Nexalin Technology CEO Provides Letter to Shareholders
05 Gennaio 2023 - 2:30PM
Nexalin Technology, Inc. (the “Company” or “Nexalin”)
(Nasdaq: NXL; NXLIW), today provided the following
business update and letter to shareholders from its Chief Executive
Officer, Mark White:
To our valued shareholders,
I would like to thank all of you for your
tremendous support, as we look towards a very bright future in 2023
and beyond. Nexalin has built a solid foundation, grounded in
strong intellectual property, and backed by growing clinical
data. Our goal has been and continues to be establishing the
Company as the preeminent producer of innovative neurostimulation
devices to uniquely and effectively help combat the ongoing global
mental health epidemic.
Our first-generation (Gen-1) 4-milliamp
frequency-based device was previously cleared by the U.S. Food and
Drug Administration (FDA) to treat patients with anxiety,
depression, and insomnia. However, with the evolution of our
business and regulatory strategy, we have implemented important
technology enhancements to our Gen-1 device and waveform. The
enhancements will increase the waveform power from 4 milliamps to
15 milliamps. Nexalin believes that a stronger and more powerful
waveform will allow deeper penetration in the brain and provide
enhanced patient response without any adverse side effects. A new
improved modern enclosure, referred to as Generation 2 (Gen-2),
will administer the new waveform in a clinical setting.
Additionally, the Nexalin design team has completed prototype
designs for the new patient headset, referred to as Generation 3
(Gen-3). Nexalin is planning to present Gen-2 and Gen-3 to the FDA
in Q1 2023 for the treatment of anxiety and insomnia. Strategic
planning for a PMA with the FDA for the treatment of Major
Depressive Disorder (MDD) is planned for Q3 2023. The strategy will
be supported by a large blinded clinical trial with the Gen-3
headset.
Specifically, we are moving forward with
conducting clinical trials of our Gen-2 and Gen-3 devices for
various mental health disorders in the United States. Nexalin is
seeking to expand our innovative neurostimulation devices to
address the current mental health epidemic including substance use
disorder (addiction),Alzheimer’s, traumatic brain injury (TBI),
PTSD and chronic pain.
Given the favorable results of recent safety
data provided by the University of California San Diego, which
supports the safety of utilizing our new waveform technology, we
are excited to take the next step on this journey with a goal of
bringing this new, effective, safe, and drug-free therapy to our
patients with mental and neurodegenerative illnesses.
On the heels of the approval of our Gen-2
medical device by China’s National Medical Products Administration
(NMPA) for insomnia and depression, we are making progress with the
commercial rollout of our device in China through our joint venture
partner, Wider Come Limited. We are currently making strategic
plans for additional clinical trials for the use of Gen-2 and Gen-3
devices in China to scientifically validate the new advanced
waveform.
Most recently, we announced the publication of a
white paper, titled, “A case report of Nexalin Gen-2 device in the
treatment of somatic symptoms of anxiety,” by the Second Xiangya
Hospital of Central South University, China, validating our Gen-2
device for the treatment of generalized anxiety disorder and
associated somatic (physical) symptoms. The patient, a 42-year-old
female teacher, suffered repeated mental and physical discomfort
for 23 years, as well as anxiety attacks and sleep disturbance. The
treatment consisted of 2 treatments per day over 10 days. Notably,
the hospital reported the disappearance of all somatic anxiety
symptoms and improved quality of sleep. Nexalin believes this
response to the patient’s somatic symptoms that originated from
anxiety, demonstrates the potential of the new advanced waveform
for the treatment of mental and physical symptoms associated with
generalized anxiety disorder. As a result, we look forward to the
results of new and current clinical trials.
In September 2022 we achieved a historic
milestone for our Company by listing on the Nasdaq Stock Market and
concurrently raising $9.6 million. This financing puts us on
solid footing to execute our strategy and we believe our listing on
a major U.S. exchange provides us increased visibility, liquidity,
and the opportunity to attract a broader investor base. As a
result, we believe we are well funded to support the clinical
development, sales, and marketing activities around our innovative
medical devices. While we recognize the volatility in the
stock market, especially among micro-cap companies, which has
caused concern for many of our investors, we appreciate your
continued support and remain confident the steps we have taken will
drive significant long-term value for our shareholders.
Once again, let me take this opportunity to
thank you, our shareholders, as well as our hard-working employees
and our board of directors, for your faith, dedication, and
support. We remain fully committed to executing on our business
model and could not be more excited about the outlook for the
business. We remain encouraged by the potential of our
neurostimulation devices for improving healthcare outcomes among
patients with mental and neurodegenerative illnesses as a proven
alternative to psychiatric drugs. We look forward to providing
further updates on our clinical research, and commercial programs
as we continue to make progress heading into the new
year.
I look forward to the new year with great optimism, not only for
our shareholders, but the countless patients whose lives we hope to
change.
Best regards,Mark White
About Nexalin Technology,
Inc.
Nexalin designs and develops innovative neurostimulation
products to uniquely and effectively help combat the ongoing global
mental health epidemic. All Nexalin’s products are non-invasive and
undetectable to the human body and provide relief to those
afflicted with mental health issues without adverse side effects.
Nexalin utilizes bioelectronic medical technology to treat mental
health issues without the need for drugs or psychotherapy. Nexalin
believes the 15 milliamp medical device can penetrate structures
deep in the mid-brain that are associated with mental health
disorders. Nexalin believes the deeper penetrating waveform will
generate enhanced patient response without any adverse side
effects. The Nexalin tACS device was recently approved in China by
the National Medical Products Administration (NMPA) for the
treatment of insomnia and depression. In September 2018, Nexalin
entered into a series of agreements with Wider Come Limited
(“Wider”), a company formed under the laws of the People’s Republic
of China. Pursuant to this agreement, Nexalin and Wider have agreed
to explore the formation of a joint venture entity to be domiciled
in Hong Kong. This new entity will conduct clinical research and
implement a business distribution plan for the Nexalin device in
the Asia Pacific.
Contact:Crescendo Communications, LLCTel: (212)
671-1020Email: NXL@crescendo-ir.com
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