{"id":939453,"date":"2026-02-24T08:34:02","date_gmt":"2026-02-24T13:34:02","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/"},"modified":"2026-02-24T08:34:02","modified_gmt":"2026-02-24T13:34:02","slug":"nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/","title":{"rendered":"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market"},"content":{"rendered":"
\n

\n 150-Patient, Triple-Blinded, Sham-Controlled Study Designed to be Executed in Collaboration with Lindus Health to Support Future FDA Submission for Drug-Free Insomnia Treatment<\/i>\n <\/p>\n

\n Builds on Prior Peer-Reviewed Clinical Data and International Regulatory Approvals<\/i>\n <\/p>\n

HOUSTON, TX, Feb. 24, 2026 (GLOBE NEWSWIRE) — Nexalin Technology, Inc.<\/b><\/a> (Nasdaq: NXL)<\/b> (the \u201cCompany\u201d or \u201cNexalin\u201d), the leader in Deep Intracranial Frequency Stimulation (DIFS\u2122) of the brain, today announced continued advancement toward its planned pivotal clinical trial evaluating HALO\u2122 Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin\u2019s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical research organization engaged to oversee trial execution, regulatory preparation, and patient recruitment.<\/p>\n

The randomized, triple-blinded, sham-controlled study is designed to enroll a minimum of 150 participants across the United States. Structured as a fully decentralized trial, participants are expected to complete treatments and assessments remotely within Nexalin\u2019s recently launched NeuroCare virtual clinic and its advanced Electronic Data Capture (EDC) system. The NeuroCare virtual clinic is designed to eliminate traditional site visit requirements, while expanding access to a broader patient population.<\/p>\n

The pivotal study is designed to support the planned de novo insomnia submission to the U.S. Food and Drug Administration and represents a key milestone in the execution of Nexalin\u2019s global strategy to expand its DIFS\u2122 platform into high-prevalence neuropsychiatric indications.<\/p>\n

The pivotal study to support Nexalin\u2019s planned FDA submission builds on Nexalin\u2019s previously reported and published clinical results in chronic insomnia, including a 120-participant randomized, double-blind, placebo-controlled, multicenter study published in the Journal of Psychiatric Research. In that study, Nexalin reported clinically meaningful and statistically significant improvements across key sleep parameters compared to placebo, with no significant adverse effects reported. Nexalin\u2019s Gen-2 15 mA device has also received regulatory approvals internationally for insomnia and related indications.<\/p>\n

Insomnia affects approximately 30 million adults in the United States, with many patients reporting dissatisfaction with existing treatment options due to concerns regarding dependency, tolerability, or long-term use. The global insomnia therapeutics market represents a multi-billion-dollar annual opportunity and continues to grow as awareness and diagnosis increase.<\/p>\n

HALO\u2122 Clarity leverages Nexalin\u2019s proprietary 15 mA DIFS\u2122 technology, which is engineered to target deeper brain structures associated with sleep regulation and other mental health conditions. Unlike conventional transcranial stimulation approaches primarily targeting cortical regions, DIFS\u2122 is engineered to modulate deeper neural circuits implicated in sleep architecture, offering a potential non-pharmacological treatment alternative.<\/p>\n

Under the collaboration, Lindus Health is expected to provide comprehensive clinical research services, including protocol finalization, regulatory preparation and submission support, patient recruitment strategy, study management, data oversight, biostatistics, and medical writing.<\/p>\n

The planned study will include adults aged 22 to 65 with moderate to severe insomnia, who are expected to be randomized to receive either active HALO\u2122 Clarity therapy or sham treatment for four weeks, followed by a four-week follow-up period to evaluate durability of response.<\/p>\n

\u201cThis planned pivotal trial marks an important milestone for Nexalin,\u201d said Mark White, Chief Executive Officer of Nexalin Technology. \u201cInsomnia is a large and underserved market where millions of patients are seeking drug-free treatment options. Advancing HALO\u2122 Clarity toward a fully powered pivotal study designed to support our planned FDA submission reflects the maturity of our DIFS\u2122 platform and our commitment to expanding its clinical reach. We believe successful execution of this study and continued advancement along the FDA pathway will position Nexalin to pursue regulatory clearance in a high-demand market, further validate the broader potential of our technology, and support our ongoing efforts to expand regulatory pathways across additional indications.\u201d<\/p>\n

\u201cWe are pleased to collaborate with Nexalin in the advancement of this important study,\u201d said Michael Young, Co-CEO of Lindus Health. \u201cOur team looks forward to supporting the execution of a rigorous, patient-centric trial designed to evaluate this novel approach to insomnia treatment.\u201d<\/p>\n

Nexalin continues to focus on strengthening the clinical and regulatory foundation of its DIFS\u2122 platform as it advances toward potential commercialization across multiple neuropsychiatric indications.<\/p>\n

\n About Nexalin Technology, Inc.<\/b>\n <\/p>\n

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are believed to be non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, Oman and Israel. Additional information about the Company is available at: https:\/\/nexalin.com\/<\/a><\/u>.<\/p>\n

