Study Proceeding for Sensydia’s Non-Invasive Cardiac Performance System

Sensydia has enrolled the first patient in its multi-center pivotal study to evaluate the accuracy of its Cardiac Performance System (CPS) for hemodynamic assessment compared to the gold-standard: invasive right heart catheterization.

“Enrolling the first patient in our pivotal study marks a significant milestone for Sensydia as we advance our mission to transform cardiac care,” Sensydia President/CEO Anthony Arnold said. “We believe CPS has the potential to provide clinicians with critical hemodynamic information without the risks associated with invasive procedures.”

Sensydia’s CPS acquires cardiovascular signals, including heart sounds, and analyzes them using artificial intelligence algorithms to give clinicians a non-invasive tool for earlier cardiac function assessment and to help them more effectively guide therapy for patients suffering from heart failure and pulmonary hypertension. The current practice to obtain these measurements is to conduct an echocardiography and invasive right heart catheterization, which are resource intensive, restricted to medical facilities, and only provide snapshot data. In contrast, CPS assessments are fast, safe, may be repeated as frequently as needed, and can be performed in the clinic with minimal training, according to Sensydia.

Related: Sensydia Secures $3M to Advance AI-Based Cardiac Assessment Platform

Previous studies have demonstrated the potential of CPS to accurately estimate pulmonary pressure, suggesting its utility in clinical practice. This multi-center observational study will evaluate CPS’s accuracy compared to the gold-standard invasive right heart catheterization in measuring hemodynamic parameters.​ The study’s outcomes will support Sensydia’s efforts toward a U.S. Food and Drug Administration (FDA) submission and commercialization of CPS.

“The ability to obtain accurate hemodynamic assessments non-invasively will significantly impact how we manage patients with heart failure and pulmonary hypertension,” said James D. Murphy, M.D., principal study investigator at the first site – Huntsville Hospital Heart Center in Alabama. “We are excited to participate in this important study evaluating CPS.”

CPS is undergoing a clinical study and is not yet approved by the FDA.

Sensydia is developing the Cardiac Performance System, a non-invasive platform that provides real-time measurements of critical cardiac function. CPS is designed to deliver rapid, safe, and accurate assessments to improve outcomes for patients with heart failure and pulmonary hypertension. The company received FDA 510(k) clearance for non-invasive measurement of ejection fraction using first-generation hardware in 2018.