Nexalin Technology Signs Definitive Exclusive Distribution and Local Manufacturing Agreement for Brazil and South America, Marking a Major Step in its Transition Toward Commercial Revenue Generation

Distributor-funded Brazilian manufacturing provides for device compensation and disposable-electrode royalties without capital costs to Nexalin.

Rhea-AI Summary

Nexalin Technology (Nasdaq: NXL) signed a definitive exclusive distribution agreement with Inovanexa Medical Technologies covering seven South American countries.

The 10-year agreement covers Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela and supersedes the February 2026 letter of intent. It includes a binding initial order for 10 Nexalin Sync devices, five for immediate delivery, and a Brazilian clinical pilot targeted within 90 days. Sync has ANVISA approval in Brazil for anxiety, depression and insomnia.

A pricing framework covers the first 100 devices. After purchasing the first 30, Inovanexa must establish Brazilian manufacturing at its own cost. Nexalin receives fixed compensation per locally manufactured device placed in the market and royalties per locally manufactured disposable electrode sold. Exclusivity requires minimum revenue thresholds; renewals and manufacturing depend on distributor performance.

13 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointDefinitive 10-year agreement establishes exclusive distribution across seven countries, replacing the February 2026 letter of intent.
• Moderate pointANVISA approval covers Nexalin Sync treatment of anxiety, depression and insomnia in Brazil.
• Minor pointBinding initial order for 10 devices includes five for immediate delivery.
• Minor pointFirst 100 devices have a structured pricing framework for commercialization.
• Minor point. Forward-looking: it has not happened yet and may not happen.Equal profit-sharing applies to qualifying private-sector transactions involving devices assembled in Brazil.

8 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Distributor-funded manufacturing requires a Brazilian facility after the first 30 device purchases, at zero capital cost to Nexalin.
• Minor point. Forward-looking: it has not happened yet and may not happen.Fixed per-device compensation applies to each locally manufactured device placed in the marketplace.
• Minor point. Forward-looking: it has not happened yet and may not happen.Per-unit royalties apply to every locally manufactured disposable electrode sold.
• Minor pointDistributor-paid costs cover importation, regulatory compliance and marketing.
• Minor pointGovernment and public-sector access authorizes the distributor to pursue tenders and procurement opportunities throughout the territory.
• Minor pointIntellectual property ownership remains entirely with Nexalin, which exclusively supplies the devices’ encrypted circuit boards.
• Minor pointCompleted University of São Paulo clinical trial reported a 77.8% anxiety response rate.
• Minor point. Forward-looking: it has not happened yet and may not happen.Brazilian clinical pilot is targeted to launch within 90 days.

Negative

• Minor pointExclusivity depends on defined distributor performance requirements, including minimum revenue thresholds payable to Nexalin.
• Minor pointSuccessive 10-year renewals and local manufacturing are subject to distributor performance requirements and agreement terms.

News Explained

The distributor bears specified rollout costs, while the agreement does not establish sales beyond the initial 10-device order.

Under the signed agreement, Inovanexa bears importation, regulatory-compliance, marketing and local-manufacturing costs; qualifying private-sector transactions involving Brazil-assembled devices carry equal profit-sharing with Nexalin. The agreement sets a pricing framework for an initial 100-device program, but the only binding purchase order disclosed is for 10 devices; the company says further orders are not assured.

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+69.16% vs previous close $7.24 last price 10782.5x rel. volume Open Argus

Details

Market move: NXL +69.16% vs previous close. South America partnership

+56.1% Peak in 20 min

$4.49 – $7.93 Day Range

$6.00M Market Cap

On Oct 1, the day this news came out, the latest delayed price for NXL is 69.16% above the previous close. Argus tracked a peak move of +56.1% during the session. Our momentum scanner has recorded 61 alerts for this stock so far that day. The latest delayed price is $7.24. Relative volume is exceptionally heavy at 10782.5x the average.

