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Technology CEO Provides Letter to Shareholders

Key Takeaway: Technology CEO Provides Letter to Shareholders on growing clinical data supporting its neurostimulation technology and progress advancing its new Gen-3 HALO Clarity Virtual Clinic model HOUSTON, TEXAS, April 10, 2024 - Nexalin Technology, Inc. (the "Company" or "Nexalin") (Na

Full Press Release Details

Technology CEO Provides Letter to Shareholders
on growing clinical data supporting its neurostimulation technology
and progress advancing its new Gen-3 HALO Clarity Virtual Clinic model
HOUSTON, TEXAS, April 10, 2024 - Nexalin
Technology, Inc. (the "Company" or "Nexalin") (Nasdaq: NXL; NXLIW) today provided the following letter
to shareholders from the Company's CEO, Mark White, including updates regarding the growing clinical data supporting its non-invasive,
frequency-based deep brain stimulation device, as well as, progress on its new Gen-3 HALO Clarity & Virtual Clinic model:
To our valued shareholders,
I want to take this opportunity to express
my sincere gratitude for your continued trust and investment in our mission. In 2023, we achieved significant progress, and we are poised
for even greater achievements in 2024 to support our goal of improving mental healthcare outcomes among patients across a wide array of
indications. We believe our technology holds tremendous potential, including treatment applications for large and underserved markets
within the fields of insomnia, depression, and anxiety. We are also investigating a more expansive treatment for other
mental health conditions such as, addiction, substance use disorder, Alzheimer's, traumatic brain injury and post-traumatic stress
disorder (PTSD). The broad potential of our technology is especially noteworthy given the growing number of patients seeking more effective
non-pharmacological treatment options.
Positive Clinical Results
We've hit the ground running in 2024 with a
series of favorable developments that solidify Nexalin's position as an innovator in the field. We recently announced positive results
from a clinical study conducted at the University of California, San Diego (UCSD). The data from this study demonstrated that our Gen-2
tACS reduced post-concussive symptoms and PTSD symptoms among the sample of military veterans suffering from mild traumatic brain injury
(mTBI). We view this as a significant breakthrough, as mTBI is a prevalent and often debilitating condition with limited treatment options.
This market with respect to mTBI alone was valued at approximately $3.3 billion in 2022 and is projected to reach over $7.2 billion in
We also announced encouraging results from
a recent clinical study of our Gen-2 tACS device for treating adult patients with chronic insomnia. The published results from this clinical
study demonstrated clinically meaningful and statistically significant improvements in key sleep parameters, compared to patients treated
with placebo. Data published in the Journal of Psychiatric Research suggests that the Gen-2 tACS device may have the potential to reduce
chronic insomnia and consistently improve sleep quality in adults.
Additionally, the Nexalin clinical teams have
published 6 additional clinical studies in recognized international peer-reviewed journals evaluating the safety, tolerability and efficacy
of the new advanced 15 milliamp waveform. The data in these published studies, showing statistically significant improvements in key parameters
(as compared to a placebo cohort), provide a basis for optimism that our devices could have applicability for multiple disciplines related
Introducing the HALO Clarity &
the Nexalin Virtual Clinic
Building on our strong clinical momentum, we
recently unveiled the HALO Clarity (HALO), a headset powered by various processing systems and microprocessors to deliver a new
Gen-3 waveform at 15 milliamps. Redesigned to incorporate Deep Intracranial Frequency Stimulation (DIFS ), the HALO is a significant
leap forward over prior versions of the device, in multiple respects, and will enable patients to receive treatment within the convenience
and accessibility of our Virtual Clinic setting.
We believe that HALO, developed on an advanced
technology platform, possesses the capability to penetrate structures deep in the mid-brain that are associated with mental health disorders.
We believe that the innovative technique underlying the HALO architecture, and embedded in all of our next-generation devices, will generate
enhanced patient therapeutic responses without adverse side effects.
Our Virtual Clinic will allow patients to be
treated by the HALO within the privacy of their own homes. The Virtual Clinic will afford remote access to our prescribing physicians
so that they can seamlessly monitor patient data through a proprietary medical app, a cloud-based program providing secure, "over-the-air"
electronic transmission of patient data.
The development of the Virtual Clinic is far
