BioCardia (NASDAQ:BCDA) said its first-quarter update was marked by progress in regulatory discussions for its CardiAMP cell therapy program in ischemic heart failure, including what President and Chief Executive Officer Peter Altman described as a favorable consultation with Japan’s Pharmaceutical and Medical Devices Agency.
On the company’s earnings call, Altman said the Japanese agency is “inclined to accept” BioCardia’s existing CardiAMP Heart Failure Trial data as the basis for a regulatory submission and potential approval in Japan for an initial indication aligned with the trial results. The company is preparing a formal Shonin pre-market application and expects the process of preparing and submitting the application to take about seven months.
Japan Submission Becomes a Top Priority
Altman said BioCardia is prioritizing both the Japanese Shonin application and enrollment in the CardiAMP Heart Failure II trial. He said the Japanese regulatory process will include auditing clinical data and manufacturing, along with a detailed review of the submission package.
In response to an analyst question from Laura Suriel of Alliance Global Partners, Altman said BioCardia had already prepared a large STED document that Japanese regulators have been reviewing as part of the process. He said he expects the submission to be completed in roughly seven months, followed by a review process lasting about a year.
“Our expectation is if things go as planned in roughly 19 months, we’ll be approved and in the market in Japan,” Altman said.
Altman added that any approval in Japan would be followed by a post-marketing study conducted with medical societies and the PMDA. He said that study would collect additional procedural safety data and track standard-of-care outcomes, with reimbursement available during the post-marketing period.
CardiAMP Data Showed Signals in Heart Function
Altman reviewed data from the CardiAMP Heart Failure Trial that had been presented earlier in March at the Technology and Heart Failure Therapeutics Conference in Boston. He said blinded echocardiography data analyzed by Yale University’s Echocardiographic Core Laboratory showed “compelling signals” of improved heart function in treated patients compared with control patients over time.
According to Altman, heart volumes at both full relaxation and maximum contraction did not increase over time in treated patients, while they did increase in control patients. He said increasing heart volumes are typical in this patient population and are associated with worsening long-term outcomes.
In a subgroup of patients with elevated biomarkers of heart stress, Altman said the benefits in heart function were statistically significant and aligned with a three-tier composite outcome that included survival without heart replacement therapy, fewer major adverse events and improved quality of life. He said that composite endpoint also reached statistical significance.
Altman said the CardiAMP therapy may be working through a mechanism involving microvascular repair, including promoting new capillary growth and reducing tissue fibrosis in the heart. He noted that patients in the trial were already receiving maximum guideline-directed medical therapy.
CardiAMP HF II Enrollment Continues
BioCardia said the four activated centers in the ongoing CardiAMP Heart Failure II study have continued enrolling patients. Altman said the study is designed as a 250-patient trial, with 160 patients needed to achieve 80% power.
The company is onboarding additional centers and plans to expand enrollment as resources allow, he said. Altman also said BioCardia expects in the second quarter to complete one or more transactions to fund the Japan PMDA submission and the CardiAMP Heart Failure II trial.
The company also highlighted progress in other programs. Altman said results from CardiAMP cell therapy in chronic myocardial ischemia were accepted for oral presentation at the EuroPCR meeting. He also said BioCardia completed a pre-submission meeting with the FDA regarding approval of the Helix transendocardial delivery system.
According to Altman, the FDA raised no concerns about Helix safety data, device performance or compatibility with general classes of agents. He said the agency’s preferred pathway would be approval simultaneous with the CardiAMP cell therapy system for heart failure, while a follow-on pre-submission could support a de novo pathway for Helix as a standalone delivery system.
First-Quarter Expenses and Loss Narrow
Chief Financial Officer David McClung said total expenses decreased to $2.3 million in the first quarter of 2026 from $2.7 million in the same period of 2025.
- Research and development expense fell to $1.2 million from $1.5 million, primarily due to the closeout of the CardiAMP Heart Failure Trial, partially offset by early enrollment in CardiAMP Heart Failure II and regulatory work in Japan.
- Selling, general and administrative expenses declined to $1.0 million from $1.2 million, mainly due to lower professional service fees.
- Net loss was $2.3 million, compared with $2.7 million in the prior-year quarter.
- Net cash used in operations was $1.7 million, compared with $1.6 million a year earlier.
- The company ended the quarter with $951,000 in cash and cash equivalents.
McClung said BioCardia will continue to carefully manage its capital while working toward its milestones.
During the question-and-answer session, Altman said the potential market in Japan includes roughly 300,000 patients with ischemic etiology heart failure who could be appropriate candidates, though he said the initial market would be limited by appropriate-use conditions and could be about 20,000 patients. Using the company’s current U.S. reimbursement figure of $20,000 per procedure, Altman said that could represent a $400 million market opportunity.
Altman closed the call by calling the positive regulatory interaction in Japan a “transformative milestone” and said BioCardia would continue updating investors on its progress toward submission and approval.
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.
