Nexalin Technology Launches Patient Recruitment for Clinical Study
Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW), a pioneering company in Deep Intracranial Frequency Stimulation (DIFS™), has reached a pivotal moment in its journey by announcing the initiation of patient recruitment for a significant clinical study at the University of California, San Diego (UCSD). Following the recent Institutional Review Board (IRB) approval, UCSD has received its first shipment of HALO™ Clarity devices, paving the way for research focused on treating mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) among military and civilian populations. The recruitment of patients is set to commence without delay.
Milestone Achieved with HALO™ Clarity Devices
This announcement marks a noteworthy milestone for Nexalin, especially after the successful completion of pilot tests and evaluations of the HALO technology at UCSD. The clinical trial aims to assess the effectiveness of Nexalin's proprietary DIFS™ technology, which offers a non-invasive deep-brain stimulation alternative, eliminating the need for drugs and invasive procedures.
Advanced Technology Integration
The initial batch of HALO devices has been integrated with Nexalin's innovative app-controlled remote monitoring system. This enables healthcare providers to seamlessly manage treatment compliance and monitor patient progress effectively. Plans are in place to supply an additional 40-50 HALO™ Clarity devices as the study advances.
Key Advantages of HALO™ Clarity Technology
The HALO™ Clarity device comes with several significant benefits that enhance its value as a treatment option:
- Non-Invasive Therapy – It provides a drug-free approach to treating neurological and mental health disorders, minimizing the side effects typically associated with conventional treatments.
- At-Home Convenience – The design facilitates easy usage within a home environment, increasing patient adherence and accessibility.
- AI-Integrated Remote Monitoring – The application of advanced Electronic Data Capture (EDC) and Patient Monitoring System (PMS) allows for real-time data collection and physician oversight.
CEO's Vision for the Future
In a statement, Mark White, CEO of Nexalin Technology, expressed enthusiasm about the initiation of patient recruitment, highlighting it as a crucial step in validating the HALO Clarity device as a viable treatment for TBI and PTSD. He reiterated that UCSD's independent study is an essential milestone in proving the transformative potential of DIFS technology, aimed at providing accessible, non-invasive solutions for those in need.
Pioneering Advances in Neurostimulation
David Owens, Chief Medical Officer of Nexalin Technology, echoed the excitement regarding the deployment of the first HALO devices for clinical application. He emphasized how DIFS technology combined with a robust virtual clinic model enhances real-time monitoring of patients. This ensures a smooth and focused treatment experience aimed at mental health improvement.
Nexalin continues its mission to develop groundbreaking neurostimulation technologies that address the pressing needs within mental health and neurological care. Although the HALO device is still pending FDA approval for its intended uses, advancements being made signal promising developments in neurostimulation treatments for mental health disorders.
About Nexalin Technology
Nexalin is dedicated to designing and developing advanced neurostimulation products tailored to combat the growing global mental health crisis. Its product line is characterized by non-invasive features that are unobtrusive to users. Utilizing bioelectronic medical technology, Nexalin aims to address mental health concerns effectively, targeting structures deep within the mid-brain recognized to be connected to mental health disorders. With the introduction of generation-two neurostimulation devices, Nexalin aims for superior patient outcomes while avoiding adverse effects. Notably, the Nexalin Gen-2 15 milliamp device has received approval in various countries including China, Brazil, and Oman.
Frequently Asked Questions
What is Nexalin Technology known for?
Nexalin Technology is known for its innovative Deep Intracranial Frequency Stimulation (DIFS™) technology, which targets neurological and mental health disorders non-invasively.
What is the HALO™ Clarity device?
The HALO™ Clarity device is a non-invasive treatment tool designed to help individuals with mild traumatic brain injury (mTBI) and PTSD, facilitating home use with integrated remote monitoring.
Who is participating in the clinical trial?
The clinical trial will recruit both military personnel and civilian populations who are affected by mTBI and PTSD.
What are the main benefits of using the HALO™ Clarity?
Benefits include non-invasive therapy, ease of use at home, and real-time physician monitoring, which enhances treatment adherence.
Is the HALO device approved by the FDA?
Currently, the HALO device is under evaluation and has not yet received FDA approval for use in the United States.
