Nexalin Technology Enrolls First Patients and Advances Toward Treatment in UCSD Clinical Trial
Nexalin Technology (Nasdaq: NXL) has initiated patient treatment in its clinical trial at the University of California, San Diego (UCSD) in collaboration with the VA San Diego Healthcare System. The trial evaluates the company's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, delivered through HALO™ Clarity devices, for treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in both military and civilian populations.
The study marks a transition from recruitment to active participation, utilizing non-invasive, at-home neurostimulation therapy with AI-integrated remote monitoring. The company's Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS) enable real-time tracking of patient adherence and treatment progress. Additional HALO™ Clarity devices will be deployed as the study advances to ensure comprehensive patient coverage and data collection.
Nexalin Technology (Nasdaq: NXL) ha avviato il trattamento dei pazienti nel suo studio clinico presso l'Università della California, San Diego (UCSD) in collaborazione con il Sistema Sanitario VA di San Diego. Lo studio valuta la tecnologia proprietaria Deep Intracranial Frequency Stimulation (DIFS™) dell'azienda, somministrata attraverso i dispositivi HALO™ Clarity, per il trattamento di lesioni cerebrali traumatiche lievi (mTBI) e disturbo da stress post-traumatico (PTSD) sia in popolazioni militari che civili.
Lo studio segna una transizione dalla fase di reclutamento alla partecipazione attiva, utilizzando una terapia di neurostimolazione non invasiva a casa con monitoraggio remoto integrato con intelligenza artificiale. La piattaforma di Cattura Dati Elettronici (EDC) e il Sistema di Monitoraggio dei Pazienti (PMS) dell'azienda consentono il tracciamento in tempo reale dell'aderenza dei pazienti e dei progressi nel trattamento. Dispositivi aggiuntivi HALO™ Clarity saranno distribuiti man mano che lo studio avanza per garantire una copertura completa dei pazienti e una raccolta dati efficace.
Nexalin Technology (Nasdaq: NXL) ha iniciado el tratamiento de pacientes en su ensayo clínico en la Universidad de California, San Diego (UCSD) en colaboración con el Sistema de Salud VA de San Diego. El ensayo evalúa la tecnología patentada Deep Intracranial Frequency Stimulation (DIFS™) de la empresa, administrada a través de dispositivos HALO™ Clarity, para el tratamiento de lesiones cerebrales traumáticas leves (mTBI) y trastorno de estrés postraumático (PTSD) en poblaciones militares y civiles.
El estudio marca una transición de la reclutación a la participación activa, utilizando una terapia de neuroestimulación no invasiva en casa con monitoreo remoto integrado por inteligencia artificial. La plataforma de Captura Electrónica de Datos (EDC) y el Sistema de Monitoreo de Pacientes (PMS) de la empresa permiten el seguimiento en tiempo real de la adherencia de los pacientes y el progreso del tratamiento. Se desplegarán dispositivos adicionales HALO™ Clarity a medida que avance el estudio para garantizar una cobertura completa de los pacientes y la recolección de datos.
Nexalin Technology (Nasdaq: NXL)는 샌디에이고 캘리포니아 대학교(UCSD)에서 샌디에이고 VA 의료 시스템과 협력하여 임상 시험에서 환자 치료를 시작했습니다. 이 시험은 회사의 독점 기술인 Deep Intracranial Frequency Stimulation (DIFS™)를 평가하며, HALO™ Clarity 장치를 통해 제공됩니다. 이 기술은 군인과 민간인 모두의 경미한 외상성 뇌손상(mTBI) 및 외상 후 스트레스 장애(PTSD) 치료에 사용됩니다.
이 연구는 모집 단계에서 적극적인 참여로의 전환을 나타내며, 인공지능 통합 원격 모니터링을 통해 비침습적인 가정용 신경 자극 치료를 활용합니다. 회사의 전자 데이터 수집(EDC) 플랫폼과 환자 모니터링 시스템(PMS)은 환자의 치료 준수 및 진행 상황을 실시간으로 추적할 수 있게 해줍니다. 연구가 진행됨에 따라 추가 HALO™ Clarity 장치가 배치되어 환자 커버리지와 데이터 수집을 보장할 것입니다.
Nexalin Technology (Nasdaq: NXL) a lancé le traitement des patients dans son essai clinique à l'Université de Californie, San Diego (UCSD), en collaboration avec le système de santé VA de San Diego. L'essai évalue la technologie propriétaire Deep Intracranial Frequency Stimulation (DIFS™) de l'entreprise, délivrée via des dispositifs HALO™ Clarity, pour le traitement des lésions cérébrales traumatiques légères (mTBI) et du trouble de stress post-traumatique (PTSD) chez les populations militaires et civiles.
Cette étude marque une transition du recrutement à la participation active, utilisant une thérapie de neurostimulation non invasive à domicile avec un suivi à distance intégré à l'intelligence artificielle. La plateforme de capture de données électroniques (EDC) et le système de surveillance des patients (PMS) de l'entreprise permettent un suivi en temps réel de l'adhésion des patients et des progrès du traitement. Des dispositifs supplémentaires HALO™ Clarity seront déployés au fur et à mesure de l'avancement de l'étude pour garantir une couverture complète des patients et une collecte de données efficace.
Nexalin Technology (Nasdaq: NXL) hat die Behandlung von Patienten in seiner klinischen Studie an der University of California, San Diego (UCSD) in Zusammenarbeit mit dem VA San Diego Healthcare System aufgenommen. Die Studie bewertet die firmeneigene Technologie Deep Intracranial Frequency Stimulation (DIFS™), die über HALO™ Clarity Geräte bereitgestellt wird, zur Behandlung von leichten traumatischen Hirnverletzungen (mTBI) und posttraumatischen Belastungsstörungen (PTBS) in sowohl militärischen als auch zivilen Bevölkerungen.
