Biocardia Inc Stock Price, News & Analysis

BioCardia (NASDAQ: BCDA) completed a third preliminary clinical consultation with Japan’s PMDA on CardiAMP Cell Therapy for ischemic heart failure (HFrEF) on Dec 16, 2025. PMDA indicated BioCardia may advance to a formal clinical consultation to assess whether existing clinical data are acceptable for a regulatory submission in Japan. The company says its compiled Phase I, II and III data show favorable safety and efficacy signals, including improved survival, reduced major adverse cardiovascular events, and better heart function and quality of life versus controls. The data remain subject to ongoing regulatory discussions in Japan and the United States, and a formal PMDA determination would be required before a Japan regulatory filing.

BioCardia (NASDAQ: BCDA) announced the election of Marvin Slosman to its Board of Directors, effective December 2, 2025, and the completion of Dr. Richard Krasno’s term on the same date. Slosman brings commercial and regulatory experience in interventional cardiology and medical devices, including executive roles at InspireMD, Johnson & Johnson, GE Healthcare, and Baxter.

Management highlighted Dr. Krasno’s contributions to clinical evidence for CardiAMP and the Morph DNA FDA approval, and thanked him for his service.

BioCardia (NASDAQ: BCDA) will present at the CSI Focus Devices in Heart Failure congress in Frankfurt, Germany.

Peter Altman, PhD, President and CEO, will deliver an invited presentation titled “Intramyocardial Cell Therapy for Ischemic Heart Failure of Reduced Ejection.” The session is on Friday, December 5, 2025, during the Myocardial structural therapies targeting the ventricles session from 10:30–11:30 CET.

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".