公司資料
BioCardia 股價、新聞與催化劑
- 股票代碼:
- BCDA
- 交易所:
- NASDAQ
- 產業:
- Biopharma
- 所在地:
- United States
股票表現
0.94 USD (-3.46%)
收盤價
最後更新: 2026年8月17日
10.2M USD
市值
股價為何變動
As of Aug 17, 2026, BCDA closed down 3.46% at $0.9400. No new same-company headline was identified in the current news window.
公司概覽
Cardiovascular Cell Therapy Company
BioCardia develops cellular and cell-derived therapies for cardiovascular and pulmonary diseases. Its platform includes autologous CardiAMP and allogeneic CardiALLO cell therapies, supported by the Helix delivery and Morph vascular-navigation technologies.
CardiAMP Heart Failure Program
CardiAMP Cell Therapy is primarily being developed for ischemic heart failure with reduced ejection fraction. BioCardia has engaged both Japan’s PMDA and the FDA regarding safety, efficacy evidence, and potential approval pathways.
Delivery Platform Value
In addition to its own cell therapies, BioCardia serves as a biotherapeutic delivery partner for programs in heart failure, chronic myocardial ischemia, and acute myocardial infarction. The delivery technologies are an important component of the company’s platform value.
Dual-Market Regulatory Strategy
BioCardia is pursuing distinct approval paths in Japan and the United States. The Japanese Shonin process and the FDA-supported confirmatory study strategy provide separate routes for validating and commercializing the CardiAMP system.
未來催化劑
- BioCardia is advancing a Japanese Shonin submission for the CardiAMP Cell Therapy System.
- The FDA recommended continuation of the CardiAMP HF II trial as a confirmatory study supporting a potential PMA, making future enrollment and data key U.S. regulatory milestones.
- Further FDA interaction regarding the Helix Transendocardial Delivery Catheter and a potential De Novo pathway could establish an additional regulatory milestone for the device platform.
近期新聞
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