Thanks for sharing asx11. Here are some of my thoughts and perspective on this matter.
The CT scan requirement issue (which from AF's language could in part be a regulatory condition for XV LVAS) is in the grand scheme of things not an insurmountable challenge but in my view probably the opposite. Nor is it a show stopper; rather a "nice not to have." For adults, I expect this to be a one-time requirement only for VX LVAS (so not too onerous).
There would be multiple technological and non-technological pathways to overcoming this requirement, and AF in that webinar confirmed as much ("multiple technological pathways to removing that requirement" he says). They've got onboard a team of very smart software engineers working on this. He also said "it won't be very long" and
"we're not very far away" to overcoming this issue - and I am inclined to believe him on that because the last time he said "we've very close" was in relation to the CT:VQ data in mid May 2023 webinar and that early indications were that the CT:VQ results were positive - and then just 2 weeks after, the company released and presented that clinical data from that CT:VQ data that confirmed success for that product and an indication of FDA registration and approval within about a year.
CT LVAS clearance:
- For Australia, I'd expect this not to be an active issue. CT LVAS is approved and is being rolled out in favour of XV LVAS through I-MED. One can probably conclude that you don't need a prior chest CT for CT LVAS because it should kill two birds with one stone:
- For the USA, I'd be very surprised if CT LVAS is not being considered for FDA registration (maybe it is already in the works). Once FDA cleared, this also provides an alternative to XV LVAS and supersedes that prior chest CT requirement. You'd expect FDA clearance to be easily granted, given this is a sister product to XV LVASbased on similar tech and we as a company we've been vetted by the FDA and have FDA product clearance history as well as CT LVAS being approved in Oz. Another reason why I think CT LVAS registration process could be in the pipeline is because of CT:VQ - CT will be used for VQ so we may as well have CT LVAS registered in advance (or both concurrently)!
XVD Scanner:
- The prior chest CT scan requirement could realistically be addressed by one of the various technological pathways they are exploring, before regulatory approval is sought.
Finally as a general point, we should really let the company go on about their business to address opportunities and challenges that every business encounters (many of which we would be unaware).If we were to dissect every minute aspect of a growing business' areas for improvement, we'd be killing ourselves doing so.An example is Apple which didn't have the best iteration of the iPhone at inception and has continually improved it, and similarly for the products of Afterpay, PME, RMD or COH. The products got better as years went on, addressing challenges from user feedback, and with incremental improvements in user experience, the adoption grew larger and flywheels spun faster.
(20min delay)