Nanosonics (ASX: NAN) has commenced its Nanosonics CORIS Market Release, with the first unit now live and reprocessing flexible endoscopes in a UK hospital. This follows the system’s UK certification and UKCA marking, representing a critical transition from development to real-world validation.
The infection prevention specialist has confirmed additional Controlled Market Release (CMR) sites will start shortly in Australia and Ireland. The US CMR will commence following the first 510(k) FDA regulatory clearance for expanded scope indications and preliminary insights from UK and Australian installations.
Nanosonics launches CORIS controlled market release with first UK hospital installation
The first CORIS unit is now operational in a UK hospital, marking a significant development milestone after years of research and development. This installation follows the system’s UK certification and UKCA marking, allowing the company to begin gathering real-world performance data in a live clinical environment.
The company has confirmed further CMR sites are planned to start shortly in Australia and Ireland. The timing of the US CMR is linked to receiving the first 510(k) FDA clearance for expanded scope indications, combined with preliminary insights from the UK and Australian installations.
Broader commercialisation of CORIS is targeted for FY27, positioning this CMR phase as a critical validation period before full-scale market launch.
What is a controlled market release and why does it matter?
A Controlled Market Release is a staged rollout with selected partner sites designed to gather real-world performance data before a full-scale commercial launch. Companies use CMR to validate product performance across different hospital workflows and settings, identify operational refinements, and build clinical evidence.
For investors, CMR success reduces commercialisation risk by demonstrating the product functions effectively in diverse clinical environments. The data generated during this phase can strengthen sales conversations and support broader market adoption during the planned FY27 rollout.
This approach allows Nanosonics to work closely with hospital partners to capture insights that may not emerge during development testing, ensuring CORIS is optimised for real-world use before widespread deployment.
CORIS positions Nanosonics for endoscope reprocessing market expansion
CORIS is an innovative cleaning system for flexible endoscopes, representing Nanosonics’ expansion beyond its established trophon ultrasound probe disinfection platform. The system addresses the endoscope reprocessing market, opening a new vertical in infection prevention for the company.
The product has achieved UK certification and UKCA marking, with US 510(k) clearance pending for expanded scope indications. This regulatory progress positions CORIS for multi-market deployment, with FY27 commercialisation representing the next major revenue catalyst.
For Nanosonics investors, CORIS diversifies the company’s product portfolio beyond its core trophon business and provides exposure to the addressable market opportunity in endoscope reprocessing.
Michael Kavanagh, CEO & President
“CORIS represents a major advancement in endoscope reprocessing. Seeing the system operating in a live hospital environment is a significant moment after many years of development. The Controlled Market Release allows us to work closely with selected hospital partners across different workflows and settings, ensuring we capture real-world insights before full commercialisation in FY27.”
Key milestones and upcoming catalysts
The roadmap ahead includes several validation checkpoints that investors should monitor:
- UK CMR now live – Data collection underway in live hospital environment
- Australia and Ireland CMR sites – Planned to commence shortly
- US 510(k) FDA clearance – Required for expanded scope indications (timing to be confirmed)
- US CMR commencement – To follow FDA clearance and preliminary UK/Australian insights
- Broader commercialisation – Targeted for FY27
Each milestone provides validation of CORIS performance across different regulatory jurisdictions and clinical settings. US regulatory clearance and the FY27 commercial launch represent the key catalysts for investors to monitor as leading indicators of revenue potential.
What this means for Nanosonics investors
The CMR commencement demonstrates execution on the CORIS development roadmap, transitioning the product from a development-stage asset to one generating real-world clinical data. This de-risks the commercialisation pathway by validating system performance in live hospital environments before full-scale market deployment.
The FY27 commercialisation timeline positions CORIS as the next revenue inflection point for Nanosonics, complementing its established trophon business with exposure to the endoscope reprocessing market. However, investors should note the product remains in CMR phase, not full commercial release.
Investors should watch for CMR feedback updates and US regulatory news as leading indicators of FY27 launch success. The real-world data generated during this controlled phase will be critical in supporting broader market adoption and validating the commercial opportunity.
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