BioCardia's Q4 2024: Regulatory Contradictions in CardiAMP's Japan Approval and Commercialization Strategy

These are the key contradictions discussed in BioCardia's latest 2024Q4 earnings call, specifically including: CardiAMP approval process in Japan, commercialization strategy in Japan for CardiAMP, CardiAMP's submission approval timeline in Japan, and BioCardia's collaboration with CellProthera on further trials:



CardiAMP Heart Failure Trial Outcomes:
- BioCardia reported primary outcome data from the CardiAMP Heart Failure trial, showing a 47% relative risk reduction in heart death equivalents and a 16% relative risk reduction in major adverse cardiac events, with a 10.5-point improvement in quality of life and a 13.9-meter improvement in 6-minute walk distance out to 2-year follow-up.
- The trial, which was not successful in meeting its primary endpoint due to the 6-minute walk test distance in healthier patients without elevated NTproBNP, showed strong trends favoring therapy in patients with elevated NTproBNP, reaching statistical significance with a p-value of 0.02.

Financial Performance and Cost Management:
- BioCardia's total expense decreased by 35% year-over-year to $8.1 million in 2024, with research and development expense decreasing by 43% to $4.4 million.
- This reduction was primarily due to the completion of the CardiAMP Heart Failure trial and realignment of personnel and cost reductions, reflecting efficient use of resources.

Regulatory Engagement and Pathways:
- BioCardia plans to submit CardiAMP-HF results and request consultation with the FDA and PMDA, aiming to align on pathways for making the therapy available to physicians and patients.
- The company's strong data set and the breakthrough device designation for CardiAMP cell therapy may support favorable regulatory discussions, given the unmet clinical need in the targeted patient population.