulatory approval process in a high-demand market.