BioCardia (Nasdaq:BCDA) announced today that it completed the submission of its CardiAMP cell therapy system to Japan’s regulatory authorities.
Sunnyvale, California-based BioCardia submitted CardiAMP to Japan’s Pharmaceutical and Medical Device Agency (PMDA). It seeks approval for the indication of ischemic heart failure with reduced ejection fraction (HFrEF). It expects a formal consultation with PMDA to review the submission within three months. This would mark BioCardia’s third consultation with PMDA.
BioCardia designed CardiAMP to use a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. It potentially stimulates the body’s natural healing response. The company’s multicenter clinical trial screened for cell characteristics in order to improve patient outcomes — marking the first such trial.
CardiAMP incorporates a pre-procedural cell analysis, a high target dosage and a proprietary delivery system. BioCardia says no previous investigational cardiac cell therapies utilize these proprietary elements. The company noted that its delivery system proved safer than other intramyocardial delivery systems.
BioCardia President and CEO Peter Altman said existing safety and efficacy data and existing approvals in Japan provide confidence in a coming approval. Existing European approval for the same indication may also give the company’s regulatory efforts a boost.
“While there is potential that PMDA will require additional data for approval, BioCardia has designed a post-marketing study in collaboration with two globally recognized Japanese cardiology investigators who would lead the study as co-National Principal Investigators to enable the CardiAMP cell therapy to be advanced safely for the benefit of the patients in Japan who suffer from ischemic HFrEF,” Altman said.