Welcome to our dedicated page for Nexalin Tech news (Ticker: NXLIW), a resource for investors and traders seeking the latest updates and insights on Nexalin Tech stock.
Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) generates news centered on its non-invasive, frequency-based neurostimulation devices and their application in mental health and neurological disorders. News coverage for Nexalin often highlights developments related to its proprietary Deep Intracranial Frequency Stimulation (DIFS™) platform, including clinical data, regulatory milestones, and international commercialization activities.
Investors and followers of Nexalin’s news can expect updates on peer-reviewed studies involving the company’s technology in conditions such as Alzheimer’s disease, dementia, attention deficit hyperactivity disorder (ADHD), and gambling disorder with alcohol use disorder comorbidity. Recent announcements have described randomized, sham-controlled trials and case reports that examine changes in cognition, attention, and brain network function using tools like EEG, MEG, and functional MRI, as well as reported safety and tolerability outcomes.
Nexalin’s news flow also includes regulatory and strategic updates, such as Q-Submission interactions with the U.S. Food and Drug Administration for the Gen-2 SYNC™ console in Alzheimer’s disease, acceptance of FDA filings, and discussions of potential De Novo pathways. Internationally, the company reports on regulatory approvals in markets including China, Brazil, Oman, and Israel, along with distribution agreements like its exclusive partnership with Carmi Masha Technologies Ltd. in Israel.
Additional coverage may feature corporate events, investor webinars, conference participation, and Scientific Advisory Board appointments that relate to Nexalin’s focus on mental health, Alzheimer’s disease, and traumatic brain injury research. For users tracking NXLIW and NXL, this news page offers a centralized view of clinical, regulatory, and corporate developments that shape Nexalin’s progress in the neurostimulation and mental health space.
Nexalin Technology announced the pricing of a $5.2 million public offering, involving 3,000,000 shares of common stock at $1.75 per share. The company expects to generate gross proceeds of approximately $5.25 million before fees and expenses. Maxim Group is the sole placement agent for this offering, which is scheduled to close on July 1, 2024, contingent on standard closing conditions. This offering was made under a registration statement declared effective by the SEC on June 27, 2024. The final prospectus will be filed with the SEC, and copies can be obtained from Maxim Group
Nexalin Technology (Nasdaq: NXL; NXLIW) announced positive outcomes from a clinical study on their Deep Intracranial Frequency Stimulation (DIFS®) technology combined with escitalopram (Lexapro) for treating major depressive disorder (MDD). The 4-week, double-blind, randomized trial included 66 participants. Results showed that 66.7% of patients receiving the combination therapy improved, compared to 33.3% in the control group. The study revealed significant reductions in Hamilton Depression Rating Scale (HAMD-17) scores and found no serious adverse events. These findings were published in the journal Brain Stimulation, affirming the efficacy and feasibility of combining tACS with antidepressants for MDD treatment.
Nexalin Technology announced that the USPTO has awarded it U.S. Patent No 12,011,591 for its non-invasive Deep Intracranial Frequency Stimulation (DIFS®) device, designed to treat Alzheimer's and dementia-related diseases. The patent covers the Gen-2 and Gen-3 devices that use a proprietary frequency-based waveform for pain-free, undetectable brain stimulation. The global dementia treatment market is projected to grow from over $18 billion to $28 billion by 2030. The device also holds potential for other mental health disorders, including depression, migraines, anxiety, insomnia, addiction, and PTSD. The new patent enhances Nexalin's intellectual property portfolio and reflects significant advancements over the Gen-1 system. CEO Mark White emphasized the importance of this milestone, highlighting the growing need for innovative treatments in the expanding dementia market.
Nexalin Technology announced the regulatory approval of its Gen-2, 15 mA neurostimulation device by the Brazilian Health Regulatory Agency (Anvisa) on June 13, 2024. This marks Nexalin's second regulatory approval outside China this year. Brazil, the ninth largest economy globally with over 215 million people, includes more than 35 million individuals suffering from mental health disorders. CEO Mark White highlighted the strategic importance of this approval, positioning it as a gateway to broader South American markets. Nexalin is in advanced talks with a key distributor in Brazil, promising more updates soon.
Nexalin Technology (Nasdaq: NXL; NXLIW) announced its participation in the Spring MicroCap Rodeo Conference on June 6, 2024, in New York City. CEO Mark White will present at 10:00 a.m. Eastern Time, with the presentation available via live webcast. Nexalin's management will also hold one-on-one meetings with approved investors throughout the event. Further details and registration for the conference can be found on the MicroCap Rodeo website.
Nexalin Technology announced that the FDA has provided feedback and reached consensus on the design for clinical studies of its Gen-3 HALO Clarity™ headset. These studies, focusing on anxiety and insomnia, are set to commence in Q3 2024. Each study will involve 75 patients receiving active treatment and 75 receiving sham treatment. The HALO device uses Deep Intracranial Frequency Stimulation (DIFS™) to potentially offer an effective alternative to pharmacological treatments. Following the studies, Nexalin plans to submit a De Novo request to the FDA, seeking a new marketing pathway for the device.
The production of over 500 units of the HALO headset has started to support these studies. Nexalin aims to manage the patient-physician relationship through a virtual clinic model, allowing at-home use with remote monitoring by a physician. CEO Mark White sees this as a significant step towards revolutionizing mental health treatment standards.
Nexalin Technology announced that its new division, Nexalin America, has joined the National Traumatic Brain Injury (TBI) Registry Coalition. This Coalition comprises private sector and non-profit organizations dedicated to advancing research, raising awareness, and supporting clinical trials for TBI, affecting millions annually. Members include the NFL Players Association, Spaulding Rehabilitation at Mass General, United States Brain Injury Alliance, Abbott, and American Academy of Neurology. Nexalin America will leverage its neurostimulation technology expertise to contribute to developing a national TBI registry. CEO Mark White highlighted this partnership as a significant step towards combating brain injuries through advanced technology and collaborative research.
Nexalin Technology, Inc. is hosting an exclusive live investor webinar on May 23, 2024, featuring CEO Mark White discussing the company's clinical data on its deep brain stimulation device and new clinic model. Investors can register for the event and submit questions online.
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