NXL

Exclusive Distribution Agreement: Nexalin Technology has signed an exclusive distribution agreement with Carmi Masha Technologies to market its Gen-2 Console ("SYNC") neurostimulation device in Israel, following regulatory approval for its use in treating mental health disorders.

Focus on Mental Health Treatment: The SYNC device is designed to provide non-invasive, drug-free treatment for conditions such as insomnia, depression, and anxiety, with potential future applications for PTSD, TBI, and dementia.

Partnership Goals: The collaboration aims to leverage Carmi Masha's expertise in introducing medical technologies to enhance access to Nexalin's innovative solutions in Israel, aligning with the growing demand for effective mental health treatments.

Global Expansion Strategy: This agreement is part of Nexalin's broader strategy to expand its presence in international markets, particularly in the Middle East, while continuing to develop advanced neurostimulation products for mental health issues.

FDA Acceptance: Nexalin Technology's Q-Submission for its Gen-2 Console ("SYNC") system aimed at treating Alzheimer's disease and dementia has been accepted by the FDA, marking a significant step towards initiating U.S. clinical studies.

Clinical Trial Discussion: The upcoming regulatory meeting with the FDA will focus on clinical trial design, study endpoints, and the regulatory pathway for evaluating the SYNC system as a non-invasive therapy for cognitive impairments.

Positive Internal Data: Recent internal data and published research indicate improvements in cognitive performance and a favorable safety profile for Nexalin's neurostimulator, which utilizes a proprietary waveform technology.

Strategic Collaborations: Nexalin is exploring partnerships with leading research institutions to expedite both U.S. and international studies involving its Gen-2 SYNC and next-generation Gen-3 HALO platforms.