Electricity regulates the beats of a healthy human heart, telling its chambers when to contract. Though the role of electrical signals in heartbeats is well understood, Analytics 4 Life says they can offer much more. The startup has closed $25 million in financing to test a medical device meant to read the heart’s electrical activity to help clinicians make treatment decisions.
The Series B announced Wednesday came from a group of unnamed private investors in the U.S., Europe, and China, says CEO Don Crawford. Though Analytics 4 Life (A4L) is based in Toronto, the company maintains a U.S. headquarters in Research Triangle Park, NC, where Crawford and much of the company’s executive team work. A4L’s investors are betting that its technology can offer a less invasive and less expensive way to test for coronary artery disease, a buildup of plaque on the walls of the coronary artery, which in turn limits the blood flow to the heart. An estimated 15.5 million people in the U.S. have the condition, according to the American Heart Association.
To diagnose CAD, doctors need to see what’s going on inside the heart. They can get that picture in several ways. With an angiogram, a dye is injected into the arteries to outline blockages that show up on an X-ray. Stress tests evaluate blood flow at rest and under exertion and can also be used to look for CAD. But such tests also use imaging agents injected into the body, and in the case of nuclear stress tests, expose patients to radiation.
A4L’s device, called CorVista, reads electrical signals via six electrodes placed on the body. In the span of three minutes, the device scans 10 million data points from a patient at rest. Crawford describes the process as “seeing the motion of energy.” The heart is a mechanical electrical pump that produces a lot of energy with each beat, Crawford says. The A4L device captures those signals, then sends the information into a secure Amazon Web Services cloud portal. There, an A4L algorithm identifies patterns of energy moving through diseased tissue. That analysis produces an image of the heart that pinpoints the areas that could spell trouble.
“We’re looking at the noise coming from the heart, which is a massive amount of energy from each cardiac cycle, and we are able to make sense from all of that electric signaling,” Crawford says.
The approach is similar to technology used by the military to detect missiles. In fact, that’s where the A4L technology came from. Company founder and chief scientific officer Sunny Gupta is an electrical engineer by training. Crawford says that Gupta was working on a defense contract with the Canadian military, developing a way to read radio frequency signals to locate launched missiles. Gupta realized that this approach could also have medical applications. In 2012, he founded A4L.
Crawford was the founder and CEO of Sapheon, a Morrisville, NC, startup that developed a medical device to treat varicose veins. In 2014, Covidien acquired the company for $238 million. Crawford’s medical device experience also includes positions at Medtronic (NYSE: MDT) and Guidant. He joined A4L in early 2016, following the company’s $7.5 million Series A round.
As with Sapheon, Crawford is overseeing a clinical trial for an experimental medical device. The FDA considers the CorVista a Class 2 medical device, which in some cases can receive marketing clearance without clinical data, Crawford says. But because CorVista is a completely new technology with no predicate device to compare it to, the regulator requires data from human testing. A4L is taking a novel approach to its trial—each of the more than 2,000 patients will be his or her own control. Patients are first tested by CorVista to see which are blocked. The patients are then tested by angiogram. The results are compared to see if the A4L device spotted the blockages just as well, Crawford says. Meanwhile, the anonymized data from each patient helps build A4L’s final algorithm. Though CAD is the initial focus for A4L, Crawford says CorVista could also says that the device could also have future applications diagnosing other heart conditions, such as heart failure and arrhythmia.
A4L has been a tenant of JLABS @ Toronto, a Johnson & Johnson Innovation life science incubator, since the start of this year. Toronto is the home of A4L’s software development team. With the new capital, Crawford says A4L can complete clinical trial enrollment, and if all goes well, file for FDA approval in the first quarter of 2018. A4L is ramping up for commercialization in the U.S., which will be managed from the company’s RTP site. The company is also readying plans to secure approvals in Asia, primarily China, which Crawford says was the source of a “significant part” of the Series B funding.
Photo by Analytics 4 Life.