Nexalin Technology Announces Initiation of Patient Recruitment for UCSD’s TBI & PTSD Clinical Study Following IRB Approval
Nexalin Technology (NXL) has initiated patient recruitment for a clinical trial at the University of California, San Diego (UCSD) following IRB approval. The study will evaluate the company's HALO™ Clarity device for treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in military and civilian populations.
The trial will test Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, which provides non-invasive deep-brain stimulation without drugs or invasive procedures. The first batch of HALO devices has been delivered, randomized, and integrated with app-controlled remote monitoring. An additional 40-50 devices will be supplied as the study progresses.
Key features of the HALO™ Clarity device include:
- Non-invasive, drug-free therapy
- At-home usage capability
- AI-integrated remote monitoring through Electronic Data Capture platform
Nexalin Technology (NXL) ha avviato il reclutamento di pazienti per uno studio clinico presso l'Università della California, San Diego (UCSD) dopo l'approvazione del comitato etico. Lo studio valuterà il dispositivo HALO™ Clarity dell'azienda per il trattamento di lesioni cerebrali traumatiche lievi (mTBI) e disturbo da stress post-traumatico (PTSD) in popolazioni militari e civili.
La sperimentazione testerà la tecnologia proprietaria di Nexalin, Deep Intracranial Frequency Stimulation (DIFS™), che fornisce stimolazione cerebrale profonda non invasiva senza farmaci o procedure invasive. Il primo lotto di dispositivi HALO è stato consegnato, randomizzato e integrato con un monitoraggio remoto controllato da app. Ulteriori 40-50 dispositivi saranno forniti man mano che lo studio avanza.
Le caratteristiche principali del dispositivo HALO™ Clarity includono:
- Terapia non invasiva e priva di farmaci
- Possibilità di utilizzo a casa
- Monitoraggio remoto integrato con intelligenza artificiale tramite piattaforma di acquisizione dati elettronici
Nexalin Technology (NXL) ha iniciado el reclutamiento de pacientes para un ensayo clínico en la Universidad de California, San Diego (UCSD) tras la aprobación de la junta de ética. El estudio evaluará el dispositivo HALO™ Clarity de la compañía para el tratamiento de lesiones cerebrales traumáticas leves (mTBI) y trastorno de estrés postraumático (PTSD) en poblaciones militares y civiles.
El ensayo probará la tecnología patentada de Nexalin, Deep Intracranial Frequency Stimulation (DIFS™), que proporciona estimulación cerebral profunda no invasiva sin medicamentos ni procedimientos invasivos. El primer lote de dispositivos HALO ha sido entregado, randomizado e integrado con monitoreo remoto controlado por aplicación. Se suministrarán 40-50 dispositivos adicionales a medida que avance el estudio.
Las características clave del dispositivo HALO™ Clarity incluyen:
- Terapia no invasiva y sin medicamentos
- Capacidad de uso en casa
- Monitoreo remoto integrado con inteligencia artificial a través de la plataforma de Captura de Datos Electrónicos
Nexalin Technology (NXL)는 IRB 승인을 받은 후 샌디에이고 캘리포니아 대학교(UCSD)에서 임상 시험을 위한 환자 모집을 시작했습니다. 이 연구는 군 및 민간 인구에서 경미한 외상성 뇌 손상(mTBI) 및 외상 후 스트레스 장애(PTSD) 치료를 위한 회사의 HALO™ Clarity 장치를 평가할 것입니다.
시험은 약물이나 침습적 절차 없이 비침습적인 심부 뇌 자극을 제공하는 Nexalin의 독점 기술인 Deep Intracranial Frequency Stimulation (DIFS™)를 시험합니다. 첫 번째 HALO 장치 배치는 전달되어 무작위화되었으며 앱 제어 원격 모니터링과 통합되었습니다. 연구가 진행됨에 따라 추가로 40-50개의 장치가 공급될 예정입니다.
HALO™ Clarity 장치의 주요 기능은 다음과 같습니다:
- 비침습적이며 약물이 필요 없는 치료
- 집에서 사용 가능
- 전자 데이터 수집 플랫폼을 통한 AI 통합 원격 모니터링
Nexalin Technology (NXL) a lancé le recrutement de patients pour un essai clinique à l'Université de Californie, San Diego (UCSD) après l'approbation du comité d'éthique. L'étude évaluera le dispositif HALO™ Clarity de l'entreprise pour le traitement des lésions cérébrales traumatiques légères (mTBI) et du trouble de stress post-traumatique (PTSD) dans les populations militaires et civiles.
L'essai testera la technologie propriétaire de Nexalin, Deep Intracranial Frequency Stimulation (DIFS™), qui offre une stimulation cérébrale profonde non invasive sans médicaments ni procédures invasives. Le premier lot de dispositifs HALO a été livré, randomisé et intégré avec un suivi à distance contrôlé par application. Quarante à cinquante dispositifs supplémentaires seront fournis au fur et à mesure de l'avancement de l'étude.
Les caractéristiques clés du dispositif HALO™ Clarity comprennent:
- Thérapie non invasive et sans médicaments
- Possibilité d'utilisation à domicile
- Suivi à distance intégré avec intelligence artificielle via la plateforme de capture de données électroniques
Nexalin Technology (NXL) hat die Rekrutierung von Patienten für eine klinische Studie an der Universität von Kalifornien, San Diego (UCSD) nach der Genehmigung durch die Ethikkommission gestartet. Die Studie wird das HALO™ Clarity Gerät des Unternehmens zur Behandlung von leichten traumatischen Hirnverletzungen (mTBI) und posttraumatischen Belastungsstörungen (PTBS) in militärischen und zivilen Bevölkerungsgruppen bewerten.
