ReHeart by Cuorips: status and timeline

ReHeart

Restore cardiac function by transplanting a sheet of living heart muscle cells onto the damaged heart surface, offering a regenerative cure for patients with severe ischemic cardiomyopathy.

DeployStage 4 of 5

Conditional approval in Japan (Feb 2026); commercial sales planned autumn 2026.

Updated 6 Mar 2026Checked 11 Oct0 updates this week

Milestones

Next · Listing on drug price list and insurance coverage

Investigator-initiated clinical trial conducted2023Complete.
Clinical data shows safety and efficacy in eight patients2025Complete.
Japanese regulatory approval recommendation21 Feb 2026Complete.
Conditional and time-limited approval granted28 Feb 2026Complete.
Listing on drug price list and insurance coverageTarget Sep 2026Current milestone.
Commercial sales launchTarget Oct 2026Not yet reached.
Full approval data collection (75 patients target)Target 2033Not yet reached.

Most important updates

Upcoming

Sep 2026Listing on drug price list and insurance coverage (next)
Oct 2026Commercial sales launch
2033Full approval data collection (75 patients target)

Current obstacles

Immune toleranceAllogeneic donor cardiomyocytes may be rejected; long-term tolerance mechanisms and potential immunosuppression strategies are still being optimized.
Surgical precisionSuccessful integration requires precise positioning and suturing of the thin sheet onto the beating heart, which is technically challenging.
VascularizationThe transplanted sheet must develop new blood vessels to survive and function long-term; achieving reliable vascularization remains a technical challenge.

Physics limits

Sheet mechanical propertiesA thin sheet of cultured cells is mechanically fragile and cannot provide active pumping force; it works by supporting damaged tissue, not replacing lost contractility.
Electrical integrationThe transplanted sheet must develop electrical coupling with host heart tissue to synchronize contraction; achieving reliable integration is limited by cell biology.
Scalable cell productionManufacturing large sheets of functional cardiomyocytes at clinical scale requires reliable differentiation protocols and quality control; variability between cell batches remains a challenge.

How it works

3 parts

Cell source

iPSC-derived cardiomyocytes

Heart muscle cells are generated from donor iPSCs, which can differentiate into any cell type in the body.

Sheet assembly

Organized tissue patch

The cells are cultured into a thin, organized sheet that resembles native heart tissue and can conduct electrical signals.

Transplantation

Direct heart surface implant

The patch is surgically applied to the damaged region of the heart, where it integrates and restores myocardial function.

Spec sheet

Spec	ReHeart
Patch diameter	4–5 cm^R (reported)
Patch thickness	0.1 mm^R (reported)
Investigator-initiated trial enrollment	Eight patients^R (reported)
Trial cases judged effective	8 of 8^R (reported)
Target for full approval	75 patients^R (reported)

^R reported by the company

Update log

2 updates

Fri 6 Mar

Major: Japan grants conditional approval to ReHeart, first iPSC-derived therapy for heart failurePressRegulatory

Fri 20 Feb

Major: Japan's Pharmaceutical Affairs Council recommends conditional approval for Cuorips' ReHeart iPSC-derived therapyPressRegulatory

About Cuorips

The team behind ReHeart

Cuorips

ReHeart, iPSC cardiomyocytes, heart failure transplant

Cuorips is a Japanese biotech founded in 2017 from Osaka University, developing iPSC-derived cardiomyocyte sheets for severe heart failure. Listed on TSE Growth (ticker 4894).

Conditional approval in Japan (Feb 2026) for ReHeart, world's first iPSC cardiomyocyte sheet therapy for ischemic heart failure.
Investigator trial of eight patients: all showed improvement, no adverse events; commercial launch planned autumn 2026.
Targets severe ischemic heart failure patients who have exhausted conventional treatment options or surgery.

cuorips.com (opens cuorips.com)Company profile →

Founded: 20179 yrs
Headquarters: Japan
Status: Public
Listed: 4894 (opens google.com)TSE
Valuation: public
Last round: Corporate investment2021
Works in: BiotechCell & organ therapies
Coverage: 1 program · 2 updateslatest 6 Mar 2026checked 11 Oct
Lead investors: Fujifilm
Partners: Osaka University (opens osaka-u.ac.jp)
Investors: Fujifilm (opens fujifilm.com)Daiichi Sankyo (opens daiichisankyo.com)

Spec

ReHeart

Patch diameter

4–5 cm^R (reported)

Patch thickness

0.1 mm^R (reported)

Investigator-initiated trial enrollment

Eight patients^R (reported)

Trial cases judged effective

8 of 8^R (reported)

Target for full approval

75 patients^R (reported)