Infection prevention specialist Nanosonics (ASX: NAN) has been granted ‘De Novo’ clearance by the US Food and Drug Administration (FDA) for its innovative CORIS system designed to improve cleaning outcomes for flexible endoscopes.
This formal tick of approval has now established CORIS as a completely new category for endoscope cleaning technology in the US. It marks a key step in the company’s commercialisation efforts in the lucrative American market.
Commercialisation push ramps up
Management noted that the first phase of its commercialisation drive remains on track for the first quarter of the 2026 fiscal year (FY26). Here, the company plans to build market awareness and conduct a targeted controlled market release with numerous hospitals.
A broader market introduction is targeted for the second half of FY26.
In essence, Nanosonics is gearing up for a commercial launch of CORIS on an international scale which also includes obtaining the necessary approvals for the UK, Europe, and Australia. These authorisations are expected to be in place in early FY26.
In conjunction, the first 510K submission for expanded scope indications in the US is being prepared for FDA submission.
More specifically, the CORIS system has been designed to automate and provide superior cleaning outcomes for the channels of all categories of flexible endoscopes.
However, the initial submission to the FDA was associated with colonoscopes only.
The company now intends to expand these indications to cover all major categories of flexible endoscopes via its 510K submission.
Nanosonics chief executive officer and president, Michael Kavanagh, commented:
“CORIS represents a significant opportunity for the organisation and the FDA de novo clearance marks a key milestone for the Company and an important step in bringing this much needed innovation to market.”
Addressing a significant medical need
Management estimates that more than 60 million flexible procedures are performed annually across major global markets, including nearly 35 million procedures in the US. And endoscopes require cleaning and disinfection – known as reprocessing – following each use.
According to Nanosonics, manual cleaning can be problematic for hospitals and clinics with contaminated endoscopes considered as a potential source of infection.
CORIS combines cutting-edge science and engineering with practical usability through an automated mechanism of action. In other words, it helps automate the cleaning process for endoscopes.
In turn, the device addresses what the company regards as one of the most critical challenges in medical device reprocessing.
Positioning for growth
The commercialisation push for CORIS builds on the company’s growing sales of its ‘trophon’ disinfection systems used in ultrasound probes, coupled with associated consumable products.
In H1 FY25, Nanasonics reported a global installed base of nearly 36,000 trophon and trophon2 devices, including more than 31,000 in the US.
Total revenue for the period clocked in at about $94 million, marking an 18 per cent year-on-year jump. This included about $24 million from the sale of trophon devices and nearly $70 million from consumable products.
In turn, consolidated profit before tax of about $11 million surged by 124 per cent from the previous corresponding period.
Nanosonics is also in the process of establishing a new manufacturing site for both trophon and CORIS consumables at its existing US facility in Indianapolis. Completion and registration is expected in the second half of FY25.
Management believes this expanded facility could deliver an array of benefits including margin improvements and reduced transportation costs.