TOKYO, June 01 (Pulse News Wire) – Heartseed Inc. (219A.T) announced positive results from its phase 1/2 clinical trial (LAPiS study) evaluating the safety and efficacy of allogeneic induced pluripotent stem cell-derived cardiac myocytes (HS-001) for treating severe heart failure due to ischemic heart disease.
The primary endpoint focused on safety showed no concerns impacting future regulatory approval plans. Secondary endpoints assessing efficacy, including independent third-party imaging evaluations, confirmed several supportive outcomes related to cardiac pump function and reduction of enlarged hearts. These data will be used in the manufacturing and marketing application process.
Based on these findings, Heartseed aims to file for domestic manufacturing and marketing approval within 2026. Detailed results will be disclosed through upcoming academic presentations and publications. There are no revisions to the company's fiscal year 2026 December-end earnings forecast due to this development.
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