Welcome to our dedicated page for Nexalin Tech news (Ticker: NXL), a resource for investors and traders seeking the latest updates and insights on Nexalin Tech stock.
Nexalin Technology (NXL) delivers non-invasive neurostimulation therapies for mental health and neurological conditions through its patented transcranial electrical stimulation (TES) and deep intracranial frequency stimulation (DIFS) technologies. This page provides investors and healthcare professionals with centralized access to official updates on clinical trials, regulatory milestones, and strategic initiatives.
Discover timely announcements including FDA clearances, partnerships with medical institutions, and advancements in AI-integrated treatment platforms. All content is sourced directly from company releases to ensure accuracy, with a focus on developments impacting mental health innovation and neurostimulation markets.
Key updates cover device efficacy studies, intellectual property expansions, and revenue model evolution through licensing agreements. Bookmark this page to monitor Nexalin's progress in providing drug-free alternatives for anxiety, depression, and neurological disorders while maintaining compliance with financial disclosure standards.
Nexalin Technology (NASDAQ: NXL) completed a substantive FDA Q-Submission meeting for its Gen-2 SYNC™ neurostimulation console targeting mild-to-moderate Alzheimer’s disease on December 3, 2025. The FDA provided a clear framework for Nexalin’s planned U.S. Pilot Study and discussed a potential De Novo classification pathway.
FDA and Nexalin aligned on pilot and pivotal trial design elements, patient population, dosing paradigm, statistical plan, and primary/secondary endpoints including cognitive tests, PET, blood biomarkers, and functional imaging. Company will use feedback for its U.S. IDE submission.
Nexalin Technology (Nasdaq: NXL) invites investors to a live webinar on December 4, 2025 at 4:15 p.m. ET hosted by RedChip Companies.
CEO Mark White will discuss Nexalin’s proprietary non-invasive Deep Intracranial Frequency Stimulation (DIFS™), recent clinical collaborations including UC San Diego, the Gen-3 HALO™ Clarity headset, and a Virtual Clinic model for scalable at-home treatment. The company says it has secured regulatory approvals internationally while pursuing U.S. expansion and targets the $537 billion mental health market. Management will highlight patented technology, real-time AI-driven patient monitoring, and global footprint growth, followed by a live Q&A. Registration is free at the RedChip webinar page and questions can be pre-submitted to NXL@redchip.com.
Nexalin Technology (Nasdaq: NXL) reported a peer-reviewed case report in The American Journal on Addictions showing promising results using its 15 mA neurostimulation device to treat gambling disorder comorbid with alcohol use disorder.
In a single patient treated at Shanghai Mental Health Center, 20 outpatient sessions over 10 days (15 mA at 77.5 Hz for 40 minutes each) produced complete abstinence from gambling and alcohol, improved cognitive control, and no adverse effects during a three-month follow-up. The study (ClinicalTrials.gov NCT06195995) received ethics approval. The device is approved in China for depression and insomnia. Authors recommend larger controlled trials to confirm findings.
Nexalin Technology (Nasdaq: NXL) announced an exclusive distribution agreement with Carmi Masha Technologies Ltd. to market and sell Nexalin’s Gen-2 SYNC 15 mA non-invasive neurostimulation console in Israel.
The agreement follows regulatory approval by the Israeli Ministry of Health authorizing commercial sale for indications including insomnia, depression, and anxiety. Carmi Masha will handle importation, registration, sales, marketing, clinical education, and distribution to hospitals, clinics, and private centers.
The companies also plan to explore future clinical applications for PTSD, TBI, Alzheimer’s, and dementia as part of ongoing global clinical initiatives.
Nexalin Technology (Nasdaq: NXL) announced that the U.S. Food and Drug Administration accepted its Q-Submission for the Gen-2 SYNC console for treatment of Alzheimer’s disease and dementia on November 5, 2025.
The acceptance schedules a regulatory meeting later in 2025 to discuss clinical trial design, endpoints, statistical plans and the regulatory pathway toward a potential U.S. Investigational Device Exemption (IDE).
Company-reported supportive signals include encouraging internal data, published studies showing improved cognitive performance, no serious adverse events across international use, and EEG/qEEG evidence of waveform-induced neural connectivity changes for dementia-related conditions.
Nexalin Technology (Nasdaq: NXL) announced regulatory approval from the Israeli Ministry of Health to sell its Gen-2 SYNC 15 mA neurostimulation DIFS™ device in Israel on October 30, 2025. The company said the clearance enables commercial launch discussions with regional distribution partners and strengthens global credibility after prior approvals in China, Brazil, and Oman. The approval supports Nexalin’s strategy to expand its non‑invasive mental health therapy platform across the region.
Nexalin Technology (Nasdaq: NXL) announced three independently peer‑reviewed studies (Alzheimer's Research & Therapy; Journal of Alzheimer’s Disease; Radiology) showing cognitive and network benefits from its 15 mA Gen‑2 Deep Intracranial Frequency Stimulation (DIFS) device.
Key study details: a randomized double‑blind trial (46 patients) used 30 one‑hour DIFS sessions over 15 days with immediate MMSE and MoCA gains; fMRI studies reported increased hippocampal activation, fALFF, ReHo and improved hippocampus–cortex connectivity. The company frames DIFS as a non‑invasive, drug‑free alternative with no reported serious side effects.
Nexalin Technology (Nasdaq: NXL) appointed Dr. Robert Rothstein to its Scientific Advisory Board to support Alzheimer’s disease and traumatic brain injury (TBI) programs and to aid preparation of a Q-submission with the FDA later in 2025. Dr. Rothstein brings 40+ years of clinical and translational experience in emergency medicine, psychiatric care, and medical technology advisory roles.
Nexalin plans to initiate Alzheimer’s-specific trials in Q4 2025 and targets a TBI-focused submission thereafter, leveraging MEG-guided protocols, imaging biomarkers, and expanded SAB oversight.
Nexalin Technology (Nasdaq: NXL, NXLIW) announced it will participate in the 2025 Maxim Growth Summit on October 22, 2025 at The Hard Rock Hotel NYC.
Management will meet attendees to discuss Nexalin’s proprietary Deep Intracranial Frequency Stimulation (DIFS™), described as a non-invasive, drug-free, clinically proven neurostimulation therapy the company says has potential to scale worldwide.
The announcement highlights investor and public engagement opportunities at the conference and provides registration details for the Maxim Growth Summit.
Nexalin Technology (Nasdaq: NXL) reported peer-reviewed clinical results (Radiology, Oct 8, 2025) showing its Gen-2 SYNC 40-Hz, 15 mA DIFS neurostimulation device produced statistically significant cognitive gains and measurable brain-connectivity changes in mild Alzheimer’s disease.
Key findings: significant MMSE and MoCA score improvements versus sham (P = .001 and .03), increased hippocampal-cortical and network functional connectivity on resting-state fMRI, a connectivity–naming-test correlation (r = 0.65, FDR-adjusted P = .008), and no reported adverse events. Device has regulatory approvals for other indications in China, Brazil, and Oman.
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