HeartFlow, Inc.

Yeah.

Philip asks, um, "Does a focus on inflammation mean that Caristo would be more valuable for screening than Cleerly?" Though just to be clear, uh, Cleerly, Illucid, and HeartFlow are competitive technologies for assessing coronary artery, but they don't look at inflammation.

Uh, Caristo has FDA for e-exclusive inflammation indication.

The others are looking at, uh, plaque burden, vulnerable plaque, abnormal flow reserve.

it will not open the door to more digital health IPOs, which is a big problem because we haven't had a lot in the last three years.

We had HeartFlow, we had Hinge, and we had Omada.

And those were a while ago.

And there's over 100 digital health unicorns that are healthcare companies that want to IPO, and they can't IPO because the market's not right for them.

The second and third analysis came in.

Uh, that was HeartFlow and then QAngio, which was-- QAngio was the pre-specified.

All three of those analyses agreed with each other, with Cleerly being the outlier.

And throughout all of this, including a number of odd patterns we're not gonna take the time to get into here, went back to Cleerly every single time, said, "Come on, there's enough data that keeps-- that's accumulating at this point." They continued to say no.

It's not a, it's not a new study in terms of new scans or anything.

Same data.

But this time, looking at the analysis through using two different tools, QAngio and HeartFlow, instead of Cleerly, which was used in the, in the former retracted paper.

A lot of people online are getting confused, and people are citing the retracted paper, or some people are citing the new paper.

There are two new commercial technologies out.

So the first one is called HeartFlow.

And it's a CAT scan, but it actually, with the use of AI, and I don't know the specifics of it, it actually, you get an injection of dye in your arm, and then they're a CAT scan through your chest, and it actually measures the blood flow through your coronary arteries.

So it actually can measure, if you've got, let's say you've got an aralene of 30% or something, based on the calcium that's there, it actually will measure the if the blood flow was being significantly obstructed because a lot of people, for example, won't have chest pain until their, their coronary arteries might narrow to 80 or 90% or even more.

C-L-E-E-R-L-Y.

These are both just out in the last year or two.

So this is kind of a competitor to HeartFlow, but they have different purposes.

CLEERLY measures soft plaque.

So you got to be careful you're not taking something away from them on the financial aspects of things when delivering the new technology.

What's interesting is if you look at the adoption curve of any product that is an AI product the FDA has approved in the last five years, the only ones that are seeing that ramp up would be like HeartFlow, Viz.ai, and us.

You want to know what the clear, consistent trade across all of those are? It's CMS reimbursement.

And if you take a step back to earlier in my career and then you look at EMR adoption, the spike in adoption only really happened when meaningful use created a pool of capital to subsidize the adoption of EMRs.

Yeah.

So I don't know when this is going to air, but I am going to say that we are working with HeartFlow and we are having some

repeat CT angiograms.

Or I should put it this way, repeat analyses of our original CT angiograms.

It, it's basically looking at your coronary arteries, uh, your heart's blood vessels, to provide a little bit more detailed insight into your cardiovascular health.

And if you're doing something similar to what I got, like there's one called the HeartFlow.

One I did is called the Cleerly.

The software that they run the scan through has special algorithms in it that can measure the exact volume and the location and even the composition of arterial plaque, which is kinda cool.

There haven't been a lot of digital health IPOs.

So two years ago and one year ago, there was Hinge, Omada, and HeartFlow, and there just hasn't been anything for over a year now, for a while.

At the same time, the IPO window is open, and we saw the remarkable IPO of SpaceX, which is, last I checked, it was valued at something like $1.8 trillion today.

And it's considered to be a successful IPO, so that's a good sign.

That too did not match any of the outside analyses.

Finally, we end up getting a HeartFlow and QAngio analysis.

Those are the other two analyses of our scans, and they do have the patterns that I just now described.

They do have regressers, just like the semi-quantitative.

Yeah, so as Dave has reviewed, after the publication came out, we found out that the analysis wasn't blinded, which is, uh, entirely inappropriate unequivocally.

Then they wouldn't redo the analysis.

Then two subsequent independent analyses, including the pre-specified methodology, QAngio, and a properly blinded analysis by HeartFlow were done that agreed with each other and disagreed with Cleerly.

After all this, they still refused to reconduct the analysis in a blinded fashion.

So that was, there was, let's say, the diabetes company, which I'll think of its name in a second.

And there was HeartFlow and Omada and Hinge, Omada's diabetes company.

And

then we haven't seen any more.