Nexalin Technology Announces Issuance of U.S. Patent Covering HALO™ Clarity Device Featuring DIFS™ Technology
Nexalin Technology (NASDAQ: NXL) has secured U.S. Design Patent No. D1,092,758 for its HALO™ Clarity neuromodulation device, providing 15 years of design protection. The device utilizes the company's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology to deliver non-invasive, drug-free treatment for mental health and neurological conditions.
The HALO™ Clarity system enables at-home, professionally supervised treatment with remote monitoring capabilities. The company is conducting multiple clinical studies across various indications including anxiety, insomnia, PTSD, and mild traumatic brain injury. The FDA has already provided consensus on pivotal trial designs for anxiety and insomnia indications.
The DIFS™ platform has demonstrated safety and efficacy signals in over two dozen trials worldwide. Nexalin has completed usability, safety, and design verification testing and is scaling manufacturing for broader clinical deployment.
Nexalin Technology (NASDAQ: NXL) ha ottenuto il Design Patent USA n. D1,092,758 per il proprio dispositivo di neuromodulazione HALO™ Clarity, garantendo 15 anni di protezione del design. Il dispositivo impiega la tecnologia proprietaria Deep Intracranial Frequency Stimulation (DIFS™) per offrire un trattamento non invasivo e privo di farmaci per disturbi mentali e neurologici.
Il sistema HALO™ Clarity permette un trattamento a domicilio supervisionato da professionisti, con capacità di monitoraggio remoto. L’azienda sta conducendo numerosi studi clinici su varie indicazioni, tra cui ansia, insonnia, PTSD e lieve trauma cranico. La FDA ha già fornito un consenso sui progetti di studi pivotal per ansia e insonnia.
La piattaforma DIFS™ ha mostrato segnali di sicurezza ed efficacia in oltre una dozzina di studi a livello mondiale. Nexalin ha concluso test di usabilità, sicurezza e verifica del design e sta potenziando la produzione per una più ampia implementazione clinica.
Nexalin Technology (NASDAQ: NXL) ha obtenido la Patente de Diseño de EE. UU. n.º D1,092,758 para su dispositivo de neuromodulación HALO™ Clarity, con 15 años de protección de diseño. El aparato utiliza la tecnología propietaria Deep Intracranial Frequency Stimulation (DIFS™) para brindar un tratamiento no invasivo y libre de fármacos para trastornos mentales y neurológicos.
El sistema HALO™ Clarity permite un tratamiento en casa, supervisado por profesionales con capacidades de monitoreo remoto. La empresa está llevando a cabo varios ensayos clínicos en diferentes indicaciones, incluidas ansiedad, insomnio, TEPT y lesión cerebral traumática ligera. La FDA ya ha mostrado consenso sobre los diseños de ensayos cruciales para ansiedad e insomnio.
La plataforma DIFS™ ha demostrado señales de seguridad y eficacia en más de dos docenas de ensayos en todo el mundo. Nexalin ha completado pruebas de usabilidad, seguridad y verificación de diseño y está escalando la fabricación para una implementación clínica más amplia.
Nexalin Technology (NASDAQ: NXL)은 HALO™ Clarity 신경조절 장치에 대해 미국 디자인 특허 No. D1,092,758를 확보하여 디자인 보호를 15년간 제공합니다. 이 기기는 회사의 독점 기술 Deep Intracranial Frequency Stimulation (DIFS™)을 이용해 비침습적이며 약물 없이 정신 건강 및 신경 질환 치료를 제공합니다.
HALO™ Clarity 시스템은 가정에서 전문 감독 하에 치료를 가능하게 하며 원격 모니터링 기능을 갖추고 있습니다. 회사는 불안, 불면증, PTSD, 경도 뇌손상 등 다양한 적응증에 대한 다수의 임상 연구를 진행 중이며 FDA는 불안 및 불면증 적응증에 대한 핵심 시험 설계에 이미 합의했습니다.
DIFS™ 플랫폼은 전 세계 20건이 넘는 임상시험에서 안전성 및 효능 신호를 입증했습니다. Nexalin은 사용성, 안전성 및 디자인 검증 테스트를 완료했고 더 넓은 임상 적용을 위해 제조 속도를 확대하고 있습니다.
Nexalin Technology (NASDAQ: NXL) a obtenu le Brevet de Dessin américain n° D1,092,758 pour son dispositif de neuromodulation HALO™ Clarity, offrant 15 ans de protection du dessin. L’appareil utilise sa technologie propriétaire Deep Intracranial Frequency Stimulation (DIFS™) pour proposer un traitement non invasif et sans médicament pour les troubles mentaux et neurologiques.
