Analytics for Life Wraps Up Study of Elevated Pulmonary Capillary Wedge Pressure Test

Analytics For Life in collaboration with its U.S. commercial partner CorVista Health, announced the successful completion of a clinical study evaluating a machine learning-based algorithm for non-invasively identifying patients with elevated pulmonary capillary wedge pressure (PCWP), a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF).

The study met its primary endpoint for sensitivity, marking a significant milestone in the advancement in point-of-care (POC) diagnostics for heart failure patients. Results will be submitted for peer-reviewed publication and presented at an upcoming scientific conference.

Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure, typically performed by a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, potentially providing a novel method to aid in the assessment of patients being evaluated for pulmonary hypertension or heart failure.

“Reaching our primary endpoint in sensitivity is a testament to the dedication of our team to pushing the boundaries of cardiovascular diagnostics. Our ability to deliver non-invasive, rapid assessment of PCWP could be a game-changer, making early detection of HFpEF, HFrEF and PH subtypes more accessible for patients,” said Charles R. Bridges, M.D., executive vice president and chief scientific officer, Analytics for Life and CorVista Health. “With the clinical study now complete, we plan to initiate dialogue with regulatory agencies in preparation for the next phase of development.”

HFpEF accounts for more than 50% of all heart failure cases and carries the highest rates of morbidity and mortality. Underdiagnosis of HFpEF remains one of the greatest unmet needs in cardiovascular medicine today, contributing an estimated $25 billion in direct costs to the U.S. healthcare system each year. Pulmonary hypertension, similarly underdiagnosed, requires accurate subtype classification to guide life-saving, guideline-directed therapy.

The proposed PCWP add-on represents a major advancement in cardiology with far-reaching implications for early diagnosis, equitable care, and cost reduction. The CorVista System Add-On for elevated PCWP is currently an investigational device, limited by U.S. federal law to investigational use and not commercially available.

“This milestone demonstrates the power of our rapid, point-of-care solution and represents an important step toward expanding the clinical utility of the CorVista System,” CorVista Health President/CEO Adrian Lam stated. “Adding PCWP and heart failure capabilities would allow our system to provide diagnostic support to more than 70% of all people with symptomatic cardiovascular disease—itself the leading cause of death worldwide. As we pursue a PCWP add-on, our goal is to bring advanced diagnostic accuracy into the primary care setting, enabling faster and more accurate treatment decisions while reducing the overall cost of care.”

Developed by Analytics For Life and commercialized in the U.S. by CorVista Health, the CorVista System is a POC digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or elevated pulmonary artery pressure in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in more than 40 years and setting a new standard for patient care.

Analytics 4 Life stands at the forefront of digital health, dedicated to propelling next-generation technologies that revolutionize POC diagnostics. Headquartered in Toronto, Canada, Analytics For Life specializes in pioneering non-invasive diagnostic solutions for cardiovascular diseases. The CorVista System offers a non-invasive, POC solution enabling physicians to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise.