SUNNYVALE, Calif. – BioCardia, Inc. (NASDAQ: BCDA), a biotechnology company focused on developing cell-based therapies for cardiovascular and pulmonary diseases, is making significant progress toward securing approval for its heart failure treatment in Japan. The company’s leading therapeutic candidate, BCDA-01, is being evaluated for treating ischemic heart failure with reduced ejection fraction (HFrEF), a severe form of heart disease.
In a recent meeting with Japan’s Pharmaceutical and Medical Device Agency (PMDA), BioCardia’s President and CEO, Dr. Peter Altman, revealed that the agency has invited the company for further consultation following the submission of final clinical data. This data includes a two-year follow-up study assessing the safety and effectiveness of BCDA-01. The PMDA is reviewing the results from BioCardia’s CardiAMP Heart Failure Trial and other studies as part of its evaluation for the potential registration of the CardiAMP Cell Therapy System in Japan.
Dr. Altman stated that the company is on track to lock the data from the CardiAMP trial, which involved 125 patients, with final results expected by the first quarter of 2025. He expressed optimism about the PMDA’s willingness to consider the trial data as part of the registration process.
Despite these positive developments, BioCardia faces financial challenges. The company’s financial health has been flagged as “weak” by InvestingPro, with a significant 87.5% decline in revenue over the past year and a rapid cash burn rate.
However, BioCardia maintains a strong balance sheet, with more cash than debt.
BioCardia’s BCDA-01 therapy has already received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) and is being developed with support from the Maryland Stem Cell Research Fund. The company also benefits from reimbursement for its clinical trials in the U.S., including those involving BCDA-01 and BCDA-02, from the Centers for Medicare & Medicaid Services.
Headquartered in Sunnyvale, California, BioCardia is recognized for its biotherapeutic platforms, including CardiAMP® autologous and CardiALLO™ allogeneic cell therapies. These treatments are being tested in clinical trials using BioCardia’s Helix™ delivery system and Morph® vascular navigation platform.
In addition to its efforts in Japan, BioCardia has made strides in the U.S. as well. During its recent third-quarter earnings call, the company reported progress in its CardiAMP Heart Failure trials, which have received FDA breakthrough designation and CMS reimbursement. The company also expanded the CardiAMP Heart Failure II trial to include additional patients.
On the financial front, BioCardia recently raised $7.2 million through a public offering, strengthening its cash position and reducing its net loss to $1.7 million. The company has outlined strategic goals for the remainder of 2024, including locking data for the CardiAMP Heart Failure I trial and expanding its trial sites for the CardiAMP Heart Failure II trial.
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