Nexalin Technology Announces Completion of Phases One Through Five of its Virtual Clinic and Digital Ecosystem for HALO™ Clinical Research and Patient Management
Nexalin Technology (Nasdaq: NXL) has announced the successful completion and launch of phases one through five of its proprietary virtual clinic and digital research ecosystem. The AI-powered platform, launched at UCSD, will support the recently announced TBI/PTSD military study using the HALO™ headset.
The virtual clinic features include:
- AI-Powered Electronic Data Capture (EDC) for real-time data collection
- Remote Patient Monitoring System (PMS) for treatment oversight
- Telemedicine integration for virtual treatment
- Cloud-based compliance management
The system enables civilian and military patients to receive Deep Intracranial Frequency Stimulation (DIFS™) treatment at home while ensuring protocol compliance. This digital infrastructure manages clinical research, tracks patient progress, and optimizes treatment delivery for mental health disorders, TBI, addiction, and neurodegenerative conditions.
Nexalin Technology (Nasdaq: NXL) ha annunciato il completamento con successo e il lancio delle fasi da uno a cinque del suo esclusivo ecosistema digitale e clinica virtuale proprietaria. La piattaforma basata su intelligenza artificiale, lanciata presso UCSD, supporterà lo studio militare recentemente annunciato su TBI/PTSD utilizzando il casco HALO™.
Le caratteristiche della clinica virtuale includono:
- Acquisizione elettronica dei dati (EDC) potenziata da AI per la raccolta dati in tempo reale
- Sistema di monitoraggio remoto del paziente (PMS) per la supervisione del trattamento
- Integrazione della telemedicina per trattamenti virtuali
- Gestione della conformità basata su cloud
Il sistema consente a pazienti civili e militari di ricevere il trattamento con Stimolazione Frequenziale Intracranica Profonda (DIFS™) a domicilio, garantendo il rispetto dei protocolli. Questa infrastruttura digitale gestisce la ricerca clinica, monitora i progressi dei pazienti e ottimizza la somministrazione dei trattamenti per disturbi mentali, TBI, dipendenze e patologie neurodegenerative.
Nexalin Technology (Nasdaq: NXL) ha anunciado la finalización exitosa y el lanzamiento de las fases uno a cinco de su ecosistema digital y clínica virtual propietaria. La plataforma impulsada por IA, lanzada en UCSD, apoyará el estudio militar recientemente anunciado sobre TBI/PTSD utilizando el casco HALO™.
Las características de la clínica virtual incluyen:
- Captura electrónica de datos (EDC) potenciada por IA para la recolección de datos en tiempo real
- Sistema de monitoreo remoto de pacientes (PMS) para supervisión del tratamiento
- Integración de telemedicina para tratamientos virtuales
- Gestión de cumplimiento basada en la nube
El sistema permite que pacientes civiles y militares reciban el tratamiento de Estimulación Frecuencial Intracraneal Profunda (DIFS™) en casa, asegurando el cumplimiento del protocolo. Esta infraestructura digital gestiona la investigación clínica, realiza el seguimiento del progreso del paciente y optimiza la administración del tratamiento para trastornos mentales, TBI, adicciones y enfermedades neurodegenerativas.
Nexalin Technology (나스닥: NXL)가 독자적인 가상 클리닉 및 디지털 연구 생태계 1단계부터 5단계까지 성공적으로 완료하고 출시했다고 발표했습니다. UCSD에서 출시된 AI 기반 플랫폼은 HALO™ 헤드셋을 사용한 최근 발표된 TBI/PTSD 군사 연구를 지원할 예정입니다.
가상 클리닉의 주요 기능은 다음과 같습니다:
- 실시간 데이터 수집을 위한 AI 기반 전자 데이터 캡처(EDC)
- 치료 감독을 위한 원격 환자 모니터링 시스템(PMS)
- 가상 치료를 위한 원격의료 통합
- 클라우드 기반 준수 관리
이 시스템은 민간인과 군인이 심층 두개내 주파수 자극 치료(DIFS™)를 집에서 받으면서 프로토콜 준수를 보장할 수 있게 합니다. 이 디지털 인프라는 임상 연구를 관리하고 환자의 진행 상황을 추적하며 정신 건강 장애, TBI, 중독 및 신경퇴행성 질환 치료를 최적화합니다.
