Key facts
- Japan has approved RiHeart, an iPS cell-derived cardiac muscle sheet therapy, for public health insurance coverage.
- RiHeart is designed for patients with severe heart failure who have not responded to conventional treatments.
- The therapy involves applying a sheet of cardiac muscle cells, generated from iPS cells, directly to the surface of the heart.
- This approval marks a significant milestone for regenerative medicine, with RiHeart being the world's first approved therapy using iPS cell-derived cardiomyocytes for heart failure.
- Cuorips, the developer of RiHeart, plans to put the product on sale in Japan this autumn at a price of ¥53.2 million ($326,400).
Japan has made a significant stride in regenerative medicine with the approval of RiHeart, an iPS cell-derived cardiac muscle sheet therapy, for public health insurance coverage, effective September 1, 2026. This marks a historic milestone as it is the world's first approved therapy using iPS cell-derived cardiomyocytes for treating heart failure.
RiHeart, developed by Cuorips, a startup originating from Osaka University, consists of sheets of cardiac muscle cells generated from induced pluripotent stem (iPS) cells. These sheets are applied directly to the surface of the heart to promote the formation of new blood vessels and restore pumping function in patients with severe ischemic heart failure who have exhausted conventional treatment options.
The therapy underwent trials between 2020 and 2023, treating eight patients across four sites led by Osaka University Hospital. All participants showed improvement, with no evidence of tumor formation. The Japanese Ministry of Health, Labour and Welfare had previously granted conditional, time-limited marketing approval for RiHeart in March 2026.
This development follows the earlier approval of Amshepri, a dopaminergic neural progenitor cell therapy for Parkinson's disease developed by Sumitomo Pharma and RACTHERA, which also received insurance coverage in May 2026. Both RiHeart and Amshepri are products born from Professor Yamanaka's iPS cell technology. The ministry will make a final decision on full-scale approvals after collecting additional treatment data over the next seven years.
Cuorips plans to launch RiHeart in Japan this autumn with an official domestic price set at ¥53.2 million ($326,400). The actual out-of-pocket expenses for patients will be significantly reduced due to the application of the high-cost medical care benefit system.