Die Studie wird die proprietäre Technologie von Nexalin, Deep Intracranial Frequency Stimulation (DIFS™), testen, die eine nicht-invasive tiefen Hirnstimulation ohne Medikamente oder invasive Verfahren bietet. Die erste Charge von HALO-Geräten wurde geliefert, randomisiert und mit einer app-gesteuerten Fernüberwachung integriert. Weitere 40-50 Geräte werden im Verlauf der Studie bereitgestellt.
Wichtige Merkmale des HALO™ Clarity Geräts sind:
- Nicht-invasive, medikamentenfreie Therapie
- Fähigkeit zur Anwendung zu Hause
- KI-integrierte Fernüberwachung über die Plattform zur elektronischen Datenerfassung
- IRB approval received for clinical trial initiation
- First shipment of HALO devices successfully delivered
- Remote monitoring system integration completed
- Expansion potential with 40-50 additional devices planned
- Product not yet FDA approved
- Clinical trial outcomes uncertain
- Timeline for study completion not specified
Insights
Nexalin's announcement marks a critical inflection point in the company's clinical development pathway. Following IRB approval, the shipment of HALO™ Clarity devices to UCSD and initiation of patient recruitment represents significant progress in validating their proprietary Deep Intracranial Frequency Stimulation technology for TBI and PTSD treatment.
What makes this particularly significant is the focus on dual-market opportunities across both military and civilian populations. TBI and PTSD represent substantial unmet medical needs with effective treatment options, creating a potentially valuable niche if clinical data proves favorable.
The company's technology offers three key differentiators: non-invasive application, home-based delivery, and AI-integrated monitoring. This aligns with healthcare's broader shift toward remote care models and non-pharmaceutical interventions for neurological conditions.
However, investors should recognize important caveats. This represents an early-stage clinical validation step, with the explicit statement that the device remains unapproved by the FDA. With a modest
This milestone advances Nexalin's validation pathway but should be viewed within the context of a longer regulatory journey before commercial potential can be realized.
The commencement of patient recruitment following IRB approval represents a significant advancement for Nexalin's DIFS™ technology. The non-invasive approach to deep brain stimulation addresses a fundamental challenge in neurostimulation therapy – delivering effective treatment without surgical intervention or pharmaceutical side effects.
TBI and PTSD present particularly complex treatment challenges due to their multifaceted pathophysiology. Current treatment options often yield inconsistent results, creating substantial opportunity for innovative approaches like Nexalin's. The military application is especially noteworthy given the prevalence of these conditions among service members.
The technology's integration of remote monitoring capabilities through their Electronic Data Capture platform adds valuable clinical oversight while potentially generating robust real-world data. This could prove instrumental not only for regulatory purposes but also for refining treatment protocols and demonstrating real-world effectiveness.
From a scientific perspective, independent validation through UCSD adds important credibility to Nexalin's approach. The university's willingness to conduct this study following initial pilot testing suggests the technology demonstrated sufficient promise in preliminary evaluation to warrant further investigation. However, the ultimate value will depend on the study's design rigor, participant numbers, and statistical power – details not specified in this announcement.
HALO™ Clarity Devices Successfully Shipped for First Phase of Clinical Trials
HOUSTON, TX, Feb. 28, 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 following Institutional Review Board (IRB) approval, the University of California, San Diego (UCSD) has received the first shipment of HALO™ Clarity devices to commence its clinical trial evaluating the treatment of mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) in military personnel and the civilian population. Patient recruitment for the study is now set to begin immediately.
This milestone follows the successful IRB approval, pilot testing and evaluation of Nexalin’s Halo technology at UCSD. The study will evaluate Nexalin’s proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology, which delivers non-invasive deep-brain stimulation without the use of drugs or invasive procedures.
The initial devices have been randomized and integrated with Nexalin’s app-controlled remote monitoring system, ensuring seamless oversight of treatment adherence and progress. An additional 40-50 HALO devices will be delivered as the study progresses.
Key Advantages of the HALO™ Clarity Device Include:
- Non-Invasive Therapy – A drug-free alternative for neurological and mental health conditions, reducing side effects associated with traditional treatments.
- At-Home Convenience – Designed for easy use in a home setting, increasing patient compliance and accessibility.
- AI-Integrated Remote Monitoring – Enables real-time data capture and physician oversight through Nexalin’s advanced Electronic Data Capture (EDC) platform and Patient Monitoring System (PMS).
Mark White, CEO of Nexalin Technology, stated, “The initiation of patient recruitment marks a major milestone in the validation of our HALO Clarity device for TBI and PTSD treatment. UCSD’s independent study is a crucial step in demonstrating the transformative potential of our Deep Intracranial Frequency Stimulation (DIFS) technology for military personnel and others affected by these conditions. With this deployment, we are moving closer to making non-invasive deep brain stimulation an accessible, real-world solution for those in need.”
David Owens, CMO of Nexalin Technology, added, “We are delighted to see the first HALO devices in place for clinical use. The combination of DIFS technology with our advanced virtual clinic model enables real-time tracking of patient progress while providing a seamless, patient-centered treatment experience. We look forward to the data from this study as we continue to push the boundaries of neurostimulation for neurological and mental health care.”
Nexalin remains committed to pioneering cutting-edge neurostimulation 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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