Ann: U.S. FDA 510(k) clearance received for next gen sensor, page-109

In repsonse to @Speckn above (reply button did not work, for whatever reason).

Have a look at announcements from 2017 to present. There are a few related to FDA 501(k) clearances. As per this ann:

“This FDA decision increases the number of 510(k) cleared Adherium devices to ten in the U.S. and represents an unequalled and formidable track record of development and experience by the market leader in respiratory digital health.”

What I have learnt through investing with other biotechs that have achieved successful commercialisation in the US is that it is a hard, slow graft, and requires plenty of cash. It is an extremely difficult market to penetrate, and there can be incentives in place to slow progress (particularly from competitors or incumbent products). The Hailie product is good, so it is really now on the management to execute against the strategy.