HeartFlow CEO, John Farquhar.

Cardiac Imaging

HeartFlow Lands $215M Series F

Fourteen months after canceling a SPAC deal that would have helped solidify its FFRCT leadership and drive its expansion across the overall CCTA AI segment, HeartFlow landed a $215M Series F round to help make those goals a reality.

Best known for its CCTA AI-based FFRct Analysis solution and widespread payor coverage (FFRCT is now covered by 100% of Medicare and >98% of payers), HeartFlow became far more diversified last year through the FDA clearances of its new coronary Plaque and RoadMap Analysis (stenosis) solutions.

• HeartFlow will use its new capital to amplify those achievements, including commercially scaling its overall CCTA AI portfolio, supporting its clinical evidence efforts, and further expanding its product lineup.

Last week’s $215M Series F brings HeartFlow’s total raise to an estimated $793M, and helps make up for its early-2022 decision to cancel a SPAC IPO that would have theoretically added $709M in capital.

• Given how most healthcare SPAC companies have performed since their IPOs, and the fact that HeartFlow’s Series F is now official, staying private seems to have proved to be a smart decision.

HeartFlow and other cardiovascular startups have captured a disproportionate share of recent imaging AI funding, as last week’s massive round was preceded by sizable raises from Cleerly ($223M Series C), Elucid ($27M Series B), and Us2.ai ($15M Series A) since early 2022.

• During the same period, Circle CVI gained private equity backing via a $213M acquisition and two of the largest imaging AI vendors (Aidoc & Viz.ai) significantly increased their focus on cardiology. 

The factors driving those cardiovascular AI investments (cardiac CT growth, guideline support, AI momentum, more reimbursements) also drove a wider field of competitors into the CCTA AI arena, including the first wave of FFRCT-focused AI companies and more companies looking to develop similarly-broad CCTA AI portfolios.

• HeartFlow’s FFRCT first-mover status and large installed base has served as a competitive advantage until now, so it’s no surprise that it plans to use its funding to further scale its commercial operations and expand its product portfolio while many of its competitors are still early-stage.

The Takeaway

With dozens of imaging AI companies still in search of their next funding round, HeartFlow’s Series F is a testament to the opportunities VCs expect from the CCTA AI space and the strength they see in its current market position. With its $215M Series F now complete, HeartFlow can fully capitalize on those cardiac CT opportunities and build upon the product and commercial advantages that earned it its FFRCT leadership position before now.

ECG Data You Can Trust

Noise and artifacts can make automated ECG analysis less reliable than what’s required for the exacting standards of cardiac safety trials. Monebo’s Kinetic Intervals ECG Algorithm provides precise interval measurements between any two points on the ECG waveform, allowing clinicians to utilize data they can trust.

PIA Medical Processes It All

Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

Start Measuring What Matters

Looking to optimize your cardiovascular imaging services, but don’t know what to measure? Check out this Change Healthcare report for insights on how to track and evaluate your cardiovascular imaging performance, assess quality, and enhance operational efficiency. Read the full article now and start measuring what matters!

The Wire

• Aktiia Matches ABPM: A new Nature Hypertension Research study showed that daytime blood pressure measurements produced by Aktiia’s bracelet-style cuffless BP monitor largely matched 24-hour measurements from a traditional ambulatory BP monitor (ABPM). The Aktiia-led study monitored 52 patients who were enrolled in a 12-week cardiac rehabilitation program, finding no significant differences between the Aktiia monitor and ABPM for systolic BP, and non-significant differences for diastolic BP.

• Aktiia Doesn’t Match ABPM & HBPM: Meanwhile, a high–buzz study found that Aktiia’s cuffless blood pressure monitor didn’t accurately track key changes. Forty-one participants (80% hypertensive) wore Aktiia’s cuffless BP device for 6–12 days, finding that it recorded higher average 24-hour and nighttime systolic BPs (differences: 4.9 & 15.5 mmHg) and diastolic BPs (differences: 4.2 & 11.8 mmHg) than their ambulatory BP monitors, but similar daytime levels. Measurements from three participants with hypertension showed very different SBP/DBP declines after two weeks of antihypertensive medication uptitration with Aktiia than their home BP monitors (–1.0/–0.8 vs. –19.7/–11.5 mmHg).

• Rock Health Q1 Report: Rock Health’s Q1 2023 digital health funding report is out and its title couldn’t have put it any better: VCs are investing like it’s 2019 again. Last quarter’s US digital health funding totaled $3.4B across 132 rounds, which is up from the last two quarters ($2.7B & $2.2B), although much of that increase came from six >$100M mega rounds. Cardiology digital health startups have typically been well represented in Rock Health’s reports, although none were mentioned this time around. For a deeper dive, here’s Digital Health Wire’s coverage.

