Nexalin Technology Unveils Next-Generation HALO™ Clarity
11 Gennaio 2024 - 2:30PM
Nexalin Technology, Inc. (the “Company” or
“Nexalin”)
(Nasdaq: NXL; NXLIW) today unveiled its
Gen-3 HALO™ Clarity 15 milliamp (mA) neurostimulation device
designed to treat a variety of mental health conditions, including
Major Depressive Disorder (MDD), addiction and substance use
disorder, Alzheimer’s disease, traumatic brain injury (TBI),
post-traumatic stress disorder (PTSD), chronic pain and other
potentially-applicable stress-related neuropsychiatric disorders.
The HALO™ Clarity utilizes an advanced
technique, Deep Intracranial Frequency Stimulation (DIFS™), to
penetrate structures deep in the mid-brain that are associated with
mental health disorders. Nexalin believes that this innovative
technique in its next-generation devices will generate enhanced
patient therapeutic responses without adverse side effects. The
HALO™ Clarity device has been the subject of multiple clinical
trials in China whose findings were published in medical journals.
In these published clinical studies, the resulting data shows a
substantial and statistically significant benefit to patients.
Nexalin believes that the HALO™ Clarity
represents a significant leap forward over prior versions of the
device in multiple respects: it enables patients to receive
treatment in the privacy of their own homes, and provides
physicians with remote access to seamlessly monitor their patient
data through a proprietary medical app which uses a secure
electronic method of transmission. The HALO™ Clarity, designed for
maximum comfort and convenience, has completed usability and
electrical testing by the China National Medical Products
Administration with positive results.
Nexalin plans to conduct clinical trials of the
HALO™ Clarity in the U.S. and is in the process of consulting with
the U.S. Food and Drug Administration (FDA) as part of its
pre-submission meetings. The Company expects that its upcoming
clinical trials will be completed in a quicker timeframe and at a
considerably lower expense, due to the fact that the HALO™ Clarity
treatment can be administered at home, as opposed to a hospital or
outpatient clinical setting, and the resulting data can be
captured, and patient response, contemporaneously transmitted
electronically. In addition, and contingent upon FDA
approval, the home-use aspect of HALO™ Clarity is expected to
significantly reduce patient treatment costs, while increasing
compliance with applicable standards.
Mark White, CEO of Nexalin Technology, stated,
“The HALO™ Clarity marks a significant advance and possibly the
most meaningful event in the history of the Company. When we
established Nexalin and embarked on this journey, we set out to
develop a first-in-class neurostimulation device, superior to
anything currently available in the market. The HALO™ Clarity
represents the culmination of years of research, testing and
product development. I truly believe this device will revolutionize
how we treat mental health disorders in the United States and
around the world.”
“We approached the market from both the
physician and patient perspective. Our goal has been to build an
entire digital ecosystem to address inefficiencies in the market
and stigmas associated with mental health disorders. Not only does
our device build on extensive clinical data demonstrating the
potential therapeutic effect of our prior generation devices, but
it adds a whole new level of functionality, enabling treatment from
the comfort and convenience of one’s own home, as well as remote
monitoring by a physician. We anticipate that the ability to
remotely treat and monitor patients will significantly reduce the
financial and economic burden of mental healthcare.”
“Overall, we are clearly executing on our
mission to transform the paradigm of mental health treatment, while
reducing the growing dependence on drugs that are often ineffective
and may have undesirable side effects. We could not be more excited
about the outlook for the business and I look forward to providing
further updates.”
About Nexalin Technology, Inc.
Nexalin designs and develops innovative
neurostimulation products to uniquely and effectively help combat
the ongoing global mental health epidemic. All of Nexalin’s
products are non-invasive and undetectable to the human body and
developed to provide relief to those afflicted with mental health
issues. Nexalin utilizes bioelectronic medical technology to treat
mental health issues. Nexalin believes its neurostimulation medical
devices can penetrate structures deep in the mid-brain that are
associated with mental health disorders. Nexalin believes the
deeper penetrating waveform in its next-generation devices will
generate enhanced patient response without any adverse side
effects. The Nexalin Gen-2 15 milliamp (mA) neurostimulation device
has been approved in China by the National Medical Products
Administration (NMPA) for the treatment of insomnia and depression.
Additional information about the Company is available at:
https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that
constitute "forward-looking statements," These statements relate to
future events or Nexalin’s future financial performance. Any
statements that refer to expectations, projections or other
characterizations of future events or circumstances or that are not
statements of historical fact (including without limitation
statements to the effect that Nexalin or its management “believes”,
“expects”, “anticipates”, “plans”, “intends” and similar
expressions) should be considered forward looking statements that
involve risks and uncertainties which could cause actual events or
Nexalin’s actual results to differ materially from those indicated
by the forward-looking statements. Forward-looking statements
are subject to numerous conditions, many of which are beyond the
control of the Company, including those set forth in the Risk
Factors section of the Company's Report on Form 10-K for the year
ended December 31, 2022 and other filings as filed with the
Securities and Exchange Commission. Copies of such filings are
available on the SEC's website, www.sec.gov. Such forward-looking
statements are made as of the date hereof and may become outdated
over time. Such forward-looking statements are made as of the date
hereof and may become outdated over time. The Company undertakes no
obligation to update these statements for revisions or changes
after the date of this release, except as required by law.
Contact:Crescendo Communications, LLCTel: (212)
671-1020Email: NXL@crescendo-ir.com
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