Nexalin Technology Accelerates Manufacturing of Its HALO Clarity Following Successful Usability, Feasibility, and Electrical Testing
Nexalin Technology Accelerates Manufacturing of Its HALO Clarity Following Successful Usability, Feasibility, and Electrical Testing
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.
Nexalin科技公司（以下简称“公司”或“Nexalin”）（纳斯达克股票代码：NXL；NXLIW）今天宣布，在美国完成了第一个完整的生产测试，并成功地进行了可用性、可行性设计验证和电气安全测试，为其新的第3代HALOClarity 15毫安（mA）神经刺激设备做好了准备。因此，该公司现在正在加紧制造，以便在计划中的临床试验之前生产约500台设备于2024年第三季度。
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科技公司的CEO马克·怀特（Mark White）表示：“我非常高兴地宣布，HALOClarity通过了一系列严格的测试，验证了我们的制造工艺并说明了我们的设备符合最高的产品标准。鉴于这一成功，我们现在正在加快HALOClarity设备的生产，以支持即将进行的临床试验。 HALOClarity设备不仅建立在广泛的临床数据之上，证明了我们以前一代设备的潜在治疗效果，而且还增加了全新的功能水平，可以在舒适和便利的家庭环境中治疗，以及由医生远程监控。 总的来说，我们对HALOClarity在革新美国和全球治疗心理健康障碍方面的潜力比以往任何时候都更加有信心。
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.
Nexalin计划在美国开展HALO Clarity的临床试验，并在其预提交会议中与美国食品和药品管理局（FDA）进行咨询。该公司预计，由于HALO Clarity治疗可以在家中进行，而不是在医院或门诊临床设置中进行，因此即将进行的临床试验将在加快时间和显著降低成本方面得到完成。 并且因为捕获的数据可以及时通过电子方式传输，因此可以获取病人反应的实时数据。在FDA批准的前提下，HALO Clarity的家庭使用方面预计将显著降低病人治疗成本，同时提高符合适用标准的遵从度。
