Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback
Nexalin Technology (NASDAQ: NXL) has announced plans to submit a Q-Submission to the FDA for its Gen-2 SYNC system, marking a crucial step in its regulatory pathway. The Q-Sub aims to facilitate discussions with the FDA regarding clinical trial design for treating Alzheimer's disease, dementia, and mild cognitive impairment (MCI).
This decision follows encouraging internal data and preliminary FDA feedback. The Gen-2 SYNC system features technical improvements, including a redesigned enclosure and integration of Nexalin's proprietary 15 milliamp advanced waveform. The company is also undertaking a rebranding initiative to differentiate this system from previous versions.
Nexalin Technology (NASDAQ: NXL) ha annunciato l'intenzione di presentare una Q-Submission alla FDA per il suo sistema Gen-2 SYNC, segnando un passaggio fondamentale nel percorso regolatorio. La Q-Sub mira a facilitare il dialogo con la FDA riguardo alla progettazione degli studi clinici per il trattamento di Alzheimer, demenza e deterioramento cognitivo lieve (MCI).
Questa decisione segue dati interni promettenti e un feedback preliminare dalla FDA. Il sistema Gen-2 SYNC presenta miglioramenti tecnici, tra cui un involucro ridisegnato e l'integrazione della forma d'onda avanzata da 15 milliampere proprietaria di Nexalin. L'azienda sta inoltre avviando un'iniziativa di rebranding per distinguere questo sistema dalle versioni precedenti.
Nexalin Technology (NASDAQ: NXL) ha anunciado planes para presentar una Q-Submission a la FDA para su sistema Gen-2 SYNC, marcando un paso crucial en su camino regulatorio. La Q-Sub busca facilitar las discusiones con la FDA sobre el diseño de ensayos clínicos para el tratamiento de la enfermedad de Alzheimer, demencia y deterioro cognitivo leve (MCI).
Esta decisión sigue a datos internos alentadores y a una retroalimentación preliminar de la FDA. El sistema Gen-2 SYNC presenta mejoras técnicas, incluyendo un diseño renovado de su carcasa y la integración de la forma de onda avanzada de 15 miliamperios propia de Nexalin. La compañía también está llevando a cabo una iniciativa de rebranding para diferenciar este sistema de versiones anteriores.
Nexalin Technology (NASDAQ: NXL)는 Gen-2 SYNC 시스템에 대해 FDA에 Q-Submission을 제출할 계획을 발표하며 규제 절차에서 중요한 단계를 밟았습니다. Q-Submission은 알츠하이머병, 치매, 경도 인지 장애(MCI) 치료를 위한 임상 시험 설계에 대해 FDA와의 논의를 원활하게 하는 것을 목표로 합니다.
이 결정은 내부에서 긍정적인 데이터와 FDA의 초기 피드백에 따른 것입니다. Gen-2 SYNC 시스템은 재설계된 외관과 Nexalin 고유의 15밀리암페어 고급 파형 통합 등 기술적 개선을 특징으로 합니다. 회사는 또한 이 시스템을 이전 버전과 구분하기 위한 리브랜딩 작업도 진행 중입니다.
Nexalin Technology (NASDAQ : NXL) a annoncé son intention de soumettre une Q-Submission à la FDA pour son système Gen-2 SYNC, marquant une étape clé dans son parcours réglementaire. Cette Q-Sub vise à faciliter les échanges avec la FDA concernant la conception des essais cliniques pour le traitement de la maladie d'Alzheimer, de la démence et du trouble cognitif léger (MCI).
Cette décision fait suite à des données internes encourageantes et à un retour préliminaire de la FDA. Le système Gen-2 SYNC intègre des améliorations techniques, notamment un boîtier repensé et l'intégration de la forme d'onde avancée de 15 milliampères propriétaire de Nexalin. L'entreprise mène également une initiative de rebranding pour différencier ce système des versions précédentes.
Nexalin Technology (NASDAQ: NXL) hat Pläne angekündigt, eine Q-Submission bei der FDA für sein Gen-2 SYNC-System einzureichen, was einen wichtigen Schritt im regulatorischen Prozess darstellt. Die Q-Sub soll die Gespräche mit der FDA bezüglich des Designs klinischer Studien zur Behandlung von Alzheimer, Demenz und leichter kognitiver Beeinträchtigung (MCI) erleichtern.
Diese Entscheidung folgt auf vielversprechende interne Daten und vorläufiges Feedback der FDA. Das Gen-2 SYNC-System weist technische Verbesserungen auf, darunter ein neu gestaltetes Gehäuse und die Integration der firmeneigenen 15 Milliampere Advanced Waveform von Nexalin. Das Unternehmen führt zudem eine Rebranding-Initiative durch, um dieses System von früheren Versionen abzuheben.
