BioCardia delivered solid progress in Q3, advancing its innovative cardiac therapies and engaging in constructive regulatory discussions that may accelerate market entries in both the U.S. and Japan.

• Received FDA breakthrough designation for CardiAmp therapy, aimed at treating ischemic heart failure, enhancing its expeditious approval pathway.
• Demonstrated strong preliminary results from the chronic myocardial ischemia trial, with 60% of patients showing significant improvements in exercise tolerance and angina reduction.
• Actively enrolling in the CardioAmp HF2 Phase III trial, with centers reporting rapid patient recruitment and anticipated reimbursements from CMS for both treated and control groups.