Cuorips Inc. (TSE Growth: 4894) has a price. Japan's Central Social Insurance Medical Council, known as Chuikyo, approved a national health insurance reimbursement price of ¥53.2mn for ReHeart, the company's lab-grown cardiac tissue sheet, at a general meeting held on July 22. That single number turns a regulatory approval into a commercial one: it is the price hospitals will actually be paid once the treatment reaches patients.
ReHeart is an allogeneic sheet of heart-muscle cells derived from human induced pluripotent stem (iPS) cells. It is intended for patients with severe heart failure caused by ischemic cardiomyopathy who have not responded adequately to standard treatment, including drug therapy and invasive procedures. The product received conditional, time-limited manufacturing and marketing approval from Japanese regulators on March 6, 2026; Tuesday's decision is the pricing step that follows.
Chuikyo classified ReHeart under category C2, reserved for products built on new function or new technology, and priced it using a cost-calculation method rather than comparison with an existing similar product. On top of that base cost, regulators added a 10% marketability premium, tagged as "Premium (I)" in the disclosure, with an adjustment coefficient of 1.0 applied to the final figure.
| Item | Detail |
|---|---|
| Product name | ReHeart |
| Decision category | C2 (new function / new technology) |
| Target indication | Severe heart failure from ischemic cardiomyopathy unresponsive to standard treatment |
| Approved reimbursement price | ¥53.2mn |
| Pricing method | Cost-calculation method |
| Marketability premium | Premium (I), 10% |
| Adjustment coefficient | 1.0 |
| Scheduled insurance listing date | September 1, 2026 |
The reimbursement price does not put ReHeart on sale immediately. The formal insurance listing, published through an official government gazette notice, is scheduled for September 1, 2026. Only after that listing takes effect can Cuorips begin commercial sales.
Cuorips said it has received a large number of inquiries from outside Japan and is working on a global expansion effort to reach severe heart-failure patients beyond its home market, though the disclosure gives no further detail on which countries or regulators are involved. On the financial side, the company said it is still assessing how the pricing decision will affect its consolidated results for the fiscal year ending March 2027 and will disclose the impact once that review is complete. For now, the only hard number on the table is the price itself: ¥53.2mn, with a September 1 start date attached.