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) has completed enrollment and dosing in the low dose cohort of its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial. The study targets patients with ischemic heart failure of reduced ejection fraction (HFrEF) who have elevated markers of heart stress and systemic inflammation.
The trial consists of a Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo procedure-controlled cohort. The Phase I study will test three escalating doses: 20 million, 100 million, and 200 million cells, using BioCardia's minimally invasive delivery system. The first Data Safety Monitoring Board review is expected in March 2025.
The therapy utilizes 'off the shelf' mesenchymal stem cells, manufactured at BioCardia's Sunnyvale facility, and is delivered using the FDA-approved Morph DNA steerable guide. The treatment aims to provide immunomodulatory benefits and enhance microvascular repair in heart failure patients.
BioCardia (NASDAQ: BCDA) has announced that its CardiAMP HF Phase 3 study results will be presented at the American College of Cardiology 2025 Scientific Sessions in Chicago, March 29-31, 2025. The presentation, featuring results from the double-blind randomized placebo-controlled trial investigating an autologous cell therapy in patients with HFrEF, will be delivered by Dr. Amish N. Raval from the University of Wisconsin at Madison.
The presentation is scheduled for March 30, 2025, at 3:30 PM in the Main Tent as part of the Featured Clinical Research II session. The American College of Cardiology Scientific Sessions is a prominent forum for cardiovascular clinical trial developments, attracting experts from medical, pharmaceutical, biotechnology, and medical device sectors.
BioCardia (NASDAQ: BCDA) has announced the commercial launch of its Morph DNA steerable introducer product family, which is currently being used in the company's ongoing cell-therapy clinical trials. The company is pursuing an organic sales approach without engaging a direct sales force or third-party partners to minimize operating costs.
The company maintains its focus on the CardiAMP Heart Failure I and II clinical trials, which are studying their FDA-designated breakthrough cell therapy product for ischemic heart failure treatment. Final results for CardiAMP Heart Failure I Trial and updates on five actively enrolling centers in the CardiAMP Heart Failure II Trial are expected by the end of Q1 2025.
BioCardia (Nasdaq: BCDA) announced a successful consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding its lead therapeutic asset, BCDA-01, for treating ischemic heart failure. The PMDA has invited BioCardia for a follow-up consultation after reviewing final clinical data with two-year follow-up from the CardiAMP Heart Failure Trial.
The agency indicated openness to considering results from the CardiAMP Heart Failure Trial and previous trials as sufficient evidence for registering the CardiAMP Cell Therapy System in Japan. The company expects final data from its fully enrolled 125-patient trial to be available in Q1 2025. The therapy has received FDA Breakthrough Designation and is supported by the Maryland Stem Cell Research Fund and CMS reimbursement.
BioCardia (NASDAQ: BCDA) reported Q3 2024 financial results and business updates. The company completed the last protocol-specified follow-up visit in the CardiAMP Heart Failure Trial, with top-line data expected in Q1 2025. Research and development expenses decreased to $931,000 from $1.9 million in Q3 2023. Net loss improved to $1.7 million from $2.6 million year-over-year. The company closed a $7.2 million public offering in September 2024. Notable developments include FDA approval of their steerable introducer sheath product family and completion of a PMDA submission for potential approval in Japan.
BioCardia (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, will host its Q3 2024 corporate update and financial results conference call on November 13, 2024, at 4:30 PM ET. The call will include management remarks followed by a Q&A session. Participants can register online or dial in (U.S.: 1-833-316-0559, International: 1-412-317-5730). A live webcast and replay will be available through November 27, 2024.
BioCardia has completed its Phase III CardiAMP HF trial, a randomized, double-blind, placebo-controlled study evaluating the CardiAMP Cell Therapy System for heart failure treatment. The trial enrolled 125 patients across 18 US hospitals, with 115 patients randomized 3:2 between treatment and control groups. The therapy, which received FDA Breakthrough Device Designation, aims to reduce deaths, hospitalizations, and improve quality of life for patients with heart failure of reduced ejection fraction (HFrEF). Top-line results are expected in Q1 2025. The company has submitted plans to the FDA and is pursuing approval discussions with both FDA and Japan's PMDA.
BioCardia, Inc. [Nasdaq: BCDA] has regained full compliance with Nasdaq Capital Market's Listing Requirements, as confirmed by Nasdaq on September 17, 2024. This follows the company's successful efforts to improve its balance sheet, including raising new capital. Recent developments include:
1. FDA approval of CardiAMP® Cell Therapy Heart Failure II protocol amendment
2. Completion of the last roll-in patient in the CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial
3. Positive pre-IND meeting for Helix™ partner CellProthera's cell therapy
4. FDA market clearance for Morph® DNA™ product family
5. Closing of a $7.2M financing
BioCardia's focus remains on developing therapies for cardiovascular and pulmonary diseases, with near-term priorities including finalizing CardiAMP HF I trial data for Japan PMDA and FDA, and randomizing first patients in the CardiAMP HF II trial.
BioCardia, Inc. (Nasdaq: BCDA) has successfully closed an upsized $7.2 million public offering priced at-the-market under Nasdaq rules. The offering included 2,400,000 shares of common stock (or pre-funded warrants) and warrants to purchase up to 2,400,000 shares at a combined price of $3.00 per share and accompanying warrant. The warrants have an exercise price of $3.00 per share, are immediately exercisable, and will expire in five years. The offering saw participation from management, directors, institutional investors, and existing investors. BioCardia plans to use the net proceeds for working capital and general corporate purposes, including advancing their investigational biotherapeutic candidates and biotherapeutic delivery partnering business.
BioCardia (Nasdaq: BCDA), a leader in cardiovascular and pulmonary disease therapeutics, has announced the pricing of an upsized $7.2 million public offering. The offering includes 2,400,000 shares of common stock (or pre-funded warrants) and warrants to purchase up to 2,400,000 shares at $3.00 per share and accompanying warrant. The warrants have a 5-year expiration and are immediately exercisable. The offering, priced at-the-market under Nasdaq rules, is expected to close on September 3, 2024. Proceeds will be used for working capital and advancing BioCardia's biotherapeutic candidates and delivery partnering business. A.G.P./Alliance Global Partners is the sole placement agent for this offering.