BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure

SUNNYVALE, Calif.–  BioCardia^®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission for regulatory approval of the CardiAMP® cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF) based on the Company’s three completed clinical trials of this therapy in HFrEF.    

PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT).  PMDA noted that the positive outcomes seen in the trial were credible. It is estimated that 20,000 of the 300,000 patients in Japan would initially be eligible for this therapy.  PMDA requested BioCardia demonstrate that enrolled patients were on GDMT and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation.

“PMDA’s recognition of the urgent unmet clinical need in HFrEF and their support of this novel therapy is valued,” said BioCardia Chief Executive Dr. Peter Altman. “We believe the clinical package prepared for this submission will be sufficient to support approval.”

As part of the submission review for approval of CardiAMP Cell Therapy, the Agency requests post-marketing study plans including the criteria for patient selection, the clinical decision-making framework, and appropriate medical infrastructure and specialist involvement.  BioCardia has been guided to collaborate with relevant Japanese academic societies to establish proper-use guidelines and sufficiently consider product training, proctoring, and post market surveillance.

BioCardia’s timeline for PMDA submission is seven months.  BioCardia plans to submit with a Designated Marketing Authorization Holder as the optimal pathway for regulatory submission, regulatory review, and to initiate commercialization of the CardiAMP Cell Therapy System while conducting the post market study in Japan.  The PMDA review process will be rigorous, and BioCardia believes the documentation to support review is in good shape.  BioCardia is ISO13485 compliant for the design, manufacture, and distribution of medical devices for cardiovascular procedures, including catheters for use in delivery of therapeutic agents directly to the heart, and currently manufactures FDA cleared products.  When PMDA concludes its technical assessment and recommends approval, the Ministry of Health, Labour and Welfare (MHLW) ultimately issues the certificate enabling commercialization.

About CardiAMP Autologous Cell Therapy

Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. 

About BioCardia^®

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP^® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph^® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies.  For more information visit www.biocardia.com.

Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120