Nexalin Technology, Inc. (NXL), announced the recent approval from the University of California Institutional Review Board for clinical testing of its HALO Clarity headset in human subjects.
The HALO device utilizes Nexalin's proprietary Deep Intracranial Frequency Stimulation or DIFS technology, providing a non-invasive alternative to treat mild traumatic brain injury or mTBI and post-traumatic stress disorder or PTSD, particularly in military personnel.
This approval follows a successful pilot testing protocol conducted with the research team of the University of California, San Diego (UCSD).
UCSD will receive 50 HALO devices for this independent research project, which is not sponsored or controlled by Nexalin.
The HALO headset offers a drug-free, at-home treatment solution, designed for patient comfort and convenience, with remote monitoring capabilities that allow physicians to track patient progress.
Nexalin's virtual clinic model integrates artificial intelligence or AI and telemedicine features to enhance patient care, allowing real-time monitoring and communication with clinical teams during the trial.
Mark White, CEO of Nexalin, expressed, "This IRB approval marks a significant milestone in validating our DIFS technology and its potential to help those suffering from mTBI and PTSD."
The clinical trials will provide further insights into the safety and effectiveness of HALO, contributing to the growing body of research on the device's ability to support brain health without adverse side effects.
The HALO device is currently under evaluation and has not yet received FDA approval.
NXL closed Tuesday's (Feb.18 2025) trading at $3.46 up by 4.53%.
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