Sensydia advancing in studies of device to detect PH quickly, easily
Its CPS platform uses artificial intelligence to analyze heart sounds
Sensydia announced that it successfully completed a fifth study of its investigative Cardiac Performance System (CPS), intended to more easily and quickly detect pulmonary hypertension (PH) and heart failure than current approaches.
CPS is a handheld and noninvasive device, powered by artificial intelligence, that uses heart sound analysis to detect PH. The study involved 50 participants and was conducted at the University of Minnesota.
The company reports that the work is part of an initial phase of a broad testing project for the device and its algorithms, which is supported by a $3 million total Fast-Track Small Business grant from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health.
A pulmonary hypertension diagnosis currently requires multiple tests
“This is Sensydia’s fifth successful study, and we will continue to collect data across leading cardiac care institutions to improve the performance and utility of the artificial intelligence algorithms that power our breakthrough CPS platform,” Anthony Arnold, Sensydia’s president and CEO, said in a company press release.
“We’re working to overcome today’s barriers in acquiring vital hemodynamic [blood-related] measures for monitoring and managing cardiac patients,” Arnold added.
A PH diagnosis currently follows multiple tests, including echocardiography, various scans, and right heart catheterization, an invasive procedure to measure pulmonary artery pressure via a catheter inserted in a vein of the neck, arm, or groin. These approaches, which can only be conducted at medical facilities, also collect data at a single time point, Sensydia noted.
CPS is reported to use sensitive biosensors to assess within minutes key parameters of cardiac performance, including pulmonary artery pressure, ejection fraction — the percentage of blood pumped from the heart when it contracts — and cardiac output, a measure of the amount of blood the heart pumps in one minute.
Pulmonary capillary wedge pressure, an indirect measure of pressure in the heart’s top left chamber, also is recorded. According to Sensydia, the device can be used almost anywhere with minimal training.
“The CPS platform shows promise as a non-invasive alternative to routine echocardiography and right-heart catheterization. It has the potential to positively impact the way patients … are monitored, managed, and ultimately to improve clinical outcomes,” said Tamas Alexy, MD, a professor of medicine and a principal investigator at University of Minnesota Medical School. “These measurements are essential in the diagnosis and ongoing management of patients with heart failure as well as pulmonary hypertension.”
Sensydia previously completed two studies, conducted at the University of Pittsburgh Medical Center, that supported U.S. Food and Drug Administration (FDA) clearance of the device’s pulmonary pressure algorithm and general clinical utility. Likewise, FDA clearance of the device’s ejection fraction algorithm was supported by data from a study at the Ronald Reagan UCLA Medical Center, and its cardiac output algorithm by a study at the Oregon Health & Science University’s Knight Cardiovascular Institute.
The FDA also designated the CPS platform a breakthrough device, a status that aims to accelerate the development and review of products aiming to more effectively treat or diagnose life-threatening or irreversibly debilitating diseases.