Hi everyone,
EMV is no longer flying under the radar. There was a 63% jump in attendance at the AGM today……….
All 11 of us had a great meeting (includes three couples).
Not too much to share really that we don’t all know already but I will put down a few thoughts and answers to some questions.
We all sat around the board room table again in a very relaxed and warm environment.
Question regarding NAN issue with trial and having to re do some in the US.
They are acutely aware of this and know exactly why it happened and will work to avoid similar issues. Will also address the issue with the FDA in Q1 next year to avoid any surprises.
They will meet with the FDA to agree trial metrics but essentially they drive this by the way they frame it. They outline what the device does, what it’s meant to do, the degree of accuracy it does it with etc and presents a package for the FDA to then come back with any questions. They now have a person on board in Dr Christian Wight who has over 50 FDA, TGA and CE approvals under his belt and are confident in their approach.
How would you compare scan quality between Gen 1 and Gen 2?
Gen 2 matches the quality of Gen 1 and has the added advantage of a whole of brain scan in one go where as Gen 1 needs two scans (different parts of the head).
Great to see the company start to increase awareness in our second indication of TBI - I asked if the Gen 2 device could one day end up at all major sporting events for concussion tests. Scott said that it’s certainly possible. The device would currently pick up medium and serious concussion but they need to do further work to ensure it could reliably pick up mild concussion.
TBI would involve a software upgrade for the existing devices but would increase use and consumable sales.
The image is currently removed from the device via a USB but will eventually be transferred digitally once the device is integrated into the hospital PAX system.
We had a demo of the device with a shareholder volunteering to be scanned. It all happened very fast. The cap felt like a cold tight beanie. The image literally took a minute or so once the USB was put into the laptop. Happy to say the persons brain looked very clean and as it should be. The image quality was amazing.
I asked if there was any chance of an upfront payment from a distribution agreement. That was unlikely and more common in Pharma.
Scott was asked about the eventual need for a CR. While he didn’t rule it out he was not keen to discuss it as he is determined to drive further forward with non dilutive funding. He said there are heaps of opportunities available and it’s just a case of what they could win. Military was even mentioned as a possible funding source which was interesting. You get the feeling that Scott is genuine in trying to minimise the SOI. If a CR is completed one day it will be out of a genuine need, done thoughtfully and in all shareholders best interests.
A question was asked about low liquidity and that funds need more liquidity to invest. Scott said that a lot of funds are waiting for a placement and have been since 2020. He says “let them wait”, if they want shares let them buy on market! (My type of CEO). He said that us retail investors would be better shareholders as most funds would flip on a 30% profit. (Music to my ears).
Not much else to share except that it was great catching up with some friends and other shareholders. It was good to spent some time with Scott and the team.
We are all invested in a wonderful company with excellent management, brilliant science and a life saving device with genuine global appeal. They are excited about the RSNA conference and showing the device off. Commercialisation is not that far away and 2024 should be a very exciting year.
DYOR and Not advice
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