FFR-CT Archives - The Imaging Wire

Cardiac AI specialist Heartflow went public last week, and the IPO was a watershed moment for the imaging AI segment. The question is whether Heartflow is blazing a path to be followed by other AI developers or if the company is a shooting star that’s more likely to be admired from afar than emulated.

First the details: Heartflow went public August 8, raising $317M by issuing 16.7M shares at $19 each – and finishing up 50% for the day.

The IPO beat analyst expectations, which originally estimated gross proceeds of $215M, and put the company’s market capitalization at $2.5B – well within the mid-cap stock category.

So what’s so special about this IPO? Heartflow’s flagship product is FFR_CTAnalysis, which uses AI-based software to calculate fractional flow reserve – a measure of heart health – from coronary CT angiography scans.

This eliminates the need for an invasive pressure-wire catheter to be threaded into the heart.

Heartflow got an early start in the FFR-CT segment by nabbing FDA clearance for Heartflow FFR_CT Analysis in 2014, and since then has been the single most successful AI company in winning reimbursement from both CMS and private payors.

In fact, a 2023 analysis of AI reimbursement found that FFR_CT Analysis was the top AI product by number of submitted CPT claims, at 67.3k claims – over 4X more than the next product on the list.

That’s created a revenue stream for Heartflow that clearly bucks the myth that clinicians aren’t getting paid for AI.

And in an IPO filing with the SEC, Heartflow revealed how reimbursement is driving revenue growth, which was up 44% in 2024 over 2023 ($125.8M vs. $87.2M, respectively).

But it’s not all sunshine and rainbows at the Mountain View, California company, which posted significant net losses for both 2024 and 2023 ($96.4M and $95.7M).

As a public company, Heartflow may have a shorter leash in getting to profitability had it remained privately held.

But the bigger picture is what Heartflow’s IPO means for the imaging AI segment as a whole.

It’s easily the biggest IPO by a pure-play imaging IT vendor in years, and dispels the conventional wisdom that investors are shying away from the sector.

The Takeaway

Heartflow’s IPO shows that in spite of clinical AI’s shortcomings (slow adoption, sluggish reimbursement, etc.), it’s still generating significant investor interest. The company’s focus on achieving both clinical and financial milestones (i.e. reimbursement) should be an example for other AI developers.

Performing automated CT-derived fractional flow reserve with Shukun Technology’s software reduced referrals to invasive coronary angiography by 19% in a new study in Radiology. The findings suggest that software-based FFR-CT can serve a gatekeeper role in managing workup of patients with suspected coronary artery disease.

Cardiac CT has been a revolutionary tool for assessing people with heart problems, evolving rapidly into a first-line modality that’s eclipsed other more traditional imaging technologies.

But CCTA’s prowess also has a downside – more referrals to invasive coronary angiography, in some cases for patients without obstructive disease.

Rising to this challenge is FFR-CT, which uses automated software to calculate maximum blood flow in the coronary arteries and detect dangerous coronary lesions that could be early signs of a cardiac event.

The segment to date has been dominated by Heartflow, thanks to its early start in the field: its FFR_CT software got FDA clearance in 2014 and the company has used its dominance to build a massive cash position.

In the new China CT-FFR Study 3, researchers in China used another FFR-CT application, Shukun’s skCT-FFR, and compared angio referral rates for 5.3k patients with suspected coronary artery disease who were scanned with either CCTA alone or CCTA and FFR-CT. They found …

Referral rates were lower for those who got FFR-CT (10% vs. 12.4%), a 19% relative difference.
Fewer cardiac events occurred in the FFR-CT group at one year (0.5% vs. 1.1%).
There was no statistically significant difference in major adverse cardiac event rates at 90 days (0.5% vs. 0.8%, p=0.12) and one year (2.9% vs. 2.8%, p=0.9).

Shukun is not as well known in the West as other developers of FFR-CT software like Heartflow, but the company has raised over $250M to date – enough to land it in the top echelon of AI developers.

One advantage of Shukun that was evident with the new study is that image processing was performed on-site, rather than being shipped off-site as is the case with other applications.

The Takeaway

The study shows that FFR-CT can make cardiac CT more precise while tamping down on referrals to invasive angiography that have come from growing CT use. The results should also help put Shukun on the radar of many industry observers in a segment that so far has been dominated by HeartFlow.

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