Nexalin Technology Reports Results of Clinical Study Supporting the Therapeutic Benefits of its Gen-2, 15 Milliamp Neurostimulation Device in Treating Migraine Headaches and Related Symptoms
2023年8月7日 - 9:30PM
Nexalin Technology, Inc. (the “Company” or
“Nexalin”)
(Nasdaq: NXL; NXLIW) today provided an
update on the growing body of clinical data supporting the
potential therapeutic benefits of its second-generation (Gen-2), 15
milliamp (mA) neurostimulation device, including the results of a
study in patients with migraine headaches, which indicated a
substantial and statistically significant benefit in
patients.
The clinical trial was funded by the Company’s
joint venture partner, Wider Come Limited (“Wider”), and its
related companies, and was conducted at the Vertigo Center,
Department of Neurology, Second Affiliated Hospital of Zhengzhou
University. The results were also presented in Chin J
Neuromed, a peer-reviewed scientific journal in China, which
concluded that repeated treatment with Nexalin’s neurostimulation
device suggests a significant reduction in the frequency and degree
of pain of migraine patients. In addition, a strong safety
profile was reported.
As part of the clinical study, 40 migraine
patients (without migraine aura) were treated at the Vertigo
Center. Patients were randomly assigned 1:1 to experimental and
sham groups. Treatment was administered for four consecutive
weeks with a 4 week follow-up period. Efficacy and adverse
reactions were assessed before treatment, at the end of treatment,
and at the end of follow-up, respectively.
A statistically significant improvement was
achieved across all key metrics, including Visual Analog Scale
(VAS), Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety
Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD) and
Migraine-Specific Quality of Life Questionnaire (MSQ) scores (see
charts below). All of these measures are used as standard scales in
clinical practice to assess the severity and impact of migraine and
related symptoms, as well as the effectiveness of treatment.
Additionally, no adverse events were observed during treatment in
the two groups.
Migraine trial results
The migraine study follows the Company’s recent
clinical study in depression, which demonstrated statistically
significant improvements among patients. Numerous studies
have indicated an association between migraines and major
depressive disorder (MDD), and depression is estimated to affect
nearly 80% of all migraine sufferers.
The previous 8-week randomized, double-blind,
sham-controlled trial evaluating 100 patients with MDD, published
in the international journal, Brain, indicated that patients
receiving treatment with the Company’s Gen-2, 15mA neurostimulation
device had better remission and response rates than the sham group.
Compared with sham treatment, almost all depressive symptoms among
the active treatment showed significant improvement. Moreover,
there was no significant statistical difference in adverse events
between the two groups.
Depression trial results
According to the World Health Organization
(WHO), the prevalence of mental health disorders and conditions is
increasing worldwide and there has been a 13% increase in mental
health conditions and other depressive disorders in the last decade
alone. Notably, in 2020, among adolescents between ages 12 and 17,
17% percent had a major depressive episode (MDE), and 12% had MDE
with severe impairment in 2020, according to the USA Department of
Health and Human Services (HHS).
Mark White, CEO of Nexalin Technology, stated,
"Research and Markets estimates the migraine and depression markets
at roughly $3.9 billion and $11.2 billion, respectively. We
believe the data we have reported in our clinical studies provide
evidence of potential clinical efficacy, without any significant
adverse effects, which is especially noteworthy given the growing
number of patients seeking non-pharmacological treatment options,
since pharmaceuticals often come with very negative side
effects. We look forward to conducting additional clinical
trials in new indications – many of which will be fully funded by
Wider, our new JV partner.”
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
was recently 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
- Migraine trial results
- Depression trial results
Nexalin Technologies (NASDAQ:NXL)
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Nexalin Technologies (NASDAQ:NXL)
過去 株価チャート
から 6 2023 まで 6 2024