Le système HALO™ Clarity permet un traitement à domicile, supervisé par des professionnels avec des capacités de surveillance à distance. L’entreprise mène plusieurs études cliniques sur diverses indications, notamment l’anxiété, l’insomnie, le PTSD et les lésions cérébrales légères. La FDA a déjà donné son accord sur les conceptions d’essais pivot pour l’anxiété et l’insomnie.
La plateforme DIFS™ a démontré des signaux de sécurité et d’efficacité dans plus de deux douzaines d’essais à travers le monde. Nexalin a terminé les tests d’utilisabilité, de sécurité et de vérification du design et augmente la production pour une mise en œuvre clinique plus large.
Nexalin Technology (NASDAQ: NXL) hat den US-Designpatent Nr. D1,092,758 für sein HALO™ Clarity-Neuromodulationsgerät erhalten und damit 15 Jahre Designschutz gesichert. Das Gerät verwendet die firmeneigene Deep Intracranial Frequency Stimulation (DIFS™)-Technologie, um eine nicht-invasive, medikamentenfreie Behandlung mentaler Gesundheits- und neurologischer Erkrankungen bereitzustellen.
Das HALO™ Clarity-System ermöglicht Behandlung zu Hause, professionell überwacht mit Fernüberwachungsfunktionen. Das Unternehmen führt mehrere klinische Studien zu verschiedenen Indikationen durch, darunter Angststörungen, Schlaflosigkeit, PTSD und leichte traumatische Hirnverletzungen. Die FDA hat bereits eine Zustimmung zu den Designs pivotaler Studien für Angstzustände und Schlaflosigkeit gegeben.
Die DIFS™-Plattform hat in weltweit über zwei Dutzend Studien Sicherheits- und Wirksamkeitssignale gezeigt. Nexalin hat Usability-, Sicherheits- und Designverifikationstests abgeschlossen und skaliert die Fertigung für eine breitere klinische Anwendung.
Nexalin Technology (NASDAQ: NXL) حصلت على براءة تصميم الولايات المتحدة رقم D1,092,758 لجهازها HALO™ Clarity للن neuromodulation، مما يمنح حماية تصميم لمدة 15 عامًا. يعتمد الجهاز على تقنيتها الملكية Deep Intracranial Frequency Stimulation (DIFS™) لتقديم علاج غير غ invasive وخالٍ من الأدوية لحالات الصحة العقلية والأعصاب.
نظام HALO™ Clarity يتيح علاجاً في المنزل تحت إشراف محترف مع ميزات المراقبة عن بُعد. الشركة تجري عدة دراسات سريرية عبر مؤشرات مختلفة بما في ذلك القلق، والأرق، واضطراب ما بعد الصدمة، وإصابة الدماغ الخفيفة. وقد قدمت إدارة الغذاء والدواء الأمريكية بالفعل توافقاً حول تصميمات التجارب المحورية للقلق والأرق.
لقد أظهرت منصة DIFS™ إشارات السلامة والفعالية في أكثر من اثنتي عشرة تجربة حول العالم. أكملت Nexalin اختبارات القابلية للاستخدام والسلامة والتحقق من التصميم وتقوم بتوسيع الإنتاج لاستخدامات سريرية أوسع.
Nexalin Technology (NASDAQ: NXL) 已获得美国设计专利号 D1,092,758，覆盖其 HALO™ Clarity 神经调控设备，设计保护期为 15 年。该设备采用公司自有的 Deep Intracranial Frequency Stimulation (DIFS™) 技术，提供非侵入、无药物治疗的精神健康与神经疾病解决方案。
HALO™ Clarity 系统支持 在家中由专业人员监督的治疗，具远程监控能力。公司正在开展多项临床研究，覆盖焦虑、失眠、创伤后应激障碍（PTSD）以及轻度创伤性脑损伤等适应症。FDA 已就焦虑和失眠适应症的关键试验设计表达共识。
DIFS™ 平台在全球超过两打以上的试验中显示出安全性和有效性信号。Nexalin 已完成可用性、安全性与设计验证测试，并正在扩大生产，以实现更广泛的临床部署。
- Secured 15-year design patent protection for HALO™ Clarity device
- FDA consensus achieved on pivotal trial designs for anxiety and insomnia indications
- Platform demonstrated safety and efficacy in over two dozen trials
- At-home treatment capability could reduce healthcare costs and improve patient compliance
- Successfully completed usability, safety, and design verification testing
- Product still requires regulatory clearance before commercialization
- Clinical trials are still ongoing with no definitive completion timeline
Insights
Nexalin secures 15-year patent protection for HALO™ Clarity device, strengthening its position in non-invasive neuromodulation for neurological conditions.
