Nexalin Technology CEO Mark White Issues Letter to Shareholders Highlighting Recent Achievements and Outlook for 2025
Nexalin Technology (NXL) has released a shareholder letter highlighting achievements and 2025 outlook. The company's Deep Intracranial Frequency Stimulation (DIFS) technology has shown significant results in mental health treatment, achieving a 65% response rate in depression trials. Their Gen-3 Halo headset delivers a proprietary 15 mA waveform that's 5-10 times more powerful than existing devices.
Key developments include: launching a virtual clinic with AI integration, conducting 29 IRB-approved clinical trials, and receiving regulatory approvals in China, Brazil, and Oman. The company is pursuing CE Mark approval for European market entry in 2025. Research shows promising results in Alzheimer's treatment, with increased brain activity in memory-related areas. The company is also focusing on PTSD and TBI research through collaborations with UC San Diego and the VA.
With the neuromodulation market projected to reach $11 billion by 2028, Nexalin aims to expand its global presence while advancing research in mood disorders, Alzheimer's, and addiction treatment.
Nexalin Technology (NXL) ha pubblicato una lettera agli azionisti evidenziando risultati e prospettive per il 2025. La tecnologia Deep Intracranial Frequency Stimulation (DIFS) dell'azienda ha mostrato risultati significativi nel trattamento della salute mentale, raggiungendo un 65% di tasso di risposta negli studi sulla depressione. Il loro headset Gen-3 Halo offre un'onda proprietaria da 15 mA, da 5 a 10 volte più potente rispetto ai dispositivi esistenti.
Sviluppi chiave includono: il lancio di una clinica virtuale con integrazione AI, la conduzione di 29 studi clinici approvati dall'IRB e il ricevimento di approvazioni regolatorie in Cina, Brasile e Oman. L'azienda sta perseguendo l'approvazione CE per l'ingresso nel mercato europeo nel 2025. Le ricerche mostrano risultati promettenti nel trattamento dell'Alzheimer, con incremento dell'attività cerebrale nelle aree legate alla memoria. L'azienda si sta anche concentrando sulla ricerca su PTSD e TBI attraverso collaborazioni con UC San Diego e il VA.
Con il mercato della neuromodulazione previsto per raggiungere $11 miliardi entro il 2028, Nexalin punta ad espandere la propria presenza globale mentre avanza nella ricerca su disturbi dell'umore, Alzheimer e trattamento delle dipendenze.
Nexalin Technology (NXL) ha lanzado una carta a los accionistas destacando logros y perspectivas para 2025. La tecnología Deep Intracranial Frequency Stimulation (DIFS) de la compañía ha mostrado resultados significativos en el tratamiento de la salud mental, alcanzando una tasa de respuesta del 65% en ensayos sobre depresión. Su auricular Gen-3 Halo proporciona una forma de onda propietaria de 15 mA que es de 5 a 10 veces más potente que los dispositivos existentes.
Los desarrollos clave incluyen: el lanzamiento de una clínica virtual con integración de IA, la realización de 29 ensayos clínicos aprobados por el IRB y la obtención de aprobaciones regulatorias en China, Brasil y Omán. La empresa está buscando la aprobación CE para ingresar al mercado europeo en 2025. Las investigaciones muestran resultados prometedores en el tratamiento del Alzheimer, con un aumento de la actividad cerebral en áreas relacionadas con la memoria. La compañía también se está enfocando en la investigación sobre el TEP y la TBI a través de colaboraciones con UC San Diego y el VA.
Con el mercado de la neuromodulación proyectado para alcanzar $11 mil millones para 2028, Nexalin busca expandir su presencia global mientras avanza en la investigación de trastornos del estado de ánimo, Alzheimer y tratamiento de adicciones.
Nexalin Technology (NXL)는 성과 및 2025년 전망을 강조하는 주주 서한을 발표했습니다. 회사의 Deep Intracranial Frequency Stimulation (DIFS) 기술은 정신 건강 치료에서 중요한 결과를 보여주었으며, 우울증 시험에서 65%의 반응률을 달성했습니다. 그들의 Gen-3 Halo 헤드셋은 기존 장치보다 5-10배 더 강력한 15 mA 파형을 제공합니다.
