Biocardia, INC 8-K filings

BioCardia has received FDA clearance to market its Morph DNA Steerable Introducer product family.

BioCardia has announced that the FDA has approved a protocol amendment for its CardiAMP Heart Failure II Trial, allowing for more patients to receive cell therapy treatment.

BioCardia announced its second quarter 2024 financial results, showcasing advancements in its cell therapy programs and biotherapeutic delivery technologies.

BioCardia has submitted a 510(k) application to the FDA for its Morph DNA Steerable Introducer Sheath, a device intended to facilitate the delivery of medical instruments in various vascular procedures.

BioCardia has initiated patient enrollment in its Phase 3 clinical trial for CardiAMP cell therapy, targeting ischemic heart failure with reduced ejection fraction.

BioCardia has been granted a U.S. patent for its Morph DNA multi-directional steerable catheter technology, which is expected to enhance transseptal access procedures.

BioCardia and CellProthera reported successful Phase II trial results for ProtheraCytes in treating acute myocardial infarction and plan to move forward with a Phase III trial.

BioCardia, Inc. sold 335,112 shares of common stock for gross proceeds of approximately $1.85 million between April 1, 2024 and June 10, 2024.

BioCardia has been granted a U.S. patent for its radial and transendocardial delivery catheter, which is designed for minimally invasive delivery of cell aggregates to the heart.

BioCardia has executed a 1-for-15 reverse stock split and reduced its authorized common stock shares from 100 million to 50 million, effective May 30, 2024.

BioCardia, Inc. will implement a 1-for-15 reverse stock split effective May 30, 2024, to increase its stock price and maintain its Nasdaq listing.

BioCardia announced first quarter 2024 financial results and highlighted positive clinical trial data for its cell therapies, including a significant reduction in mortality risk for heart failure patients.

BioCardia's CardiAMP Cell Therapy trial shows promising early results with significant improvements in exercise tolerance and reduction in angina episodes for patients with chronic myocardial ischemia.

BioCardia announced its 2023 financial results and provided updates on its clinical programs, including positive subgroup data from its CardiAMP Heart Failure trial.

BioCardia and StemCardia have announced a long-term partnership to develop a cell therapy for heart failure, leveraging BioCardia's delivery system.

BioCardia, Inc. is facing potential delisting from the Nasdaq Capital Market after failing to meet minimum market value and bid price requirements, and has requested a hearing to appeal the decision.

BioCardia has received CMS approval for reimbursement coverage of its Phase III clinical trial for CardiAMP cell therapy in ischemic heart failure patients.

BioCardia reports positive interim results from its Phase III CardiAMP heart failure trial, showing significant reductions in heart death equivalents and major adverse cardiac events, particularly in patients with elevated NTproBNP.

BioCardia, Inc. has entered into a private placement agreement to sell shares and warrants, expecting to raise approximately $875,000 for general corporate purposes.

BioCardia has announced the activation of its CardiAMP HF II pivotal trial, a randomized controlled study for patients with ischemic heart failure.

BioCardia will present two scientific abstracts on its CardiAMP and CardiALLO cell therapy programs at the Technology and Heart Failure Therapeutics Conference in March.