Nexalin Technology Reports Significant Positive Results of Clinical Study Supporting the Therapeutic Benefits of its Gen-2, 15 Milliamp Neurostimulation Device on Treatment-Resistant Depression
19 December 2023 - 12:30AM
Nexalin Technology, Inc. (the “Company” or “Nexalin”)
(Nasdaq:
NXL; NXLIW) today reported the results of a study in patients
with treatment-resistant depression (TRD), concerning the potential
therapeutic benefits of its second-generation (Gen-2), 15 milliamp
(mA) neurostimulation device, 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 Xuanwu Hospital, Capital Medical
University in Beijing, China. The results were also published in
General Psychiatry, an open-source, peer-reviewed scientific
journal. The published results of the study concluded that repeated
treatment with Nexalin’s neurostimulation device suggests an acute
effect in reducing depressive symptoms in patients with TRD. In
addition, no adverse events were observed during treatment.
Major depressive disorder (MDD), also known as clinical
depression, is a mental health condition that affects mood,
behavior, appetite, and sleep. According to a 2022 National Survey
on Drug Use and Health, an estimated 22.47 million adults, or 8.8%
of all US adults in the United States, had at least one major
depressive episode. According to Future Market Insights, the MDD
treatment market is forecast to reach US$ 14.96 billion by 2032
from US$ 11.51 billion in 2022. It is estimated that one-third of
patients with MDD will not respond to two or more antidepressant
drugs with different mechanisms with these patients being referred
to as having treatment-resistant depression (TRD). American
military veterans are particularly at risk for TRD, with nearly one
in seven suffering from MDD considered to have TRD. In part for
this reason, the President’s 2023 Budget Request included $13.9
billion towards Veterans Mental Healthcare services, an increase of
14% above the 2022 Budget.
As part of the clinical study, 7 migraine patients were treated
at the Xuanwu Hospital. Treatment was administered for 4
consecutive weeks via the forehead and both mastoid (twice per day,
5 days a week). Efficacy and adverse reactions were assessed at a
2-week screening/baseline period followed by a 4-week treatment
phase. The study concluded that twice daily 15mA tACS, a unique
form of non-invasive brain stimulation, offers an acute effective
intervention for patients with TRD. The study showed that all
patients with TRD had a significant reduction in depression
symptoms after the 4-week treatment, and all of them achieved a
clinical response (defined as HAMD-17/ MADRS scores that decreased
by 50% or more from the baseline).
Figure 1 Clinical outcomes. (A) The mean HAMD-17
total scores significantly decreased from baseline to week 4. The
error bars represent the SD. The asterisk (*) indicates a
statistically significant difference with p<0.05. (B) Total YMRS
scores at baseline and week 4. HAMD-17, 17-item Hamilton Rating
Scale for Depression; No. number; SD, standard deviation; YMRS,
Young Mania Rating Scale.
The previous 8-week randomized, double-blind,
sham-controlled trial evaluating 100 patients with major depressive
disorder (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.
Mark White, CEO of Nexalin Technology, stated,
“We are pleased to report the results of this study in patients
with treatment-resistant depression (TRD), which have been featured
in a leading peer-reviewed journal. These results reinforce
the growing body of clinical evidence supporting the potential of
Nexalin's new advanced waveform to help combat the ongoing global
mental health epidemic. We believe the data provides further
evidence of the significant impact of our non-invasive, drug-free
device on improving mental healthcare outcomes among patients
affected with TRD. No significant adverse effects were reported,
which is especially noteworthy given the growing number of patients
seeking non-pharmacological treatment options. Overall, we
remain committed to our mission of bringing our new, effective, and
drug-free therapy to patients with mental health issues in the
United States and around the world.”
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
- Nexalin Clinical Outcomes Data Table
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