주요 발전 사항으로는 AI 통합 가상 클리닉 출범, 29건의 IRB 승인 임상 시험 진행, 중국, 브라질 및 오만에서의 규제 승인 획득이 포함됩니다. 회사는 2025년 유럽 시장 진입을 위한 CE 마크 승인을 추구하고 있습니다. 연구는 알츠하이머 치료에서 유망한 결과를 보여주며, 기억 관련 영역에서 뇌 활동이 증가했습니다. 이 회사는 UC 샌디에이고와 VA와 협력하여 PTSD 및 TBI 연구에도 집중하고 있습니다.
신경 조절 시장이 2028년까지 110억 달러에 이를 것으로 예상되는 가운데, Nexalin은 기분 장애, 알츠하이머 및 중독 치료 연구를 발전시키면서 글로벌 입지를 확장하는 것을 목표로 하고 있습니다.
Nexalin Technology (NXL) a publié une lettre aux actionnaires soulignant ses réalisations et ses perspectives pour 2025. La technologie Deep Intracranial Frequency Stimulation (DIFS) de l'entreprise a montré des résultats significatifs dans le traitement de la santé mentale, atteignant un taux de réponse de 65% lors des essais sur la dépression. Le casque Gen-3 Halo livre une forme d'onde propriétaire de 15 mA, de 5 à 10 fois plus puissante que les dispositifs existants.
Parmi les développements clés, on trouve : le lancement d'une clinique virtuelle avec intégration de l'IA, la conduite de 29 essais cliniques approuvés par l'IRB et l'obtention d'approbations réglementaires en Chine, au Brésil et à Oman. L'entreprise vise l'approbation CE pour entrer sur le marché européen en 2025. Des recherches montrent des résultats prometteurs dans le traitement de l'Alzheimer, avec une augmentation de l'activité cérébrale dans les zones liées à la mémoire. L'entreprise se concentre également sur la recherche sur le PTSD et le TBI en collaboration avec l'UC San Diego et le VA.
Avec un marché de la neuromodulation prévu pour atteindre 11 milliards de dollars d'ici 2028, Nexalin vise à étendre sa présence mondiale tout en faisant progresser la recherche sur les troubles de l'humeur, l'Alzheimer et le traitement des addictions.
Nexalin Technology (NXL) hat einen Aktionärsbrief veröffentlicht, der Erfolge und Aussichten für 2025 hervorhebt. Die Deep Intracranial Frequency Stimulation (DIFS)-Technologie des Unternehmens hat signifikante Ergebnisse in der Behandlung von psychischen Erkrankungen gezeigt und eine 65%ige Ansprechrate in Depressionstests erreicht. Ihr Gen-3 Halo-Headset liefert eine proprietäre 15 mA-Wellenform, die 5-10 Mal stärker ist als vorhandene Geräte.
Wichtige Entwicklungen umfassen: die Einführung einer virtuellen Klinik mit KI-Integration, die Durchführung von 29 von der IRB genehmigten klinischen Studien und den Erhalt von Zulassungen in China, Brasilien und Oman. Das Unternehmen strebt eine CE-Kennzeichnung für den Einstieg in den europäischen Markt im Jahr 2025 an. Forschungen zeigen vielversprechende Ergebnisse in der Alzheimer-Behandlung, mit erhöhter Gehirnaktivität in gedächtnisbezogenen Bereichen. Das Unternehmen konzentriert sich auch auf die Forschung zu PTSD und TBI in Zusammenarbeit mit der UC San Diego und dem VA.
Mit einem prognostizierten Markt für Neuromodulation von 11 Milliarden Dollar bis 2028 beabsichtigt Nexalin, seine globale Präsenz auszubauen und gleichzeitig die Forschung zu Stimmungserkrankungen, Alzheimer und der Behandlung von Süchten voranzutreiben.
- 65% response rate in depression trials, outperforming traditional antidepressants
- Successful regulatory approvals in China, Brazil, and Oman
- Launch of AI-integrated virtual clinic in December 2024
- Technology is 5-10 times more powerful than existing neurostimulation devices
- 29 IRB-approved clinical trials completed or in progress
- 14 peer-reviewed studies published supporting technology efficacy
- CE Mark approval for European market still pending
- Operating in a highly competitive neuromodulation market
Insights
The clinical achievements and technological advancements detailed in this shareholder letter represent substantial progress in neurostimulation therapy. The 65% response rate in depression trials surpasses typical antidepressant efficacy by 15 percentage points, while the combination therapy showing a 66% response rate versus 33% in sham groups demonstrates remarkable therapeutic potential.
