BCDA

Price & events

Pipeline stages · 3 programs

Pipeline · 3 trials · 1 upcoming

Catalyst news & presentations · 9

• 2026-06-05fda agreementCardiAMP Cell Therapy System · FDA Q-Sub meeting minutes confirm ongoing trial may support PMA for market clearance.SEC 8-K
• 2026-05-08fda agreementHelix Transendocardial Delivery Catheter System · FDA identified two marketing clearance pathways for Helix, raised no safety concerns, and preferred simultaneous approval with CardiAMP for heart failure.SEC 8-K
• 2026-03-17fda agreementHelix Transendocardial Delivery Catheter · FDA accepted pre-submission package for approvalSEC 8-K
• March 3, 2026conferencedata presentationsecondaryPhase 3CardiAMP HF · Late breaking echocardiography results presented at Technology and Heart Failure Therapeutics conference.SEC 8-K
• 2025-12-16fda agreementCardiAMP Cell Therapy · Completed third preliminary PMDA consultation; allowed to advance to formal clinical consultation for HFrEF.SEC 8-K
• 2025-08-13partnershipExclusive development and commercialization agreement for Heart3D Fusion Imaging.SEC 8-K
• July 24, 2025regulatory submissionFiled (NDA/BLA)CardiAMP autologous cell therapy · Submitted for clinical consultation with Japan's PMDASEC 8-K
• now enrollingtrial initiationsecondaryPhase 3CardiAMP · University of Wisconsin site now enrolling patients in the ongoing pivotal Phase 3 CardiAMP HF II trial.SEC 8-K
• 2024-12-04fda agreementBCDA-01 · Successful completion of PMDA consultation on next steps for registration submission in Japan for ischemic heart failure of reduced ejection fraction.SEC 8-K