Nexalin’s HALO™ Clarity Receives UCSD IRB Approval
Nexalin Technology, Inc. (NASDAQ: NXL; NXLIW), a frontrunner in the field of Deep Intracranial Frequency Stimulation (DIFS™), is thrilled to announce that the University of California, San Diego (UCSD) has granted Institutional Review Board (IRB) approval for its HALO™ Clarity headset. This announcement marks a notable milestone in the realm of clinical testing aimed at addressing mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD).
Study Overview and Goals
The independent clinical study at UCSD will explore the effectiveness of the HALO headset in treating military personnel suffering from mTBI and PTSD. Nexalin will facilitate this important research by supplying 50 HALO devices, which will be utilized in trials designed to ascertain the technology's potential.
Device Deployment and Initial Steps
With IRB approval in place, UCSD will receive the first shipment of HALO devices soon. This project signifies a comprehensive step towards a deeper understanding of non-invasive treatment strategies in the mental health domain, especially for those who have served in the military. The planning emphasizes the use of HALO for trials that prioritize patient health and safety.
HALO™ Clarity Technology Explained
The HALO™ Clarity headset develops its strength from Nexalin’s proprietary DIFS technology, enabling drug-free deep-brain stimulation that is non-invasive and safe for human use. Here are some of the noteworthy attributes of this technology:
Advantages of HALO™ Clarity
- Non-Invasive Treatment: Designed to provide a safe, alternative solution for mental health issues, minimizing risks tied to traditional pharmacological approaches.
- At-Home Use: Patients can experience convenient treatments within their own homes, ensuring comfort and privacy.
- Remote Monitoring: Physicians have the capability to evaluate and monitor patients without the need for frequent in-person visits, enabling ongoing care.
Innovative Virtual Clinic Model
Nexalin has taken significant strides in enhancing patient care through a virtual clinic model. This platform combines AI with a proprietary Electronic Data Capture (EDC) system, taking into account several developments:
Core Features of the Virtual Clinic
- AI Integration: Real-time data acquisition and analysis enhance clinical trial efficiency, ensuring the study maintains high compliance standards.
- Patient Monitoring System (PMS): A user-friendly smartphone application facilitates real-time interaction between clinicians and patients, making necessary treatment adjustments seamlessly.
- Telemedicine Capabilities: The direct communication lines foster a tailored support system throughout the treatment journey.
Leadership Insights
The IRB approval has been met with enthusiasm from Nexalin’s leadership. Mark White, CEO, stated, "Securing IRB approval from UCSD is a pivotal advancement for validating HALO technology’s potential. This critical study will offer invaluable insights into treating mTBI and PTSD. We are poised to redefine the landscape of neurologic treatments with HALO.”
Additionally, David Owens, the Chief Medical Officer, expressed confidence in the implementation of HALO technology, stating, "Our commitment to advancing neurostimulation therapy is unwavering. By equipping healthcare providers with 50 HALO devices, we are not only making treatment more accessible but also enhancing patient outcomes through technological advancements. The forthcoming research will yield significant information regarding HALO’s efficacy in clinical settings.”
Future Commitment to Innovative Healthcare
Nexalin’s focus extends beyond this milestone, with a broader aim of pushing forward innovative neuromodulation technologies to fulfill existing gaps in mental health and neurological care. Though HALO is still undergoing evaluation, its potential applications bring optimism for improved treatment modalities.
Frequently Asked Questions
What is the purpose of the UCSD clinical trial?
The trial aims to evaluate the efficacy of HALO™ Clarity in treating mTBI and PTSD among military personnel.
How does the HALO device work?
It uses DIFS technology to provide non-invasive brain stimulation without drugs, promoting safer treatment options.
What are the benefits of using HALO at home?
Patients enjoy privacy, comfort, and convenience while receiving treatments without needing frequent visits to a clinic.
What role does AI play in Nexalin’s clinical trials?
AI facilitates real-time data monitoring and analysis, supporting efficient trial management and compliance adherence.
Is the HALO device FDA-approved?
No, the HALO device is currently under evaluation and has not yet received FDA approval for its intended uses in the U.S.