Nexalin's newly issued design patent (D1,092,758) represents a significant intellectual property milestone for the company, providing 15 years of protection for their HALO™ Clarity device. This strengthens their position in the competitive neuromodulation market where IP protection is critical for maintaining market advantage.
The patent specifically covers their DIFS™ (Deep Intracranial Frequency Stimulation) technology platform, which targets high-value therapeutic areas including depression, anxiety, insomnia, PTSD, and neurodegenerative conditions like Alzheimer's and dementia. The non-invasive, drug-free approach represents a potentially disruptive alternative to pharmaceutical interventions in these massive markets.
What distinguishes this technology from competitors is its at-home supervised treatment model. This hybrid approach – combining home-based treatment with professional oversight – addresses several healthcare delivery pain points: patient convenience, treatment compliance, and healthcare resource constraints. The remote monitoring capability creates a scalable treatment model that could significantly reduce delivery costs while generating valuable real-world data.
From a regulatory perspective, Nexalin has made meaningful progress with the FDA, establishing consensus on pivotal trial designs for anxiety and insomnia indications. This regulatory clarity reduces uncertainty around approval pathways. The company's clinical development program spans multiple indications and includes independent validation studies at respected institutions like UC San Diego, which adds scientific credibility.
Manufacturing scale-up activities suggest the company is preparing for broader deployment, though revenue impact timing depends on regulatory clearance timelines.
HOUSTON, TX, Sept. 25, 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 the United States Patent and Trademark Office (USPTO) has issued U.S. Design Patent No. D1,092,758, entitled Transcranial Electro-Stimulation Device, providing 15 years of design protection for the Company’s next-generation HALO™ Clarity neuromodulation device.
HALO™ Clarity is designed to deliver non-invasive neuromodulation by stimulating deep brain structures associated with mental health and neurological conditions, such as Alzheimer’s, without reliance on pharmaceuticals or surgery. The newly issued patent strengthens Nexalin’s expanding intellectual property estate, supporting the Company’s DIFS™ platform and ongoing clinical and regulatory initiatives.
“This patent represents another important milestone in our mission to transform mental health and neurological care,” said Mark White, Chief Executive Officer of Nexalin. “HALO™ Clarity is engineered for comfort, usability, and performance to deliver our proprietary DIFS™ technology — a non-invasive, drug-free approach we believe can meaningfully impact conditions such as depression, anxiety, insomnia, trauma-related disorders, and neurodegenerative diseases including Alzheimer’s and dementia. Importantly, the system is designed for supervised use from the patient’s home, giving physicians the ability to monitor and guide treatment remotely while offering patients a safe and convenient alternative to in-clinic visits. We believe this unique capability has the potential to expand access, improve compliance, and lower the cost of care for patients worldwide.”
The at-home, professionally supervised treatment model enabled by HALO™ Clarity provides a number of advantages:
- Enhanced convenience and accessibility. Patients may receive therapy in the comfort of their own home, reducing the need for frequent office visits or travel.
- Remote clinician oversight and monitoring. Physicians can review treatment data in real time and adjust protocols as needed through secure telemedicine integration.
- Improved compliance and continuity. The reduction of logistical burdens helps patients adhere to prescribed treatment regimens more consistently.
- Potential for lower overall cost of care. With fewer in-clinic resources required, HALO™ Clarity may reduce the total cost of care while alleviating burdens on healthcare infrastructure.
- Scalable clinical trial design and data capture. The ability to collect data remotely can streamline clinical trials, shortening timelines and reducing costs.
The Company is advancing multiple clinical studies of HALO™ Clarity across indications including anxiety, insomnia, post-traumatic stress disorder, and mild traumatic brain injury. Feedback from the U.S. Food and Drug Administration has already established consensus on the design of pivotal trials for anxiety and insomnia, paving the way for future regulatory submissions. Independent trials at leading academic institutions such as the University of California, San Diego are also underway, evaluating the device in PTSD and related conditions. Nexalin’s DIFS™ platform has been studied in more than two dozen completed or ongoing trials worldwide, demonstrating consistent signals of safety and efficacy.
With this new patent, Nexalin has further strengthened its intellectual property portfolio, adding to previously issued utility patents that protect the home-use aspect of the HALO™ Clarity system. Having successfully completed usability, safety, and design verification testing, the Company is scaling manufacturing in preparation for broader clinical deployment.
As Nexalin continues to pursue regulatory clearance and eventual commercialization, the Company remains committed to making safe, effective, and drug-free treatment options available to patients struggling with mental health and neurological conditions. The HALO™ Clarity system reflects Nexalin’s vision of combining innovative science with real-world practicality — offering patients relief under the supervision of their clinicians, from the comfort and convenience of home.
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 believed to be 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. 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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