Nexalin Technology Accelerates Manufacturing of its HALO™ Clarity Following Successful Usability, Feasibility, and Electrical Testing
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Insights
The completion of production tests and the advancement towards clinical trials for the Gen-3 HALO™ Clarity neurostimulation device represents a pivotal step for Nexalin Technology. From a manufacturing standpoint, the ability to produce 500 units in anticipation of clinical trials underlines the company's commitment to scale operations. This readiness could potentially shorten the time to market, assuming clinical success and regulatory approval.
The emphasis on home-use functionality and remote physician monitoring points to a strategic alignment with current healthcare trends towards telemedicine and home health care. This not only aligns with patient convenience but may also reduce the cost burden on the healthcare system. If the device proves to be effective, it could capture a significant market share in the mental health treatment segment, which is increasingly seeking non-pharmacological interventions.
Mark White's comments on the HALO™ Clarity device suggest a strategic move to leverage the home-use feature as a cost-reduction and compliance-improving factor. If the device can indeed deliver treatment effectively outside of traditional clinical settings, it could disrupt the current economic model of mental health care. By potentially lowering direct costs associated with in-clinic treatment and indirect costs like patient travel and time, the device could be economically advantageous.
However, the real economic impact will depend on the clinical trial outcomes and subsequent FDA approval. The claim of expedited trials and reduced expenses will be closely watched by stakeholders, as these factors can significantly influence the return on investment and the price point at which the device can be offered to the market. The long-term implications for the healthcare system could be substantial, especially if treatment efficacy and compliance rates improve.
Engagement with the FDA in pre-submission meetings is a critical step that indicates Nexalin's proactive approach to regulatory compliance. The company's expectation of an expedited clinical trial process could be due to the home-use nature of the device, which may streamline the data collection process. However, it's important to note that FDA approval is never guaranteed and the regulatory pathway can be unpredictable.
The company's claim of alignment with applicable standards and the potential for reduced patient treatment costs will be under scrutiny. Any deviation from regulatory expectations could delay or derail market entry. Stakeholders should be aware that the regulatory process is complex and rigorous, especially for devices claiming to treat mental health disorders, which are under increased scrutiny for safety and efficacy.
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:
Crescendo Communications, LLC
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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