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 HALOClarity 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 HALOClarity device to support our upcoming clinical trials. Not only does the HALOClarity 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 HALOClarity'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.