Nexalin Technology Taps Neuromodulation Commercial Executive Robert DiTota to Advise on its Global Commercialization Strategy

Appointment as Senior Strategic Advisor marks the Company’s expansion from clinical development toward commercialization of its DIFS™ platform in the United States, Europe and South America

DiTota spent over two decades in neuromodulation at Abbott and Medtronic, two of the largest companies in the field, including responsibility for Abbott’s North America commercial neuromodulation business, a division representing approximately $700 million in business

Nexalin’s Gen-2 SYNC device is already approved in China, Brazil, Oman and Israel; the engagement is intended to build the distribution relationships, go-to-market plan and commercial infrastructure required to convert those approvals into commercial sales

HOUSTON, TX, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), developer of non-invasive Deep Intracranial Frequency Stimulation (DIFS™) technology, today announced the appointment of Robert DiTota as Senior Strategic Advisor, Global Commercialization, effective September 15, 2026. Mr. DiTota will work directly with Nexalin’s executive management team, and with its Board of Directors as requested, to advise on the Company’s commercial strategy, international distribution and market development plan, go-to-market approach, and the commercial infrastructure and organizational development needed to support distribution of the Company’s neurostimulation platform.

The appointment marks an expansion of focus for Nexalin. Over the past several years the Company has concentrated on building the clinical and regulatory foundation for its DIFS™ platform, including peer-reviewed publication of its Alzheimer’s trial results, completed clinical work in Brazil, an FDA Q-Submission meeting in support of a planned U.S. pilot study in Alzheimer’s disease, and the initiation of the HALO™ Clarity pivotal program in insomnia, which is ongoing. The Company’s Gen-2 SYNC 15 milliamp device has been approved in China, Brazil, Oman and Israel. With that foundation in place, Nexalin is now building the commercial capability to distribute its technology, beginning in those approved markets and extending to the United States and Europe as regulatory milestones are achieved.

The Company is pursuing that opportunity in a market that Grand View Research estimates at approximately $7.0 billion in 2026 and projects will reach $13.9 billion by 2033. Nexalin’s position in that market rests on its clinical record. The Company’s Gen-2 SYNC device was evaluated in a randomized, double-blind, sham-controlled trial that showed statistically significant improvement versus sham on the Mini-Mental State Examination (P = .001) and the Montreal Cognitive Assessment (P = .03), together with treatment-associated changes in functional connectivity observed on MRI, and those results were published in the Journal of Alzheimer’s Disease and in Radiology. The Company believes that combination of controlled clinical data, peer-reviewed publication and regulatory approval in four countries differentiates its DIFS™ platform within non-invasive neurostimulation and provides a foundation for commercial development.

Mr. DiTota has spent more than two decades in neuroscience and medical device sales, including over 20 years in neuromodulation at Medtronic and Abbott. Beginning in 2016 he held a series of increasingly senior commercial roles at Abbott Medical Devices, most recently as Divisional Vice President of Sales for North America Commercial Neuromodulation, where he was responsible for downstream marketing, commercial excellence, sales operations, enterprise accounts, commercial strategy and sales training across a division representing approximately $700 million in business, as well as for the division’s merger and acquisition activity. As Vice President of Sales for North America Movement Disorders, he increased revenue by more than $20 million within his first year in the role. Earlier at Abbott, as Regional Sales Manager for the Northeast, he led a market development effort that opened 60 new implanting centers and grew that business from zero to more than $16 million.

Prior to Abbott, Mr. DiTota spent nine years at Medtronic, Inc., where he supported the Deep Brain Stimulation franchise across the New York metropolitan region and served as a sales and marketing representative on the launch of Medtronic’s Activa platform. He is a named co-author on published research in deep brain stimulation, including work appearing in the Journal of Clinical Neuroscience.

“The clinical and regulatory work of the past several years is what makes this next phase possible,” said Mark White, President and Chief Executive Officer of Nexalin Technology. “We have approvals in four countries and a growing body of published data behind the technology. What we need to build now is the commercial organization that turns that into sales. Rob has spent his career doing exactly that in neuromodulation, at Abbott and at Medtronic,in the United States. He understands how these products reach physicians and patients, how distribution partners are selected and held accountable, and what has to be in place before a launch. We are fortunate to have him working alongside us as we make this transition.”

“Nexalin has established an important clinical and regulatory foundation,” said Robert DiTota. “The company has generated controlled clinical data, published peer-reviewed results, and secured regulatory approvals for its Gen-2 SYNC device in four countries. The commercial opportunity now is to translate that foundation into disciplined market development in approved geographies while continuing to build the evidence, regulatory strategy and infrastructure needed for broader commercialization. That is the work in front of us.”

The Company intends to provide further updates as its commercialization strategy advances.

About Nexalin Technology, Inc.

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. Nexalin’s medical devices are non-invasive and undetectable to the human body. Nexalin products are developed to provide relief to those afflicted with mental health issues using frequency based bioelectronic medical technology. 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 supports enhanced patient response with a favorable tolerability profile. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, Oman and Israel. Additional information about the Company is available at: https://nexalin.com/.