The Deep Intracranial Frequency Stimulation (DIFS) technology's 5-10x power increase over existing devices, coupled with its undetectable delivery mechanism, presents a unique value proposition in the $11 billion neuromodulation market. The extensive validation through 29 IRB-approved trials and 14 peer-reviewed publications provides robust scientific credibility.
The integration of multiple neuroimaging modalities (EEG, fMRI, MEG, PET) for efficacy validation represents a comprehensive approach to proving therapeutic impact, particularly notable in the Alzheimer's research showing increased hippocampal activity.
The virtual clinic launch with AI integration marks a significant technological leap in mental health treatment delivery. The combination of electronic data capture, real-time patient monitoring and telemedicine capabilities creates a scalable infrastructure for both clinical trials and patient care. This digital transformation could substantially reduce operational costs while expanding patient access.
The Gen-3 Halo headset's integration with the virtual platform demonstrates forward-thinking product development that aligns with modern healthcare delivery trends. The pursuit of CE Mark approval for European market entry in 2025, combined with existing approvals in China, Brazil and Oman, positions Nexalin for significant market expansion.
With a modest market cap of $33.2 million, Nexalin appears significantly undervalued given its technological achievements and market positioning. The company's target market - projected to reach $11 billion by 2028 - presents substantial growth potential, especially considering the company's competitive advantages in treatment efficacy and delivery method.
The strategic focus on military and veteran populations through Nexalin America, particularly addressing PTSD and TBI, opens access to substantial government contracts. The company's multi-pronged approach targeting depression, Alzheimer's and addiction, combined with its international expansion strategy, creates multiple revenue streams and risk mitigation.
DIFS Technology: A Potential Game-Changer for Mental Health Treatments
Setting New Benchmarks:
Alzheimer’s Research Shows Promising Results with Increased Brain Activity
Virtual Clinic Poised to Revolutionize Mental Health Care with AI Integration
Pursuing CE Mark to Expand into European Markets in 2025
Strategic Focus on PTSD, TBI, and Addiction Research for Veterans
Global Growth with Approvals in China, Brazil, and Oman
Neuromodulation Market Positioned to Reach
HOUSTON, TX, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) the leader in Deep Intracranial Frequency Stimulation (DIFS) of the brain, is pleased to release a detailed letter from CEO Mark White, providing an update on the Company’s technology advancements, clinical achievements, and strategic focus for 2025.
Dear Shareholders,
I want to take this opportunity to thank you for your continued trust and support in Nexalin Technology. Our progress over the past year reflects our commitment to addressing the global mental health crisis through innovative, noninvasive neurostimulation solutions. Recently, Dr. David Owens, our Chief Medical Officer, and I conducted a comprehensive review of our clinical programs and strategic initiatives for 2025. This evaluation, as summarized below, highlights extraordinary successes which have positioned Nexalin as a leader in advanced mental health treatment technologies.
Groundbreaking Technology Developments
In 2019, regulatory updates from the FDA prompted our engineering team to revisit the foundational technology behind our Gen-1 devices. Through rigorous research, we developed a new proprietary frequency-based waveform designed to interact with the brain’s natural energy patterns. This waveform, 5 to 10 times more powerful than existing neurostimulation devices, enables targeted stimulation of deep brain structures—regions critical to addressing mental health conditions.
By 2022, this innovation had been awarded a U.S. patent, solidifying its place as a groundbreaking technology. Termed “Deep Intracranial Frequency Stimulation” (DIFS), we believe this approach provides an unparalleled standard of care for conditions such as depression, insomnia, Alzheimer’s, post-traumatic stress disorder (PTSD), and more. Importantly, the treatment utilizing the Company’s advanced waveform technology is designed to be undetectable to the human body, ensuring patient comfort without side effects.
