Japan's Pharmaceutical Affairs Council recommends conditional approval for Cuorips' ReHeart iPSC-derived therapy

Cuorips/ReHeart

Japan's Pharmaceutical Affairs Council recommended conditional and time-limited marketing approval for ReHeart, an iPSC-derived cardiomyocyte patch for severe ischemic heart failure. An investigator-initiated trial of eight patients showed improvements in cardiac function with no serious adverse events.

• Eight-patient investigator trial showed cardiac function improvement in all cases
• No adverse events reported during trial
• Approval is conditional and time-limited; full approval requires seven-year follow-up with 75 additional patients
• Health Minister Kenichiro Ueno indicated formal approval expected as early as March 2026