Highlights:

Nanosonics gains FDA clearance for new trophon3 and trophon2 Plus products in the US

Nanosonics estimates ~30,000 new device opportunity in US hospitals and clinics

The company identifies global upgrade market across ~30,000 existing trophon devices

Nanosonics Limited (ASX:NAN) has secured clearance from the United States Food and Drug Administration (FDA) for its latest ultrasound probe disinfection technologies—trophon3 and the trophon2 Plus software upgrade enabling their commercial launch across the US healthcare market. This regulatory milestone allows Nanosonics to expand its reach within US hospitals and private clinics, segments representing an estimated 30,000 potential new device installations. The new trophon3 system introduces improvements over previous generations, including a shorter disinfection cycle time (over 40% faster), enhanced digital integration features, and expanded traceability options.

trophon3 supports traceability through integration with DICOM imaging systems, the international standard for medical imaging. The system is also designed to adapt to various clinical workflows through programmable settings. While these enhancements aim to streamline operations, the core function remains unchanged delivering high-level disinfection of ultrasound probes. Nanosonics also introduced trophon2 Plus, a software upgrade designed for current trophon2 users. This package allows facilities to access several of the advanced features introduced in trophon3 without replacing their existing hardware.

Together, trophon3 and trophon2 Plus represent a significant global upgrade opportunity. The company has identified approximately 10,000 trophon EPR devices, its first-generation systems, that could be replaced with trophon3 units. In addition, around 20,000 trophon2 devices are currently in the market, eligible for the new software enhancement. CEO and President Michael Kavanagh commented that the US FDA clearance and commercial launch mark an important step in the company's product lifecycle strategy. The move is intended to both expand Nanosonics’ installed base and address replacement demand across legacy platforms.

Founded in Sydney, Nanosonics Limited is a medical technology company specialising in infection prevention solutions, particularly for ultrasound probe disinfection. Its flagship product line, trophon, is used globally in hospitals and clinics to ensure compliance with infection control standards. The US remains a key market for the company, given its stringent regulatory requirements and large-scale healthcare infrastructure. With the latest FDA clearance, Nanosonics intends to address both new customer segments and the upgrading of its existing base through a dual product pathway. As the healthcare sector continues to focus on infection prevention, the introduction of new and updated disinfection solutions reflects ongoing demand for clinical efficiency, traceability, and compliance with evolving standards.

NAN is trading 2.96% higher at AUD 4.00 per share as of 6 August 2025.