Nexalin Technology accelerates manufacturing of HALO Clarity

Nexalin Technology 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 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. 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 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.