Nexalin Technology Announces UCSD IRB Approval for use of HALO™ Clarity in Clinical Trials for mTBI and PTSD Treatment
Nexalin Technology (NXL) has received IRB approval from UCSD for clinical testing of its HALO™ Clarity headset. UCSD will conduct independent research using 50 HALO devices to evaluate its efficacy in treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel.
The HALO device utilizes Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS) technology, offering non-invasive, drug-free brain stimulation. The system includes a virtual clinic model featuring AI integration, patient monitoring, and telemedicine capabilities through a smartphone application.
Key features include at-home treatment administration, remote physician monitoring, and an AI-powered Electronic Data Capture platform. The device is currently under FDA evaluation and not yet approved for these uses in the United States.
Nexalin Technology (NXL) ha ricevuto l'approvazione dell'IRB da UCSD per la sperimentazione clinica del suo HALO™ Clarity headset. UCSD condurrà una ricerca indipendente utilizzando 50 dispositivi HALO per valutare la sua efficacia nel trattamento di lesioni cerebrali traumatiche lievi (mTBI) e disturbo da stress post-traumatico (PTSD), in particolare nel personale militare.
Il dispositivo HALO utilizza la tecnologia proprietaria di Nexalin, Deep Intracranial Frequency Stimulation (DIFS), che offre una stimolazione cerebrale non invasiva e priva di farmaci. Il sistema include un modello di clinica virtuale con integrazione dell'IA, monitoraggio dei pazienti e capacità di telemedicina attraverso un'applicazione per smartphone.
Le caratteristiche principali includono l'amministrazione del trattamento a casa, il monitoraggio remoto da parte dei medici e una piattaforma di acquisizione elettronica dei dati alimentata dall'IA. Il dispositivo è attualmente in fase di valutazione da parte della FDA e non è ancora approvato per questi usi negli Stati Uniti.
Nexalin Technology (NXL) ha recibido la aprobación del IRB de UCSD para las pruebas clínicas de su HALO™ Clarity headset. UCSD llevará a cabo una investigación independiente utilizando 50 dispositivos HALO para evaluar su eficacia en el tratamiento de lesiones cerebrales traumáticas leves (mTBI) y trastorno de estrés postraumático (PTSD), especialmente en personal militar.
El dispositivo HALO utiliza la tecnología patentada de Nexalin, Deep Intracranial Frequency Stimulation (DIFS), que ofrece estimulación cerebral no invasiva y libre de medicamentos. El sistema incluye un modelo de clínica virtual con integración de IA, monitoreo de pacientes y capacidades de telemedicina a través de una aplicación para smartphone.
Las características clave incluyen la administración del tratamiento en casa, el monitoreo remoto por parte de médicos y una plataforma de Captura Electrónica de Datos impulsada por IA. El dispositivo está actualmente en evaluación por la FDA y aún no está aprobado para estos usos en los Estados Unidos.
Nexalin Technology (NXL)는 UCSD로부터 HALO™ Clarity 헤드셋의 임상 시험에 대한 IRB 승인을 받았습니다. UCSD는 50개의 HALO 장치를 사용하여 경미한 외상성 뇌손상(mTBI) 및 외상 후 스트레스 장애(PTSD) 치료의 효능을 평가하는 독립 연구를 수행할 예정입니다. 특히 군인들에 중점을 두고 있습니다.
HALO 장치는 Nexalin의 독점 기술인 Deep Intracranial Frequency Stimulation (DIFS)를 활용하여 비침습적이고 약물 없는 뇌 자극을 제공합니다. 이 시스템은 AI 통합, 환자 모니터링 및 스마트폰 애플리케이션을 통한 원격 의료 기능을 갖춘 가상 클리닉 모델을 포함합니다.
주요 기능에는 자택 치료 관리, 원격 의사 모니터링 및 AI 기반 전자 데이터 수집 플랫폼이 포함됩니다. 이 장치는 현재 FDA 평가 중이며, 미국 내에서 이러한 용도로는 아직 승인이 나지 않았습니다.
Nexalin Technology (NXL) a reçu l'approbation de l'IRB par l'UCSD pour des essais cliniques de son HALO™ Clarity casque. L'UCSD mènera une recherche indépendante en utilisant 50 appareils HALO pour évaluer leur efficacité dans le traitement des lésions cérébrales traumatiques légères (mTBI) et du trouble de stress post-traumatique (PTSD), en particulier chez le personnel militaire.
Le dispositif HALO utilise la technologie propriétaire de Nexalin, Deep Intracranial Frequency Stimulation (DIFS), offrant une stimulation cérébrale non invasive et sans médicament. Le système comprend un modèle de clinique virtuelle intégrant l'IA, le suivi des patients et des capacités de télémédecine via une application pour smartphone.
Les caractéristiques clés incluent l'administration du traitement à domicile, le suivi à distance par des médecins et une plateforme de capture de données électroniques alimentée par l'IA. Le dispositif est actuellement en évaluation par la FDA et n'est pas encore approuvé pour ces usages aux États-Unis.
Nexalin Technology (NXL) hat die IRB-Zulassung von UCSD für klinische Tests mit seinem HALO™ Clarity Headset erhalten. UCSD wird unabhängige Forschungen mit 50 HALO-Geräten durchführen, um deren Wirksamkeit bei der Behandlung von leichten traumatischen Hirnverletzungen (mTBI) und posttraumatischen Belastungsstörungen (PTSD), insbesondere bei Militärpersonal, zu bewerten.
Das HALO-Gerät nutzt die proprietäre Technologie von Nexalin, Deep Intracranial Frequency Stimulation (DIFS), die nicht-invasive und medikamentenfreie Gehirnstimulation bietet. Das System umfasst ein virtuelles Klinikmodell mit KI-Integration, Patientenüberwachung und Telemedizin-Funktionen über eine Smartphone-Anwendung.
