HOUSTON, Texas — October 1, 2026
Nexalin Technology, Inc. announced that it has signed a definitive exclusive distribution and local manufacturing agreement with Inovanexa Medical Technologies S.A. covering Brazil, Argentina, Chile, Uruguay, Paraguay, Ecuador and Venezuela. The 10-year agreement establishes a structured commercialization framework for the ANVISA-approved Nexalin Sync™ non-invasive neurostimulation device, which is approved in Brazil for the treatment of anxiety, depression and insomnia. The partnership begins with a binding order for 10 devices, including five devices for immediate delivery, and establishes an initial 100-device commercialization program across a territory representing more than 300 million people. A clinical pilot program in Brazil is targeted to begin within 90 days, while the distributor will fund future local manufacturing and commercialization activities. The agreement represents a significant commercial development for Nexalin as it seeks to transition from research and development activities toward recurring revenue generated through international device sales and disposables.
Nexalin Establishes 10-Year South America Distribution Framework
The agreement grants Inovanexa exclusive distribution rights across seven South American countries, subject to defined performance requirements and other contractual conditions. The distributor will be responsible for importation, regulatory compliance, marketing, commercialization and local manufacturing activities throughout the territory and will operate under the trade name Nexalin LATAM. The initial commercialization program covers the first 100 Nexalin Sync devices and includes a structured pricing framework as well as provisions for larger strategic transactions involving government and private-sector customers. In Brazil, the distributor is authorized to pursue federal, state and municipal tenders, along with procurement opportunities involving public hospitals and universities. The agreement follows more than two years of work in Brazil, including ANVISA approval of Nexalin Sync, a clinical trial conducted at the Institute of Psychiatry of Hospital das Clínicas at the University of São Paulo and research evaluating the device’s potential application in mental health. The company said the commercial framework is intended to provide a foundation for broader deployment across both private and public healthcare channels.
Local Manufacturing Creates Recurring Revenue Model
Nexalin’s agreement includes a distributor-funded local manufacturing strategy designed to generate recurring revenue without requiring capital expenditure from Nexalin. After the purchase of the first 30 devices, Inovanexa is required to establish a manufacturing facility in Brazil at its own expense, operating under Nexalin’s technical supervision and according to quality standards aligned with FDA-compatible requirements. Nexalin will receive fixed compensation for locally manufactured devices placed into the market and a per-unit royalty on locally manufactured disposable electrodes sold to customers. The structure is intended to create a recurring, usage-driven revenue stream as the installed base expands. Nexalin will also retain full ownership of its intellectual property, technology, know-how, patents and trademarks, while encrypted circuit boards required for the devices to operate will continue to be supplied exclusively by Nexalin. The company said this model allows its commercial partner to fund manufacturing and market development while Nexalin maintains control over the core technology and participates economically in future device and disposable sales.
Nexalin Builds Commercial Platform for Neurostimulation Growth
The South American agreement builds on Nexalin’s broader strategy to commercialize non-invasive neurostimulation technology for mental health conditions. The company develops Deep Intracranial Frequency Stimulation (DIFS™) technology intended to deliver frequency-based bioelectronic stimulation to structures deep within the brain. Nexalin said its Gen-2 15 milliamp neurostimulation device has received approvals in China, Brazil, Oman and Israel, providing a regulatory foundation for international commercialization. The company is also pursuing a U.S. FDA De Novo pathway for its technology. The Brazil agreement adds a defined commercial structure to Nexalin’s international expansion strategy, combining an initial device order, clinical deployment, potential government procurement and distributor-funded manufacturing. However, the company cautioned that future purchase orders and commercial objectives remain subject to the distributor meeting contractual performance requirements. With a 10-year framework covering seven countries, an initial 100-device program and recurring revenue provisions tied to devices and disposables, Nexalin is establishing a broader commercial pathway for its neurostimulation platform across South America.
Source:Nexalin Technology,, press release



