Shares in Nanosonics (ASX: NAN) were up over 10% at the open after the infection prevention company announced a watershed nod of approval from the United States Food and Drug Administration (FDA).
Approvals from the FDA are difficult to obtain, so when the company announced De Novo clearance for its latest innovation, the CORIS system, the market responded in kind.
In case you were wondering, De Novo clearance provides a marketing pathway to classify novel medical devices like CORIS.
As an advanced cleaning system, CORIS is designed to address one of the biggest challenges in medical device reprocessing - cleaning flexible endoscopes.
Flexible endoscopes provide the unique ability to reach cavities and viscera that cannot be seen with the naked eye.
Medical devices that are expected to benefit from applications like CORIS include those used in procedures like colonoscopies that are extremely difficult to clean.
Better cleaning is expected to reduce infection risk while enhancing patient safety.
Gap in infection control
What the FDA's approval does is provide the all-important confirmation that the technology meets strict regulatory standards, while also filling a glaring gap in infection control.
Today’s announcement follows FDA approval of Nanosonic’s trophon device in 2018. This has become the global standard for disinfecting ultrasound probes.
Commenting on today’s market update, CEO Michael Kavanagh told investors that FDA clearance was a "key milestone" and a crucial step toward launching the product commercially.
“The CORIS system has been designed to automate and provide superior cleaning outcomes for the channels of all categories of flexible endoscopes,” said Kavanagh.
“The initial submission to the FDA was associated with colonoscopes and the intent is to expand these indications to cover all major categories of flexible endoscopes over time.”
Next steps
Following a controlled market release - working with select hospitals – the company is planning a broader commercial launch in the second half of FY 2026.
Over the longer term, Nanosonics also expects to widen CORIS's applications to cover a much broader range of flexible endoscopes beyond colonoscopes.
Beyond the U.S. the company is also planning to receive regulatory approvals for CORIS in the UK, Europe, and Australia by the first quarter of FY 2026.
Recent results
In 1H FY25 the company reported total revenue of $93.6 million, up 18% on the previous period, while capital revenue of $24.4 million was up 11%.
Cash flow for the half was $13.8 million, with cash and cash equivalents of $144.5 million at 31 December 2024. This was debt-free.
Nanosonics' market cap is $1.4 billion making it an ASX300 stock; the share price is up 80% in one year and up 60% year to date.
The stock is in a strong bullish trend confirmed by multiple indicators.
Consensus is Hold.
This article does not constitute financial product advice. You should consider independent advice before making financial decisions.
