Fogarty Innovation’s First Company, HeartFlow, Continues to Break Ground

by | Jan 28, 2021 | Companies

The entrepreneurs who work with Fogarty Innovation are pioneers, and Chris Zarins, MD, co-founder and senior vice president of medical affairs for HeartFlow, is no exception. In fact, when he first started working on the technology with co-founder and current board member Charles Taylor, Ph.D., at Stanford, no one had ever built a computational flow model from medical imaging before.   

In addition, the technology required to make their vision a reality, such as computing power or diagnostic imaging capability, was not nearly advanced enough at the time. However, Chris and Charles were both committed to finding a better way to diagnose patients with coronary artery disease, the leading cause of death. They persevered through 15 years of research on patient-specific computational flow modeling to develop their eventual technology, the HeartFlow FFRct Analysis.

The company’s device is the first and only non-invasive technology that quantifies the extent of coronary artery disease (CAD) and its impact on blood flow to the heart, and is considered one of the most exciting and accurate solutions in this space. Compared to traditional cardiac stress testing, HeartFlow provides more predictive and actionable information for physicians to diagnose and treat patients with coronary artery disease and helps interventionalists make better informed decisions about when to perform an angiogram.

Setting a precedent

As the first company to join Fogarty Innovation, HeartFlow is an incredible success story a decade later. Their vast accomplishments encompass a validation of the technology through successful clinical trials and articles in more than 400 peer-reviewed publications that earned them FDA clearance, along with PMDA approval in Japan and CE Marking in Europe. “There’s probably not been a more well-documented technology, with proof of effectiveness, safety, usefulness and value,” Chris said.

From their first pilot site at El Camino Hospital, there are now more than 400 international sites using HeartFlow, including the top hospitals in the U.S., Europe, Canada and Japan, and more than 75,000 patients worldwide have received a HeartFlow Analysis. The test is reimbursed by Medicare and private insurance in the U.S. and by the NHS England in the U.K.

“It’s beyond exciting to realize how far we’ve come in the past 10 years—introducing a valid FDA-cleared technology that is a real benefit to patients worldwide. It’s gratifying to hear overwhelmingly positive feedback from the medical community. Physicians say that HeartFlow is changing the landscape and allowing them to more effectively treat patients and therefore greatly improving outcomes,” he says.

That success has allowed HeartFlow to raise more than $500 million in funding and earn a valuation of over $1.5 billion.

Providing extra value during COVID-19

When medical providers had to pivot to reduce in-person, physical procedures due to COVID-19, the HeartFlow Analysis became even more relevant thanks to its ability to get the information a physician needs to make a precise diagnosis with minimal patient exposure. In fact, the CT scan can be done in the hospital in 10 minutes, then the CT data is securely uploaded from the hospital’s system to the cloud. HeartFlow leverages deep learning and highly trained analysts to create a personalized, digital 3D model of the patient’s coronary arteries, and then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow.

The HeartFlow Analysis is provided to the patient’s physician via a secure web interface, and the physician can then read the report or interact with the 3D model and deliver the information to the patient virtually in a remote video interaction. “There’s been a big push worldwide to assess patients with coronary disease with a coronary CT-first strategy because it more precisely identifies who does or does not need interventional treatment. Combined with the current COVID environment, the HeartFlow Analysis has really become the optimal choice for reliability and efficacy, which has led to increased usage worldwide,” Chris says.

More innovation in the pipeline

In a continuing quest to improve the solution, Chris is excited about HeartFlow’s upcoming treatment planner capability, which will enhance the current diagnostic software. This new technology allows physicians to better plan for their procedures by allowing them to modify the computational model to simulate different treatment scenarios. 

Physicians will be able to modify the HeartFlow model by virtually enlarging the lumen diameter in an area of stenosis to determine what effect this has on coronary flow. The computational flow model will update in real time with each additional modification of the lumen diameter, allowing the physician to simulate any number of treatment options. This will enable physicians to evaluate and compare different treatment options and decide on the best strategy for each individual patient before they go to the cath lab.  

This functionality has been cleared by the FDA and is currently in the beta phase, and the team anticipates it will soon be available to physicians.

A patient-first philosophy

Despite these extensive successes, Chris says that what makes him most proud—and remains his driving force—is that what they are doing is ultimately good for patients. “I learned this from Tom Fogarty 30 years ago when we were both at Stanford, and still see it to this day in his former work. As someone who has innovated and created tons of ideas, Tom was the first to reject something that wasn’t good for patients. The fact that what we’re doing is good for patients is ingrained in HeartFlow from top to bottom. It’s why we do what we do, and we love what we do.”

Chris also expresses gratitude for the benefits he was afforded during his time at Fogarty Innovation. “While Stanford supports a lot of research, we needed a place like Fogarty Innovation to make something clinically useful and commercially available and applicable to patients. It gave us a foothold and allowed us to take our very first steps to make this a commercial enterprise that’s valuable for patients.”

(Photo: James Joye, MD, El Camino Hospital; with Chris Zarins, MD, and Charles Taylor, Ph.D., during HeartFlow’s early days at Fogarty Innovation)

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