Echo IQ (EIQ) Status Update summary

Clinical validation and product performance

• EchoSolve HF achieved 99.5% sensitivity and 91% specificity in a major Mayo Clinic validation study across a 17,000-patient dataset.

• The platform can accurately identify all major heart failure subtypes, including HFpEF, and has shown near-perfect results in diagnosing severe aortic stenosis.

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

• The technology leverages phenotypic analysis from echocardiogram measurements, enabling real-time, workflow-integrated decision support for cardiologists.

• The solution is designed to reduce underdiagnosis and misdiagnosis, addressing significant unmet needs in large, underserved cardiovascular markets.

Market opportunity and disease burden

• US heart failure and aortic stenosis markets are valued at $87B and $16B respectively, with significant growth expected through 2035.

• 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 US heart failure market is estimated at $55 billion and growing, with aortic stenosis at $10 billion; both are expected to expand due to aging populations and improved diagnostics.

Commercial strategy and market adoption

• Three commercial pathways are prioritized: hospital integrations, reimbursement strategy, and a scalable subscription model, with a focus on accelerating US adoption.

• Commercial pathway includes free trials, rapid hospital integration, and a subscription model with reimbursement support.

• Early engagement with top US echo facilities and academic centers is underway, with increasing inbound interest following the Mayo Clinic study results.

• The company is preparing for large-scale hospital integrations and has the technical capacity to process 10,000–15,000 echoes per minute, with plans to scale further.

• Subscription fees are tied to reimbursement approval rates, incentivizing process improvements at hospital sites.