• Investment Losses Driving Hospital Declines: Health systems might be among the types of investors that we’ll be seeing less of. Health Affairs presented a beautiful breakdown of the performance (or lack thereof) for the investment portfolios of ten large health systems during 2022. The well known health systems saw their operating margins plummet from 9% in 2021 to -6% in 2022, and although lower patient volumes and higher labor costs weren’t helping anyone, investment losses accounted for 85% of their financial woes.

• Alirocumab Relieves Plaque Burden: The ARCHITECT study (n=104) found that the PCSK9 inhibitor alirocumab (Regeneron & Sanofi’s Praluent) significantly reduces coronary plaque burden and stabilizes plaque in patients with familial hypercholesterolemia. In the phase IV trial, alirocumab plus high-intensity statin therapy led to notable decreases in LDL-C levels (138.9 mg/dL → 45.0 mg/dL) and coronary plaque burden (34.6% → 30.4%) over 78 weeks. The study also observed an increase in calcified and fibrous plaque proportions and a decrease in fibro-fatty and necrotic plaque percentages.

• Icentia’s CardioSTAT Clearance: Icentia announced the FDA 510(k) clearance of its CardioSTAT ambulatory continuous ECG monitoring solution, expanding CardioSTAT to the U.S. after being prescribed to over 170k patients in other regions. The single-use CardioSTAT recorder is designed to be worn on the upper chest, recording data for up to 14 days with a reported 99.9% compliance rate.

• Ablation Reduces VT and Shock Burden: For patients with a history of heart attacks, catheter ablation was better at reducing ventricular tachycardia (VT) and shock burden than simply upping their antiarrhythmic drug (ADD) therapy. In the 23.4-month VANISH trial (259 patients), ablation-treated participants experienced a 40% lower shock-treated VT event burden and a 39% lower appropriate shock burden compared to those receiving escalated AAD therapy. However, these benefits were limited to patients with amiodarone-refractory VT.

• HHS Streamlines Prior Auth for MA: Prior authorization should get less onerous for Medicare Advantage beneficiaries (and their doctors) under new HHS rules. The new rules state that once a prior authorization approval has been granted, it remains in effect “as long as medically necessary,” while adding stricter oversight of denial-of-care decisions.

• Febuxostat’s Antioxidant Potential: The xanthine oxidase inhibitor febuxostat appears to significantly lower a key atherosclerosis and oxidative stress marker – the MDA-LDL/LDL-C ratio – in hyperuricemic patients with asymptomatic carotid atherosclerosis. In a 24-month subanalysis of the PRIZE study, 200 participants taking febuxostat achieved far lower MDA-LDL/LDL-C ratios than the 183 patients in the control group, while the two groups had similar MDA-LDL and LDL-C levels. Although more research is needed, the study suggests that febuxostat may have an antioxidant effect.

• VAS Adds to Series B: Vascular calcification treatment startup AVS added $8.8M to its Series B round (Series B now $28.8M) to fund clinical trials evaluating its pulsatile intravascular lithotripsy (PIVL) technology. AVS’ balloon-based Pulse IVL System is the only minimally invasive technology to treat calcified arterial disease with a single device. The Pulse IVL System has already been studied in peripheral arterial disease trials and the new funding will expand VAS’ research to coronary cases.

• Geisinger Virtual Cardiac Rehab: It seems Geisinger has been seeing solid ROI from its virtual cardiac rehab program. Since launching in 2021, Geisinger has delivered over 30k virtual cardiac rehab appointments and tripled its participation using a system co-designed with Recora. That system includes a multidisciplinary support team (exercise physiologists, dieticians) and a personalized recovery kit (resistance bands, monitoring tools), but Geisinger said that the secret sauce was Recora’s engagement efforts with eligible participants.

A New Standard of Cardiovascular Care

Heart disease is the leading cause of death, so it might be time to change how we think about heart attack prevention. Read Cleerly’s manifesto on why our current approach is unsustainable, how Cleerly’s AI-based platform can transform care, and what it will take to change today’s unacceptable heart disease statistics.

Making Echo Accurate, Efficient, and Accessible

Check out this Imaging Wire Show featuring Us2.ai’s co-founders – James Hare and Dr. Carolyn Lam – for a great discussion about Us2.ai’s continued clinical and commercial expansion, and their efforts to improve echocardiography accuracy, efficiency, and accessibility.

HeartFlow FFRct’s Clinical Data Foundation

HeartFlow FFRct Analysis’ widespread payor support and adoption by 80% of the top 50 US heart hospitals is built on a deep foundation of peer-reviewed clinical research. See how HeartFlow FFRct has consistently proven to reduce unnecessary angiograms and the cost of care, making it a “game changer” for its users.