HEARTio’s founders got a Forbes 30 Under 30 nod. Here’s what’s next for the Pittsburgh healthtech company

The Centers for Disease Control and Prevention estimates that 356,000 people have an out-of-hospital cardiac arrest every year.

Thus, HEARTio cofounders Adam Butchy, Utkars Jain and Michael Leasure point out that almost everyone loves someone who has suffered due to heart disease. It’s part of why they say they’d like to help diagnose coronary artery disease faster and help patients have better outcomes.

The plan to do this is through the ECGio platform, the Oakland-based company’s diagnostic tool that can provide fast information about potential heart problems, so patients in danger aren’t sent home in lieu of receiving needed treatment. ECGio uses AI to elevate routine cardiovascular tests to provide patients with answers without having to go to invasive or time-consuming extremes, according to the founders, who all have ties to University of Pittsburgh. (Butchy and Jain are bioengineering Ph.D.s, while Leasure graduated from Pitt’s business school.)

Founded in 2018, the company has gained attention from entities inside and outside of Pittsburgh — so much so that the three cofounders were recently named on the Forbes Magazine 30 under 30.

A proud Pitt moment for sure! Congrats to @PittTweet alumni startup HEARTio for being named @Forbes' "30 Under 30 Healthcare" 2024! 🎉 HEARTio is developing an algorithm called ECGio to help doctors detect coronary artery disease faster. ❤️ https://t.co/1vX6xLKRVe @PittAlumni pic.twitter.com/cmPznxqSuf

— Big Idea Center (@pittbigidea) November 28, 2023

Although the designation was flattering, the cofounders agree that what matters most is addressing a severe problem.

“In the grand scheme of things, it’s not going to get us any closer to getting FDA approval or getting our application in the hands of physicians and used on patients,” Jain told Technical.ly. “But I think that it does feel good to be recognized, it does feel good, that [we] have been vetted by judges and all that. So I think it shows that the problem is real, and that our solution is interesting.”

The founders are now focusing much of their effort on securing FDA approval. In 2020, the company submitted ECGio its device to the FDA as a breakthrough device seeking recognition for its novelty and ability to help patients. (The designation is a sign that a device shows promise of improving patients’ lives in the near future, and is meant for products that treat or diagnose life-threatening diseases.)

They were granted that distinction, so next, HEARTio’s leaders hope to get their study about ECGio’s ability to accurately predict and diagnose coronary artery disease approved by the FDA, which would answer crucial questions about the device’s safety and efficacy.

“This year, we’ve really been leveraging that trying to get our pivotal study approved by the FDA saying that, if we run it properly, this stands the best chance of getting our device cleared or approved by the FDA,” Butchy said.

In addition to pursuing FDA approval, Butchy, Jain and Leasure say they’ve spent the past year strengthening the clinical side of the company by establishing clinical partnerships. While they’re still finalizing the details on some yet-to-be-announced partnerships, in November 2021, HEARTio launched one with the Allegheny Health Network for a large-scale study to validate the company’s device in a general population; Leasure said much of this year has been focused on completing that study. In the coming month, three to five more clinical studies will be announced.

“We started in Pittsburgh, and we try to do great research that makes the Pittsburgh [community] proud,” Butchy said.

Growth is in mind, too. HEARTio has secured some $1.5 million in investments from a mix of angel investors, Pitt’s Big Idea Fund, the Richard King Mellon Foundation and competitions. For the past few years, HEARTio’s staff has consisted of only Butchy, Jain and Leasure, but there are hopes to expand with more fundraising in the future.

“We’ve tried to be as lean as possible because you have to be at this stage of the game,” Jain said. “But when we will raise our Series A, we will hire additional people to handle some tasks that we cannot all do.”

Ultimately, the founders say, the goal for HEARTio is not to stop with their current technology. They’d like to eventually see their tech evolve into something that can analyze ECG data from wearable devices from patients’ homes and send updates to physicians for the best care possible.

“We’re an algorithm company. Our first product is going to be utilizing ECGs for the determination of anatomical disease. But that is definitely not going to be our last stop on this journey,” Jain said. “Eventually, we’re hoping you will be able to use your Apple Watch or any wearable device and be able to track exactly the level of plaque and functional disease that your heart has, without having to go in a physician’s office.”