Nexalin Technology Announces Regulatory Approval to Sell Gen 2 SYNC, 15 mA Neurostimulation DIFS™ Device in Israel
Nexalin Technology (Nasdaq: NXL) announced regulatory approval from the Israeli Ministry of Health to sell its Gen-2 SYNC 15 mA neurostimulation DIFS™ device in Israel on October 30, 2025. The company said the clearance enables commercial launch discussions with regional distribution partners and strengthens global credibility after prior approvals in China, Brazil, and Oman. The approval supports Nexalin’s strategy to expand its non‑invasive mental health therapy platform across the region.
Nexalin Technology (Nasdaq: NXL) ha annunciato l'approvazione regolamentare da parte del Ministero della Salute israeliano per vendere il suo dispositivo DIFS™ di neurosincronizzazione Gen-2 SYNC da 15 mA in Israele il 30 ottobre 2025. L'azienda ha dichiarato che l'autorizzazione consente discussioni sul lancio commerciale con partner di distribuzione regionali e rafforza la credibilità globale dopo le approvazioni precedenti in Cina, Brasile e Oman. L'approvazione supporta la strategia di Nexalin di ampliare la propria piattaforma di terapia non invasiva per la salute mentale nella regione.
Nexalin Technology (Nasdaq: NXL) anunció la aprobación regulatoria del Ministerio de Salud de Israel para vender su dispositivo DIFS™ de neuroestimulación Gen-2 SYNC de 15 mA en Israel el 30 de octubre de 2025. La compañía dijo que la aprobación permite iniciar discusiones de lanzamiento comercial con socios de distribución regionales y refuerza la credibilidad global tras las aprobaciones previas en China, Brasil y Omán. La aprobación respalda la estrategia de Nexalin de ampliar su plataforma de terapia de salud mental no invasiva en la región.
Nexalin Technology (Nasdaq: NXL)은 이스라엘 보건부로부터 이스라엘에서 15 mA 신경자극 DIFS™ 장치인 Gen-2 SYNC를 판매하기 위한 규제 승인을 받았다고 발표했습니다. 2025년 10월 30일에 시행될 예정입니다. 회사는 이 승인이 지역 유통 파트너와의 상용 출시 논의를 가능하게 하고 중국, 브라질, 오만의 이전 승인 이후 글로벌 신뢰도를 강화한다고 밝혔습니다. 이 승인은 지역 전역으로 확장하는 비침습적 정신 건강 치료 플랫폼을 확대하려는 Nexalin의 전략을 뒷받침합니다.
Nexalin Technology (Nasdaq : NXL) a annoncé l'approbation réglementaire du ministère israélien de la Santé pour vendre son dispositif DIFS™ de neurostimulation Gen-2 SYNC de 15 mA en Israël le 30 octobre 2025. La société a déclaré que cette autorisation permet des discussions sur le lancement commercial avec des partenaires de distribution régionaux et renforce la crédibilité mondiale après les autorisations précédentes en Chine, Brésil et Oman. Cette approbation soutient la stratégie de Nexalin d'étendre sa plateforme de thérapie non invasive pour la santé mentale dans la région.
Nexalin Technology (Nasdaq: NXL) hat die regulatorische Freigabe des israelischen Gesundheitsministeriums zum Verkauf seines Gen-2 SYNC 15 mA DIFS™-Geräts zur Neurostimulation in Israel am 30. Oktober 2025 bekannt gegeben. Das Unternehmen sagte, dass die Freigabe Diskussionen über den kommerziellen Start mit regionalen Vertriebspartnern ermöglicht und die globale Glaubwürdigkeit nach früheren Zulassungen in China, Brasilien und Oman stärkt. Die Zulassung unterstützt Nexalins Strategie, seine Plattform für nicht-invasive Therapien im Bereich der mentalen Gesundheit in der Region auszubauen.
تكنولوجي نيكسالين (ناسداك: NXL) أعلنت عن موافقة تنظيمية من وزارة الصحة الإسرائيلية لبيع جهاز التحفيز العصبي DIFS™ Gen-2 SYNC بقدرة 15 مA في إسرائيل في 30 أكتوبر 2025. قالت الشركة إن الترخيص يمكّن مناقشات الإطلاق التجاري مع شركاء التوزيع الإقليميين ويعزز المصداقية العالمية بعد الموافقات السابقة في الصين والبرازيل وعمان. وتدعم الموافقة استراتيجية Nexalin لتوسيع منصتها غير الجراحية لعلاج الصحة العقلية عن طريق العلاج غير التدخلي في المنطقة.
- Regulatory approval granted by Israeli Ministry of Health
- Device: Gen-2 SYNC 15 mA neurostimulation DIFS
- Market expansion enabled into Israel and regional distribution talks
- Prior approvals in China, Brazil, and Oman bolster credibility
- None.
HOUSTON, TX, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that its Gen-2 Console (“SYNC”), 15 milliamp (mA) neurostimulation device has been granted regulatory approval for sale in Israel by the Israeli Ministry of Health.
Mark White, CEO of Nexalin Technology, stated, “We are extremely proud to have received regulatory clearance in Israel, which is recognized worldwide for its rigorous and highly respected health regulatory standards. This approval is an important milestone that not only allows us to introduce our innovative, drug-free technology to patients and providers in Israel but also strengthens the global credibility of our platform as we pursue additional international markets. Globally, this builds on our prior approvals in China, Brazil and Oman. This recent approval in Israel directly supports our strategy to aggressively expand our presence across the region.”
“With this clearance in Israel, we are accelerating our discussions with regional distribution partners to launch commercial sales and deliver much-needed, non-invasive solutions for the treatment of mental health disorders,” added Mr. White.
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, Oman and Israel. 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
What did Nexalin announce about the Gen-2 SYNC device on October 30, 2025?
How does the Israel approval affect Nexalin (NXL) international footprint?
Will Nexalin begin commercial sales of Gen-2 SYNC in Israel immediately?
What therapy does the Gen-2 SYNC DIFS device target for patients in Israel?
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How did Nexalin describe the significance of Israel regulatory clearance?
