The interview with Scott from EMVision is now on the meetings page and you can access the transcript here: EMV Transcript 2026.pdf

Pre-commercial/pre-revenue companies are always further up the risk spectrum, but these guys appear to be getting very close to the regulatory inflection point needed to start selling. Scott noted that while 2026 is a pivotal year for FDA clearance, the readout from their current trial might be just as significant because it removes the primary layer of clinical uncertainty. If and when they get the green light, there is a huge market opportunity with no competing product that offers the same value proposition.

The barrier to entry for hospitals is also relatively low because the device is much cheaper than traditional scanners or million-dollar mobile stroke units. To speed up adoption, they are pursuing a New Technology Add-on Payment in the US, which provides an extra payment to hospitals beyond the standard reimbursement bucket for the first few years of use. They also have a solid funding runway with around eighteen months of cash when you factor in their recent raise and the R&D rebates expected this quarter.

Buying now means you are likely getting a bargain *IF* they get approval and sales ramp up as hoped. Buying after the trial results are in and FDA clearance is granted significantly reduces the risk, but it also lowers the potential upside since the market will likely reprice the stock as soon as the data is public. Given that this is non-invasive technology and they have already successfully trained their algorithms using extensive simulation pipelines, it does not seem like a major long shot. But nothing is certain, and this is an area rife with promising ideas that ultimately failed.

I am still on the sidelines for now.

Very good conversation with Scott, @Strawman! My takeaways:

Funding

Scott appeared very relaxed about funding - he used the phrase “not in pressing need”, which surprised me.

Confirmed EMV has an active grant strategy and a “portfolio of grants” where they go hard to win any and all available grants.

“Avoid dilution that does not add value” was another phrase Scott used - he elaborated a bit on Keysight and their being “very motivated to grow healthcare”. 

From these comments, I suspect EMV has already lined up Keysight for a funding top up, as a last resort, if non-dilutive funding dries up, and would go that route vs a general market capital raise. Funding is still a concern for me, but Scott’s relaxed attitude and funding-related comments provides comfort that it is very much under control.

Future Growth Beyond The Initial Focus on Stroke Detection

Running a parallel study at 2 Aust sites to continue collecting data relating to traumatic brain injury which goes into their training library. This is front-end load work to allow for subsequent FDA 510k approvals to add more indications, and hence more pathways to chase the TAM

Other use cases that are on EMV’s radar for future growth - Treatment for ischaemia, positive identification for haemorrhage, Ruling out no blood in the brain in the same way non-contrast CT does today 

Commercialisation Strategy

• US-focus, FDA first, then back to Australia for TGA approval, then Europe for CE mark approval 
• Within US, focus on the southern states which have the highest incidence of stroke rates vs national rates
• Have good reference sites in Texas, Mayo Clinic etc
• Expect to have direct sales force on the ground in the US - “need to know how to sell your own technology before someone else can sell it “

Very comfortable with where EMV is and is heading. The next 6-12M will be very interesting. But as SM says, still some ways to go to get to FDA approval, then commercialisation, before the technology and company takes off.

Discl: Held IRL and in SM