The new Gen-3 HALO™ Clarity 15 milliamp (mA)
HOUSTON, TX, April 09, 2024 (GLOBE NEWSWIRE) -- 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:
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Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
RedChip Companies Inc.
Dave Gentry
407-644-4256
or 407-491-4498
Email: nxl@redchip.com
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