Forum Topics EMV EMV FY24 AGM, Interesting Slides

Pinned straw:

Added one year ago

There were some interesting slides in the EMV FY2024 slide pack. No new news as EMV has communicated clearly and regularly to the market but there were a few background/context slides which was interesting to note.

Discl: Held IRL and in SM

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The Stroke Indication was always front-and-centre

Seeing “Traumatic Brain Injury” as a second indication for the first time since I started deep-diving EMV

Also seeing the introduction of “Time Sensitive Medical Emergencies” for the first time - makes good sense and probably provides an indication of EMV’s direction and focus areas in the longer term

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The step improvement in size and mobility illustrates how game changing EMV’s products will be in improving the diagnosis and treatment options

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Don’t recall seeing a TAM slide like this before, so this was really useful

No target sale price for First Responder yet, so size of the TAM is unclear, but the significantly higher number of potential units surprised me somewhat

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Nice summary of the pre-validation clinical results - that is seriously impressive accuracy

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Nice summary of what’s ahead

End CY2025 Market Entry target is key from a funding standpoint - if that holds, and assuming no additional funding is obtained, EMV should have consumed ~55% of available cash at 30 Sep 2024 to get to that point (5 quarters vs ~9.4 quarters available funding)

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First Responder timeline

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Amen, but I would have liked to have seen a line or 2 to confirm “we have available cash to see us through to market entry”!

jcmleng
Added 5 months ago

@Chagsy , I went back to all CY 2024 and CY2025 EMV announcements around diagnostic performance. Figured that anything prior to that would not be terribly useful. Attached the links to the announcements as there is medical-related information that you may make better sense of.

Being completely clueless in all things medical, from an investment perspective, I have relied on the following to feel comfortable that things are progressing well in the lead up to FDA De Novo approval. The underlying assumption is that if there was anything fundamentally wrong, medically, which would threaten the viability of EMU or First Responder, one or some of these "channels" would have raised concern which EMV will have had to disclose as part of continuous disclosure requirements.

  • The test results from an investment perspective, look like good continuous improvement and progress to me
  • Peer reviews of all the preso's and papers that EMV will have presented/published to the medical world
  • EMV has also had a really good continuous run of non-dilutive fundung grants - have to assume that the grant organisations see the potential and value of EMU and the First Responder devices
  • Keysight, EMV's partner that ploughed $15m into EMV a year or so ago - they must be seeing the commercial value in the product
  • Then the Pivotal Trial sites are happening at all world class stroke facilities - Mayo, Royal Melb, UT Health, TMC


The planets have aligned across these various channels, giving me good confidence to stay invested.

The pivotal trial results would provide the next set of results and will be watching those more closely around what you have flagged.

27 Mar 2024

https://wcsecure.weblink.com.au/pdf/EMV/02789241.pdf

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27 May 2024

https://wcsecure.weblink.com.au/pdf/EMV/02810628.pdf

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12 Nov 2024

https://wcsecure.weblink.com.au/pdf/EMV/02879465.pdf

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21 May 2025

https://wcsecure.weblink.com.au/pdf/EMV/02948705.pdf

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Chagsy
Added 5 months ago

Great stuff @jcmleng and @Strawman I definitely take your point

i am travelling currently but will definitely take a better look. I apologise for being unduly negative- it is definitely a bias in this area for me!

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jcmleng
Added 5 months ago

@Chagsy no need to apologise at all! I totally appreciate the pushback/challenge as it forces me to take a closer look, which then helps me convince myself that all is still well. So please keep them coming!

I actually had a look at the AGM slides which got you going and this was interesting.

This was the AGM slide which you based your calculations on.

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This was in the ASX announcement prior to the 1HFY25 results notification:

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So, there was a stuff up in the EMV 1H24 slides, which you rightly picked up ...

This is a data point that no one cared to look at the detail of the AGM slides, myself included, except you! Note to myself, RTF slides!


