CorVista Health Announces Publication of Real-World Case Series in the Journal of the American College of Cardiology Exploring its Non-Invasive Test for Earlier Diagnosis of Pulmonary Hypertension

Case series demonstrates the CorVista System®’s clinical utility in identifying pulmonary hypertension (PH) earlier, including where existing standard of care failed to raise suspicion

BETHESDA, Md., Sept. 04, 2025 (GLOBE NEWSWIRE) -- CorVista Health today announced the publication of a new case series in the Journal of the American College of Cardiology (JACC), showcasing real-world clinical applications of the CorVista System^®, a novel non-invasive, point-of-care diagnostic test for pulmonary hypertension (PH). The publication, titled Facilitating Earlier Diagnosis of Pulmonary Hypertension Using a Novel Non-Invasive Diagnostic: A Case Series¹, highlights how the FDA-cleared CorVista System can enable earlier detection of PH, even in patients where standard transthoracic echocardiography (TTE) failed to suggest disease.

Pulmonary hypertension is a rare but devastating condition that affects an estimated 1% of the global population and up to 10% of people over age 65. In the United States, more than 500,000 people are estimated to be living with PH, though many remain undiagnosed. Timely identification is critical, as untreated PH leads to progressive right heart failure and significantly reduced survival. Unfortunately, PH is frequently underdiagnosed due to the limitations of TTE, particularly when tricuspid regurgitant velocity (TRV) is unmeasurable.²

Unlike TTE, which can fail to visualize TRV in up to 41 percent of cases¹, the CorVista System uses machine-learned algorithms to analyze non-invasive signals collected at rest, providing diagnostic results within minutes. In the reported case series, the CorVista System detected PH in a patient who underwent multiple TTEs negative for PH, prompting confirmatory right heart catheterization (RHC), an invasive and resource-intensive procedure. Three additional cases with measurable TRV also tested positive with the CorVista System and were confirmed via RHC to have PH, including both pre-capillary and post-capillary subtypes.

“People living with undiagnosed PH are being asked to endure years of uncertainty, undergoing repeated echocardiograms and visiting multiple specialists before receiving an accurate diagnosis. For those with a rare and particularly deadly type of PH which primarily affects young women, Pulmonary Arterial Hypertension (PAH), the delay has severe consequences. They wait, on average up to three years for a correct diagnosis—time during which the disease silently progresses, often with irreversible heart failure,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, CorVista Health. “The results published in JACC are a landmark step in showing that the CorVista System can change this paradigm. By enabling physicians to identify pulmonary hypertension within minutes, non-invasively, and even when traditional tests fail, we are offering a new standard of care that has the potential to save lives and preserve quality of life for countless patients worldwide”

The published case series includes four real-world patients evaluated at clinical sites in the United States and Hong Kong. Each patient underwent testing with the CorVista System, followed by confirmatory right heart catheterization (RHC), the gold standard for pulmonary hypertension diagnosis. Cases included both patients with clear echocardiographic signs of PH and those where echocardiography failed to raise suspicion, demonstrating the system’s utility across varied clinical scenarios.

Key insights from the case studies series published include:

• The CorVista System identified PH in a patient whose prior echocardiograms, including three TTEs and a transesophageal echocardiogram, showed no signs of PH.
• Positive results prompted RHC, which confirmed PH with a mean pulmonary artery pressure (mPAP) of 35 mmHg.
• In all four patients, results were confirmed by RHC, identifying both pre-capillary and post-capillary PH with 100 percent confirmation in real-world use.
• Across the three supporting cases, the CorVista System detected PH in patients with confirmed mPAP ranging from 22 mmHg to 43 mmHg.
• All four patients tested positive using the system’s score threshold.
• Results directly influenced clinical care in all four patients, prompting earlier diagnosis and changes in treatment, including referrals to heart failure and PH specialists, SGLT2 inhibitor therapy, and sleep apnea treatment.
• By identifying PH in minutes using a non-invasive test, the CorVista System may help reduce the current years-long average delay and the need for multiple echocardiograms and multiple specialist visits typically required for diagnosis.³
  

About CorVista System^®

The CorVista System is a point-of -care 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 high pressure in the lungs—all 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 over 40 years and setting a new standard for patient care.

About CorVista Health

CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care.

For more information on CorVista Health, please visit: www.corvista.com

Media Contact:
media@corvista.com

¹Aben R, Burton T, Fathieh F, et al. Facilitating Earlier Diagnosis of Pulmonary Hypertension Using a Novel Non-Invasive Diagnostic: A Case Series. J Am Coll Cardiol. 2025. https://www.jacc.org/doi/10.1016/j.jaccas.2025.104876

²Janda S, Shahidi N, Gin K, Swiston J. Diagnostic accuracy of echocardiography for pulmonary hypertension: a systematic review and meta-analysis. Heart. 2011;97(8):612-622.

³Didden E, Lee E, Wyckmans J, Quinn D, Perchenet L. Time to diagnosis of pulmonary hypertension and diagnostic burden: A retrospective analysis of nationwide US healthcare data. Pulm Circ. 2023;13(1):e12188.

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