Nexalin Technology Accelerates Manufacturing of its HALO™ Clarity Following Successful Usability, Feasibility, and Electrical Testing
09 Aprile 2024 - 2:30PM
Nexalin Technology, Inc. (the “Company” or “Nexalin”)
(Nasdaq: NXL; NXLIW) today announced it has completed the
first full production test run and successfully performed
usability, feasibility design verification, and electrical safety
testing for its new Gen-3 HALO™ Clarity 15 milliamp (mA)
neurostimulation device in the U.S. As a result, the Company is now
ramping up manufacturing in advance of its planned clinical trials
and expects to produce approximately 500 units in the third quarter
of 2024.
Mark White, CEO of Nexalin Technology, stated,
“I am thrilled to report that the HALO™Clarity passed a series of
rigorous tests, validating our manufacturing process and
illustrating that our device meets the highest product standards.
Given this success, we are now accelerating production of the
HALO™Clarity device to support our upcoming clinical trials. Not
only does the HALO™Clarity 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. Overall,
we are more confident than ever in the HALO™Clarity’s potential to
revolutionize how we treat mental health disorders in the United
States and around the world.”
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 an expedited
timeframe and at a considerably lower expense, since 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 can be contemporaneously
transmitted electronically. 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.
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 Oman and China. 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, 2023 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
RedChip Companies Inc. Dave Gentry407-644-4256or
407-491-4498Email: nxl@redchip.com
- The new Gen-3 HALO™ Clarity 15 milliamp (mA)
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