Analytics 4 Life plans to file for FDA clearance later this year and launch its noninvasive CAD diagnostic next year.
Analytics 4 Life, which is developing a noninvasive, artificial intelligence-based platform that quickly diagnoses coronary artery disease, raised $25 million in series B financing to carry its device through clinical trials.
The Toronto-based company's CorVista platform is built on its Phase Space Tomography technology. The system identifies areas of ischemia—to which blood flow is blocked—by measuring and mathematically modeling the signals emitted by the heart.
"The heart produces energy, and the healthy heart does so in a very predictable way," said CEO Don Crawford. "Beat after beat, energy moves through the heart in a very predictable fashion that can be seen by our sensors."
A patient undergoes a scan, which is sent to the cloud, where the company's software analyzes it. The software creates a 3D model of the patient's heart that shows potential areas of CAD. This, along with a patient's symptoms and medical history, can guide physicians treating patients with chest pain.
RELATED: IBM launches Toronto startup hub, enrolls first participant
Diagnosing coronary artery disease can take several weeks and involve the injection of contrast agents and putting stress on the heart. With its noninvasive test, Analytics 4 Life aims to cut down on the time it takes to return a diagnosis, as well as remove the need for radiation, contrast agents and cardiac stress.
Specifically, the company will use its new funding to bring the device through the final stage of clinical testing, Crawford said. It is currently in a two-stage clinical trial at 13 U.S. sites with more than 2,000 patients enrolled. Analytics 4 Life plans to announce data at the Transcatheter Cardiovascular Therapeutics conference next month and will file for de novo clearance with the FDA later this year. It expects to launch the device in the U.S. in 2018.
