US FDA clearance received for next generation trophon

Open PDF
Stock Nanosonics Ltd (NAN.ASX)
Release Time 6 Aug 2025, 9:29 a.m.
Price Sensitive Yes
 Nanosonics receives US FDA clearance for next generation trophon
Key Points
  • US FDA clearance received for latest trophon innovation, enabling launch of trophon3 and trophon2 Plus
  • Offers over 40% faster cycle time, greater digital integration and broader traceability capabilities
  • Significant upgrade opportunity with ~10,000 first generation trophon EPR devices and ~20,000 trophon 2 devices
Full Summary

Nanosonics Limited, a leader in infection prevention, has announced that it has received clearance from the US Food and Drug Administration (FDA) for its latest trophon innovation, enabling the company to commercially launch trophon3 and trophon2 Plus, a software upgrade package for existing trophon 2 users, in the US. trophon3 delivers a range of new benefits to customers while maintaining the highest standard in clinical efficacy for patient safety. The new innovation is over 40% faster than previous generations and has expanded digital integration capabilities, offering the widest traceability capabilities in the ultrasound reprocessing market, including new digital traceability through customers' DICOM imaging database systems. Fully programmable and adaptable, trophon3 can be customised to suit a range of customer workflows, enhancing efficiency while delivering consistent, reliable disinfection in a safe, effective, and environmentally friendly way. trophon3 is expected to support continued growth in the company's installed base in both the hospital and private physician market segments, as well as drive a significant upgrade opportunity for approximately 10,000 original trophon EPR devices. trophon2 Plus is a software upgrade package that enables existing trophon2 users to access the key new features of trophon3. With approximately 20,000 trophon2 devices globally, this new package represents a significant software upgrade opportunity.

Outlook

The FDA clearance and US launch of trophon3 and trophon2 Plus mark important milestones for Nanosonics, setting a new benchmark in automated high-level disinfection and unlocking significant growth opportunity through both new installed base and upgrades.