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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

Globe Newswire•01/10/2026•08:30 ET
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Key Highlights

  • ➤Nexalin (NXL) signs 10-year exclusive distribution agreement covering seven South American countries
  • ➤Initial binding order covers 10 Nexalin Sync devices, with five delivered immediately
  • ➤100-device commercialization program includes structured pricing and larger strategic transaction mechanisms
  • ➤Distributor must fund Brazilian manufacturing after 30 devices, generating device and disposable royalties
  • ➤Clinical pilot in Brazil targeted to launch within 90 days

Expert Statements

Mark White, Chief Executive Officer of Nexalin Technology

“This Agreement is the commercial culmination of everything we have methodically built in Brazil — and the launch pad for all of South America,”

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.”

Mark White, Chief Executive Officer of Nexalin Technology

“This is a 10-year exclusive framework across seven countries and more than 300 million people, with a binding initial order placed at signing.”

Mark White, Chief Executive Officer of Nexalin Technology

“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.”

Mark White, Chief Executive Officer of Nexalin Technology

“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.”

Mark White, Chief Executive Officer of Nexalin Technology

“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.”

Mark White, Chief Executive Officer of Nexalin Technology

“Brazil is the template, not the exception.”

Mark White, Chief Executive Officer of Nexalin Technology

“We now have the clinical foundation, the intellectual property, the regulatory pathway and the commercial leadership to scale it.”

Dr. Raphael Luz Pereira Romano, Chief Medical Officer of Inovanexa Medical Technologies S.A.

“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,””

Dr. Raphael Luz Pereira Romano, 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.”

Dr. Raphael Luz Pereira Romano, Chief Medical Officer of Inovanexa Medical Technologies S.A.

“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.”

Dr. Raphael Luz Pereira Romano, Chief Medical Officer of Inovanexa Medical Technologies S.A.

“Our immediate focus is executing the clinical pilot program and building the foundation for scale across both the private and public healthcare sectors.”

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

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