BioCardia (NASDAQ:BCDA) said its second-quarter progress was driven by regulatory discussions in Japan and the United States concerning its CardiAMP cell therapy for ischemic heart failure and its Helix transendocardial delivery catheter.
President and Chief Executive Officer Peter Altman said Japan’s Pharmaceuticals and Medical Devices Agency, or PMDA, issued a Consultation Record of Advice in May that supports the company’s plan to advance CardiAMP toward a Shonin pre-market approval submission. The agency said positive outcomes from CardiAMP trials were credible, according to Altman, while requesting additional information before and as part of the submission.
Japan submission preparations underway
Altman said BioCardia believes it can address the agency’s requests and is preparing its Shonin submission for next quarter. The company is completing its electronic trial master file, conducting third-party Japanese Good Clinical Practice audits, structuring clinical research data under CDISC standards and reviewing product documentation. BioCardia also expects to sign an agreement with a designated marketing authorization holder, or DMAH, to serve as its local regulatory representative in Japan.
During the question-and-answer session, Altman said the DMAH would support regulatory and quality responsibilities rather than act as a commercial partner that would sell the therapy for royalties. BioCardia’s current plan is to sell CardiAMP itself during the required post-marketing study, while working through local hospital distributors.
The company expects its initial Japanese indication to cover about 20,000 patients, with approval anticipated about 12 months after completing the Shonin submission. Altman said reimbursement would be determined following approval through discussions with Japan’s Ministry of Health, Labour and Welfare.
BioCardia noted that another cardiac cell therapy for the same indication received Japanese approval in March and reimbursement confirmation in July at JPY326,000 per treatment. Altman characterized that product as different from CardiAMP, saying it requires surgical implantation and uses an induced pluripotent stem cell approach, while CardiAMP is delivered minimally invasively and uses autologous mononuclear cells. He said BioCardia believes its clinical experience and delivery approach could be attractive to physicians and patients.
FDA discussions on CardiAMP and Helix
In the U.S., BioCardia said minutes from a June Q-Sub meeting with the Food and Drug Administration’s Center for Biologics Evaluation and Research confirmed that the ongoing CardiAMP Heart Failure II trial may support pre-market approval. Altman said the company interprets the FDA’s feedback as viewing the study as a confirmatory trial, with the primary focus on efficacy rather than safety or delivery.
BioCardia expects additional FDA discussions on outcome measures, particularly the quality-of-life component of the trial’s composite endpoint. The endpoint includes all-cause mortality, non-fatal cardiac major adverse events and quality of life. Altman said the company intends to streamline the trial to focus on the primary outcome measure, an effort he said could aid enrollment.
Four clinical sites have enrolled patients in the CardiAMP Heart Failure II trial and are actively recruiting, according to management. Three additional patients were expected to qualify during August, with two procedures scheduled for the month. The company did not provide the total number of patients enrolled. Altman said management was not aware of any safety issues and that additional centers were being onboarded.
BioCardia also discussed its May de novo pre-submission meeting with the FDA for the Helix catheter system. The agency agreed there are two potential routes to marketing clearance and did not raise concerns regarding Helix safety data, device performance or compatibility with general classes of agents, Altman said. FDA’s preferred route would be approval alongside the CardiAMP cell therapy system, while a follow-on pre-submission could potentially support a standalone de novo pathway.
The company had not yet received formal meeting minutes for the Helix discussion, although Altman said the FDA confirmed BioCardia’s understanding by email on the day of the call and indicated formal minutes would be sent soon. Helix has previously received CE marking and market approval in Europe, the company said.
Quarterly expenses decline as cash runway extends into 2027
Chief Financial Officer David McClung reported net cash used in operations of approximately $1.7 million in the second quarter, compared with $1.6 million a year earlier. For the first six months of 2026, operating cash use was $3.4 million, versus $3.3 million in the prior-year period, with the small increase primarily attributed to the timing of supplier payments.
- Second-quarter total expenses fell to $1.6 million from $2.1 million a year earlier.
- Research and development expense declined to $0.9 million from $1.4 million, primarily due to the closeout of the prior CardiAMP Heart Failure trial.
- Selling, general and administrative expense was unchanged year over year at $0.7 million.
- Net loss narrowed to $1.6 million from $2.0 million in the prior-year quarter.
During the quarter, BioCardia raised approximately $4.9 million in net proceeds through its at-the-market facility at an average price of $1.22 per share. The company ended June with $5.4 million in cash and cash equivalents and said that balance provides operating runway into 2027. McClung said BioCardia ended the quarter with $2.7 million of equity, which management believes keeps the company compliant with Nasdaq listing standards.
Altman said BioCardia has active business-development conversations in the Asia-Pacific region involving its cardiovascular therapeutics and separately is pursuing opportunities around biotherapeutic delivery, including potential applications for gene-based therapies. The company said it has sufficient capital to complete its planned PMDA submission, while a modest financing with long-term investors could accelerate the CardiAMP Heart Failure II program.
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.
