Biocardia Inc Stock Price, News & Analysis

BioCardia (NASDAQ:BCDA) has outlined its regulatory timeline for seeking approvals of its CardiAMP® Cell Therapy System and Helix™ Transendocardial Delivery Catheter from both FDA and Japan PMDA. The company plans to submit a DeNovo 510(k) application for the Helix system in Q3 2025, backed by safety data from over 4,000 intramyocardial deliveries.

In Q4 2025, BioCardia will request an FDA meeting to discuss CardiAMP Cell Therapy's approval for heart failure treatment, supported by its Breakthrough Designation status and clinical trial results. Simultaneously, the company expects an in-person consultation with Japan's PMDA regarding CardiAMP system approval, potentially benefiting from Japan's adaptive framework for regenerative medical products.

BioCardia (NASDAQ:BCDA) has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA). The submission includes comprehensive clinical data from the completed CardiAMP HF trial and the principal clinical portion of the Summary Technical Documentation (STED).

The PMDA consultation will evaluate the therapy's efficacy and safety data, assess target patient populations, and determine its fit within Japan's heart failure treatment landscape. A successful review could enable BioCardia to pursue market approval in Japan, potentially leading to a post-marketing study in 2026.

BioCardia (NASDAQ:BCDA) announced that Henry Ford Health in Detroit has begun enrolling patients with ischemic heart failure in the pivotal CardiAMP HF II trial. The study investigates an autologous cell therapy using patients' own bone marrow cells to treat ischemic heart failure with reduced ejection fraction (HFrEF).

The investigational therapy aims to promote microvascular repair, reduce fibrosis, and increase capillary density. The procedure involves harvesting and processing patients' cells at bedside, followed by minimally invasive catheter delivery to damaged heart areas. This confirmatory trial builds on promising results from previous TABMMI, TACHFT, and CardiAMP HF trials.

BioCardia (NASDAQ: BCDA) has been granted US Patent No. 12,311,127 for its Helix biotherapeutic delivery system, a minimally invasive catheter technology for delivering biological therapies to specific sites in the heart. The patent, titled "Radial and Trans-endocardial Delivery Catheter", protects the company's helical needle-tipped catheter technology platform.

According to scientific literature, this technology represents the safest and most efficient approach for biotherapeutic delivery to the heart. The system is crucial for BioCardia's CardiAMP Cell Therapy development program, targeting patients with ischemic cardiomyopathies of heart failure and refractory angina.

BioCardia (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced its CEO Peter Altman's participation in a fireside chat at the A.G.P. Virtual Healthcare Company Showcase on May 21, 2025. The presentation, scheduled for 3:40 p.m. EDT, will focus on recent business developments and the company's therapeutic pipeline, particularly highlighting their lead product CardiAMP, an autologous cell therapy for treating ischemic heart failure. The session will be moderated by Jim Molloy, AGP's Managing Director of Equity Research Biotechnology & Specialty Pharmaceuticals.

BioCardia (NASDAQ: BCDA) reported its Q1 2025 financial results and key developments. The company's CardiAMP HF Trial showed significant two-year results, demonstrating increased survival, decreased cardiovascular events, and improved quality of life for heart failure patients. Notable improvements were seen in patients with active heart stress (50% of enrolled patients). The company's CardiAMP HF II Trial is progressing with three active enrollment sites. Financial results showed R&D expenses of $1.5M (vs $1.2M in Q1 2024), SG&A expenses of $1.2M (vs $1.1M in Q1 2024), and a net loss of $2.7M (vs $2.3M in Q1 2024). The company's CardiALLO Cell Therapy completed its low-dose cohort with no adverse events, and their Helix delivery system demonstrated strong safety performance. BioCardia's IP portfolio includes over 60 patents and applications worldwide, with recent patent approval in Japan.

BioCardia (NASDAQ:BCDA), a company specializing in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has scheduled its Q1 2025 corporate update and financial results conference call for May 14, 2025, at 4:30 PM EDT. The call will include management's formal remarks followed by a Q&A session.

Participants can pre-register online or join by phone: U.S. callers should dial 1-833-316-0559, while international callers should use 1-412-317-5730. A live webcast will be available, and replay options will be accessible until May 28, 2025, through both web and telephone platforms.

BioCardia (NASDAQ: BCDA) has announced the initiation of patient enrollment at the University of Wisconsin at Madison for its pivotal Phase 3 CardiAMP HF II trial. The study is evaluating the CardiAMP™ Cell Therapy Product for treating patients with ischemic heart failure of reduced ejection fraction (HFrEF) and elevated markers of cardiac stress.

Dr. Amish Raval, Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, will serve as Site Principal Investigator and Co-National Principal Investigator. The minimally invasive autologous approach has shown promising results, avoiding the need for immune suppression while preserving therapeutic options including heart transplant for patients.

BioCardia (NASDAQ: BCDA) has announced the enrollment of the first patient in its Phase III CardiAMP HF II clinical trial at BayCare Morton Plant Hospital in Florida. The trial evaluates the company's lead autologous cell therapy for heart failure treatment. The CardiAMP cell therapy is unique as it personalizes treatment using the patient's own cells, avoiding immune suppression needs. The procedure utilizes the Helix minimally invasive delivery platform and new Morph DNA steerable navigation catheter for targeted cell delivery into heart muscle. Dr. Leslie Miller, Chief of the Congestive Heart Failure and Heart Function Clinic, serves as Principal Investigator. BioCardia is preparing regulatory submissions in Japan and the USA for approvals of both the cell therapy and delivery platform based on existing clinical data.