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SUNNYVALE, Calif., Oct. 01, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its revised Pre-Submission to FDA Center for Devices and Radiological Health (CDRH) under its Q-Submission program for the approval of its Helix Catheter (“Helix”) for therapeutic and diagnostic agent delivery to the heart. In May 2026, the Company and FDA met and
SUNNYVALE, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today provided an update on near term milestones. CardiAMP® Autologous Cell Therapy for Ischemic Heart Failure BioCardia is working towards a Shonin pre-market regulatory submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA) in Q4 2026. The Company has recently provided detailed
SUNNYVALE, Calif., Sept. 10, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that Peter Altman, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 28th Annual Global Investment Conference. The conference will be held at the Lotte New York Palace Hotel in New York City, September 14-16, 2026. Dr. Altman will provide an update
SUNNYVALE, Calif., Aug. 24, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces receipt of FDA confirmation of the outcome of its Pre-Submission Meeting on the Helix Transendocardial Delivery Catheter System (Helix). FDA has reviewed and accepted the meeting minutes provided by BioCardia in May 2026 which are now considered final. This ratifies the understan
BioCardia advances toward Japanese Shonin submission and FDA approval pathways while managing cash runway into 2027.
Moby summary of BioCardia, Inc.'s Q2 2026 earnings call
SUNNYVALE, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter 2026 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2026 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business
SUNNYVALE, Calif., Aug. 05, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced it will provide a corporate update and report its financial results for the second quarter of 2026 by conference call on Wednesday, August 12, 2026 at 4:30 PM EDT. Following management’s formal remarks, there will be a question-and-answer session. Participants can register for the con
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