World’s First iPSC-Derived Cardiomyocyte Therapy for Heart Failure Receives Conditional Approval in Japan

• 2026/03/06
• NEWrelease

TOKYO, March 6, 2026 — Cuorips Inc. (TSE: 4894), a biotechnology company developing regenerative therapies based on human induced pluripotent stem cells(iPSC), today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted conditional and time-limited marketing approval for its allogeneic iPSC-derived cardiomyocyte sheet therapy (Development Code: IPSOC-1).

This decision marks a historic milestone in regenerative medicine, representing the world’s first approved therapy using cardiomyocytes derived from iPS cells for the treatment of heart failure.

The therapy is designed for patients with severe ischemic heart failure who have exhausted conventional treatment options, offering a regenerative strategy aimed at restoring cardiac function by supporting damaged myocardium.

A Breakthrough in Cardiac Regenerative Medicine

Heart failure remains one of the leading causes of death worldwide, affecting more than 60 million people globally. Despite advances in pharmacological therapy and device-based treatments, patients with advanced disease often face limited options, including heart transplantation.

Cuorips’ therapy utilizes allogeneic cardiomyocyte sheets derived from human iPS cells (RiHEART®), which are transplanted onto the surface of the heart to support myocardial repair and improve cardiac function.

This regenerative approach aims to restore damaged heart tissue rather than merely slowing disease progression, representing a fundamentally new paradigm for treating heart failure.

Regulatory Milestone for iPSC-Based Therapies

The product was approved under Japan’s Conditional and Time-Limited Approval pathway for regenerative medical products, a regulatory framework designed to accelerate patient access to innovative therapies while additional clinical data are collected.
Japan has emerged as a global leader in regenerative medicine regulation, enabling pioneering therapies based on iPS cells to reach patients.

This approval represents a major step toward the clinical realization of iPS cell technology, first discovered by Nobel Laureate Shinya Yamanaka.

Next Steps Toward Global Impact

Following the approval, Cuorips will proceed with commercial launch preparations and post-marketing clinical evaluation as required by Japanese regulatory authorities.

The company aims to further advance the global development of regenerative therapies based on iPS cells to address severe cardiovascular diseases with high unmet medical need.