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Key Figures

Initial agreement term: 10 years Territory: 7 countries Territory population: More than 300 million people +5 more

Initial agreement term

10 years

Exclusive distribution framework; renewals are subject to performance

Territory

7 countries

Exclusive distribution rights across Brazil and six other South American countries

Territory population

More than 300 million people

Combined population of the covered territory

Initial binding purchase order

10 devices

Five devices are to be delivered immediately

Clinical pilot timing

Within 90 days

Targeted launch of the initial Brazil pilot

Initial commercialization program

100 devices

Structured pricing framework for the initial program

Local manufacturing trigger

Purchase of the first 30 devices

Distributor must establish a Brazil facility at its own cost

Anxiety response rate

77.8%

Completed Brazilian clinical trial cited in the article

Historical Context

1 past event · Latest: Sep 29

1 event

1. Sep 29

   Commercialization appointment

   24h Move

   +3.5%

   Named a global commercialization adviser ahead of planned distribution efforts, including Brazil.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

royalty, de novo pathway

2 terms

royalty financial

"per-unit royalty on every locally manufactured disposable electrode sold"

A royalty is a payment made to the owner of a resource or asset—such as a patent, mineral rights, or creative work—whenever others use or profit from it. For investors, royalties provide a steady stream of income without owning the entire asset, similar to earning a small commission each time a product is sold or a service is used. This makes royalties an important factor in valuing certain types of investments.

de novo pathway regulatory

"ongoing FDA De Novo pathway in the United States"

A de novo pathway is a regulatory route that allows manufacturers to win approval for a novel low- to moderate-risk medical device when there is no previously approved similar product, by showing reasonable assurance of safety and effectiveness. It matters to investors because successful de novo clearance opens a company to an untapped market and can create a first-mover advantage while reducing long-term regulatory uncertainty—like getting a permit to open a new type of store in a neighborhood where none existed before.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Agreement establishes an initial 100-device commercialization program for the ANVISA-approved Nexalin Sync™ across seven countries and more than 300 million people, with a structured pricing framework and a mechanism for larger strategic transactions with government and private-sector customers

Agreement establishes a 10-year commercial framework covering Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela, anchored by an initial 100-device commercialization program and minimum revenue thresholds payable to Nexalin to maintain exclusivity

Binding initial purchase order at signing and a clinical pilot targeted within 90 days, supporting a distributor-funded manufacturing framework that is designed to generate recurring royalty revenue on every device and every disposable placed into the market

HOUSTON, TX, Oct. 01, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in non-invasive Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced that it has signed a definitive international distribution agreement (the “Agreement”) with Inovanexa Medical Technologies S.A. (the “Distributor”), appointing the Distributor as Nexalin’s exclusive distributor for the importation, distribution, commercialization, promotion and sale of the Company’s Nexalin Sync™ non-invasive neurostimulation device — which has been approved by Brazil’s National Health Surveillance Agency (ANVISA) for the treatment of anxiety, depression and insomnia — across Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela, a combined territory of more than 300 million people. The Agreement formalizes and supersedes the Letter of Intent entered by the parties in February 2026 and carries an initial 10-year term, with successive 10-year renewals subject to performance.

The Agreement converts more than two years of deliberate groundwork in Brazil — ANVISA regulatory approval of the Nexalin Sync device, a completed clinical trial at the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo that reported a 77.8% anxiety response rate, and award-winning investigator research — into a definitive commercial launch platform for South America. Brazil is one of the ten largest economies in the world, with a population in excess of 215 million, of whom more than 35 million are estimated to be affected by mental health disorders.

Key terms of the Agreement include:

• Exclusive rights across seven countries. The Distributor is appointed as Nexalin’s exclusive distributor across Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela, subject to defined performance requirements, and is authorized to operate under the trade name “Nexalin LATAM.”
• Immediate, binding initial order and rapid clinical ramp-up. The Distributor is required to place an initial binding purchase order for 10 Nexalin Sync devices with 5 delivered immediately and then deploying the initial devices in a clinical pilot program in Brazil targeted to launch within 90 days.
• Initial 100-device commercialization program. The Agreement establishes a structured pricing framework for the first 100 Nexalin Sync devices, together with a mechanism for larger strategic transactions with government and private-sector customers, including equal profit-sharing on qualifying private-sector transactions involving devices assembled in Brazil.
• Royalty-bearing local manufacturing — at zero capital cost to Nexalin. Upon the purchase of the first 30 devices, the Distributor is required to establish a local manufacturing facility in Brazil entirely at its own cost, operating under Nexalin’s technical supervision and aligned with FDA-compatible quality standards. Nexalin is entitled to receive fixed per-device compensation for each locally manufactured device placed into the marketplace, together with a per-unit royalty on every locally manufactured disposable electrode sold, which is intended to create a recurring, usage-driven revenue stream.
• Full access to government and public-sector channels. The Distributor is authorized to pursue federal, state and municipal tenders and procurement opportunities, as well as public hospitals and universities, in Brazil — home to one of the largest government-run public healthcare systems in the world — and throughout the territory.
• Nexalin retains full ownership of all intellectual property. Nexalin remains the sole and exclusive owner of all intellectual property, technology, know-how, patents and trademarks relating to the Nexalin Sync platform, and all encrypted circuit boards required for the devices to function will be loaded, encrypted and supplied exclusively by Nexalin.

