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Japan's PMDA supports CardiAMP cell therapy data for ischemic heart failure market approval

Market News
20 Apr 2026
GlobeNewsWire
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Bullish
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BioCardia announced that Japan's Pharmaceutical and Medical Device Agency (PMDA) has positively reviewed the clinical safety and efficacy data of its CardiAMP Cell Therapy for ischemic heart failure, deeming it likely sufficient for market clearance. The PMDA agreed on the acceptability of U.S.-developed clinical data and the therapy's use in patients, with plans for post-marketing studies in Japan. BioCardia awaits detailed feedback and a potential filing timeline, aiming to introduce the first minimally invasive biologic therapy for ischemic heart failure in Japan. This marks a significant step toward regulatory approval and market entry in Japan for CardiAMP, which uses a patient's own bone marrow cells to treat heart failure.

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Comcast faces price target cuts amid rising competition and NBCUniversal spin-off plans

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Lotto.com appoints new COO and VP of HR to drive US digital lottery expansion

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Ipsen repurchases 28,541 shares in early July at an average price of €166.05 per share.

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