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Heartseed Reports Positive Phase I/II Results for iPS-Derived Heart Failure Treatment HS-001

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Heartseed (TYO:219A) said the Phase I/II LAPiS Study of HS-001, an allogeneic iPS cell-derived cardiomyocyte spheroid therapy for severe ischemic heart failure, met its primary safety endpoint with no concerns affecting its future approval application, according to a Tokyo bourse filing on Monday.

The secondary efficacy endpoint analysis, which included independent third-party evaluations, showed supportive results across multiple measures such as cardiac pump function and reduction in heart enlargement.

The company plans to submit a manufacturing and marketing approval application in Japan in the current year.

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