SUNNYVALE, Calif. – BioCardia, Inc. (NASDAQ:BCDA), a $10 million market cap biotechnology company engaged in the development of cellular therapeutics for cardiovascular and pulmonary diseases, announced its recent progress with Japan's Pharmaceutical (TADAWUL:2070) and Medical (TASE:PMCN) Device Agency (PMDA) regarding its leading therapeutic asset, BCDA-01, for treating ischemic heart failure with reduced ejection fraction (HFrEF). According to InvestingPro data, the company maintains a relatively strong balance sheet with more cash than debt, though it faces significant challenges with its current "Weak" Financial Health Score of 1.53 out of 5.
During a recent meeting with the PMDA, BioCardia's President and CEO, Peter Altman, Ph.D., shared that the agency has invited the company for a subsequent consultation following the submission of final clinical data, which includes a two-year follow-up to assess the safety and efficacy of the BCDA-01 program. This development comes as the company faces significant financial challenges, with InvestingPro analysis showing an 87.5% revenue decline in the last twelve months and rapid cash burn rate. The PMDA is considering the data from the fully enrolled CardiAMP Heart Failure Trial and previous studies as potential evidence for the registration of the CardiAMP Cell Therapy System for heart failure patients in Japan.
Dr. Altman indicated that the company is preparing the data lock from the CardiAMP Heart Failure Trial, which involves 125 patients, and expects to have the final data available in the first quarter of 2025. He emphasized the significance of the PMDA's openness to the trial results as evidence for registration.
BioCardia's BCDA-01 has received Breakthrough Designation from the FDA Center for Biological Evaluation and Research, with its development being supported by the Maryland Stem Cell Research Fund. Additionally, the company's clinical trials in the United States, including BCDA-01 and BCDA-02, benefit from reimbursement from the Center for Medicaid and Medicare Services.
The company, headquartered in Sunnyvale, California, is recognized for its biotherapeutic platforms, CardiAMP® autologous and CardiALLO™ allogeneic cell therapies, which are currently undergoing clinical trials. These therapies are facilitated by BioCardia's Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms. For investors seeking deeper insights into BioCardia's financial health and growth prospects, InvestingPro offers comprehensive analysis through its Pro Research Report, available alongside 10+ additional ProTips and detailed financial metrics for informed investment decisions.
BioCardia's announcement includes forward-looking statements subject to risks and uncertainties. The company does not undertake any obligation to update these statements and advises that actual results may differ from those projected. The information is based on a press release statement.
In other recent news, BioCardia, Inc. reported significant developments during its third-quarter earnings call. The biotechnology company announced progress in its CardiAMP cell therapy trials for heart failure, which have received FDA breakthrough designation and CMS reimbursement. The CardiAMP Heart Failure II trial has also been expanded to include more patients.
Financially, BioCardia strengthened its cash position following a public offering that raised $7.2 million, and managed to reduce its net loss to $1.7 million. The company also revealed its strategic plans for launching its therapies in Japan, leveraging regulatory advantages that could expedite the process.
In addition, BioCardia plans to complete key objectives by the end of Q4 2024, including data lock on the CardiAMP Heart Failure I trial and activating additional centers for the CardiAMP Heart Failure II trial. Despite some challenges due to natural disasters, the company remains optimistic about its growth and success in the coming years.
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