Business
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
Clinical studies in anxiety and insomnia expected to commence in the third quarter of 2024 HOUSTON, TX, June 03, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology,
About this update from Nexalin Technology, Inc.
[{"type":"text","content":"Clinical studies in anxiety and insomnia expected to commence in the third quarter of 2024\nHOUSTON, 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 anxiety and insomnia, respectively. These two studies are intended to build on the positive results of prior published clinical studies evaluating Nexalin’s Gen-3 HALO utilizing the new advanced DIFS™ waveform. Dr. David Owens, Chief Medical Officer of Nexalin, commented, \"We are proud to have arrived at a consensus with the FDA for the clinical protocols to evaluate the safety and efficacy of HALO in both anxiety and insomnia. This marks a major milestone for Nexalin and a significant step forward in the regulatory pathway. These studies will build upon our extensive prior published clinical studies in the U.S. and Asia, which have repeatedly demonstrated the efficacy of our proprietary waveform.” Mark White, CEO of Nexalin, added, “The approval of these protocols underscores the potential of HALO headset to revolutionize the standard of care in mental health treatment. We believe our technology represents a major breakthrough, as it offers an effective alternative to pharmacological treatments, which often have limited efficacy and may have severe side effects. Moreover, the HALO medical device will be prescribed and managed through Nexalin’s proprietary digital platform in a virtual clinic. Nexalin intends to manage the patient-physician relationship through a vi...