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

Core Insights - Nexalin Technology, Inc. has received FDA consensus on the design for clinical studies targeting anxiety and insomnia using its Gen-3 HALO Clarity™ device, a non-invasive Deep Intracranial Frequency Stimulation (DIFS™) headset [1][3] - The initial pilot and pivotal studies are set to begin in Q3 2024, involving 150 patients per study to assess HALO's effectiveness in reducing symptoms of anxiety and insomnia [2] - The company plans to submit a De Novo request to the FDA for HALO after the studies, which will provide a marketing pathway for novel medical devices [1] Clinical Studies - The pivotal studies will consist of 75 patients receiving active treatment and 75 receiving sham treatment, aimed at evaluating HALO's efficacy [2] - These studies will build on previous positive clinical results from Nexalin's Gen-3 HALO using the advanced DIFS™ waveform [2] Company Statements - Dr. David Owens, Chief Medical Officer, highlighted the consensus with the FDA as a significant milestone for Nexalin, emphasizing the safety and efficacy evaluation of HALO [3] - CEO Mark White stated that HALO has the potential to revolutionize mental health treatment, offering an alternative to pharmacological options that may have limited efficacy and side effects [3] - Nexalin is initiating a large production run of over 500 units to support the FDA protocols for the upcoming studies [3] Company Overview - Nexalin Technology, Inc. focuses on developing innovative neurostimulation products to address the global mental health crisis, utilizing bioelectronic medical technology [4] - The company's devices are designed to be non-invasive and aim to provide relief for mental health issues by penetrating deep brain structures associated with these disorders [4] - The Nexalin Gen-2 neurostimulation device has recently received approval in Oman and China, indicating the company's expanding market presence [4]