KardioDiagnostix, the Halifax maker of AI for analyzing paediatric heart murmurs, has expanded its research and development efforts via an agreement with a clinic in Toronto after gathering data from about 400 patients in Nova Scotia.

In an interview this week, Co-Founders Dr. Robert Chen, Dr. Santokh Dhillon and Mohammed Shameer Iqbal, the CEO, said they hope to commence similar operations in the United States, Saudi Arabia and India by the end of this year.

The final regulatory hurdle KardioDiagnostix must clear to receive Health Canada approval is conducting a clinical study to prove the software is effective. With the right staffing, which the founders plan to fund with an in-progress, $2 million raise, Iqbal said the study will likely take about five months.

 “The sensitivity of our tool now is as good, maybe even better than a cardiologist,” said Chen. “Specificity is the same as a cardiologist. So basically, the tool gives access to a paediatric cardiologist to every primary care person.”

Iqbal said Canadian regulators are willing to accept some types of data from research conducted in the U.S., while American regulators have requirements that are in some ways stricter, such as in their requirements about the demographic makeup of studies. That, plus, the fact the data is being gathered in Canada, makes it possible that approval could come before the U.S. sign-off, but he hopes to commercialize in both countries at relatively the same time.

“For FDA, they won’t accept any assumptions of a platform being device agnostic, so you have to prove every device,” Chen said.

In practical terms, he added KardioDiagnostix can be used with essentially any digital stethoscope, since patterns in a patient’s heart sounds are more important than the frequencies themselves. All healthy hearts have similar sound signatures, Chen said, whereas hearts with structural problems all sound a little different. So the KardioDiagnostix AI need not be able to identify specific pathologies, only whether or not a child's heart sounds normal.

“The fundamentals of the platform should not care what device is attached, as long as … you have a relatively flat frequency response from about 50 hertz to about 1,000 hertz,” Chen said.

The KardioDiagnostix team now has seven full-time staff, or a headcount of 12 counting part-time employees. The company’s staff are on track to publish five peer-reviewed articles about their work this fall, which will contribute to their regulatory bid. In total, Chen said he hopes to go to market in about two years.

“I think we should be ready by next spring or summer in both jurisdictions, have the clinical study and have approval to sell,” said Iqbal. “But we want to add additional stethoscopes and fine-tune everything.”

The company also recently signed a partnership with another East Coast startup, St. John's-based Sparrow Bioacoustics. Sparrow's app, which is notable for being the lone United States Food and Drug Administartion-approved software capable of recording a patient's heart sounds with only a phone's built-in microphone, will be used by KardioDiagnostix's team for gathering data.

When KardioDiagnostix does go to market, Iqbal added, its business development strategy will be aimed heavily not at paediatricians, but at parents.

“It’s not the doctor that has the pain, it’s the parents,” he said. “If someone tells me, ‘Okay, your kid has a heart murmur. You’ve got to wait 13 months, or you right now can pay to have a diagnosis by the app,’ I would pay several hundred dollars.”