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) is a clinical-stage leader developing cellular therapies for cardiovascular and pulmonary diseases. This news hub provides investors and medical professionals with timely updates on clinical trials, regulatory milestones, and corporate developments.
Access verified press releases and analysis covering the company’s proprietary CardiAMP® cell therapy platform, Morph® delivery systems, and strategic partnerships. Track progress across key areas including FDA designations, randomized controlled trials, and intellectual property advancements.
Our curated news collection enables informed decision-making with updates on ischemic heart failure therapies, financial disclosures, and scientific breakthroughs. Content is organized for quick scanning while maintaining technical accuracy for expert audiences.
Bookmark this page for consolidated access to BioCardia’s latest developments in regenerative medicine, including updates on the CardiALLO allogeneic cell therapy platform and Helix™ biotherapeutic delivery technology.
BioCardia (NASDAQ: BCDA) has reported its financial results for 2024, showing a reduced net loss of $7.9 million compared to $11.6 million in 2023. The company's net cash used in operations decreased to $8.0 million from $10.0 million in 2023.
Key financial metrics include:
- Cash and cash equivalents: $2.4 million at year-end
- Revenues: $58,000 (down from $477,000 in 2023)
- R&D expenses: $4.4 million (decreased from $7.7 million)
- SG&A expenses: $3.7 million (reduced from $4.4 million)
Notable developments include completion of the CardiAMP HF Trial's last protocol-specified follow-up visit, with results to be presented at the ACC Scientific Sessions. The company has also completed treatment of the low-dose cohort in the CardiALLO Cell Therapy trial and launched commercial Morph DNA steerable introducer devices. Japan's PMDA has shown openness to considering existing trial results for potential product registration.
BioCardia (NASDAQ:BCDA), a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has scheduled key events for March 2025. The company will release its 2024 financial results on March 26, 2025, followed by a corporate update conference call on March 31, 2025.
Additionally, BioCardia will present the principal results of the CardiAMP-HF Trial at the American College of Cardiology 2025 Scientific Sessions in Chicago on March 30, 2025. The presentation will focus on 'A Double-blind, Randomized Controlled Trial of an Autologous Cell Therapy in Patients with HFrEF'.
BioCardia (BCDA) has been granted Japanese Patent No. 7641330 for its Helix™ Biotherapeutic Delivery System, extending protection until at least September 30, 2034. The patent covers minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart.
The Helix System, featuring helical needle-tipped catheter technology, is currently the only catheter-based intramyocardial delivery system in active clinical use. The technology enables targeted treatment while minimizing off-target toxicities and avoiding surgical heart access.
Japan represents a strategic market for these therapies due to its national commitment to supporting novel cell therapy solutions for its aging population while developing its stem cell industry.
BioCardia (BCDA) has completed data verification for its Phase 3 CardiAMP HF study, a double-blind randomized placebo-controlled trial evaluating an autologous cell therapy for ischemic heart failure. The study, involving 115 randomized patients, represents the largest cohort of ischemic HFrEF patients in a randomized autologous cell therapy trial.
The trial data has been transferred to the Statistical Data Analysis Center for analysis, with results scheduled for presentation at the Late-Breaking Clinical Trials symposium at the American College of Cardiology 2025 Scientific Sessions on March 30, 2025. The study is notable for using a precision medicine approach to identify potential responders based on cell characteristics.
The trial aims to demonstrate therapeutic benefit for HFrEF patients with elevated NT-proBNP who haven't responded sufficiently to medication. Results will support regulatory approvals in the US and Japan for both the CardiAMP cell therapy system and the Helix biotherapeutic delivery system.
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.
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