Nexalin Technology Receives IRB Approval in Brazil and Begins Clinical Trial for Anxiety and Insomnia
Nexalin Technology (Nasdaq: NXL) has received institutional review board (IRB) approval in Brazil to begin a Phase II clinical trial for its Gen-2 neurostimulation device. The study will evaluate the treatment of anxiety disorders and chronic insomnia at the Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo.
The trial will enroll 30 adult patients to assess the efficacy of Nexalin's Deep Intracranial Frequency Stimulation (DIFS™) technology. The primary endpoint will measure anxiety reduction using the Hamilton Anxiety Rating Scale (HAM-A), with secondary endpoints including assessments of depression symptoms, sleep quality, and clinical improvement.
Led by Dr. Andre Russowsky Brunoni, the study marks Nexalin's first IRB-approved trial in Brazil. The first device has been shipped to São Paulo, with additional units and disposable electrodes scheduled for delivery soon. Results will be published in a peer-reviewed scientific journal.
Nexalin Technology (Nasdaq: NXL) ha ottenuto l'approvazione del comitato etico istituzionale (IRB) in Brasile per avviare uno studio clinico di Fase II sul suo dispositivo di neurostimolazione di seconda generazione. Lo studio valuterà il trattamento dei disturbi d'ansia e dell'insonnia cronica presso l'Istituto di Psichiatria dell'Ospedale das Clínicas della Facoltà di Medicina dell'Università di São Paulo.
La sperimentazione recluterà 30 pazienti adulti per valutare l'efficacia della tecnologia Deep Intracranial Frequency Stimulation (DIFS™) di Nexalin. L'endpoint primario misurerà la riduzione dell'ansia utilizzando la Scala di Valutazione dell'Ansia di Hamilton (HAM-A), mentre gli endpoint secondari includeranno la valutazione dei sintomi depressivi, della qualità del sonno e del miglioramento clinico.
Guidato dal dott. Andre Russowsky Brunoni, lo studio rappresenta la prima sperimentazione approvata dall'IRB di Nexalin in Brasile. Il primo dispositivo è stato spedito a São Paulo, con ulteriori unità ed elettrodi monouso in consegna a breve. I risultati saranno pubblicati su una rivista scientifica peer-reviewed.
Nexalin Technology (Nasdaq: NXL) ha recibido la aprobación del comité de ética institucional (IRB) en Brasil para iniciar un ensayo clínico de Fase II con su dispositivo de neuroestimulación de segunda generación. El estudio evaluará el tratamiento de trastornos de ansiedad e insomnio crónico en el Instituto de Psiquiatría del Hospital das Clínicas de la Facultad de Medicina de la Universidad de São Paulo.
El ensayo incluirá a 30 pacientes adultos para evaluar la eficacia de la tecnología Deep Intracranial Frequency Stimulation (DIFS™) de Nexalin. El objetivo principal será medir la reducción de la ansiedad mediante la Escala de Evaluación de Ansiedad de Hamilton (HAM-A), mientras que los objetivos secundarios incluirán evaluaciones de síntomas depresivos, calidad del sueño y mejoría clínica.
Liderado por el Dr. Andre Russowsky Brunoni, el estudio representa el primer ensayo aprobado por el IRB de Nexalin en Brasil. El primer dispositivo ha sido enviado a São Paulo, y se espera la entrega de unidades adicionales y electrodos desechables pronto. Los resultados se publicarán en una revista científica revisada por pares.
Nexalin Technology (나스닥: NXL)가 브라질에서 기관심사위원회(IRB) 승인을 받아 2세대 신경자극기기의 2상 임상시험을 시작하게 되었습니다. 이 연구는 상파울루 대학교 의과대학 병원 클리닉 정신의학 연구소에서 불안장애와 만성 불면증 치료를 평가할 예정입니다.
이번 임상시험에는 성인 환자 30명이 참여하여 Nexalin의 심부 두개내 주파수 자극(DIFS™) 기술의 효능을 평가합니다. 주요 평가지표는 해밀턴 불안 평가 척도(HAM-A)를 사용한 불안 감소이며, 부차적 평가지표로는 우울 증상, 수면 질, 임상적 개선도 등이 포함됩니다.
Andre Russowsky Brunoni 박사가 주도하는 이번 연구는 Nexalin이 브라질에서 IRB 승인을 받은 첫 임상시험입니다. 첫 번째 장치는 상파울루로 배송되었으며, 추가 장치와 일회용 전극도 곧 배송될 예정입니다. 결과는 동료 심사 과학 저널에 게재될 예정입니다.
Nexalin Technology (Nasdaq : NXL) a obtenu l'approbation du comité d'éthique institutionnel (IRB) au Brésil pour lancer un essai clinique de phase II avec son dispositif de neurostimulation de deuxième génération. L'étude évaluera le traitement des troubles anxieux et de l'insomnie chronique à l'Instituto de Psiquiatria de l'Hospital das Clínicas de la Faculté de Médecine de l'Université de São Paulo.
L'essai recrutera 30 patients adultes afin d'évaluer l'efficacité de la technologie Deep Intracranial Frequency Stimulation (DIFS™) de Nexalin. Le critère principal sera la réduction de l'anxiété mesurée par l'échelle d'évaluation de l'anxiété de Hamilton (HAM-A), tandis que les critères secondaires incluront l'évaluation des symptômes dépressifs, de la qualité du sommeil et de l'amélioration clinique.
Dirigée par le Dr Andre Russowsky Brunoni, cette étude est la première autorisée par l'IRB pour Nexalin au Brésil. Le premier appareil a été expédié à São Paulo, d'autres unités et des électrodes jetables devant être livrées prochainement. Les résultats seront publiés dans une revue scientifique à comité de lecture.