Die Studie markiert den Übergang von der Rekrutierung zur aktiven Teilnahme und nutzt nicht-invasive, häusliche Neurostimulationstherapie mit KI-integrierter Fernüberwachung. Die elektronische Datenerfassungsplattform (EDC) und das Patientenüberwachungssystem (PMS) des Unternehmens ermöglichen die Echtzeitverfolgung der Patientenadhärenz und des Behandlungsfortschritts. Zusätzliche HALO™ Clarity Geräte werden im Laufe der Studie bereitgestellt, um eine umfassende Patientenabdeckung und Datenerfassung sicherzustellen.
- First patients successfully enrolled and treatment initiated in UCSD clinical trial
- Partnership with major institutions (UCSD and VA San Diego Healthcare System)
- Implementation of AI-integrated remote monitoring system for real-time patient tracking
- Early-stage clinical trial with no efficacy data yet
- Additional devices deployment needed for full study coverage
Insights
Nexalin has reached a pivotal clinical milestone with the first patient treatment in its UCSD/VA San Diego trial for PTSD and mild traumatic brain injury. This marks a critical transition from recruitment to active clinical evaluation of their proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology.
The advancement to the treatment phase represents meaningful clinical progress for a company of Nexalin's size (
What distinguishes this program is the technical integration beyond the basic treatment device – the HALO™ Clarity system incorporates AI-integrated remote monitoring and companion digital platforms for data capture and patient tracking. These elements potentially position Nexalin's approach as a comprehensive treatment ecosystem rather than merely a device.
While this news confirms operational execution in clinical development, investors should recognize that the trial remains in early stages. The company must still demonstrate efficacy data, navigate regulatory requirements, and establish a path to reimbursement. The non-invasive, at-home treatment approach does align with current healthcare trends toward decentralized care models.
The initiation of patient treatment in Nexalin's UCSD clinical trial represents a meaningful validation step for their neuromodulation platform. The DIFS™ technology addresses the growing need for non-pharmacological approaches to neuropsychiatric conditions – a market with substantial growth potential given rising concerns about drug dependency and side effects.
The collaboration with UCSD and the VA system provides dual advantages: access to an appropriate patient population and enhanced credibility through association with respected research institutions. This trial design choice demonstrates strategic awareness of how to build clinical evidence most efficiently.
The technology's deployment model – non-invasive, at-home neurostimulation with remote monitoring capabilities – positions it favorably against competing approaches that require clinical settings or invasive procedures. The AI integration and patient monitoring systems suggest a data-driven approach that could help differentiate outcomes and potentially support future reimbursement claims.
For investors, this trial initiation confirms Nexalin's ability to execute on clinical development plans, though the path from early-stage clinical evaluation to commercial success remains substantial. The focus on underserved conditions with treatment options (PTSD/TBI) could potentially reduce competitive pressures if efficacy is demonstrated.
HOUSTON, TX, April 02, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that it has successfully enrolled the first patients in its clinical trial at the University of California, San Diego (UCSD), in collaboration with the VA San Diego Healthcare System (San Diego VA). The company began treatment of the first patients this week with the Nexalin HALO™.
This significant milestone marks the transition from patient recruitment to active participation in the study, which aims to evaluate Nexalin’s proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, delivered through its HALO™ Clarity devices, as a potential treatment for mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in military personnel and the civilian population. The collaboration with UCSD and the San Diego VA underscores Nexalin’s commitment to advancing breakthrough treatment options for patients who are underserved by current therapies.
Mark White, CEO of Nexalin Technology, commented, “We are thrilled to announce that the first patients have now been successfully enrolled and treatment has begun in this important clinical trial at UCSD with the new Nexalin HALO™ headset. This marks a pivotal step forward as we move toward initiating treatments to civilians and veterans struggling with TBI and PTSD. We believe this study will provide critical insights into the efficacy and safety of our innovative DIFS™ technology, helping us further validate its potential as a transformative, drug-free approach to treating mental health disorders.”
The study is designed to gather comprehensive data on the impact of Nexalin’s DIFS™ technology in treating mental health conditions, particularly for veterans and other patient populations who often face limited treatment options. The results from this clinical trial will contribute to Nexalin’s broader regulatory and commercialization strategy as the Company works toward gaining further approvals and expanding the reach of its technology.
“We are pleased to work alongside esteemed researchers at UCSD in collaboration with the San Diego VA as we advance this study,” White continued. “Our goal is to offer new hope to individuals struggling with PTSD, depression, and anxiety, and we look forward to analyzing the findings as the trial progresses.”
The trial follows the recent successful shipment and integration of Nexalin’s HALO™ Clarity devices at UCSD, where they are being used to provide non-invasive, at-home neurostimulation therapy with AI-integrated remote monitoring. Nexalin’s Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS) enable real-time tracking of patient adherence and treatment progress. As the study progresses, additional HALO™ Clarity devices will be deployed to ensure optimal patient coverage and data collection.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https://nexalin.com/.
About HALO™ Clarity
The HALO™ Clarity device currently is under evaluation, and to date, is not approved for marketing and commercial sale in the U.S. The safety and efficacy of the HALO™ Clarity device have not been fully evaluated by the FDA. For more information about the HALO Clarity device, visit www.nexalin-usa.com.
Forward-looking statements
This press release contains statements that constitute “forward-looking statements,” These statements relate to future events or Nexalin’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward-looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's Report on Form 10-K for the year ended December 31, 2024, and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC’s website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
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