A new world of non-invasive cardiac diagnostics

Genetesis and Analytics 4 Life have developed non-invasive approaches to cardiac diagnostics.

heart, doctor, cardiac

Toronto-based Analytics 4 Life just raised $25 million in Series B financing to develop and ultimately commercialize their non-invasive cardiovascular diagnostic. The device, called CorVista, reads electrical signals from the heart and, with a little AI assistance, converts them into images to help clinicians assess cardiovascular damage. To some degree, the technology is adapted from rocket science.

“Our founding scientist (Sunny Gupta) was investigating signal processing for missile defense,” said President and CEO Don Crawford in a phone interview. “He was taking signals from a thousand miles away and figuring out what they come from – airplane, balloon, missile? If he could identify signals, he could apply the same technology to the body. He focused on the heart because it’s a giant electro-mechanical pump.”

CorVista is noninvasive, requires no drugs, radiation or stress testing. Clinicians place seven sensors on the patient, which collect 10 million data points in about three minutes. The data is sent to the cloud, analyzed and sent back as three-dimensional images physicians can interpret.

“Heart cells under stress give off different frequencies and amplitudes,” said Crawford. “As energy moves through the heart, it moves differently through areas of ischemia or disease. We’re looking at one-millionth of a volt in differences. That’s where the machine-learned algorithm comes into play.”

Analytics 4 Life is conducting a clinical trial with more than 2,000 patients at 13 sites. “We should wrap up the trial before the end of the year and file with the FDA in the first quarter of next year, said Crawford.”

Across the border, near Cincinnati, Genetesis is taking a similar, noninvasive approach to detecting heart disease, looking for a better way to rule out cardiac events.

“The standard of care is EKG, serial blood troponins, but you’ve got very low negative predictive values with these tests,” said co-founder and CEO Peeyush Shrivastava in a phone interview. “The population health indicates 75 percent of these cases aren’t cardiac. But with these low negative predictive tests, physicians aren’t necessarily confident ruling out cardiac-origin chest pain.”

The main concern is that a patient will have a myocardial infarction shortly after they leave the hospital. At present, the solution is to observe the patient over time, possibly days, put them on a treadmill for stress testing or conduct a catheterization procedure.

“Where our technology fits in is we have a really high negative predictive value,” said Shrivastava, “giving physicians the ability to rule out cardiac-origin chest pain, very quickly, without any invasiveness.”

The Genetesis device, called CardioFlux, requires more infrastructure than CorVista, including a shielded chamber to filter out magnetic sources. The sensors don’t touch the patient, so no prep is required, and the scan takes around 60 seconds. Algorithms convert the magnetic data into maps that highlight coronary artery disease, particularly ischemia.

So far, the technology has received some high-profile endorsements, including seed round funding from Mark Cuban and CincyTech. The company is collecting clinical data and hopes for FDA clearance sometime next year.

“Innovative technologies are needed,” said Shrivastava. “Not just incremental improvements but something that can really stand the test of time to solve a public health burden as large as this one.”

Photo: Brian A Jackson, Getty Images