BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission
BioCardia reaffirmed a Q4 2026 timeline for its Shonin pre-market submission to Japan's PMDA for CardiAMP autologous cell therapy in ischemic heart failure, with potential market clearance by Q4 2027. The company also plans to submit an FDA De Novo pre-submission for its Helix Transendocardial Delivery Catheter System this quarter, with the FDA targeting initial review feedback within 15 days and written feedback or a meeting within 70 days. Independent FDA clearance of Helix could expand partnering opportunities with developers of cell, gene and protein therapeutics requiring targeted cardiac delivery, while the confirmatory CardiAMP HF II trial continues enrolling at four U.S.
Key figures
- Drug Name
- CardiAMP Autologous Cell Therapy
- Phase Of Trial
- Confirmatory CardiAMP HF II study (actively enrolling)
- Trial sites enrolling
- 4
- Pmda shonin submission timing
- Q4 2026
- Fda pre sub review target days
- 15
- Potential japan market clearance
- Q4 2027
- Fda written feedback or meeting target days
- 70
AI analysis
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