Nexalin Technology (Nasdaq: NXL) hat in Brasilien die Genehmigung der Ethikkommission (IRB) erhalten, um eine Phase-II-Studie mit seinem Neurostimulationsgerät der zweiten Generation zu starten. Die Studie wird die Behandlung von Angststörungen und chronischer Insomnie am Instituto de Psiquiatria des Hospital das Clínicas der Medizinischen Fakultät der Universität São Paulo evaluieren.
Die Studie wird 30 erwachsene Patienten einschließen, um die Wirksamkeit der Deep Intracranial Frequency Stimulation (DIFS™) Technologie von Nexalin zu bewerten. Der primäre Endpunkt ist die Messung der Angstreduktion mittels Hamilton-Angstbewertungsskala (HAM-A), sekundäre Endpunkte umfassen die Bewertung von Depressionssymptomen, Schlafqualität und klinischer Verbesserung.
Leitung hat Dr. Andre Russowsky Brunoni, die Studie ist die erste von Nexalin in Brasilien genehmigte IRB-Studie. Das erste Gerät wurde nach São Paulo versandt, weitere Einheiten und Einweg-Elektroden werden bald geliefert. Die Ergebnisse werden in einer begutachteten wissenschaftlichen Fachzeitschrift veröffentlicht.
- First IRB approval in Brazil expands international presence
- Partnership with prestigious Latin American psychiatric research institution
- Trial targets two common comorbid conditions with significant market potential
- Non-invasive treatment approach offers competitive advantage
- Small trial size of only 30 patients may limit statistical significance
- Results not expected immediately as publication pending peer review
- Early Phase II stage indicates long pathway to potential commercialization
Insights
Nexalin achieves significant development milestone with IRB approval for anxiety/insomnia trial in Brazil, expanding clinical validation of its neurostimulation technology.
Nexalin Technology's receipt of institutional review board (IRB) approval in Brazil marks a concrete advancement in their clinical development pathway. This Phase II trial, targeting both anxiety disorders and chronic insomnia, represents the company's first regulatory milestone in Latin America and expands their international clinical footprint.
The selection of Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IPq-HCFMUSP) as the research site is strategically significant. This institution stands among Latin America's most prestigious psychiatric research centers, lending scientific credibility to the trial. Additionally, securing Dr. Andre Russowsky Brunoni—a globally recognized neuromodulation expert who will soon join UT Southwestern—as lead investigator further strengthens the study's scientific foundation.
From a development perspective, the trial's design demonstrates methodological rigor with clearly defined endpoints. The primary outcome measure (reduction in anxiety symptoms via HAM-A scale) and comprehensive secondary endpoints provide a robust framework for evaluating both psychiatric and sleep-related outcomes. The 30-patient sample size is appropriate for a Phase II efficacy signal-seeking study in this therapeutic area.
For medical device companies like Nexalin (market cap:
This development positions Nexalin to potentially address significant unmet needs in mental health treatment, particularly for conditions where non-invasive, non-pharmacological options could offer advantages. While the study's completion and results remain future events, securing formal approval to proceed represents meaningful progress in Nexalin's product development lifecycle.
HOUSTON, TX, April 24, 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 its proprietary Gen-2 neurostimulation device has received institutional review board (IRB) approval in Brazil for a new clinical trial evaluating its use in the treatment of anxiety disorders and chronic insomnia. The study will be conducted at the Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IPq-HCFMUSP), one of Latin America’s most prestigious psychiatric research institutions.
The first Nexalin device has been shipped to São Paulo, Brazil, with additional units and single-use disposable electrodes scheduled for delivery in the coming days. These shipments support the launch of a Phase II clinical trial in adult patients suffering from anxiety and insomnia—two conditions that are frequently comorbid and significantly affect quality of life.
“We are excited to partner with IPq-HCFMUSP on this landmark study,” said Mark White, CEO of Nexalin. “This is a key milestone in our international strategy, as we expand the clinical evaluation of our second-generation neurostimulation technology. Brazil is an important emerging market for mental health innovation, and this collaboration marks our first IRB-approved study in the region.”
The Phase II study will enroll 30 adults in São Paulo and assess the efficacy of Nexalin’s non-invasive brain stimulation in reducing anxiety symptoms and improving sleep quality. The trial’s primary endpoint is a reduction in anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A) at baseline, after treatment, and at a four-week follow-up. Secondary endpoints include assessments of depressive symptoms, sleep onset latency, total sleep time, overall sleep quality, and clinical impression of improvement.
“This trial is the first in Brazil to use Nexalin’s Gen-2, 15 mA device,” added Mr. White. “We view this as a strong validation of our global regulatory and clinical strategy as we continue to explore broader applications for our non-invasive technology.”
The study is led by Dr. Andre Russowsky Brunoni, MD, PhD, MBA, a globally recognized expert in neuromodulation and interventional psychiatry. Dr. Brunoni currently serves as Director of the Interventional Psychiatry Division at IPq-HCFMUSP and will join UT Southwestern in June 2025 as Professor of Psychiatry and of the Peter O’Donnell Jr. Brain Institute.
Dr. Brunoni commented, “Anxiety and insomnia are very common conditions that often occur together and cause significant distress. In this study, we are testing a new, non‑invasive brain stimulation technology that has shown promising results in recent research. Our goal is to offer a safe, painless, and accessible alternative to improve people’s well‑being and sleep quality.”
Results from the study are expected to be published in a peer-reviewed scientific journal.
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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