Study Confirms CorVista System’s Ability to Detect Pulmonary Hypertension

CorVista Health released study results that validate the ability of its machine learned, non-invasive algorithm to help identify pulmonary hypertension (PH) symptoms. The algorithm uses signals collected by the CorVista System, the company’s non-invasive point-of-care solution for evaluating both coronary artery disease and PH.

Trial results are detailed in European Respiratory Journal (ERJ) Open Research, a peer-reviewed journal. The published article, “Clinical validation of a machine-learned, point-of-care system to IDENTIFY pulmonary hypertension,” provides compelling evidence the CorVista System can accurately detect elevated mean pulmonary artery pressure (mPAP)—a hallmark of PH—with diagnostic performance comparable to, or surpassing, current standard-of-care modalities.

“Pulmonary hypertension remains vastly underdiagnosed, with patients waiting an average of two and a half years from symptom onset to accurate diagnosis—often after disease progression has already compromised outcomes,” CorVista Health Executive Vice President/Chief Scientific Officer Charles R. Bridges, M.D., said. “The findings published in ERJ Open Research demonstrate the clinical power of our machine-learned, non-invasive test to identify PH in just minutes at point of care. The CorVista System can transform our approach to PH diagnosis as a frontline diagnostic tool. Now that highly effective new treatment options exist for most patients with PH, earlier detection has become critically important.”

Currently, PH is primarily diagnosed through right heart catheterization (RHC), an invasive and resource-intensive procedure. Transthoracic echocardiography (TTE), while commonly used as a screening tool, can have significant limitations—particularly the inability to measure tricuspid regurgitant velocity in up to 41% of patients.

The CorVista System offers a non-invasive, stress-free test option conducted in under five minutes, making it a powerful tool to address the critical unmet need for earlier and broader diagnosis of PH, according to company bigwigs.

Key findings from the publication include:

• The algorithm achieved 82% sensitivity and 92% specificity for detecting mPAP ≥25 mmHg (95% CI: 0.78–0.87 and 0.87–0.96, respectively), meeting the study’s pre-specified primary endpoints.
• Performance remained high at the updated PH threshold of mPAP ≥21 mmHg, with 78% sensitivity and 92% specificity.
• ROC-AUC was 0.95 and 0.93 at the 25 mmHg and 21 mmHg thresholds, respectively.
• Diagnostic accuracy was consistent across PH subtypes (pre-capillary, combined pre-/post-capillary, and isolated post-capillary), as well as across sex, age, BMI, and key comorbidities such as diabetes and COPD.
• Negative predictive value (NPV):> 99%.

The study enrolled 462 symptomatic patients across 18 U.S. clinical sites and was conducted under a rigorous, blinded design. Patients underwent signal acquisition using the CorVista System before RHC or —in PH-negative controls—to CT angiography and echocardiography. Importantly, the system’s performance was validated using a dataset independent of the one used in algorithm development, supporting its real-world applicability and generalizability.

The CorVista System is a point-of-care digital health solution that can help diagnose multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze physiological signals and detect signs of serious cardiovascular diseases in under 30 minutes, allowing clinicians to interpret results and help guide treatment decisions in a single visit. The system received U.S. Food and Drug Administration (FDA) clearance for coronary artery disease in September 2023 and PH in April 2024, with additional indications, including pulmonary capillary wedge pressure (PCWP), in active development. In 2022, the CorVista System’s PH indication earned FDA Breakthrough Device Designation status—marking a major advancement in PH diagnostics and setting a new standard for patient care.

CorVista Health aims to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. The company is striving to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations.