BioCardia (NASDAQ:BCDA) executives on Tuesday outlined new clinical data for the company’s lead cell therapy program and discussed upcoming regulatory interactions in the U.S. and Japan, while also reviewing full-year 2025 financial results.
Programs and target indication
Chief Executive Officer Peter Altman said BioCardia is focused on cardiovascular disease using three primary platforms: the CardiAMP autologous, minimally processed cell therapy; the CardiALLO allogeneic, “off-the-shelf” mesenchymal cell therapy; and the Helix transendocardial biotherapeutic delivery system used in both cell therapy programs.
Phase III CardiAMP HF echocardiography results
Altman said BioCardia now has “complete and final data” from three clinical trials of CardiAMP, with the latest results from the Phase III CardiAMP HF trial presented as a late-breaking clinical trial this month at the Technology and Heart Failure Therapeutics meeting.
According to Altman, blinded echocardiography results from a core laboratory showed reductions in left ventricular volume measures in the overall disease population that “approach” statistical significance: a p-value of 0.06 when the ventricle is fully dilated and 0.09 when fully contracted. He added that in pre-specified subgroups of patients with elevated biomarkers of heart stress, the differences between treated and control patients were described as clinically meaningful and statistically significant, with p-values of 0.02 and 0.01. He said the subgroup differences exceeded 20 milliliters per meter squared and 15 milliliters per meter squared, respectively.
Altman said the echocardiographic findings support earlier results cited by the company, including reduced fatal and non-fatal major adverse cardiac and cerebrovascular events and improved quality of life in treated patients, with the strongest effects in the pre-specified elevated biomarker subgroup. He also said the trial’s findings were consistent with other heart failure therapies that associate suppression of pathological ventricular remodeling with improved mortality.
During the Q&A, Altman emphasized that long-term, “truly blinded” echo data is uncommon in the space and said Yale University served as the core laboratory. He told analysts that while p-values in the full cohort were not statistically significant, they were “just above” the 0.05 threshold, and he reiterated that BioCardia’s expectations for potential approvals are focused on patients with elevated NT-proBNP, which he described as a marker released when the heart is under stress.
Regulatory strategy: FDA and Japan PMDA
Altman said BioCardia plans to discuss the data with the U.S. Food and Drug Administration and has been discussing the program with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), including the potential for approval with post-marketing studies to collect additional safety and efficacy evidence.
He said the company expects to soon submit a Q-Submission request to FDA’s Center for Biologics Evaluation and Research (CBER) on the approvability of the CardiAMP system. He described the planned discussion as focusing on extending labeling for the CardiAMP cell processing platform—already FDA-approved for in vitro diagnostic use—to a therapeutic indication for ischemic heart failure with reduced ejection fraction. Altman also said the dedicated Helix delivery catheter has a Q-Submission “actively under review” by FDA’s Center for Devices and Radiological Health.
In Japan, Altman said the company expects to have a formal clinical consultation with PMDA to align on the acceptability of existing clinical data from the three trials for a CardiAMP system submission. If PMDA determines the data is acceptable for safety and efficacy, he said a submission for Shonin approval would likely follow.
In response to an analyst question on timing and potential post-marketing requirements, Altman said BioCardia is “imminently” planning to file for an FDA discussion on approvable pathways and estimated that, because CardiAMP has FDA breakthrough designation, the process would be under a “standard sprint” with an approximate 45-day turnaround for that discussion. He added that subsequent submission details would take additional time to prepare.
Altman also discussed possible FDA pathways, noting that although the product is regulated by CBER, it is a device system. He said the device pathway could include either PMA or De Novo and suggested that, given the safety profile, a De Novo pathway “could” be possible and potentially shorter. He added that a PMA route could take longer but may have strategic advantages.
On post-marketing studies, Altman said the company would expect studies in “many hundreds” of patients, tracking long-term survival and potentially echocardiography and biomarker data such as NT-proBNP. He said these measures are standard and could be collected in an open-label setting cost effectively, but emphasized that requirements would be determined in discussions with regulators.
Clinical pipeline updates and near-term catalysts
Altman said BioCardia has initiated the CardiAMP HF II confirmatory study, which he described as focusing on patients who were the greatest responders in CardiAMP HF and incorporating learnings on endpoints and trial design. He said University of Wisconsin–Madison and Henry Ford Health System enrolled their first patients in October and November, Emory University has been activated, and Morton Plant Mease is among four centers actively enrolling.
Altman said the company expects clarity “soon” on whether CardiAMP HF II should remain a randomized, double-blind trial or be modified to become a post-marketing registry if FDA supports earlier approval. In the Q&A, he added that enrollment has started slowly because the company’s clinical team is focused on work related to regulatory submission efforts for the Phase III dataset, but said additional sites are interested and that pace is primarily constrained by bandwidth and resources.
Altman also referenced progress in CardiAMP for chronic myocardial ischemia and the CardiALLO program for heart failure, saying additional detail was included in the day’s earnings announcement and that there “could be significant upside” in the near term.
He outlined four expected catalysts in the next quarter:
- An FDA CardiAMP heart failure Q-Submission for an approval pathway under breakthrough designation, which he said has been drafted and is under legal review.
- A formal clinical consultation with Japan PMDA on approvability of CardiAMP cell therapy.
- An FDA substantive feedback meeting on approvability of the Helix delivery system via the De Novo pathway.
- An abstract on CardiAMP and chronic myocardial ischemia accepted for oral presentation at EuroPCR in May.
Altman also commented on the competitive landscape, noting that Japan has granted conditional approval to another allogeneic cell therapy for ischemic heart failure delivered surgically via placement of cell sheets on the heart surface. He said a U.S.-listed company has announced plans to file for a Biologics License Application for an allogeneic cell therapy delivered surgically, and he expects a third company may also apply for approval for surgically delivered cells. Altman described BioCardia’s approach as minimally invasive and said it is intended to be used in addition to guideline-directed medical therapy.
Financial results for 2025
Chief Financial Officer David McClung reported that total expenses increased approximately 3% year over year to $8.3 million in 2025 from $8.1 million in 2024. Research and development expense rose 13% to $5.0 million from $4.4 million, which McClung attributed primarily to closeout activities in the CardiAMP heart failure trial, the start of enrollment in CardiAMP HF II, and regulatory activities to advance CardiAMP in Japan. He said the company anticipates R&D expenses will increase “modestly” in 2026.
Selling, general and administrative expenses decreased 10% to $3.3 million from $3.7 million, which he attributed to lower professional fees and reduced share-based compensation expense. McClung said the company expects 2026 SG&A expenses to remain close to 2025 levels.
McClung said net loss increased to $8.2 million in 2025 from $7.9 million in 2024. Net cash used in operations was approximately $7.5 million, down from $7.9 million in 2024. BioCardia ended 2025 with $2.5 million in cash and cash equivalents, compared with $2.4 million at the end of 2024. He said the company expects cash burn to be relatively consistent in 2026.
In closing remarks, Altman said the company’s base plan is to complete the CardiAMP HF II confirmatory trial while engaging with FDA and PMDA on potential near-term approvals.
About BioCardia (NASDAQ:BCDA)
BioCardia, Inc is a clinical-stage biotechnology company dedicated to developing novel cell-based therapies for patients with cardiovascular disease. The company’s core focus lies in advancing regenerative medicine approaches that address both chronic heart failure and acute myocardial infarction. BioCardia leverages proprietary delivery technologies to optimize the targeted administration of therapeutic cells directly into the heart muscle.
The company’s flagship products include the Helix Transendocardial Delivery System and the CardiAMP Cell Therapy System.
