Development of catheter administration for HS-005

「Ｈｅａｒｔｓｅｅｄ株式会社（以下、「当社」）が開発する HS-005（他家 iPS 細胞由来心筋球：カテーテル等を用いた投与方法）に関する日本国内での治験（EMERALD 試験）につきまして、この度、虚血性心疾患を原疾患とする重症心不全に対する第１例目の投与が実施され、投与後４週間のデータを基に、独立安全性評価委員会が同群における治験継続を承認いたしましたことをご報告申し上げます。」

「For HS-005, a treatment program involving catheter administration, which is less burdensome for patients, the first patient with heart failure caused by dilated cardiomyopathy was treated in the Phase I/II clinical trial in Japan using a catheter and other devices, the EMERALD trial. Based on an evaluation of data collected during the 4 weeks after administration to that patient, the independent safety review committee approved continuation of the trial for dilated cardiomyopathy.」

「As of the end of December 2025, the PMDA's 30-day review of the clinical trial notification had been completed, and the trial was formally in a position to begin in Japan.」

「For HS-005, a treatment program using catheter administration, which is less burdensome for patients, we aim to submit the clinical trial notification in 2025 in preparation for starting a domestic clinical trial, and joint development of the catheter with a new partner is also progressing smoothly.」

「We are developing HS-005 to transplant allogeneic iPS cell-derived myocardial spheres using a simpler, less burdensome method for patients, such as catheter administration.」