Core Insights - BioCardia, Inc. has appointed Farhan Shahab as Vice President of Quality, bringing over 25 years of experience in executive roles related to quality and regulatory affairs [1][2]. Company Overview - BioCardia is a global leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases [1][3]. - The company has two main biotherapeutic platforms: CardiAMP® (autologous cell therapy) and CardiALLO™ (allogeneic cell therapy), with three clinical stage product candidates currently in development [3]. Leadership and Expertise - Farhan Shahab previously held significant roles at Welldoc, Intuity Medical, Moximed, and AngioScore, focusing on quality assurance and regulatory compliance [2]. - Shahab's expertise in product quality management and regulatory submissions is expected to enhance BioCardia's ability to commercialize its investigational products [3].

Core Insights - BioCardia, Inc. will provide a corporate update and report its financial results for the three and nine months ended September 30, 2025, on November 12, 2025, at 4:30 PM EDT [1] Company Overview - BioCardia, Inc. is a global leader in cellular and cell-derived therapeutics focused on treating cardiovascular and pulmonary diseases [4] - The company has two main biotherapeutic platforms: CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, with three cardiac clinical stage product candidates currently in development [4] - BioCardia's therapies are supported by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms [4]

Core Insights - The Independent Data Safety Monitoring Board (DSMB) has recommended that the CardiALLO-HF trial proceed as planned based on a 30-day safety assessment of participants treated with a low dosage of 20 million cells [1][2] - BioCardia, Inc. is advancing its allogeneic mesenchymal stromal/stem cell therapy, which has potential implications for funding and partnerships [3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [5] - The company has two main biotherapeutic platforms: CardiAMP® (autologous) and CardiALLO™ (allogeneic), with three clinical stage product candidates currently in development [5] Trial Details - The CardiALLO Heart Failure Trial is a Phase I/II study that includes a nine-patient dose escalation cohort followed by a thirty-patient randomized double-blinded placebo-controlled cohort [4] - The trial will evaluate three escalating doses of 20 million, 100 million, and 200 million cells, utilizing the Helix minimally invasive delivery system [4] Clinical Significance - Previous clinical results from the TRIDENT trial indicated that higher dosages of MSC reduced myocardial scar and improved left ventricular ejection fraction [3] - The CardiALLO HF trial is expected to target patients with active inflammation and aims to use at least twice the effective dosage compared to previous studies [3]