- Company advancing regulatory pathway through FDA Q-Submission process
- Encouraging internal data supports potential treatment viability
- Technical enhancements implemented in Gen-2 SYNC system
- Non-invasive treatment approach for significant cognitive conditions
- No FDA approval yet for the treatment
- Clinical trials still pending design and execution
- Uncertain timeline for potential market entry
Insights
Nexalin's FDA Q-Sub for Alzheimer's treatment marks formal regulatory engagement but remains an early consulting step, not approval.
Nexalin's Q-Submission initiation represents a structured regulatory consultation with FDA regarding clinical trial design for their Gen-2 SYNC neurostimulation system. A Q-Sub is not an approval process but rather a formal mechanism for companies to receive feedback on specific development questions before submitting a marketing application. For Nexalin, this step comes after what they describe as "encouraging internal data" and "preliminary FDA feedback," suggesting they've accumulated enough evidence to warrant formal regulatory engagement.
The Q-Sub focus on clinical trial design is particularly relevant for neurological conditions like Alzheimer's, dementia, and MCI, which present complex endpoints and measurement challenges. Proper trial design can significantly impact development timelines and costs. While the company has secured approvals in China, Brazil, and Oman, FDA requirements typically differ substantially, making this U.S. regulatory engagement a distinct process.
The rebranding to "Gen-2 SYNC" signals positioning as a next-generation product, with technical enhancements including the proprietary 15 milliamp advanced waveform and redesigned enclosure. This differentiation may be important for both regulatory and marketing purposes.
This regulatory step indicates continued development progress but remains early in what is typically a multi-year FDA pathway for novel neurological devices. The Q-Sub process itself doesn't guarantee eventual approval but can help optimize subsequent development stages.
Non-invasive neuromodulation for Alzheimer's represents an alternative approach in a field with limited treatment options, though efficacy remains unproven.
Nexalin's neurostimulation approach for cognitive disorders addresses a critical need in a therapeutic area with few effective treatments. The Gen-2 SYNC system utilizes non-invasive neuromodulation, which offers potential advantages over pharmacological approaches that have shown limited efficacy in modifying Alzheimer's disease progression.
The press release highlights their proprietary 15 milliamp advanced waveform, which they claim can "penetrate structures deep in the mid-brain." This is technically significant because reaching deeper brain structures without invasive procedures represents a major challenge in neuromodulation therapies. Conventional transcranial approaches often struggle with depth of penetration.
While the company cites "encouraging internal data," no specific efficacy metrics are provided, making it impossible to assess potential clinical impact. The complex nature of cognitive disorders means that meaningful therapeutic benefits would need to demonstrate improvements in functional outcomes, not just biological markers.
The existing international approvals in China, Brazil, and Oman indicate some safety data exists, though regulatory standards for neurological devices vary considerably between countries. The FDA typically requires robust clinical evidence demonstrating both safety and efficacy.
For patients with cognitive impairment, any potential new therapeutic approach is significant given the devastating nature of these conditions. However, advancing to formal regulatory discussions is only an early step in establishing clinical utility for these challenging indications.
Company initiates formal regulatory engagement on trial design for Alzheimer’s, dementia, and MCI indications
HOUSTON, TX, May 01, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”), today announced that it plans to submit a Q-Submission (“Q-Sub”) to the U.S. Food and Drug Administration (FDA) related to its Gen-2 SYNC system. This regulatory milestone is intended to facilitate structured dialogue with the FDA regarding clinical trial design for the treatment of Alzheimer’s disease, dementia, and mild cognitive impairment (MCI).
The Company’s decision to proceed with the Q-Sub follows recent publications, a review of new encouraging internal data, and preliminary feedback received from the FDA. Nexalin believes this next phase of regulatory engagement marks a critical step toward advancing Gen-2 SYNC as a potential non-invasive therapeutic option for patients affected by debilitating cognitive conditions.
“We are encouraged by our internal findings and preliminary interactions with the FDA, which support our view that there may be a viable path forward for our Gen-2 SYNC system as a potential treatment for Alzheimer’s, dementia, and MCI,” said Mark White, CEO of Nexalin. “The upcoming Q-Submission represents an important opportunity to align with the FDA on clinical study design and regulatory strategy as we continue to be in a position to provide safe, effective, and non-invasive neuromodulation therapies to patients in need.”
The Gen-2 SYNC system reflects technical enhancements from prior-generation devices, including a newly redesigned enclosure and the integration of Nexalin’s proprietary 15 milliamp advanced waveform. To clearly differentiate the system from earlier versions, the Company has initiated a rebranding initiative, and the device will be marketed as “Gen-2 SYNC.”
Nexalin remains focused on progressing regulatory engagement and advancing its neuromodulation platform as a promising therapeutic alternative in the treatment of cognitive and neuropsychiatric disorders.
For more information about Nexalin Technology and its digital neurotherapeutic ecosystem, please visit www.nexalin.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, 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
FAQ
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