BCDA biotech catalysts & pipeline

BIOCARDIA INC · Data as of 2026-10-25

Upcoming catalysts

CardiAMP Cell Therapy — NDA/BLA submission

Q4 2026

BioCardia is working towards a Shonin pre-market regulatory submission to Japan's Pharmaceutical and Medical Device Agency (PMDA) in Q4 2026.

Source filing

Helix catheter — Filing acceptance

this quarter

BioCardia expects FDA substantive review with written feedback, followed by a meeting with BioCardia to discuss approval via the De Novo pathway, this quarter.

Source filing

CardiAMP Cell Therapy — Regulatory decision

Q4 2027

PMDA support for the submission and a successful submission review could result in market clearance by Q4 2027.

Source filing

CardiAMP Cell Therapy — Topline data

Q3 ‘29

Q3 ‘29 HF II Topline Data

Source filing

CardiAMP Cell Therapy — Conference presentation

Q4 ‘26

Q4 ‘26 Peer Reviewed Manuscript

Source filing

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