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Sensydia Announces First Patient Enrolled In Pivotal Study Of Non-Invasive Cardiac Performance System (CPS™)

Sensydia's Cardiac Performance System (CPS™) is designed for fast, safe, and non-invasive cardiac performance assessment that can be performed almost anywhere, avoiding the need to visit a catheterization lab. Source: Sensydia.

-- Study evaluates accuracy of CPS compared to gold-standard right heart catheterization to support FDA submission --

LOS ANGELES, April 28, 2025--(BUSINESS WIRE)--Sensydia, a medical technology company pioneering non-invasive cardiac assessment, today announced that the first patient has been enrolled in its multi-center pivotal study to evaluate the accuracy of the Cardiac Performance System (CPS) for hemodynamic assessment as compared to the gold-standard: invasive right heart catheterization.

Sensydia's CPS acquires cardiovascular signals, including heart sounds, and analyzes them using artificial intelligence algorithms, to provide clinicians a non-invasive tool for earlier assessment of cardiac function 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 for patients to undergo 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.

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 FDA submission and commercialization of CPS.

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

"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, MD, FACC, Principal Investigator at the first site – Huntsville Hospital Heart Center in Alabama. "We are excited to participate in this important study evaluating CPS."

Please note: CPS is undergoing a clinical study and is not yet FDA-approved.

About Sensydia

Sensydia is developing the Cardiac Performance System (CPS™), 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. Learn more at sensydia.Com.


Patients With SCD Hospitalized With CV Conditions Have High Health Care Utilization

Patients with sickle cell disease (SCD) have prolonged hospital stays and high in-hospital mortality rates related to cardiovascular complications, according to study results presented at the American College of Cardiology (ACC) Scientific Sessions 2025, held from March 29 to 31, 2025, in Chicago, Illinois.

The chronic condition SCD is associated with high cardiovascular complication risk, including for heart failure and stroke. The long-term impact of cardiovascular complications on health care utilization is not well defined for SCD.

Data for this retrospective study were sourced from the National Inpatient Sample, which includes hospital data collected in the United States. Patients (N=901,460) with SCD who were hospitalized with a cardiovascular complication between 2016 and 2021 were evaluated for in-hospital mortality, length of hospital stay, and inflation-adjusted health care costs. Cardiovascular complications were defined as acute myocardial infarction, cardiac arrhythmia, heart failure, pulmonary embolism, pulmonary hypertension, and stroke.

The most common cardiovascular complications were heart failure (n=9755) and stroke (n=6465). The average age of patients admitted to the hospital with heart failure was 57 years and with stroke was 55 years.

The overall in-hospital mortality rate among patients with SCD and cardiovascular complications was 0.8%, in which the highest in-hospital mortality rates were observed among patients with pulmonary hypertension (5.5%) and stroke (5.1%). Over time, in-hospital mortality peaked at 7.5% in 2016 among patients with stroke, decreased through 2018, and increased again through 2021.

The longest adjusted hospital stays were observed among patients admitted with pulmonary hypertension (7 days) or heart failure (6.4 days).

The highest inflation-adjusted health care costs were observed for stroke ($186,762) and pulmonary hypertension ($115,190.33).

This study was limited by not including a non-SCD comparator group.

The study author concluded, "Despite stable hospitalization trends, stroke, pulmonary hypertension, and heart failure in SCD patients drive significant mortality, prolonged hospital stays, and rising costs. Urgent, targeted interventions are needed to reduce this burden and improve outcomes for these high-risk patients."


Role Of Right Atrial Reservoir Strain In Detecting Pulmonary Hypertension In Systemic Sclerosis

Photo Credit: daveberk

The following is a summary of "Right atrial reservoir strain as an early predictor of pulmonary hypertension development in Systemic Sclerosis: a single center pilot study," published in the April 2025 issue of Rheumatology by Codullo et al. 

Regular screening for pulmonary hypertension (PH) is essential in systemic sclerosis (SSc) for early pulmonary arterial hypertension (PAH) detection. Right atrial (RA) function may reflect early right heart overload from pulmonary pressure rise. 

Researchers conducted a retrospective study to assess RA reservoir strain as a marker of early right heart overload and predictor of PH in SSc. 

They enrolled 113 patients with SSc from May 2010 to April 2022 who underwent echocardiography, including systolic pulmonary artery pressure (PASP), the measurement of tricuspid annular plane systolic excursion (TAPSE), TAPSE/PASP, and RARs measurements. 

The results showed that during a median follow-up of 43 months, 11 patients underwent RHC and PH were confirmed in 10. RARs was the only independent predictor of PH (HR 0.85, 95% CI 0.75–0.96, P=0.01). The optimal RARs cut-off was 39.6 (AUC 0.7, P=0.04, sensitivity 70%, specificity 60%). 

Investigators found that RARs were a sensitive echocardiographic parameter to predict PH development in patients with SSc. 

Source: academic.Oup.Com/rheumatology/advance-article-abstract/doi/10.1093/rheumatology/keae628/8109436





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