BioCardia (NASDAQ:BCDA) is preparing a Japanese regulatory application for its CardiAMP cell therapy for ischemic heart failure while seeking U.S. Food and Drug Administration feedback on a potential approval pathway for its Helix delivery catheter, executives said on the company’s third-quarter earnings call.
Chief Executive Officer Peter Altman said BioCardia has answered outstanding questions from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and is proceeding toward a Shonin application with a designated marketing authorization holder. The company expects most preparation tasks to be completed in the coming months, although Altman described the timing as fluid.
BioCardia reported a third-quarter net loss of $1.8 million, compared with $1.5 million a year earlier. Chief Financial Officer David McClung said the company ended September with $2.2 million in cash and cash equivalents, providing runway into 2027.
Japan application and potential launch
Altman said the designated marketing authorization holder will prepare and submit the Japanese application and serve as BioCardia’s local regulatory representative. He said a potential risk to the timeline is that product documentation could require additional work or repeat testing, though BioCardia has not identified any deficiencies.
The company expects an initial indication covering approximately 20,000 patients and anticipates approval about 12 months after completing the submission, Altman said. BioCardia would plan to train physicians and finalize a post-marketing study during the review period, with treatment beginning after approval and reimbursement are established.
In response to an analyst’s question, Altman said BioCardia is considering having roughly 20 centers trained and ready for the launch, although he cautioned that the plan may not be possible. He said the post-marketing study could involve about 200 patients and focus primarily on procedural safety, while also examining longer-term survival against historical controls. The design would be developed with the PMDA and Japanese cardiovascular societies.
Altman said BioCardia is discussing potential licensing arrangements with larger companies that could help expand the therapy in Japan and the broader Asia-Pacific region. He said BioCardia intends to remain directly involved in the post-marketing study and that partnership discussions are still at an early stage.
U.S. catheter review and clinical trial
For the Helix Transendocardial Delivery Catheter System, BioCardia recently filed a supplemental De Novo pre-submission that the FDA accepted, Altman said. The company expects feedback within six weeks.
If the FDA supports the De Novo pathway, BioCardia expects to complete a submission in the first quarter of 2027 and receive approval in mid-2027, assuming the agency meets its 150-day review target. If the agency does not support that pathway, further discussions would be needed, Altman said.
BioCardia is also enrolling patients in its U.S. CardiAMP Heart Failure II confirmatory Phase 3 trial. Four sites are actively recruiting, and seven more are being onboarded. Altman said management was not aware of any safety issues and did not provide an updated enrollment total.
He said the company does not know how many sites the trial will ultimately require and that regulatory work for CardiAMP in Japan and Helix in the U.S. is the current priority for its clinical team.
Third-quarter spending rises
Research and development expenses increased to $1.2 million in the third quarter from $0.9 million a year earlier, partly reflecting Japanese regulatory work and support for trial enrollment, McClung said. Selling, general and administrative expenses rose to $0.6 million from $0.55 million.
Net cash used in operations was approximately $1.7 million in the quarter, unchanged from the prior-year period. For the first nine months of 2026, the company’s net loss narrowed to $5.7 million from $6.2 million, primarily because of lower research and development expenses.
About BioCardia (NASDAQ:BCDA)
BioCardia, Inc. is a biotechnology company focused on developing regenerative cell therapies and delivery systems for the treatment of cardiovascular diseases. The company’s programs are designed to address conditions in which damaged or poorly functioning heart tissue may benefit from cellular therapy. BioCardia’s principal product candidates include CardiAMP Cell Therapy, an autologous treatment that uses a patient’s own bone marrow-derived cells, and CardiALLO Cell Therapy, an investigational allogeneic therapy based on mesenchymal precursor cells from a donor source.