Nexalin Technology (Nasdaq : NXL) a annoncé l’achèvement réussi et le lancement des phases un à cinq de son écosystème numérique propriétaire et de sa clinique virtuelle. La plateforme alimentée par l’IA, lancée à l’UCSD, soutiendra l’étude militaire récemment annoncée sur le TBI/PTSD utilisant le casque HALO™.
Les fonctionnalités de la clinique virtuelle comprennent :
- Collecte électronique de données (EDC) assistée par IA pour la collecte de données en temps réel
- Système de surveillance à distance des patients (PMS) pour le suivi du traitement
- Intégration de la télémédecine pour les traitements virtuels
- Gestion de la conformité basée sur le cloud
Le système permet aux patients civils et militaires de recevoir un traitement par Stimulation Fréquentielle Intracrânienne Profonde (DIFS™) à domicile tout en garantissant le respect des protocoles. Cette infrastructure numérique gère la recherche clinique, suit les progrès des patients et optimise la délivrance des traitements pour les troubles mentaux, le TBI, les addictions et les maladies neurodégénératives.
Nexalin Technology (Nasdaq: NXL) hat die erfolgreiche Fertigstellung und den Start der Phasen eins bis fünf seines proprietären virtuellen Klinik- und digitalen Forschungs-Ökosystems bekannt gegeben. Die KI-gestützte Plattform, die an der UCSD eingeführt wurde, wird die kürzlich angekündigte militärische Studie zu TBI/PTSD mit dem HALO™-Headset unterstützen.
Die Funktionen der virtuellen Klinik umfassen:
- KI-gestützte elektronische Datenerfassung (EDC) zur Echtzeit-Datenerfassung
- Fernüberwachungssystem (PMS) zur Behandlungsüberwachung
- Telemedizin-Integration für virtuelle Behandlungen
- Cloud-basierte Compliance-Verwaltung
Das System ermöglicht es zivilen und militärischen Patienten, die Behandlung mit Tiefen-intrakranialer Frequenzstimulation (DIFS™) zu Hause zu erhalten und gleichzeitig die Einhaltung der Protokolle sicherzustellen. Diese digitale Infrastruktur verwaltet klinische Forschung, verfolgt den Patientenfortschritt und optimiert die Behandlung von psychischen Störungen, TBI, Suchterkrankungen und neurodegenerativen Erkrankungen.
- Launch of fully operational AI-integrated virtual clinic platform
- Expansion of clinical research capabilities with remote monitoring system
- Enhanced treatment accessibility through home-based care options
- Integration of advanced data capture and compliance management systems
- HALO™ headset still in clinical evaluation phase
- Pending regulatory approvals needed for commercialization
Insights
Nexalin's AI-powered virtual clinic platform represents a significant technological milestone that enhances research capabilities and treatment accessibility for neurological conditions.
Nexalin has achieved a strategic infrastructure milestone with the completion of its comprehensive virtual clinic ecosystem. This AI-integrated platform creates a complete digital framework for conducting decentralized clinical research while enabling remote treatment delivery—addressing key challenges in neuromodulation therapy adoption.
The system's implementation at UCSD for military TBI/PTSD research demonstrates practical deployment rather than merely conceptual development. The platform's capabilities are substantial: AI-powered data capture, remote monitoring, telemedicine integration, and cloud-based compliance management form a cohesive ecosystem supporting their proprietary Deep Intracranial Frequency Stimulation technology.
From a technological standpoint, this development significantly enhances Nexalin's operational infrastructure by enabling at-home treatment with clinical-grade oversight. The ability to monitor treatment adherence remotely while maintaining protocol compliance solves a fundamental challenge in neurological therapy delivery. This approach could substantially improve accessibility for patients with mobility limitations or those in underserved regions.
The comprehensive data collection capabilities may accelerate their clinical research pipeline by improving data quality and participant retention. While the HALO™ headset remains in the clinical evaluation phase without immediate revenue impact, this digital ecosystem establishes the operational foundation necessary for eventual commercialization and scalable deployment.
Nexalin's virtual clinic platform significantly enhances decentralized trial capabilities, potentially accelerating research timelines and improving data quality for neurological treatments.
The launch of Nexalin's virtual clinic represents a meaningful advancement in decentralized clinical trial methodology specifically tailored for neuromodulation research. By enabling fully remote research studies with the HALO™ headset, the company addresses several persistent challenges in neurological and psychiatric clinical trials.
