企業プロフィール
BioCardia 株価・ニュース・カタリスト
- ティッカー:
- BCDA
- 取引所:
- NASDAQ
- セクター:
- Biopharma
- 所在地:
- United States
株価パフォーマンス
0.94 USD (-3.46%)
終値
最終更新: 2026年8月17日
10.2M USD
時価総額
株価変動の要因
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.
企業概要
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.
今後のカタリスト
- 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.
最近のニュース
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類似銘柄
事業成熟度、治療領域、カタリスト傾向が近い同業銘柄です。