Company Interview / Pumping along with FDA plans

Matthew Regan of Artrya Limited (ASX:AYA), is in a phase of transitioning from a startup development company to a global organisation ready for commercialisation. Their artificial intelligence (AI) driven platform, aiming to quickly diagnose heart disease with CT images, has entered the final stage of its US FDA public application process. Coupled with a strategic partnership with US hospital group Cone Health, Matthew anticipates lodging their application straight after the FDA Q sub meeting on August 19th.

Matthew says that, notwithstanding heart disease being a top global cause of death, Artrya (ASX:AYA) aims to be part of the solution by facilitating the quick treatment of patients. A government grant of 3.3 million and an R&D tax credit of 3 million gives Artrya a cash capital of 7 million to fuel their growth beyond the commercialisation phase, especially in the USA. Their business strategy includes integrating their research-use product with strategic US partners, and launching their product both in Australia and the USA.

Regarding investor concern about security, Matthew stresses the importance of having the right people and building strong software. As an assurance, their CIO, who led the IBM security practice in Asiapac, leads the security practice in Artrya as well. Looking forward, Artrya (ASX:AYA) expects an increase in their sales cycle once clearance is acquired in both the USA and Australia, making the next six months promising for the company.

Full unedited transcript:

0:00

Well. The Aussie medtech aria has entered the final phase of its US, FDA, a public application process for its AI driven platform, and secured a strategic partnership with the US hospital group Cone Health. For the details. Atria CEO Matthew Ragan joins me now. Um, good to see you. Just tell us what the update is about, where you're at. Yeah. Thanks, Julia. Thanks for having me this afternoon. Yeah. Look, we're running into a really exciting time for for us as a young organization. We're really starting to take that transition from a startup development company to an organization that can really start to commercialize, not just here in Australia, but around the world. We've got the FDA Q sub meeting coming up on the 19th of August, and at this stage, we anticipate lodging our application as soon as we can directly after that. So let's just take a step back, Matthew. You and I have spoken a couple of times, but just for you is watching on biz what it is you do because you're using artificial intelligence or a platform to detect heart disease. Absolutely. So for

0:59

those that don't know, and I'm sure everyone actually does, but heart disease is the number one, um, cause of death globally, unfortunately takes more lives than all cancers combined. And we're part of that sort of journey to help arrest that. Um, slide. And, and we take CT images and essentially help clinicians diagnose as rapidly as we can that heart disease so people can get treatment a lot quicker. So you've had a grant from the government as well, something like 3.3 million. What is your cash on hand looking like and how do you plan to deploy all of that capital? Yep. So our cash on hand at the moment is around about the 7 million mark. Uh, we're burning around about 1.3 a month. We also have an R&D tax credit coming in north of $3 million. So really, we've got enough cash, um, capital, to get us through and beyond and into our commercialization phase in the, in the USA. All going well, of course. Uh, we also have strategic partners in the US that we're already starting to integrate our research use only product into. So

1:59

that's about narrowing that sales cycle once we do get that clearance in the USA and of course in Australia, we're starting to commercialize our product as well. When do you expect that you will get that all important FDA approval?

2:11

So typically for for our sort of application, we expect it to be about three months from our submission date. And we expect to be submitting probably the tail end of this month, if not just the first few days into into September. So in terms of the platform that you're using, I mean, so much hype around AI at the moment, obviously what you're doing is very innovative. What are the concerns or how would you address investor concerns, though, about, uh, I guess, security in this space too.

2:41

Yeah. So security in this space. So it's really about, you know, we've built this product ground up. We've got, um, fantastic skill sets in this space. So our, our CIO, for instance, uh, used to lead the sort of IBM security practice here in Asiapac as well. So it's about getting the right people and developing the right software at the right time. We're very conscious, obviously, of cyber security globally and also, um, you know, data preservation, all those sort of other bits and pieces. And we're well ahead of that curve as far as our development goes. Okay. So in terms of how you expect this to overall impact or affect your company, I should say, what's the sort of upside or what's the next six months or so looking like for atria.

3:22

So yeah, thank you. The next six months is probably the most exciting time. So I'll just give you a view as a bit of a feel of it. So in Australia we go through about 350,000 CCTV scans a year, which is the scans that we would ingest in America. That's 4.4 million. And it's obviously growing as this sort of, um, heart disease is not slowing down. So that just gives you a quantum scale difference into the US. Also, the US is a revenue based system. So whilst it equates for a probably, you know, 20% of the market as far as CTAs go, globally it accounts for about 50% of the revenue.