At Last, Nanosonics (ASX:NAN) CORIS Heads to the FDA After Delays

From Delay to relief

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Big news from Nanosonics has just hit the wire, and it’s something that warrants our attention and perhaps a bit of optimism too! The company announced today that it has submitted a De Novo application for its latest innovation, CORIS, to the FDA. This move marks a significant milestone not only for the product but potentially for the company’s future trajectory. I have gone through deep dive for Nanosonics in my earlier post ( if you are interested in reading)

Understanding the Milestone

For those unfamiliar, a De Novo submission is used for new medical devices that have not yet been classified by the FDA and which are deemed to present a low to moderate risk. The submission of CORIS indicates that the clinical in-use study for this innovative system is complete. From the details shared, it sounds like Nanosonics is quite confident in CORIS's ability to outperform the current manual methods of endoscope reprocessing. This could signal a substantial shift in how such delicate instruments are sterilized, introducing higher standards of safety and efficiency into environments where they are sorely needed.

A Turning Point for Market Sentiment?

This announcement could very well act as a turning point for market sentiment towards Nanosonics. After a period of what could be seen as stagnation or cautious watchfulness from investors, this development might inject some renewed vigor into perceptions of the company’s stock. It shows progress and potential for significant impact in their market segment. However, Nanosonics still needs to demonstrate that it can grow its revenue despite pressures on hospital budgets in 2HFY24 and beyond.

Implications for R&D and Financial Health

The completion of intensive R&D phases for major projects like CORIS often suggests a forthcoming reduction in R&D spending as a percentage of revenue, at least in the medium term. This could mean a healthier financial outlook for Nanosonics, with more funds potentially being directed towards marketing, sales expansion, or even distributed as profits. Alternatively, it might allow the company to redirect resources towards other innovative projects, continuing its cycle of innovation. ( it could be bad thing as well!)

What do you think about this development? Do you see CORIS as a game-changer for Nanosonics and the broader field of medical sterilization? How do you interpret the potential financial impacts this could have on Nanosonics' operations moving forward? I’d love to hear your thoughts and predictions.