Patient recruitment and retention—traditionally major hurdles in neuropsychiatric research—may be substantially improved through the platform's at-home treatment capabilities with remote oversight. This approach reduces participant burden while maintaining protocol integrity, particularly valuable for vulnerable populations with TBI, PTSD, or mental health disorders where site visits present significant barriers.
The AI-powered Electronic Data Capture system introduces methodological advantages through standardized, real-time collection of treatment data. This capability should enhance outcome measurement consistency and reduce missing data points—perennial challenges in neurological studies that often compromise statistical power.
Importantly, the platform has moved beyond theoretical development to actual implementation at UCSD for military TBI/PTSD research, providing real-world validation of its functionality. The system's remote monitoring capabilities enable investigators to track adherence, potentially identifying protocol deviations earlier and allowing for corrective measures.
For ongoing clinical evaluation across multiple indications—mental health disorders, TBI, addiction, and neurodegenerative conditions—this infrastructure provides operational efficiency that could accelerate research timelines. While commercial implications remain future-oriented, pending clinical validation of the HALO™ device itself, this development strengthens Nexalin's research capabilities and positions them for more efficient clinical development.
AI-Powered Platform Now Fully Operational to Support Data Capture, Remote Monitoring, and Virtual Treatment with HALO™
HOUSTON, TX, April 23, 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 the successful completion and launch of phases one through five of its proprietary virtual clinic and digital research ecosystem. The launch of Nexalin’s virtual clinic took place this week at the University of California, San Diego (UCSD) to support patient recruitment in the recently announced TBI / PTSD military study. This virtual platform will manage the real-time data capture, remote monitoring, and clinical oversight of its HALO™ headset in both research and patient treatment settings. Additionally, this virtual system will allow civilian and military patients to receive treatment in the privacy of their home while the system monitors and validates compliance with clinical research protocols.
With this fully operational AI-integrated system, Nexalin has established a comprehensive digital infrastructure to manage clinical research, track patient progress, and optimize treatment delivery—all within a secure, cloud-based environment. This milestone builds upon phase one of the virtual clinic, announced in December 2024, which introduced key components such as the Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS). Now, with the completion of phases one through five, Nexalin has significantly advanced its capabilities for fully remote research studies and streamlined patient care using its non-invasive DIFS™ technology.
Key Features of Nexalin’s Virtual Clinic and Digital Ecosystem:
- AI-Powered Electronic Data Capture (EDC): Secure, real-time collection and analysis of clinical data from HALO™ headset users to ensure adherence and efficacy tracking.
- Remote Patient Monitoring System (PMS): Allows clinicians to oversee treatment sessions, adjust protocols, and provide real-time feedback through an interactive mobile app.
- Telemedicine Integration: Enables seamless communication between patients and medical teams, supporting virtual treatment and clinical trial participation.
- Cloud-Based Compliance Management: Ensures regulatory compliance and secure data storage for clinical trials and eventual commercial deployment.
Mark White, CEO of Nexalin Technology, commented, “The successful completion of phases one through five of our virtual clinic marks a major milestone for Nexalin. With this fully integrated AI-powered platform, we can now facilitate clinical research on the HALO™ device while preparing for broader patient adoption. By creating a seamless digital environment for treatment oversight and research data collection, we are advancing clinical science and improving accessibility to our non-invasive frequency-based treatment options.”
As Nexalin’s HALO™ headset continues clinical evaluation, the expanded digital ecosystem provides research institutions, healthcare providers, and future patients with a fully integrated, technology-driven approach to treatment. The system plays a critical role in managing ongoing clinical studies evaluating the effectiveness of HALO™ for mental health disorders, traumatic brain injury (TBI), addiction, and neurodegenerative conditions.
David Owens, CMO of Nexalin Technology, added, “With this digital ecosystem fully operational, we have built a strong foundation for the future of clinical research and patient care. The combination of DIFS™ technology with a robust AI-powered virtual clinic allows us to remotely monitor treatment adherence, track patient outcomes, and optimize protocols—all while providing convenience and accessibility. This achievement moves us closer to providing innovative, non-invasive treatment solutions to those who need them most.”
The successful completion of phases one through five of Nexalin’s virtual clinic infrastructure positions the Company to further expand research collaborations, advance regulatory approvals, and accelerate commercialization efforts for HALO™ and future DIFS™ technology applications.
For more information about Nexalin Technology and its innovative digital treatment ecosystem, visit www.nexalin.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, 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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