CorVista Health announced the publication of clinical validation data in European Respiratory Journal Open Research demonstrating the effectiveness of their machine-learned, non-invasive diagnostic system for pulmonary hypertension (PH). The study provides compelling evidence that the CorVista System can accurately detect elevated mean pulmonary artery pressure (mPAP) with diagnostic performance comparable to or surpassing current standard-of-care modalities.
Addressing Critical Diagnostic Delays
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. "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," said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer at CorVista Health.
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, has significant limitations, particularly the inability to measure tricuspid regurgitant velocity in up to 41% of patients.
Strong Clinical Performance Across Patient Populations
The published study, titled "Clinical validation of a machine-learned, point-of-care system to IDENTIFY pulmonary hypertension," enrolled 462 symptomatic patients across 18 U.S. clinical sites under a rigorous, blinded design. The CorVista System demonstrated robust diagnostic performance with key findings including:
- 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
- Negative predictive value exceeded 99%
Consistent Accuracy Across Diverse Populations
The diagnostic accuracy remained consistent across PH subtypes, including pre-capillary, combined pre-/post-capillary, and isolated post-capillary forms. Performance was also maintained across sex, age, BMI, and key comorbidities such as diabetes and COPD. Patients underwent signal acquisition using the CorVista System prior to RHC or, in PH-negative controls, to CT angiography and echocardiography.
FDA-Cleared Technology with Breakthrough Designation
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. The system received FDA clearance for coronary artery disease in September 2023 and pulmonary hypertension in April 2024. In 2022, the CorVista System's PH indication was awarded FDA Breakthrough Device Designation, marking a major advancement in PH diagnostics.
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. Additional indications, including Pulmonary Capillary Wedge Pressure (PCWP), are currently in active development.
"The CorVista System can transform our approach to PH diagnosis as a frontline diagnostic tool," Bridges noted. "Now that highly effective new treatment options exist for most patients with PH, earlier detection has become critically important."
