Cordio HearO™ System Performance

Sponsor: Cordio Medical

Challenge:
Heart failure (HF) patients are at high risk of acute decompensation, often leading to hospitalization. Traditional monitoring methods may not detect early signs of deterioration, resulting in delayed interventions. There was a need for a non-invasive, reliable, and user-friendly tool to monitor HF patients remotely and detect early signs of worsening condition.

Approach:
Cordio Medical developed the HearO™ system, a smartphone-based application that analyzes patients' speech patterns to detect fluid accumulation in the lungs—a key indicator of worsening HF. The system employs artificial intelligence (AI) algorithms to identify subtle changes in voice characteristics that correlate with HF status.

Multiple studies were conducted to evaluate the efficacy of the HearO™ system:

• Remote Speech Analysis in Chronic Heart Failure Patients:
  

• A multicenter, observational study involving 173 patients with NYHA Class II-III HF.

• Patients recorded five sentences daily using the HearO™ app.

• The system successfully predicted 76.9% of HF hospitalizations an average of 12.2 days in advance.
  

• Evaluation in Hospitalized Patients with Acute Decompensated Heart Failure (ADHF):
  

• A study assessing the performance of automated speech analysis in detecting pulmonary fluid overload.

• The HearO™ system distinguished between "wet" (admission) and "dry" (discharge) states in 94% of cases, demonstrating its potential in monitoring fluid status.
  

• AI-Powered Prediction of Worsening HF:
  

• In a study presented at the American Heart Association's Scientific Sessions 2023, the HearO™ app predicted 76% of HF hospitalizations approximately 24 days in advance.

• The validation phase showed a 71% accuracy rate in detecting HF events about three weeks before hospitalization.
  
  

Results:
The Cordio HearO™ system has demonstrated significant potential in remotely monitoring HF patients and predicting acute decompensation events:

• Early detection of worsening HF, allowing for timely medical interventions.

• Reduction in hospitalizations by enabling proactive outpatient care.

• High patient adherence due to the non-invasive and user-friendly nature of the app.

• Low false-positive rates, enhancing the reliability of alerts.
  
  

These findings suggest that the HearO™ system can be an effective tool in the management of HF, improving patient outcomes and reducing healthcare costs.