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 on November 24, 2025 the appointment of Farhan Shahab as Vice President of Quality. Mr. Shahab brings over 25 years of quality and regulatory experience across medical and digital health companies, most recently serving as Vice President of Quality and Regulatory at Welldoc.
His prior roles include senior quality and regulatory positions at Intuity Medical, Moximed, AngioScore and Medtronic, where he supported integration of two major acquisitions. He holds a BS in Chemical Engineering and an MBA, and is RAC-certified and a Certified Auditor (Exemplar Global). The CEO said Shahab’s background has potential to accelerate commercialization of investigational products.
BioCardia (Nasdaq: BCDA) reported Q3 2025 results on Nov 12, 2025 and filed Form 10-Q for the period ended Sept 30, 2025. Key operational items include a $6.0 million financing (net $5.2M), ongoing enrollment in the CardiAMP HF II Phase 3 trial, a planned DeNovo 510(k) submission for the Helix transendocardial delivery catheter in Q4 2025, and a positive preliminary PMDA consultation on CardiAMP with follow-up anticipated in coming months.
Clinical updates: CardiAMP roll-in cohort showed +80s exercise tolerance and -82% angina episodes at six months; CardiALLO low-dose cohort completed with no treatment-emergent adverse events and DSMB clearance to proceed. Cash was $5.3M at Sept 30, 2025, providing runway into Q2 2026 excluding new capital.
BioCardia (NASDAQ: BCDA) announced that Henry Ford Health enrolled its first patient on Nov 10, 2025 in the ongoing Phase 3 CardiAMP HF II trial for ischemic heart failure with reduced ejection fraction (HFrEF).
Company commentary notes prior CardiAMP-HF data where the primary endpoint was not met but highlighted subgroup and secondary findings reporting reduced mortality, fewer major adverse cardiac events, and improved quality of life with the investigational autologous cell therapy. BioCardia and Henry Ford position the trial as a confirmatory study intended to enhance microvascular function and patient outcomes in a population with limited treatment options.
BioCardia (NASDAQ:BCDA) will host a Q3 2025 corporate update and financial results conference call on Wednesday, November 12, 2025 at 4:30 PM EDT.
The event includes management remarks followed by a Q&A. Registered participants will receive dial-in details; U.S. callers can use 1-833-316-0559 and international callers 1-412-317-5730. A live webcast will be available and a webcast replay will be posted about one hour after the call and remain available through approximately November 26, 2025. Telephonic replay details and access codes were provided for domestic and international listeners.
BioCardia (NASDAQ: BCDA) announced that the University of Wisconsin School of Medicine and Public Health enrolled its first patient on Oct. 30, 2025 in the ongoing Phase 3 CardiAMP HF II cell therapy trial for ischemic heart failure. The company highlighted the site’s leadership and the role of Dr. Amish Raval as Co-National Principal Investigator. BioCardia said CardiAMP has shown evidence of benefit for ischemic heart failure patients with elevated heart-stress markers despite optimized medical therapy, and indicated the UW site strengthens the trial’s network and patient access.
BioCardia (Nasdaq: BCDA), a cardiovascular and pulmonary therapeutics company, has successfully regained compliance with Nasdaq Capital Market's Listing Requirements. The company received official confirmation from Nasdaq on October 1, 2025, verifying its compliance with Listing Rule 5550(b)(1), known as the Equity Rule.
This achievement follows BioCardia's efforts to strengthen its balance sheet through capital raising initiatives, which will support the continued development of its therapeutic candidates and advancement of approved products. The company's securities will maintain their listing on the Nasdaq Capital Market under the symbol "BCDA".
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary therapeutics developer, has completed a positive preliminary clinical consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding their CardiAMP Heart Failure Trial results.
The PMDA has requested additional information about the trial's prespecified composite endpoints, statistical power, and the NTproBNP subgroup's risk-benefit profile. The company plans to submit responses and anticipates a formal clinical consultation by year-end.
The consultation covers three completed clinical trials involving 178 ischemic heart failure patients, focusing on those with limited therapeutic options who showed significant benefits from BioCardia's autologous minimally invasive cell therapy.
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary disease therapeutics developer, has announced a $12 million public offering. The offering consists of 4.8 million shares of common stock and short-term warrants at a combined price of $1.25 per share and warrant.
The initial offering will raise $6 million in gross proceeds, with potential for an additional $6 million if all warrants are exercised. The warrants have an exercise price of $1.25 per share and a two-year expiration period. H.C. Wainwright & Co. serves as the exclusive placement agent, with closing expected around September 19, 2025.
Proceeds will support working capital and general corporate purposes, including advancement of BioCardia's investigational biotherapeutic candidates and delivery partnering business.
BioCardia (NASDAQ: BCDA) reported positive top-line data from the roll-in cohort of its CardiAMP® Cell Therapy trial in Chronic Myocardial Ischemia patients. The study demonstrated that patients experienced an average 80-second increase in exercise tolerance and an 82% reduction in angina episodes at the six-month primary endpoint.
The minimally-invasive procedure showed promising results with 60% of patients experiencing substantial improvements in both measures. The therapy was well-tolerated with no treatment emergent major adverse cardiac events, and results compared favorably to current FDA-approved therapies like Ranolazine and Enhanced External Counter Pulsation (EECP).
BioCardia (NASDAQ:BCDA), a cardiovascular and pulmonary therapeutics developer, announces CEO Peter Altman's upcoming presentation at the H.C. Wainwright Global Investment Conference on September 10, 2025. The presentation will focus on three key areas: the company's clinical cell therapy programs for ischemic heart disease, regulatory progress for CardiAMP® cell therapy and Helix™ delivery catheter with FDA and Japan PMDA, and recent developments including the Heart3D fusion imaging partnership and CardiALLO program funding.
Dr. Altman will present at 2:00 PM ET at the Lotte Palace Hotel in New York City and will be available for one-on-one meetings with investors during the conference, which runs from September 8-10, 2025.