BioCardia (BCDA) Corporate presentation summary

Unmet need in heart failure

• Heart failure affects 56.2 million globally, with high mortality and frequent hospitalizations despite current therapies.

• US costs projected to reach $70 billion by 2030, with half related to hospitalization.

• No current therapies directly address myocardial microvascular dysfunction and adverse remodeling.

Innovative therapeutic approach

• Focus on enhancing microvascular function by increasing capillary density and reducing fibrosis via cell-mediated paracrine signaling.

• Lead program CardiAMP uses autologous mononuclear cells; CardiALLO uses allogeneic mesenchymal cells.

• Proprietary catheter-based delivery system enables targeted myocardial injection.

CardiAMP clinical development and results

• CardiAMP has FDA Breakthrough Device Designation and CMS reimbursement code.

• Phase III trial in patients with elevated NTproBNP/BNP (>500 pg/ml) showed improved quality of life and prevention of negative heart enlargement.

• Benefit seen in reduced mortality, improved heart function, and quality of life across three trials.

• Proprietary Cell Population Analysis and biomarkers help identify responder populations.