Entry into a Material Definitive Agreement · Regulation FD Disclosure
Item 1.01 Entry into a Material Definitive Agreement. On September 28, 2026, Nexalin Technology, Inc. (the “Company”) entered into a Distribution Agreement, effective as of September 22, 2026 (the “Agreement”), with the Original Distributors (as defined in the Agreement), acting as founders of, and on behalf of, INOVANEXA MEDICAL TECHNOLOGIES S.A., a Brazilian corporation in formation (the “Distributor”).…
Filed Oct 1, 2026Accepted Oct 1, 2026, 5:00 PM EDTCIK 1527352Accession 0001829126-26-010685
We are a medical device company engaged in the design and development of innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic. We developed an easy-to-administer medical device — referred to as “Generation 1” or “Gen-1” — that utilizes bioelectronic medical technology to treat anxiety, insomnia and depression without the need for drugs or psychotherapy. Our original Gen-1 devices are cranial electrotherapy stimulation (CES) devices that emit a waveform at 4 milliamps during treatment and are presently classified by the U.S. Food and Drug Administration (the “FDA”) as a Class II device.
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Item 1.01Item 1.01 - Entry into Material Agreement
Item 1.01 Entry into a Material Definitive Agreement.
On September 28, 2026, Nexalin Technology, Inc. (the “Company”) entered into a Distribution Agreement, effective as of September 22, 2026 (the “Agreement”), with the Original Distributors (as defined in the Agreement), acting as founders of, and on behalf of, INOVANEXA MEDICAL TECHNOLOGIES S.A., a Brazilian corporation in formation (the “Distributor”). Under the Agreement, the Company appointed the Distributor as the Company’s exclusive distributor for the importation, distribution, commercialization, promotion and sale of the Company’s Nexalin Sync™ non-invasive neurostimulation device, together with related accessories and disposables (the “Products”), in Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela (the “Territory”). The Agreement has an initial term of ten years and, subject to compliance with the Agreement, including the performance requirements described below, renews automatically for successive ten-year terms. The Company retains sole and exclusive ownership of all intellectual property relating to the Products, and all encrypted circuit boards required for the Products to function will be supplied exclusively by the Company. The Distributor is authorized to operate under the trade name “Nexalin LATAM” and bears the costs of importation, regulatory compliance, marketing and local manufacturing in the Territory.
The Agreement establishes an initial 100-device commercialization program with tiered per-device pricing. The Distributor is required to place, immediately following signature of the Agreement, an initial binding purchase order for five Nexalin Sync devices, which are expected to be deployed in a clinical pilot program in Brazil targeted to launch within 90 days, and to place an order for an additional five devices within twelve months of the pilot program; the Distributor is not otherwise obligated to purchase additional Products, subject to the performance requirements described below. The Agreement also provides a mechanism for the parties to agree on alternative commercial structures for larger strategic transactions with governmental and private-sector customers, including equal sharing of the gross profit on qualifying private-sector transactions involving devices manufactured or assembled in Brazil during the initial program.
To maintain exclusivity, the Distributor must generate minimum aggregate revenues to the Company within the first 30 months following the launch of the pilot program and minimum annual revenues thereafter, in each case as set forth in the Agreement. If the performance requirements are not met, the Company may revoke the Distributor’s exclusivity and, in specified circumstances, terminate the Agreement. The Agreement contemplates a transition period of up to 30 months during which the existing Brazilian regulatory holder will continue to hold the ANVISA regulatory approvals required to import and sell the Products in Brazil; the transfer of regulatory approvals to the Distributor is conditioned on performance under the Agreement, after which the Distributor will be responsible for obtaining and maintaining regulatory approvals in the Territory. Upon the purchase of the first 30 devices, the Distributor is required to establish a local manufacturing facility in Brazil at its sole cost and expense, operating under the Company’s technical supervision, pursuant to a separate Licensing and Manufacturing Agreement to be negotiated between the parties; the Company will be entitled to fixed per-device compensation for each locally manufactured device placed into the marketplace and a per-unit royalty on locally manufactured disposables.
The Agreement contains customary provisions regarding purchase orders, payment, delivery, warranties, product liability, confidentiality, anti-corruption compliance and force majeure, and customary termination rights, including for uncured payment defaults, uncured material breach, insolvency events and changes of control.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 1.01.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On October 1, 2026, the Company issued a press release announcing the Company’s entry into the Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, including Exhibit 99.1 furnished herewith, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act, including statements regarding the anticipated benefits and performance of the Agreement, the placement and fulfillment of purchase orders, the timing of the clinical pilot program, the establishment of local manufacturing in Brazil, the Distributor’s ability to satisfy the performance requirements, and the transfer, maintenance or receipt of regulatory approvals in the Territory. These statements are subject to significant risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially, including the risks described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in its subsequent filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this Current Report, and the Company undertakes no obligation to update them, except as required by law.
Filed exhibits (1)
EX-99.1 (by filename) nexalintec_ex99-1.htm
Exhibit 99.1
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
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 - October 1, 2026 - Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in non-invasive Deep Intracranial Frequency Sti…