"This Agreement is the commercial culmination of everything we have methodically built in Brazil — and the launch pad for all of South America," said Mark White, Chief Executive Officer of Nexalin Technology. "We secured ANVISA approval, we generated compelling clinical data at one of Latin America's most prestigious psychiatric research institutions, and we said we would convert that foundation into a definitive commercial partnership. Today we have done exactly that. This is a 10-year exclusive framework across seven countries and more than 300 million people, with a binding initial order placed at signing."

Mr. White continued, "We believe this Agreement marks the inflection point Nexalin has been working toward — the shift from a pre-revenue research and development company to a revenue-producing global distribution company. The economics are capital-light by design: our partner funds the buildout while Nexalin retains intellectual property, supplies the encrypted boards at the core of every device, and earns revenue on every device and every disposable placed into the market. This Agreement gives Nexalin a scalable business plan with a non-invasive, drug-free treatment platform — while establishing a repeatable blueprint for international markets alongside our ongoing FDA De Novo pathway in the United States."

"Brazil is the template, not the exception. We have strengthened our leadership specifically to execute against that blueprint, most recently with the addition of Robert DiTota as Senior Strategic Advisor, Global Commercialization. His mandate is to help us structure and execute distribution partnerships of this caliber across North America, South America and Europe. We now have the clinical foundation, the intellectual property, the regulatory pathway and the commercial leadership to scale it."

"Nexalin has done something very few medical technology companies attempting to enter Brazil ever accomplish it arrived with regulatory approval already in hand and clinical results generated at the University of São Paulo, one of the most respected psychiatric research institutions in Latin America,” said Dr. Raphael Luz Pereira Romano, the Chief Medical Officer of Inovanexa Medical Technologies S.A. “Mental health is one of the most urgent public health priorities across our region, and access to safe, non-invasive, drug-free treatment options remains severely limited. We are committing our capital, our regulatory expertise and our commercial infrastructure — including local manufacturing in Brazil — because we believe the Nexalin Sync platform can become a new standard of care across the territory. Our immediate focus is executing the clinical pilot program and building the foundation for scale across both the private and public healthcare sectors.” 

Under the Agreement, the Distributor is responsible for all costs associated with importation, regulatory compliance, marketing and local manufacturing. Exclusivity, renewal and the local manufacturing framework are subject to the Distributor’s satisfaction of the performance requirements and other terms and conditions set forth in the Agreement, and there can be no assurance that the Distributor will meet such requirements, that purchase orders beyond the initial binding order will be placed, or that the commercial objectives of the Agreement will be achieved.

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 will generate enhanced patient response without any adverse side effects. 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 include, without limitation, the statements attributed to the Company’s management and to the Distributor in the quotations set forth in this press release, and statements regarding the anticipated benefits and revenue potential of the Agreement, whether or not they contain the words identified above. Forward-looking statements are based on Nexalin’s current expectations, assumptions, estimates, projections, and beliefs as of the date hereof and are subject to significant risks, uncertainties, and other factors, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied.

