Fair question, and honestly you can't underwrite a binary regulatory approval with precision...
What I anchor on instead is that the Companion already went through it, right? Same company got ADP (Ontario), RAMQ (Quebec) and US Medicare/Medicaid for that product. So this isn't a team that's never navigated reimbursement, they've done it across 2 countries. The Curio is following the same path (ADP under review, FDA 510k submission in progress, cybersecurity testing done), and per the CEO, trials outside Ontario just started.
That said, I mentioned it in the post, it's the core risk of the thesis and it hasn't happened yet.