Echo IQ (EIQ) Status Update summary

Clinical and Commercial Progress

• EchoSolve HF completed a clinical validation study with Mayo Clinic, achieving 99.5% sensitivity and 91% specificity in diagnosing heart failure across a 17,000-patient dataset.

• The platform detects all heart failure subtypes, including HFpEF, and is positioned as a real-time, workflow-integrated diagnostic aid for cardiologists.

• FDA submission for EchoSolve HF is imminent, with high confidence in clearance due to pre-approved protocols and strong clinical results; FDA submission is planned for Dec CY25, with clearance expected in H1 CY26.

• Commercial strategy focuses on hospital integrations, a SaaS subscription model, leveraging existing reimbursement codes, and offering free trials to drive rapid adoption.

• The company is scaling its team and backend to support rapid growth and large-scale hospital deployments.

Market Opportunity and Disease Burden

• US heart failure and aortic stenosis markets are valued at $87B and $16B respectively, with heart failure expenditures exceeding $55 billion annually.

• Heart failure affects 6.5M US adults, with 1M new cases annually and a 50% five-year mortality rate.

• Aortic stenosis impacts 760K Americans over 65, with high mortality and significant costs if untreated.

• The technology aims to reduce underdiagnosis and improve patient outcomes, especially in underserved populations.

• Expansion plans include regulatory submissions in Europe and Australia following US FDA clearance.

Product Development and Validation

• EchoSolv platform targets aortic stenosis (FDA 510K cleared) and heart failure (FDA 510K pending), with additional indications in development.

• AI detected 86% of heart failure cases alone, rising to 97% with cardiologist review.

• EchoSolve differentiates itself by using measurement-based, real-time analysis rather than image-based AI, enabling seamless integration and rapid results.

• EchoSolv leverages a large dataset (>2M echocardiograms) and integrates seamlessly into clinical workflows.

• Outperforms competitors in heart failure detection sensitivity and specificity.