Forward-looking statements in this press release include, but are not limited to, statements regarding: the anticipated benefits, execution, and performance of the Agreement; the placement and fulfillment of initial and future purchase orders; the timing and launch of the clinical pilot program in Brazil; the initial 100-device commercialization program; the establishment and operation of a local manufacturing facility in Brazil; the anticipated per-device compensation and disposable royalties payable to Nexalin, including with respect to future clinical indications; the Distributor’s ability to satisfy the minimum revenue thresholds and other performance requirements under the Agreement; the transfer or maintenance of ANVISA regulatory approvals and the receipt of any additional regulatory approvals in the territory; the pursuit of government and public-sector opportunities; the size of the market opportunity in Brazil and the broader territory; the Company’s expectations regarding capital-light and recurring revenue; the Company’s anticipated transition from a pre-revenue research and development company to a revenue-producing company and the timing of any resulting revenue; the anticipated equal profit-sharing on qualifying private-sector transactions involving devices assembled in Brazil; the Company’s expectation of establishing a repeatable blueprint for, and executing, distribution partnerships in other international markets; the assumptions underlying the foregoing, including assumptions regarding market size, the prevalence of mental health disorders in the territory, the commercial significance of the clinical results described above, and the Company’s ability to supply encrypted circuit boards; and the Company’s broader clinical, regulatory, and commercial strategy, including its FDA De Novo pathway. These forward-looking statements are not guarantees of future performance, and no assurance can be given that the transactions and revenues contemplated by the Agreement will be realized on the anticipated timeline or at all.

Such risks include, but are not limited to: the Distributor’s ability and willingness to perform its obligations under the Agreement, including placement of purchase orders, payment obligations, satisfaction of performance requirements, and establishment of local manufacturing; the fact that the structured pricing framework for the first 100 Nexalin Sync devices does not obligate the Distributor to purchase any devices beyond the initial binding ten-device order, and that the Company may never recognize revenue from devices beyond that order; the risk that the clinical pilot program in Brazil is delayed beyond the targeted 90-day period or does not generate results supporting commercial adoption; the Distributor’s limited operating history with the Company’s products and its ability to fund the contemplated local manufacturing facility, on which substantially all of the Company’s anticipated per-device compensation and disposable royalty revenue depends; the parties’ ability to negotiate and execute the contemplated Licensing and Manufacturing Agreement; risks associated with reliance on a single distributor for the territory; risks relating to the maintenance, transfer, or receipt of ANVISA and other regulatory approvals, including the cooperation of the existing Brazilian regulatory holder and the risk that the existing ANVISA approval for the Nexalin Sync device is not transferred to, or maintained for the benefit of, the Company or the Distributor; the risk that the results of the single-site investigator-initiated trial at the Institute of Psychiatry, Hospital das Clínicas, University of São Paulo, including the reported 77.8% anxiety response rate, are not replicated in larger populations or in commercial use; the risk that the Company does not obtain marketing authorization through the FDA De Novo pathway on the anticipated timeline or at all; the Company’s history of operating losses and limited revenue and its need for additional capital; risks inherent in international operations, including foreign currency, tax, customs, import/export, sanctions, political, and economic risks in Brazil and the other countries in the territory, and anti-corruption and anti-bribery compliance risks in connection with government tenders and public-sector sales; competition from existing and new treatment alternatives; market acceptance of, and reimbursement for, the Company’s products; the Company’s ability to protect and enforce its intellectual property rights internationally; manufacturing, quality-system, and supply-chain risks, including the Company’s ability to supply the encrypted circuit boards required for every device; the outcome of any government tender or procurement processes; the Company’s ability to secure adequate funding on acceptable terms; and the Company’s ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market. Additional risks and uncertainties 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”), available free of charge at www.sec.gov. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to update any forward-looking statement, except as required by law.

Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What does Nexalin’s exclusive South American distribution agreement cover?

The initial 10-year agreement appoints Inovanexa Medical Technologies as exclusive distributor in Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela. It includes an initial 100-device commercialization program, with exclusivity subject to performance requirements and minimum revenue thresholds payable to Nexalin.

How many Nexalin Sync devices are in the initial binding order?

The initial binding order covers 10 Nexalin Sync devices, with five for immediate delivery. The initial devices will be deployed in a Brazilian clinical pilot targeted to launch within 90 days.

How will Nexalin supervise Brazilian manufacturing and control its device technology?

Brazilian manufacturing will operate under Nexalin’s technical supervision and align with FDA-compatible quality standards. Nexalin retains sole ownership of the platform’s intellectual property, technology, know-how, patents and trademarks. All circuit boards required for the devices to function will be loaded, encrypted and supplied exclusively by Nexalin.