BioCardia is pursuing a two-pronged regulatory strategy in Q3/Q4 2025, seeking FDA approval for its Helix transendocardial delivery catheter and its CardiAMP Cell Therapy System for the treatment of ischemic heart failure. Concurrently, the company is engaging with Japan’s PMDA for potential approval of the CardiAMP system.
The Helix catheter submission, filed as a De Novo 510(k), leverages existing safety and performance data from twelve cell and gene therapy trials, including over 4,000 intramyocardial deliveries in CE-marked European studies. BioCardia highlights the system’s high safety profile and superior retention of therapeutic agents compared to alternative delivery methods. This separate device approval is crucial for the broader adoption of the CardiAMP system.
The CardiAMP FDA submission presents a more complex regulatory challenge. While previous trials (TABMMI, TAC-HFT, and the CardiAMP HF roll-in cohort) demonstrated safety and some efficacy signals, they did not achieve primary endpoints in pivotal studies. BioCardia is relying on the totality of the data, including two-year follow-up from the 115-patient randomized, placebo-controlled CardiAMP HF trial, to argue for approval based on overall benefit. The company is also emphasizing the FDA’s prior Breakthrough Therapy designation for CardiAMP, which acknowledges the significant unmet need in heart failure. The ongoing CardiAMP HF II trial, currently enrolling, could further bolster the case if positive interim data emerge.
This approach reflects a broader trend of sponsors seeking approvals based on real-world evidence and subgroup analyses in areas with limited treatment options. The FDA’s willingness to consider such data, particularly for devices offering less invasive treatment modalities, will be a key factor.
In Japan, BioCardia is navigating a distinct regulatory landscape. The PMDA’s adaptive framework for regenerative medicine products could favor competing allogeneic cell therapies despite their requirement for chronic immunosuppression and open-chest surgery. BioCardia’s strategy hinges on positioning CardiAMP, regulated as a point-of-care medical device, as a simpler, less risky alternative. The prior approval of the CardiAMP cell processing platform (BioCUE) in Japan for orthopedic applications provides a foundation for this argument.
Several factors will determine the success of BioCardia’s regulatory strategy. The FDA’s acceptance of less conventional efficacy data, the PMDA’s assessment of autologous versus allogeneic therapies, and the performance of the ongoing CardiAMP HF II trial will all play a role. Furthermore, if approved, BioCardia will face the challenge of market penetration against established pharmaceutical companies and emerging players in the cell therapy space. The company’s ability to secure reimbursement and demonstrate clear clinical differentiation will be critical for commercial success.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
