Nexalin Technology, Inc.

Nexalin Technology, Inc. is a medical device company focused on designing and developing neurostimulation products to address the global mental health epidemic. The company's mission is to provide innovative, non-pharmacological treatment options for various mental health conditions. Headquartered in Houston, Texas, Nexalin Technology aims to offer effective and accessible solutions for brain health.

Nexalin Technology's product portfolio includes cranial electrotherapy stimulation (CES) devices. Its Generation 1 (Gen-1) device utilizes a 4 milliamp waveform to treat anxiety, insomnia, and depression without the need for drugs or psychotherapy, and is classified as a Class II device by the U.S. FDA. The company has also developed advanced Generation 2 (Gen-2) and Generation 3 (Gen-3) devices, including the HALO™ Clarity headset, which emit a 15 milliamp waveform. These newer generations are designed to address a broader spectrum of conditions, such as depression, substance use disorder, traumatic brain injury, post-traumatic stress disorder, opioid addiction, alcoholism, chronic pain, Alzheimer's disease, and dementia. Nexalin also employs a virtual clinic model to enhance treatment accessibility.

Mark White serves as the Chief Executive Officer, having been appointed in January 2018. The company is actively advancing its clinical programs, including pivotal trials for its HALO™ Clarity device for moderate-to-severe insomnia, with patient enrollment anticipated in Q2 2026, to support a De Novo FDA classification request. Nexalin is also progressing its FDA Alzheimer's strategy, with plans for an amended FDA Q-Submission in Q2 2026. Recent peer-reviewed publications have highlighted the efficacy of Nexalin's Deep Intracranial Frequency Stimulation (DIFS™) technology in improving chronic insomnia and reducing self-injury and depression symptoms. The Gen-2 SYNC console has received regulatory approvals in international markets including Israel, China, Brazil, and Oman, underscoring the company's global market positioning in non-invasive, frequency-based neurostimulation.