along and is expected to support the monitoring and collection of HALO use data by medical professionals in a seamless manner resulting
in an integrated workflow - from assessment, to authorization, to shipment - all under medical supervision.
The HALO & Virtual Clinic project has gone
from a whiteboard vision to design to full manufacturing and testing in just 14 months. I am pleased to report that we are ahead of schedule
Targeting the U.S. Government Market
In addition to our core team, which brings
decades of experience in neural stimulation and mental health treatment, we recently announced the formation of a new military and government
advisory board aimed at fostering and enhancing relationships within and throughout federal government and public sector organizations
including the U.S. Department of Defense (DoD), U.S. Department of Veterans Affairs, and U.S. Department of Health and Human Services
The new advisory board is led by David F. Lasseter,
former Deputy Assistant Secretary of Defense for Policy and a leading government affairs veteran. We recently announced the appointment
of William A. Hudson, Jr., former Acting General Counsel to the Department of Veterans Affairs, to the advisory board. Given the backgrounds
of these individuals and others we intend to add, we look forward to their strategic advice and counsel as we advance our clinical trials
and aim to broadly deploy our devices within the U.S. military and government agencies.
We recently conducted a poster presentation
in which we presented data from our clinical study at UCSD at an event hosted by the U.S. Army Medical Research and Development Command's
Combat Casualty Care Research Program Neurotrauma Portfolio and the Biomedical Advanced Research and Development Authority (widely known
as BARDA). As a result, we are garnering expressions of significant interest within the government and military market, especially with
respect to the treatment of mTBI and PTSD. Following this event, I was invited to Washington D.C. for meetings with key government officials,
including congressmen and chiefs of staff on important committees and subcommittees in charge of veteran healthcare, as well as HHS and
DoD. I am happy to report the feedback has been quite positive.
Global Market Expansion
On the international front, we announced regulatory
approval in Oman, and commenced sales of our Gen-2 Neurostimulation Device to a new Mental Health Center in Oman dedicated to our technology.
We believe this approval and immediate adoption underscores the growing global recognition of Nexalin's technology. It provides us a foothold
to expand our presence across the Middle East and marks a crucial step in our international expansion strategy following approval in China.
We look forward to securing approval in other countries, with the ultimate goal of gaining FDA clearance in the United States.
Strengthening our IP Portfolio
Nexalin continues to innovate and enhance our
IP portfolio. We were recently issued key patents that extend through 2040. These patents cover both our core technology, DIFS , as
well as the method of use utilized in the Company's Gen-3 HALO Clarity system. As a result, we now have four key patents
and three pending patents related to the electro-stimulation techniques core to our products and services. These patents are a critical
element of our overall strategy. In addition, we plan to file additional patent applications to further enhance the IP protection of our
new advanced waveform and extend our leadership position in this market. In addition to our U.S. patents, we are in the process of filing
foreign applications to expand the scope of our patent coverage in additional countries around the world.
A Bright Future for Nexalin and Mental Health
The global mental health crisis continues to
be a pressing concern. Nexalin remains steadfast in our commitment to developing safe and effective treatments that could be used to alleviate
the burden of anxiety, insomnia, depression and other mental health conditions.
A key differentiator for our new Gen-3 HALO
Clarity is that, for the first time, patients will be able to receive treatment in the privacy of their own homes, via remote physician
monitoring at Nexalin's Virtual Clinic.
Our technology is grounded in science, backed
by 9 clinical studies published in 18 international peer reviewed journals and subject to intellectual property protection.
The recent positive clinical results, growing
market adoption, and continued innovation all point toward a bright future for Nexalin. We are confident in our belief that our innovative
neurostimulation technology has the potential to revolutionize mental health treatment and improve the lives of millions.
Looking Ahead with Shared Purpose
We are committed to keeping you informed as
we navigate the next exciting chapter in Nexalin's journey. We are actively pursuing FDA approval for our tACS device and remain dedicated
to expanding our commercial footprint both domestically and internationally.
Overall, we believe our neurostimulation device
Last updated: Apr 11, 2024