HeartFlow raising $46M after recent FDA nod for noninvasive coronary artery disease test

Screenshot courtesy of HeartFlow

HeartFlow has raised about $36 million of a targeted $46 million private financing. The startup leapt to this sizable amount on the back of a recent FDA clearance for its FFRCT software, which is the first and only noninvasive imaging technology for coronary artery disease (CAD) that shows the extent of a blockage and how it affects blood flow, according to the company.

The startup is optimistic that HeartFlow FFRCT will change the way that CAD is diagnosed and managed. The technology combines noninvasive imaging and computational fluid dynamics technology to create detailed models of a patient's cardiovascular anatomy. It is cleared for the evaluation of patients who show signs and symptoms of CAD in conjunction with other clinical patient data.

To use FFRCT, a physician uploads data from a coronary CT angiogram to HeartFlow's secure cloud. The software then analyzes the data, solving millions of equations that stimulate blood flow in the coronary arteries and calculating blood pressures around a blockage to see if it's likely to stop blood flow to the heart. The FFRCT (mathematically computed fractional flow reserve) values aid physicians in determining the patient's treatment.

Noninvasive tests to diagnose CAD are not new, but FFRCT is said to be more accurate than previous tests. This lack of accuracy can result in unnecessary procedures. According to a study published in the New England Journal of Medicine, more than half of patients who underwent invasive cardiac catheterization and angiography did not have obstructive coronary artery lesions.

The FDA clearance for FFRCT was supported by a study that showed that FFRCT had 86% diagnostic accuracy, versus 65% for coronary CT angiography alone. The difference was due to increased specificity with FFRCT. Invasive angiography was performed with 71% accuracy in the study.

"FFRCT represents a tremendous advancement in the management of coronary artery disease," Dr. Daniel Simon, president of Harrington Heart & Vascular Institute at University Hospitals Case Medical Center and Herman Hellerstein Chair and professor of medicine at Case Western Reserve University School of Medicine, said in a statement at the time of the December clearance.

He continued, "Historically, we have been faced with either using tests we knew were not always accurate or putting a patient through an invasive procedure just to determine whether they needed another invasive procedure. For the first time, we have access to a test that is both noninvasive and highly accurate in showing us the extent of a lesion, as well as how it can hinder blood flow through the vessel. I believe FFRCT has the potential to completely change the way we manage coronary artery disease globally."

HeartFlow investors include U.S. Venture Partners, Capricorn Investment Group, Sandbox Industries and HealthCor Partners Management and Johnson & Johnson.

- here is the SEC filing

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