What Cuorips does

Cuorips Inc. is a Japanese regenerative medicine biotechnology company that researches, develops, and manufactures cell therapy products derived from induced pluripotent stem cells (iPSCs). Founded in 2017 and listed on the Tokyo Stock Exchange Growth Market (TYO:4894) since June 2023, the company's core product is RiHeart (development code IPSOC-1), an allogeneic iPSC-derived cardiomyocyte sheet therapy for patients with severe ischemic heart failure who have exhausted conventional treatment options. RiHeart received conditional and time-limited marketing approval from Japan's Ministry of Health, Labour and Welfare in March 2026, marking it as the world's first approved therapy using cardiomyocytes derived from iPS cells. The therapeutic mechanism combines paracrine signaling and electrical integration of transplanted sheets with host cardiac tissue to support myocardial repair.

The company's technology platform is anchored by proprietary large-scale iPSC cardiomyocyte culture and purification processes developed through a long-standing research partnership with Osaka University. Commercial manufacturing is conducted at the CLiC-1 facility in Minoh, Osaka, which obtained Japan's Specific Cell Processing Product Manufacturing License (FA5210001) in September 2021 and also offers CDMO services to third-party cell therapy developers. Beyond RiHeart, Cuorips maintains a pipeline including catheter-based delivery (with Asahi Intecc and Terumo), expansion into dilated cardiomyopathy indication, and an in vivo regeneration factor inducer program (with Ono Pharmaceutical).

Cuorips generates revenue through product sales of RiHeart to hospitals and medical institutions under Japan's national health insurance reimbursement system (post-March 2026 approval), supplemented by CDMO services via the CLiC-1 facility. Distribution occurs primarily through direct partnerships with leading Japanese university hospitals including Osaka University Hospital, Juntendo University, Tokyo Women's Medical University Hospital, and Kyushu University Hospital. The company operates from Tokyo headquarters with R&D in Suita, manufacturing in Minoh, and a US subsidiary (iReheart Inc.) in Palo Alto for international business development. Strategic shareholders and partners include Daiichi Sankyo, Terumo, Mitsubishi Corporation, Fujifilm, and CellSource.

Name

Cuorips

Legal name

Cuorips Inc.

Website

https://cuorips.co.jp

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

51–100 employees

Short description

Cuorips Inc. is a Japanese regenerative medicine biotech developing iPSC-derived cell therapies, with RiHeart — the world's first conditionally approved iPSC-derived cardiomyocyte sheet therapy for severe heart failure — as its core product, serving patients who have exhausted conventional treatments.

Ownership category

akta.pro rank

Product category

Regenerative Cell Therapy

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (32541)

SIC

Biological Products, (No Disgnostic Substances) (2836), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)

akta.pro secondary industry

Cell Therapy CDMO (HLAGABAD)

Keywords

• Regenerative cell therapy
• IPSC cardiomyocyte sheets
• Cell therapy manufacturing
• CDMO services
• Cardiac regenerative medicine

Headquarters

HQ city

Chuo

HQ country

Japan

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Product Sales - RiHeart: Revenue from sale of iPSC-derived cardiomyocyte sheet therapy (RiHeart) to hospitals and medical institutions. Treatment received conditional approval in March 2026 under Japan's national health insurance system, enabling reimbursement through national health insurance pricing.
2. CDMO Services: Contract Development and Manufacturing Organization services providing cell therapy manufacturing capabilities to other companies. The company leverages its CLiC-1 facility and expertise in large-scale cell culture.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Cuorips develops, manufactures, and commercializes regenerative cell therapy products based on induced pluripotent stem cells (iPSCs). Its core commercial product is RiHeart (IPSOC-1), the world's first iPSC-derived allogeneic cardiomyocyte sheet therapy for severe ischemic heart failure, which received conditional approval in Japan in March 2026. The company also operates the CLiC-1 commercial cell processing facility offering contract development and manufacturing (CDMO) services to other cell therapy developers.

Product overview

Cuorips is a biotechnology company focused on the development, manufacturing, and commercialization of regenerative cell therapy products based on human induced pluripotent stem cells (iPSCs). Its core product is RiHEART/IPSOC-1, the world's first conditionally approved iPSC-derived cardiomyocyte sheet therapy for severe ischemic heart failure, launched in Japan in March 2026. The company also develops a portfolio of iPSC-derived cardiomyocyte patches and related pipeline programs including catheter-based delivery (PJ4) and an in vivo regeneration factor inducer (PJ5). Its commercial-scale CDMO business is anchored by the CLiC-1 manufacturing facility, which provides process development and contract manufacturing services for cell processing products. The company operates globally with subsidiaries in Japan (Cuorips Healthcare Science) and the US (iReheart Inc.).