\n FORWARD-LOOKING STATEMENTS<\/b>\n <\/p>\n

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or Nexalin\u2019s future financial performance. Any statements that refer to expectations, projections, or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements containing the words \u201cbelieves,\u201d \u201cexpects,\u201d \u201canticipates,\u201d \u201cplans,\u201d \u201cintends,\u201d \u201cwill,\u201d \u201cdesigned to,\u201d \u201cpositioned to,\u201d \u201cpotential,\u201d \u201ctargeted,\u201d \u201cseeking,\u201d or similar expressions) should be considered forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or Nexalin\u2019s actual results to differ materially from those indicated by the forward-looking statements. Investors are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release.<\/p>\n

References to “FDA pivotal study,” “FDA pivotal clinical trial,” or similar terminology in this press release describe the Company\u2019s intended purpose for the study and do not indicate FDA endorsement, sponsorship, approval, or oversight of the study design, protocol, or execution. No assurance can be given that the planned study will be initiated, enrolled, completed, or produce favorable results, or that any regulatory submission will result in FDA clearance or approval.<\/p>\n

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the control of the Company. Such risks include, but are not limited to: uncertainties regarding the design, enrollment, execution, timing, and completion of clinical trials; the ability to obtain regulatory clearance or approval from the FDA or other regulatory bodies; the Company\u2019s reliance on third-party collaborators, including Lindus Health; the sufficiency of clinical data to support regulatory submissions; the potential for adverse events or safety concerns; market acceptance of the Company\u2019s products; competition from existing and new treatment alternatives; and the Company\u2019s ability to secure adequate funding to complete its planned clinical and regulatory programs. Additional risks are set forth in the Risk Factors section of the Company\u2019s Annual Report on Form 10-K for the year ended December 31, 2024, and other filings with the Securities and Exchange Commission. Copies of such filings are available on the SEC\u2019s website at www.sec.gov<\/a>.<\/p>\n

Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.<\/p>\n

\n Contact:<\/b>\n <\/p>\n

Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com<\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

150-Patient, Triple-Blinded, Sham-Controlled Study Designed to be Executed in Collaboration with Lindus Health to Support Future FDA Submission for Drug-Free Insomnia Treatment Builds on Prior Peer-Reviewed Clinical Data and International Regulatory Approvals HOUSTON, TX, Feb. 24, 2026 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (Nasdaq: NXL) (the \u201cCompany\u201d or \u201cNexalin\u201d), the leader in Deep Intracranial Frequency Stimulation (DIFS\u2122) of the brain, today announced continued advancement toward its planned pivotal clinical trial evaluating HALO\u2122 Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin\u2019s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical research organization engaged to oversee trial execution, regulatory preparation, and patient … <\/p>\n

Continue reading “Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-939453","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nNexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"150-Patient, Triple-Blinded, Sham-Controlled Study Designed to be Executed in Collaboration with Lindus Health to Support Future FDA Submission for Drug-Free Insomnia Treatment Builds on Prior Peer-Reviewed Clinical Data and International Regulatory Approvals HOUSTON, TX, Feb. 24, 2026 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (Nasdaq: NXL) (the \u201cCompany\u201d or \u201cNexalin\u201d), the leader in Deep Intracranial Frequency Stimulation (DIFS\u2122) of the brain, today announced continued advancement toward its planned pivotal clinical trial evaluating HALO\u2122 Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin\u2019s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical research organization engaged to oversee trial execution, regulatory preparation, and patient … Continue reading "Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market"\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-02-24T13:34:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1OTc4NiM3NDUwODA5IzUwMDEwOTExMw==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market\",\"datePublished\":\"2026-02-24T13:34:02+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\\\/\"},\"wordCount\":1228,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTY1OTc4NiM3NDUwODA5IzUwMDEwOTExMw==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\\\/\",\"name\":\"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market - 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(Nasdaq: NXL) (the \u201cCompany\u201d or \u201cNexalin\u201d), the leader in Deep Intracranial Frequency Stimulation (DIFS\u2122) of the brain, today announced continued advancement toward its planned pivotal clinical trial evaluating HALO\u2122 Clarity for the treatment of moderate to severe insomnia, designed to support Nexalin\u2019s planned de novo submission to the U.S. Food and Drug Administration. The study is being conducted in collaboration with Lindus Health, a full-service clinical research organization engaged to oversee trial execution, regulatory preparation, and patient … Continue reading \"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/","og_site_name":"Market Newsdesk","article_published_time":"2026-02-24T13:34:02+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1OTc4NiM3NDUwODA5IzUwMDEwOTExMw==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market","datePublished":"2026-02-24T13:34:02+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/"},"wordCount":1228,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTY1OTc4NiM3NDUwODA5IzUwMDEwOTExMw==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/nexalin-announces-pivotal-halo-clarity-trial-to-support-planned-de-novo-fda-submission-targeting-multi-billion-dollar-insomnia-market\/","name":"Nexalin Announces Pivotal HALO\u2122 Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market - 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