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Chagsy
Added 5 months ago

Thanks @jcmleng

its a really interesting device. Please see my bear case from 4 years ago as to why I do not think it has a future in acute ischaemic stroke. Traumatic ICB (intracranial bleed) seems a far more rational target, but to change direction now would be challenging to say the least

I am puzzled by the quoted sensitivity of 85% for ischaemic stroke that they have provided. On the data provided it is 60%, which ain’t much better than flipping a coin:

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20 patients had ischaemic stroke, EMV correctly identified 12 (True Positives) and missed 8 (False Negatives)

TP = 12

FN = 8

=> 12/12+8 = 0.6 or 60%

Maybe I’m missing something?

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Strawman
Added 5 months ago

This is well outside my wheelhouse @Chagsy -- but I pasted your post and original bear case into chatGPT, which replied with:

To clarify the confusion around the 85% ischemic stroke sensitivity quoted by EMVision: that figure was from an updated AI algorithm performance using a cleaned and re-evaluated dataset as part of their Continuous Innovation Study, not the pivotal trial. According to the May 2025 announcement, this retrained model correctly identified 19 out of 20 ischemic cases, which equates to 95% sensitivity, not 60%.

The pivotal trial underway now is specifically designed to validate these algorithms on a statistically significant sample, and EMVision is blinded to the ongoing data, so no premature claims are being made off the pivotal study results just yet.

That said, you’re right to highlight the challenge of proving clinical utility beyond just diagnostic accuracy — particularly in acute ischemic stroke, where treatment pathways are evolving (e.g., toward mechanical thrombectomy over thrombolysis). That’s a fair concern, and one EMVision seems to acknowledge, with increased emphasis on triage applications, point-of-care settings, and longer-term AI-driven diagnostics — not just as a “tPA-or-not” tool.

Re: your point on “maybe I’m missing something” — it seems the 60% figure you're quoting is from a previous dataset or a misinterpretation of the newer AI test results, rather than the latest reported performance. But it’s absolutely worth keeping a close eye on how those pivotal trial numbers stack up once released.


Not sure if that tracks with what you're seeing? The May 2025 announcement referenced is here: Enhanced-Algorithm-Performance-From-Continuous-Innovation (1).PDF

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Chagsy
Added 5 months ago

Thanks @Strawman

I was using the numbers they provided on the slide that @jcmleng put up. The new AI model certainly changes the accuracy.....if validated. As with most post hoc improvements of previously published data sets, one should remain very sceptical until proven in a) real world conditions (ie prospectively) , b) the accuracy of imaging is confirmed in other centres not associated with EMVision, c) the numbers get into statistical significance (ie are adequately powered) and most importantly d) the introduction of a program using the EMVision device actually improves patient outcomes in comparison to the current standard of care.

So far none of those have been achieved. How much does it cost to achieve the above? Certainly many multiples of what they currently have.

Not saying they won't get there, but they have a long way to go.

During the time they are executing their proposed development pathway, one can expect that there will concomitant improvements in CT perfusion scans using AI (the current Gold standard), biomarkers of stroke (a blood test pre-hospital to diagnose stroke with out imaging, EEGs pre-hospital, Vascular US pre-hospital etc etc.

Perhaps a deep-pocketed Health care giant like GE or Siemens will be convinced by the tech and take them over so they can afford to develop it properly, but expecting an unfunded minnow to up-end the standard of care of acute ischaemic stroke is not a thesis I would sink my funds into.

Sorry to sound so gloomy.

Good luck to holders.

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Strawman
Added 5 months ago

Fair points @Chagsy and I don't doubt you're right with much of that.

My read is just that EMVision isn’t trying to replace the gold standard - it’s more about being a triage and monitoring tool for first responders and bedside use, especially where CT isn’t immediately available.

That is, they’re aiming to augment, not upend, the standard of care. If it can help prioritise care or reduce unnecessary transfers, that’s a real value add. But agreed..it’ll still need validation in real-world settings, across independent sites, and with clear outcome benefits to prove its worth.

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