Zu den Hauptmerkmalen gehören die Behandlung zu Hause, die Fernüberwachung durch Ärzte und eine KI-gestützte Plattform zur elektronischen Datenerfassung. Das Gerät befindet sich derzeit in der FDA-Bewertung und ist für diese Anwendungen in den Vereinigten Staaten noch nicht zugelassen.
- Received IRB approval from UCSD for clinical testing
- Secured deployment of 50 HALO devices for independent research
- Developed virtual clinic model with AI integration and remote monitoring capabilities
- Product not yet FDA approved for intended uses
- Company not controlling or directing the study outcomes
- Dependent on third-party research results for validation
Insights
The UCSD IRB approval marks a important advancement for Nexalin's HALO device, opening the path for clinical validation in a prestigious academic setting. The independent nature of UCSD's research adds credibility to potential findings, while the deployment of 50 devices indicates a substantial initial trial scope.
The company's innovative approach combines two significant technological advantages: Deep Intracranial Frequency Stimulation (DIFS) technology for non-invasive neuromodulation and an AI-powered virtual clinic model. This dual innovation addresses both treatment efficacy and healthcare delivery efficiency, potentially positioning Nexalin favorably in the competitive neuromodulation market.
The strategic focus on mTBI and PTSD in military personnel is particularly noteworthy for several reasons:
- The military represents a well-defined patient population with high treatment needs and established funding channels
- Success in military applications could facilitate expansion into civilian markets
- The remote treatment capability addresses accessibility challenges often faced by military personnel
The virtual clinic model, incorporating AI-driven monitoring and telemedicine capabilities, could significantly reduce the cost and complexity of both clinical trials and eventual treatment delivery. This approach aligns with broader healthcare trends toward remote patient monitoring and data-driven treatment optimization.
However, investors should note that significant milestones remain before commercialization. The device still requires FDA approval, and the timeline for completing clinical trials and achieving regulatory clearance could extend several years. The company's ability to scale manufacturing for the initial 50 devices and potential future demand will be important for long-term success.
HOUSTON, TX, Feb. 18, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, announces that it has received Institutional Review Board (IRB) approval from the University of California, San Diego (UCSD) for clinical testing of its HALO™ Clarity (HALO) headset in human subjects. This study is being conducted independently by UCSD. Nexalin is providing the HALO devices for research purposes but is not sponsoring, directing, or controlling the study or its outcomes. This approval follows a successful pilot testing protocol conducted with UCSD’s research team.
With this critical milestone achieved, UCSD has requested and will receive 50 HALO devices from Nexalin for this independent research project. Nexalin and its manufacturing partner have begun preparing the initial shipment of 50 HALO devices to UCSD. These devices will be deployed in upcoming clinical trials evaluating the efficacy of HALO in treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD), particularly in military personnel.
The HALO™ Clarity is powered by Nexalin’s proprietary Deep Intracranial Frequency Stimulation (DIFS) technology, delivering non-invasive, deep-brain stimulation without the use of drugs or invasive procedures. Key advantages include:
- Non-Invasive Treatment – Provides a drug-free alternative for mental health care, reducing the risk of side effects associated with pharmacological treatments.
- At-Home Use – Designed for patient comfort and convenience, allowing treatments to be administered in the privacy of one's home.
- Remote Monitoring – Equipped with capabilities for physicians to monitor patient progress remotely, ensuring continuous care and support.
Nexalin has developed a virtual clinic model that leverages artificial intelligence (AI) and a proprietary Electronic Data Capture (EDC) platform to enhance patient care:
- AI Integration – Utilizes AI to facilitate real-time data acquisition and analysis during clinical trials, improving efficiency and compliance.
- Patient Monitoring System (PMS) – An interactive smartphone application allows clinicians to monitor adherence to treatment protocols and make necessary adjustments in real time.
- Telemedicine Capabilities – Enables direct communication between patients and clinical teams, providing personalized care and support throughout the treatment process.
This virtual clinic model is designed to conduct the entire clinical trial process—and ultimately the treatment experience—remotely, ensuring accessibility while providing physicians with real-time digital data related to the patient’s treatment progress.
“The IRB approval from UCSD represents a significant step forward in validating the potential of our DIFS-powered HALO technology,” said Mark White, CEO of Nexalin Technology. “This approval underscores our commitment to delivering innovative, non-invasive solutions for mental health and neurological disorders. The independent study at UCSD will explore the potential of HALO in treating mTBI and PTSD. This trial at UCSD will provide essential data to further establish HALO as a revolutionary treatment option for military personnel and others suffering from mTBI and PTSD.”
David Owens, CMO of Nexalin Technology, added, “With the deployment of our first 50 HALO devices to UCSD, we are embarking on a critical phase in our mission to redefine neurostimulation therapy. The combination of DIFS technology with our virtual clinic model allows us to bring treatment into the homes of patients, ensuring accessibility, convenience, and enhanced patient outcomes. We look forward to the insights this independent research will provide regarding the HALO device's application The upcoming independent clinical trial at UCSD will provide further insights into the safety and effectiveness of HALO, building upon prior research that has demonstrated DIFS technology’s ability to modulate neural activity and support brain health without adverse side effects."
Nexalin remains committed to pioneering cutting-edge neuromodulation technologies to address unmet needs in mental health and neurological care.
The HALO device is currently under evaluation and not yet approved by the FDA for these uses in the United States.
For more information about Nexalin Technology and the HALO device, visit www.nexalin-usa.com.
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/.
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, 2023, 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
FAQ
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