Clinical Achievements
Over the past 24 months, Nexalin has either initiated, completed, or is actively conducting 29 Institutional Review Board (IRB)-approved clinical trials. These studies have consistently demonstrated the potential of our 15 mA waveform to safely and effectively treat a range of mental health disorders. Highlights include:
- Major Depressive Disorder:
- Nexalin’s technology achieved a remarkable
65% response rate in our treatment group over a four-week period, outperforming traditional antidepressants, which typically average a50% response rate. - In combination with antidepressant medication, the response rate increased to
66% , compared to33% for sham stimulation groups receiving medication alone.
- Nexalin’s technology achieved a remarkable
- Alzheimer’s Research:
- Functional MRI studies show increased blood flow and neuronal activity in the hippocampus and temporal lobes, areas critical for memory and cognition.
- These findings suggest the potential for combining DIFS with current drug therapies, providing a new pathway for treating mild cognitive impairment and Alzheimer’s disease.
- Veterans’ Studies:
- Collaborations with UC San Diego and the San Diego VA focus on using Nexalin’s Gen-3 Halo headset for veterans with traumatic brain injury (TBI) and PTSD. These efforts resulted in the establishment of Nexalin America, a subsidiary dedicated to working with the Department of Defense and Veterans Administration.
- Published Research:
- Fourteen peer-reviewed studies published in major international journals support the efficacy and safety of our technology, strengthening our competitive position in the neuromodulation market.
Innovative Virtual Clinic
In December 2024, Nexalin launched Phase 1 of its virtual clinic, leveraging cutting-edge artificial intelligence (AI) to revolutionize patient care and clinical trial processes. The virtual clinic integrates:
- Electronic Data Capture: This platform enables real-time data acquisition and analysis, ensuring seamless compliance with study protocols.
- Patient Monitoring System: This interactive smartphone application allows clinicians to monitor adherence to treatment protocols and adjust care as needed.
- Telemedicine Capabilities: Patients can communicate directly with clinicians, receiving personalized care in the comfort of their homes.
Our Gen-3 Halo headset, which administers Nexalin’s advanced 15 mA waveform, is central to this initiative. The virtual clinic represents a transformative step toward making mental health treatment more accessible, efficient, and patient-centric.
Strategic Focus for 2025
As we look to the future, Nexalin’s strategic priorities are built on a foundation of clinical success:
- Primary Mood Disorders: Expanding research and trials targeting insomnia, depression, and migraines.
- Military and Government Relations: Strengthening partnerships to address TBI and PTSD within military and veteran populations.
- Alzheimer’s and Addiction: Accelerating research in these areas, leveraging pilot studies and publications that demonstrate DIFS’ potential.
- European Market Expansion: In 2025, we are actively pursuing CE Mark approval for our Gen-3 Halo device to enable entry into the European market. This critical step will align with our global strategy of making Nexalin technology available to more patients worldwide.
Clinical Evaluation Techniques
To ensure rigorous validation of our technology, Nexalin employs advanced methodologies, including:
- Patient-Reported Outcomes: Pre- and post-treatment assessments of symptom severity and quality of life.
- Neuroimaging Tools:
- Electroencephalography (EEG) to measure brain activity.
- Functional MRI (fMRI) to track blood flow changes.
- Magnetoencephalography (MEG) for detecting brain activity.
- PET scans using radioactive tracers to visualize function.
These tools provide critical insights into DIFS’ effectiveness and ensure its differentiation from consumer-grade stimulators.
Positioning for Global Growth
In addition to our U.S.-based achievements, Nexalin has received regulatory approvals in China, Brazil, and Oman, paving the way for global adoption of DIFS technology. The CE Mark approval we are pursuing in Europe represents a pivotal milestone in our international expansion strategy. With the neuromodulation market projected to reach
Closing Remarks
The global mental health crisis touches all of us—our families, friends, and communities. Nexalin’s innovative approach to neurostimulation, utilizing Deep Intracranial Frequency Stimulation, offers a new standard of care, providing effective treatment without the risks of pharmaceuticals or invasive procedures. I am proud of the extraordinary work our team has accomplished and confident in our ability to drive meaningful change in mental health care.
On behalf of everyone at Nexalin, thank you for your unwavering support. We look forward to keeping you informed as we continue this transformative journey.
Warm regards,
Mark White, CEO
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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