Houston, TX, April 21, 2025 (Globe Newswire) – Nexalin Technology, Inc. (Nasdaq: nxl; nxliw) (The “Society” or the “Nexalin”) The leader in deep stimulation of intracranial frequency (DIFs ™) of the brain, announced today its support for the Health Tech Investment Act (S. 1399) – Bipartite legislation introduced in the American Senate which would incorporate reimbursement of the artificial intelligence of the FDA or approved medical learning.
The legislation, sponsored by senators Mike Rounds (RS.D.) and Martin Heinrich (DN.M.), offers a transitional reimbursement mechanism under Medicare to fill the current difference between approval and coverage of devices. Under the proposal, the AI compatible technologies that receive the authorization or approval of the FDA would be awarded classification codes of ambulatory payments (APC) of new technologies for up to five years, which allows the Medicare & Medicaid reimbursement centers to collect clinical data and to assess long -term reimbursement decisions.
Nexalin’s next Gen-3 Halo Clarity ™ device, currently developing for the submission of the FDA, is a new generation neurostimulation system that incorporates the advanced AI capabilities in the delivery of patient treatment and monitoring. The device is designed to provide non -invasive low -frequency waveforms that target keyword regions associated with anxiety, depression, insomnia and related mental health problems. In tandem with the device itself, Nexalin has built an ecosystem of proprietary virtual clinic which uses artificial intelligence to support remote processing, real-time clinical feedback and secure data capture-throughout an integrated electronic capture platform (EDC) and the patient monitoring system (PMS).
The company has recently completed phase 1 of its virtual clinical infrastructure fueled by AI, which allows patients to initiate home therapy via a secure mobile application, while clinicians and researchers receive automated and real -time information via AI compatible dashboards. This ecosystem is designed specifically to support the Gen-3 Halo Clarity ™ device and is a central element of Nexalin’s strategy to improve mental health care thanks to technology-oriented solutions.
“The Health Tech Investment Act reflects a change in the national health policy towards supporting intelligent innovations and centered on the patient,” said Mark White, CEO of Nexalin. “Our Gen -3 Halo Clarity ™ apparatus illustrates this approach – combining precision neurostimulation with AI -led tools that improve coordination, monitoring and adhesion of care. This legislation provides a reimbursement path which recognizes and supports this model of care. ”
The Gen-3 Halo Clarity ™ system was designed to meet the needs of patients and providers in an increasingly digital health environment. It develops the clinical bases laid down by previous generation systems of Nexalin, adding intelligent characteristics that allow clinicians to personalize treatment, analyze real -time results and ensure compliance with the protocol – whether in the clinic or remotely. The company is currently preparing for the submission of the FDA of the Gen-3 system after planned clinical trials.
Nexalin considers the law on health technology investments as a legislative step which could provide a reimbursement framework perfectly suited to the Gen-3 Halo Clarity ™ apparatus. The bill offers a clear signal that federal decision -makers prioritize the intersection of innovation and accessibility, in particular in fields such as mental health, where traditional care options remain limited or ineffective for many patients.
While the bill progresses by the congress, Nexalin remains concentrated on its regulatory and clinical stages and supports rapid bipartite action to bring this important legislation into court.
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to help fight solely on the continuous world mental epidemic. All Nexalin products are not invasive and undetectable for the human body and are developed to relieve people with mental health problems. Nexalin uses bioelectronic medical technology to deal with mental health problems. Nexalin believes that its neurostimulation medical devices can penetrate the structures deeply into the middle of the brain which are associated with mental health disorders. Nexalin believes that the deeper wave form entering its new generation devices will generate an increased patient response without any undesirable side effects. The Nexalin Gen-2 15 milliiamp neurostimulation system has been approved in China, Brazil and Oman. Additional information on the company is available on: https://nexalin.com/.
Prospective declarations
This press release contains statements that constitute “prospective declarations”, these declarations concern future events or future financial performance of Nexalin. All declarations which refer to expectations, projections or other characterizations of future events or circumstances or which are not declarations of historical facts (including without limitation of the declarations to the effect only Nexalin or his direction “believes”, “expects”, “anticipates”, “plans”, “intentions” and similar expressions) should be considered by prospective declarations. Prospective declarations are subject to many conditions, many of which are out of control of the company, including those set out in the Société risk factors section on form 10-K for the year ended December 31, 2023 and other deposits deposited with the Securities and Exchange Commission. Copies of these deposits are available on the SEC website, www.sec.gov. These prospective declarations are made on the date of these and can become exceeded over time. These prospective declarations are made on the date of these and can become exceeded over time. The company has no obligation to update these declarations for revisions or modifications after the date of this version, unless the law required.
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