Welcome to our dedicated page for Biocardia news (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on Biocardia stock.
BioCardia, Inc. (NASDAQ: BCDA) generates news centered on its development of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease. As a clinical-stage company headquartered in Sunnyvale, California, its updates often relate to progress in late-stage trials, regulatory interactions, and advances in its enabling delivery and imaging technologies.
Investors and clinicians following BCDA news can expect regular coverage of the CardiAMP autologous cell therapy platform in ischemic heart failure with reduced ejection fraction (HFrEF) and chronic myocardial ischemia with refractory angina, as well as the CardiALLO allogeneic mesenchymal stem cell platform in ischemic heart failure. Recent announcements have highlighted Phase 3 CardiAMP HF II trial enrollment at leading centers, subgroup efficacy signals from prior trials, and discussions with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the potential approvability of CardiAMP Cell Therapy for HFrEF.
News items also address BioCardia’s Helix transendocardial biotherapeutic delivery system, Morph vascular navigation platform, and Heart3D fusion imaging platform, including updates on planned regulatory submissions and performance in preclinical and clinical settings. Corporate developments such as leadership appointments, board changes, financing activities, and Nasdaq listing compliance updates are disclosed through press releases and corresponding SEC filings.
This BCDA news page brings together these announcements so readers can follow clinical milestones, regulatory consultations, device platform progress, and governance developments in one place. For those tracking investigational therapies in heart failure, refractory angina, and related conditions, the BioCardia news feed provides an ongoing view into how the company’s programs and platforms are evolving over time.
BioCardia (Nasdaq: BCDA) announced its participation in the A.G.P Biotech & Specialty Pharma Conference scheduled for October 13, 2021. The event will feature one-on-one meetings with management, led by CEO Dr. Peter Altman. This conference aims to connect institutional and retail investors with BioCardia's leadership. The company specializes in developing cellular therapies targeting cardiovascular diseases, with notable products including CardiAMP and NK1R+ platforms.
BioCardia, Inc. (Nasdaq: BCDA) announced data from its pivotal CardiAMP Cell Therapy Heart Failure trial, presented at the Heart Failure Society of America Annual Meeting on September 11, 2021. Dr. Natasha Altman discussed trial design, while Dr. Leslie Miller highlighted findings on female participants. Preliminary data suggest women may qualify for the cell potency assay at a higher rate than men (83% vs 67%), addressing underrepresentation in heart failure studies. BioCardia's trial has enrolled more patients than most previous US trials, showcasing significant progress in autologous cell therapy.
BioCardia (Nasdaq: BCDA) announced it will present at the H.C. Wainwright 23rd Annual Global Investment Virtual Conference from September 13-15, 2021. The company’s presentation will be available on demand starting at 7 AM Eastern Time. CEO Dr. Peter Altman will also conduct one-on-one meetings during the conference for interested institutional or retail investors. This participation showcases BioCardia's commitment to transparency and engagement with potential investors.
BioCardia announced its participation in two virtual investor conferences. The Q3 Investor Summit Virtual Conference will take place from August 17-18, 2021, with a corporate presentation on August 17 at 2pm ET. The SNN Network Virtual Event Conference, scheduled for August 17-19, 2021, will feature a corporate presentation on August 19 at 3pm ET. Attendees can sign up for one-on-one meetings with company representatives via the conference websites. BioCardia focuses on developing therapeutics for cardiovascular and pulmonary diseases.
BioCardia, Inc. (BCDA) reported Q2 2021 results, posting a net loss of $3.5 million, a slight decrease from $3.7 million in Q2 2020. Research and development expenses rose by 6% to $2.4 million, primarily due to the ongoing CardiAMP Heart Failure Trial. The independent Data Safety Monitoring Board recommended continuing the pivotal trial after reviewing data from 97 patients. The company ended the quarter with $18.5 million in cash. They anticipate continued patient enrollment for CardiAMP and plans for Phase I/II trials for NK1R+ therapies for ischemic heart failure and COVID-19 related distress.
BioCardia, a leader in cardiovascular therapies, will have its CEO, Peter Altman, participate in a fireside chat and one-on-one meetings at the BTIG Virtual Biotechnology Conference on August 10, 2021. The chat is scheduled from 3:30-3:55 pm ET. Interested attendees can register for the event, and a replay will be available for BTIG clients until the end of the day on August 10. BioCardia focuses on developing regenerative biologic therapies for cardiovascular and pulmonary diseases and offers advanced delivery systems for biotherapeutic applications.
BioCardia, Inc. (Nasdaq: BCDA) announced the Japan Patent Office granted Patent No: 6887216, titled “Target Site Selection, Entry, and Update With Automatic Remote Image Annotation,” expiring January 8, 2034. This patent enhances image-guided delivery for heart treatments, allowing 3D images from MRI or CT scans to inform therapeutic interventions. The patent is expected to bolster BioCardia's intellectual property for cardiovascular therapies. Their cardiac biotherapeutics include CardiAMP® autologous cell therapy, currently undergoing clinical trials.
BioCardia (Nasdaq: BCDA) announces that the independent Data Safety Monitoring Board (DSMB) has completed its review of the Phase III CardiAMP Cell Therapy Heart Failure Trial. The DSMB found no safety concerns and recommended continuing the study, which enrolls 260 patients across 40 centers. This trial aims to analyze the potential benefits of using autologous bone marrow cells for heart disease treatment. The trial's primary goal is to assess various health-related outcomes, ensuring patient safety through rigorous oversight.
BioCardia announced encouraging results from its pivotal trial, CardiAMP Cell Therapy, for ischemic heart failure. The trial achieved a mean therapeutic dosage of 627 million total nucleated cells, including 4.5 million CD34+ cells. This data was shared at the European Society of Cardiology Heart Failure Annual Meeting 2021. The therapy aims to process and deliver patient-specific cells to damaged heart regions, addressing key challenges in safe and effective treatment.
BioCardia (Nasdaq: BCDA) announced the issuance of European Patent No. 3593810, which focuses on autologous cell therapy patient diagnostics to address therapeutic variability. This patent enhances the protection of BioCardia’s CardiAMP programs aimed at treating heart failure. The therapeutic could apply to 1.7 million heart failure patients in the U.S. and a similar number in Europe. Cardiovascular diseases cause significant mortality, with over 11 million new cases annually in Europe, resulting in a €210 billion economic impact.