FDA Provides Feedback and Reaches Consensus on Nexalin’s Design for Planned Anxiety and Insomnia Clinical Studies of its Gen-3 HALO Clarity™ Headset Device
Nexalin Technology, Inc. (NXL)
Company Research
Source: GlobeNewswire
HOUSTON, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) announces that the U.S. Food and Drug Administration (FDA) has provided feedback and reached consensus on the design for its planned clinical studies in anxiety and insomnia for its new Gen-3 HALO Clarity™ (“HALO”), a non-invasive, Deep Intracranial Frequency Stimulation (DIFS™) headset device designed to address the global mental health epidemic. After the studies are completed and evaluated, Nexalin plans to submit a De Novo request application for the HALO to the FDA. The De Novo request provides a marketing pathway to classify new novel medical devices. The initial pilot and pivotal studies for anxiety and insomnia are expected to commence in the third quarter of 2024. Each of the pivotal studies will include 75 patients receiving active treatment and 75 patients receiving sham treatment and are intended to evaluate HALO’s ability to reduce symptoms of
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- Nexalin secures US patent for Alzheimer's deep-brain stimulation device [Yahoo! Finance]Yahoo! Finance
- Nano-Cap Nexalin Technology Secures US Patent For Stimulation Device For Alzheimer's And Dementia Treatment [Yahoo! Finance]Yahoo! Finance
- Nexalin Technology Awarded Key Patent Related to its Non-Invasive, Frequency-Based Deep-Brain Stimulation Device for the Treatment of Alzheimer's and Dementia [Yahoo! Finance]Yahoo! Finance
NXL
Sec Filings
- 6/24/24 - Form S-1/A
- 6/21/24 - Form 4
- 6/18/24 - Form 8-K
- NXL's page on the SEC website