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). These forward-looking statements relate to future events, future performance, or management’s current expectations, beliefs, assumptions, plans, estimates, intentions, or projections relating to the future, and are not guarantees of future performance. Any statements that are not statements of historical fact, or that refer to expectations, projections, or other characterizations of future events or circumstances (including, without limitation, statements containing the words “believes,” “expects,” “anticipates,” “plans,” “intends,” “will,” “may,” “could,” “should,” “would,” “designed to,” “positioned to,” “potential,” “targeted,” “seeking,” “continues,” “strategy,” “opportunity,” “estimates,” “projects,” “forecasts,” “predicts,” “outlook,” “guidance,” or similar expressions, or the negative of such terms), are forward-looking statements. Forward-looking statements also include the statements contained in the headline and subheadings of this press release and the statements attributed in quotations to the Company’s management and to Mr. DiTota, in each case to the extent they describe plans, objectives or expectations for future operations. Forward-looking statements are based on Nexalin’s current expectations, assumptions, estimates, projections, and beliefs as of the date hereof. These statements are subject to significant risks, uncertainties, and other factors, many of which are beyond the Company’s control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release.

Forward-looking statements in this press release include, but are not limited to, statements regarding: the Company’s expansion from a clinical development focus toward commercialization and distribution of its products; the anticipated scope, contribution and results of Mr. DiTota’s engagement as Senior Strategic Advisor, Global Commercialization, and the Company’s expectation that his experience will support the development of the Company’s commercial strategy, distribution relationships, go-to-market planning and commercial infrastructure; the Company’s ability to convert existing international regulatory approvals into commercial sales; the Company’s plans to pursue commercialization in the United States, Europe and other markets where regulatory approval has not yet been obtained; estimates of market size, market composition and market growth prepared by third parties, which are based on assumptions that may prove inaccurate and which do not represent the Company’s addressable market or any expectation of the Company’s future revenue; the design, enrollment, timing, progress, results and potential outcomes of the Company’s clinical development programs, including its planned U.S. pilot study in Alzheimer’s disease and the HALO™ Clarity pivotal study in insomnia; the mechanism of action, depth of penetration, safety profile and differentiation of Nexalin’s DIFS™ platform, including the Company’s belief that the deeper-penetrating waveform in its next-generation devices supports enhanced patient response with a favorable tolerability profile; the Company’s belief that its controlled clinical data, peer-reviewed publications and existing regulatory approvals differentiate its DIFS™ platform and provide a foundation for commercial development; management’s expectations regarding future regulatory submissions, clearances and approvals; and the Company’s strategic plans, business prospects, capital needs, and ability to continue as a going concern.

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company’s control. Such risks include, but are not limited to: the risk that the Company’s expansion toward commercialization may be delayed, may require substantially more capital, time or personnel than anticipated, or may not result in commercial sales or revenue; the risk that the engagement of a strategic advisor will not produce the commercial capabilities, distribution relationships or results the Company anticipates; the risk that the revenue growth and market development results attributed to Mr. DiTota in his prior roles at Abbott and Medtronic, which were achieved at substantially larger companies with established products, sales organizations and reimbursement, are not indicative of results the Company may achieve; the fact that Mr. DiTota is engaged as a non-exclusive independent consultant on a part-time basis, is not an officer or employee of the Company, and may terminate his engagement on thirty days’ notice; the Company’s limited commercial operations, limited revenue to date, and lack of an established sales and distribution organization; the risk that regulatory approvals obtained in international markets will not result in commercial sales; the risk that the approvals obtained in China, Brazil, Oman and Israel are limited in scope or indication, are subject to conditions, or may be modified, suspended or withdrawn; the risk that the results of the randomized, double-blind, sham-controlled trial described in this press release, including the Mini-Mental State Examination and Montreal Cognitive Assessment endpoints and the MRI functional connectivity findings, will not be replicated in larger or later-stage studies, will not be accepted by the FDA or other regulators as adequate support for marketing authorization, and may not translate into physician adoption, reimbursement or commercial demand; the Company’s dependence on third-party distributors and partners in international markets, and the risk that such arrangements may not be executed, may not be performed, or may not generate the volumes or revenue contemplated; the risk that third-party market estimates cited herein are inaccurate, measure a market broader than the products the Company offers, or that the Company will capture no meaningful share of any such market; the ability to obtain regulatory clearance or approval from the FDA or other regulatory bodies, including with respect to the Company’s planned U.S. pilot study in Alzheimer’s disease and the HALO™ Clarity pivotal program in insomnia, and the fact that the Company’s products are not currently approved for commercial sale in the United States or Europe; uncertainties regarding the design, enrollment, execution, timing, results and completion of clinical trials; the potential for adverse events, safety concerns, or product performance issues; market acceptance of, and reimbursement for, the Company’s products; the Company’s ability to protect and enforce its intellectual property rights; competition from existing and new treatment alternatives, including from substantially larger and better capitalized companies, including Abbott and Medtronic; the Company’s reliance on third-party manufacturers and suppliers; the Company’s ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market; the Company’s ability to secure adequate funding on acceptable terms to complete its planned clinical, regulatory and commercial programs; and general economic, political, regulatory and market conditions. Additional risks and uncertainties that could cause actual results to differ materially are described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2025, and in the Company’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings the Company makes from time to time with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these filings are available free of charge on the SEC’s website at www.sec.gov and on the Company’s investor relations website. New risk factors emerge from time to time, and it is not possible for the Company to predict all such risk factors or to assess the impact of all such risk factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

All forward-looking statements in this press release are qualified in their entirety by this cautionary statement and the risk factors and other cautionary statements set forth in the Company’s SEC filings referenced above, and speak only as of the date they are made. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances, or otherwise, after the date of this press release.

Contact:
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