Nexalin Technology Advances Pivotal Clinical Trial of HALO™ Clarity Toward Q2 2026 Enrollment
Nexalin Technology, Inc. (NXL)
Company Research
Source: GlobeNewswire
HOUSTON, TX, April 22, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in non-invasive Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced it has entered into agreements to advance its planned pivotal clinical trial evaluating the HALO™ Clarity device for the treatment of moderate-to-severe insomnia, with patient enrollment currently expected to begin in Q2 of 2026. The 160-participant, randomized, triple-blinded, sham-controlled clinical trial is intended to support Nexalin’s planned De Novo Classification Request to the U.S. Food and Drug Administration (FDA). If granted, the FDA’s De Novo pathway would establish the Nexalin Halo™ Clarity as a new product category. This regulatory approach is intended to distinguish Nexalin Technology’s potentially groundbreaking DIFS™ neurostimulator from currently available stimulation devices. The study is expected to mark a significant milestone in the Company’
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News
- Nexalin Advances FDA Alzheimer's Strategy Following Landmark Leadership Meetings in the U.S. and China [Yahoo! Finance]Yahoo! Finance
- Nexalin Advances FDA Alzheimer’s Strategy Following Landmark Leadership Meetings in the U.S. and ChinaGlobeNewswire
- Join Nexalin’s Exclusive Live Investor Webinar and Q&A Session on April 21GlobeNewswire
- Nexalin Announces Peer-Reviewed Study Showing the Company’s DIFS™ Technology Reduced Self-Injury and Depression Symptoms in Female AdolescentsGlobeNewswire
- Nexalin Announces Pivotal HALO™ Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia MarketGlobeNewswire
NXL
Sec Filings
- 4/22/26 - Form 8-K
- 3/25/26 - Form 10-K
- 2/25/26 - Form 8-K
- NXL's page on the SEC website