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, Inc. (BCDA) reported Q3 2021 results showing a revenue increase to $821,000, up from $34,000 year-over-year. The net loss narrowed to $2.7 million compared to $3.8 million in Q3 2020. The CardiAMP® Cell Therapy trial faces enrollment challenges due to COVID-19 but has enrolled 106 patients across 24 sites. Upcoming milestones include data reviews and IND submissions for various therapies. The company ended the quarter with $15.9 million in cash.
BioCardia, Inc. (NASDAQ:BCDA), a developer of cell-derived therapeutics for cardiovascular and pulmonary diseases, will release its third quarter 2021 financial results on November 10, 2021, at 4:30 PM ET. The company focuses on two biotherapeutic platforms: CardiAMP for cardiovascular indications and NK1R+ for potential treatments in cardiovascular and pulmonary diseases. These platforms support four product candidates aimed at benefiting millions of patients.
BioCardia, Inc. (BCDA) announced the treatment of the first patient in its Phase III CardiAMP Cell Therapy trial targeting chronic myocardial ischemia. Conducted at the University of Wisconsin, the trial aims to enroll up to 343 patients at 40 centers, focusing on improving exercise tolerance at six months. The treatment utilizes the patient's bone marrow cells delivered via a minimally invasive procedure. Additionally, the FDA approved a protocol amendment to shorten the follow-up period to six months. This trial may also enhance enrollment in the concurrent Heart Failure Study.
BioCardia recently announced the issuance of U.S. Patent No: 11,141,568 for a Multi Directional Steerable Catheter, enhancing its Helix™ Biotherapeutic Delivery System. This technology aims to improve physician control during cardiac procedures by reducing torque issues. The patented catheter is integrated into the FDA-cleared Morph® DNA™ guide and AVANCE™ introducer, expected to bolster their clinical biotherapeutics in heart disease. BioCardia estimates a significant market opportunity with approximately 1.6 million potential U.S. patients for its therapies, alongside a growing $490 million transseptal access market.
BioCardia, Inc. (Nasdaq: BCDA) has announced the treatment of the first cross-over patient in its Phase III CardiAMP® Cell Therapy trial aimed at ischemic heart failure. This milestone signifies a promising step in the trial, which allows patients initially assigned to the control group to elect therapy after completing a two-year follow-up. The procedure was conducted at Stanford University and demonstrates the minimally invasive nature of the therapy. The FDA approved an amendment to enhance patient access to this investigational treatment.
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.