Differentiator

Problem solved

Functional benefit

Brands

• RiHeart®: Allogeneic iPS cell-derived cardiomyocyte sheet therapy for severe ischemic heart failure - world's first approved iPSC-derived cardiomyocyte therapy
• iPS Cardiomyocyte Patches
• Mini Heart

Products and services

• RiHeart / IPSOC-1 (iPSC-derived Cardiomyocyte Sheet Therapy) An allogeneic iPSC-derived cardiomyocyte sheet therapy (development code IPSOC-1) designed for patients with severe ischemic heart failure who have exhausted conventional treatment options. The sheet is transplanted onto the surface of the heart to support myocardial repair and improve cardiac function through paracrine signaling and electrical integration with the host heart. Conditionally approved in Japan in March 2026 under a 7-year time-limited approval pathway.
• iPSC-derived Cardiomyocyte Patches Cardiomyocyte patches fabricated from human iPSC-derived myocardial cells, transplanted to the heart surface via minimally invasive surgery. The patches induce angiogenesis and facilitate repair of damaged cardiac tissue through paracrine signaling and electrical integration with the host heart.
• CLiC-1 Cell Therapy CDMO Services

Quantifiable outcome

• World's first iPSC-derived cardiomyocyte sheet therapy approved

Named customers4 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Stanford UniversitycoreStrategic or Co-development Partner · 1 December 2024Joint research agreement established in December 2024 for catheter-based delivery of iPSC-derived cardiomyocytes. This partnership advances the company's technology toward minimally invasive heart failure treatment delivery methods.
• Osaka UniversitycoreStrategic or Co-development PartnerLong-standing joint research partnership for iPSC-derived cardiomyocyte technology. Osaka University provided foundational research that led to the world's first iPSC-derived cardiomyocyte sheet therapy.
• Daiichi SankyocoreStrategic or Co-development PartnerCo-development partner under joint R&D contract for cell therapy development. Partnership leverages pharmaceutical industry expertise in drug development and commercialization.
• Mitsubishi Corp.minorOthersStrategic business partnership for commercial expansion and market access within Japan.
• VC Cell TherapyminorImplementation/ SI/ Consulting PartnerContracted for manufacturing and quality control services for cell therapy production.
• Earth Environmental ServiceminorOthersFacility management services for manufacturing and laboratory facilities.
• Cuorips Healthcare SciencecoreOthersSubsidiary company within the Cuorips group for healthcare and scientific operations.
• iReheart Inc.coreOthersUS-based subsidiary headquartered in Palo Alto, California for international business development and potential US market expansion.

Scale indicators4 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Heartseed Inc. Japanese clinical-stage biotech developing iPSC-derived cardiomyocyte cell therapy (HS-001) for heart failure, founded out of Keio University. Direct competitor in the same product category (iPSC-derived cardiomyocytes for severe heart failure) with overlapping clinical trial activity in Japan.

Broad incumbents

• Terumo Corporation: Global medical device company that developed the autologous skeletal myoblast sheet (Heart Sheet) for heart failure, the most direct predecessor product to Cuorips' RiHeart. Also a Cuorips shareholder and delivery technology partner, making it both a peer and a strategic collaborator.
• Daiichi Sankyo: Major Japanese pharmaceutical company that is both a co-development partner and early equity investor in Cuorips. Operates broadly in cardiovascular therapeutics and has deep regulatory and commercial reach in Japan that overlaps with Cuorips' target market.
• FUJIFILM Holdings: Conglomerate with a substantial regenerative medicine / cell therapy CDMO business (FUJIFILM Cellular Dynamics, Japan Tissue Engineering Co.). A Cuorips investor and CDMO ecosystem peer with overlapping capabilities in cell processing and commercial-scale manufacturing.
• Astellas Pharma: Large Japanese pharmaceutical company with significant investment in cell and gene therapy (including Universal Cells, Xyphos, and partnerships in regenerative medicine). Overlaps with Cuorips as a Japan-based player advancing novel cell-based therapeutics and a potential acquirer or partner.

Emerging players

• Mesoblast Limited: Clinical-stage cell therapy company developing mesenchymal precursor cell therapies for inflammatory and cardiovascular diseases, including heart failure (Revascor). Comparable as a cell therapy developer targeting the same heart failure indication via a different cell type and mechanism.
• Help Therapeutics: China-based biotech developing iPSC-derived cardiomyocyte cell therapy (HiCM-188) for heart failure. Closely comparable to Cuorips' RiHeart in cell type, indication, and approach, representing the most direct international competitor in the iPSC-cardiac space.
• CorWave SA: French developer of a next-generation left ventricular assist device (LVAD) for advanced heart failure. Competes with Cuorips for the same severe heart failure patient pool via a mechanical rather than biological approach, and is a relevant benchmark for device alternatives in the indication.

Regional players

• JCR Pharmaceuticals: Japan-based specialty pharmaceutical company with capabilities in biopharmaceuticals and regenerative medicine products, including its approved cell therapy portfolio. Comparable as a domestic Japanese player with regulatory and commercial infrastructure in the cell therapy space.

Others

• Ono Pharmaceutical: Major Japanese pharmaceutical company and Cuorips' joint development partner on the YS-1301 in vivo regeneration factor inducer program. Relevant as an ecosystem participant and adjacency rather than a direct competitor in cell sheets.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Subsidiaries2 records

Funding overview

Funding rounds4 records

Investors11 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cuorips