Nanosonics Ltd shares rose on Monday after the infection-prevention specialist secured a key US regulatory clearance for its next-generation CORIS system — a rare bright spot on a rough day for both the healthcare sector and the broader Australian market.
The stock closed at $3.58, up 4.22%, extending its gains over the past week to nearly 4%. That performance stood in contrast to the wider sell-off, with the S&P/ASX 200 Health Care index falling 3.2% and the ASX 200 dropping 2.85%.
The move followed news that the US Food and Drug Administration has granted a 510(k) clearance expanding the range of endoscopes that can be processed using Nanosonics’ CORIS system, marking the first regulatory expansion of the platform since its initial clearance.
Expanding the CORIS platform
CORIS is designed to improve how flexible endoscopes — widely used in gastrointestinal and other minimally invasive procedures — are cleaned and disinfected between uses.
These instruments are notoriously difficult to reprocess because of their long, narrow channels and complex internal components. Ensuring they are fully disinfected has been a persistent challenge for hospitals and regulators alike.
Nanosonics’ approach centres on automated, standardised disinfection processes designed to improve both safety and workflow in hospital sterilisation units.
The company said the latest 510(k) clearance broadens the range of endoscope types compatible with the CORIS system, expanding its potential use across clinical settings.
Chief executive Michael Kavanagh said the decision keeps the company on track with its development roadmap.
“This first FDA 510(k) clearance keeps us tracking to plan as we execute against our key milestones,” he said.
“It immediately broadens the range of endoscopes that can be processed with CORIS, building momentum for our upcoming market activities.”
More regulatory submissions ahead
The company is already preparing a second 510(k) submission aimed at further expanding CORIS coverage to additional endoscope types.
Each regulatory expansion widens the addressable market for the system, which Nanosonics sees as its next major technology platform beyond its flagship trophon ultrasound probe disinfection system.
While trophon established the company as a global player in infection prevention, the endoscope reprocessing market is significantly larger and more complex, making regulatory progress an important milestone in the platform’s rollout.
Early market rollout under way
Alongside the regulatory work, Nanosonics has begun introducing CORIS through a controlled market release (CMR) program.
The first sites are already operating in the United Kingdom, with additional sites expected to be added soon in Australia and the UK/Ireland.
A US controlled market release is planned to begin after the company gathers operational experience and feedback from these early installations.
Controlled market releases are commonly used by medical technology companies to refine workflows and gather real-world performance data before launching products at scale.
Nanosonics said the insights gained from these early sites will help guide the broader commercial rollout.
Looking towards commercial launch
The company currently expects a full commercial launch from FY27, with rollout across regions phased in line with the completion of the controlled market release program.
For now, the first expanded FDA clearance signals that the regulatory pathway for CORIS is progressing as planned.
With additional regulatory submissions already in preparation and early installations under way, the system is gradually moving from development towards broader hospital adoption — a transition investors appeared quick to recognise on an otherwise difficult day for healthcare stocks.