COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Cuorips
The company that took an allogeneic iPS cell-derived cardiac sheet, Reheart, from conditional approval to insurance coverage in Japan
Cuorips matters in regenerative medicine because Reheart is one of the first products made from iPS cells to be both approved in Japan and covered by the public health insurance system. The company received conditional and time-limited marketing approval for Reheart from the Ministry of Health, Labour and Welfare (MHLW) on 6 March 2026, the product was listed for insurance reimbursement on 1 September, and the first transplant under insurance coverage was performed on 29 September. The approval is nonetheless conditional and time-limited, and rests on a small trial of eight patients: it runs for seven years, and after approval the company must survey every patient treated (75 cases). This profile sets out what the company has invested, who it works with, what has been confirmed and what remains open, using primary sources only.
- Cuorips in 30 seconds, and where it stands in iPS cells and regenerative medicine
- The logo and how the name is written
- Where the company sits in iPS cells and regenerative medicine
- Scale of the company
- Resources committed to iPS cells and regenerative medicine
- Track record so far
- Plans ahead
- What the company is aiming for in iPS cells and regenerative medicine
- Partnership map
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Cuorips in 30 seconds, and where it stands in iPS cells and regenerative medicine
(moving to Osaka)Nihonbashi-Honcho. In May 2026 the board resolved to move the head office to Nakanoshima, Kita-ku, Osaka
cell therapyContract cell manufacturing (CDMO) is a secondary business
Cuorips makes cells from iPS cells in its own facility and sells them itself. In terms of the three types of company in this field, it belongs to iPS cell & cell therapy. Its product, Reheart, is made by turning iPS cells from a healthy donor into cardiomyocytes (heart muscle cells), forming them into a sheet, and attaching the sheet to the heart of a patient with severe heart failure Sourced. Note that the approval is conditional and time-limited: the regulator judged that a certain level of efficacy can be expected, not that efficacy has been confirmed. According to the MHLW's review materials, the trial was an eight-patient, open-label study with no control group, and the primary endpoint (improvement in left ventricular ejection fraction 26 weeks after transplant) was judged to have improved in 2 of the 8 patients Sourced. For the seven years after approval the product is in a phase of continuing to verify efficacy and safety through a survey of all cases, and the company has not yet received full approval. This article does not judge the product's merits or whether a treatment is appropriate; it sets out the current state of the company and its product from primary sources.
2. The logo and how the name is written
A note on names: the company is Cuorips Inc. (the English name given in its Annual Securities Report). It explains that the name combines "Cuore", the Italian word for heart, with the "iPS" of iPS cells. At its founding in March 2017 the company was called Cuore Inc., and it took its present name in June of the same year. The product's Japanese sales name is a registered trademark of the company and is romanised in this article as Reheart; its generic name is "human (allogeneic) iPS cell-derived cardiomyocyte sheet". The company's Japanese name is written phonetically in katakana; this series uses the Latin-alphabet name throughout.
Official site: https://www.cuorips.co.jp/3. Where the company sits in iPS cells and regenerative medicine
In terms of how it treats patients, Cuorips offers an allogeneic cell therapy (using cells from a donor rather than the patient) based on iPS cell-derived cells (cardiomyocytes). It does not rewrite genes. Instead it shapes finished cells into tissue (a sheet) and attaches it to a damaged heart. The Annual Securities Report explains that the company expects the patient's own heart muscle to improve through effects such as the growth of new blood vessels (a paracrine effect), driven by factors secreted by the attached cells Sourced. The MHLW's materials likewise say that the transplanted cells are assumed not so much to contract as heart muscle as to act through secreted factors that induce blood vessels in the ischaemic area Sourced. For an explanation of iPS cells themselves, see our explainer on iPS cells in this series.
4. Scale of the company
Cuorips is a small company on the eve of a product launch. In the year ended March 2026 (April 2025 to March 2026) its revenue was ¥212 million and it was still making a loss Sourced (all amounts are in Japanese yen, and the fiscal year runs from April to March).
| Metric (consolidated, ¥ thousands) | FY ended Mar 2024 | FY ended Mar 2025 | FY ended Mar 2026 |
|---|---|---|---|
| Revenue | 23,102 | 175,205 | 212,332 |
| Ordinary loss | −627,930 | −642,014 | −1,028,528 |
| Net loss attributable to owners of the parent | −632,183 | −644,342 | −1,022,640 |
| Cash flow from operating activities | −451,060 | −812,616 | −1,059,895 |
| Cash and cash equivalents at year-end | 5,582,270 | 4,793,824 | 3,900,064 |
| Net assets | 5,983,777 | 5,529,698 | 4,769,290 |
| Employees (people) | 59 | 56 | 51 |
Of the ¥212,332 thousand in revenue for the year ended March 2026, ¥210,159 thousand came from CDMO and consulting services; there is not yet any revenue from sales of Reheart, which went on sale only after insurance listing in September 2026 Sourced. On 28 July 2026 the company raised its full-year forecast for the year ending March 2027 to revenue of ¥540 million, an operating loss of ¥1.03 billion, an ordinary loss of ¥580 million and a net loss of ¥570 million Not yet confirmed. The company explains that revenue is expected to be weighted towards the third quarter onwards, and that the expected subsidy income is included in non-operating income.
As the future market size for regenerative medicine products, the Annual Securities Report quotes a global market estimate prepared by an industry body (the Forum for Innovative Regenerative Medicine). Because this is the body's estimate and not the company's own results, this article does not use the figure. The MHLW's insurance-coverage materials also contain projected patient numbers and projected sales, but these are forecasts made for the purpose of setting the price, not the company's earnings guidance. Section 7 treats them separately.
5. Resources committed to iPS cells and regenerative medicine
The whole company is a single business in regenerative medicine products, so its overall size is close to the scale it commits to this field. We separate what could be confirmed from what could not, covering people, money and outside relationships.
| Type of resource | Details | Category |
|---|---|---|
| People (headcount) | 51 consolidated employees (31 March 2026; 3 temporary staff not included). By site: head office 5, Osaka Lab (Suita, Osaka) 14, and the cell processing facility CLiC-1 (Minoh, Osaka) 32. Average age 43.1. A breakdown by job type, such as researchers and manufacturing staff, is not disclosed | Sourced |
| People (key figure) | Yoshiki Sawa, a cardiac surgeon and specially appointed professor at Osaka University, is a director. He has been Chief Technology Officer since August 2021 and Chief Medical and Scientific Officer since June 2026. He is also Director General of Osaka Police Hospital and chairman of the corporation that runs it | Sourced |
| Money (R&D expense) | Total R&D expense for the year ended March 2026 was ¥970,450 thousand (down 5.7% year on year). After deducting joint R&D funds received from joint research partners, ¥634,243 thousand was recorded in the income statement (up 89.8%). The amount deducted was ¥336,207 thousand Our calculation | Sourced |
| Money (manufacturing facilities) | Capital expenditure for the year ended March 2026 was ¥69,081 thousand. Planned investments are a pilot-scale plant at Nakanoshima Qross (Osaka) totalling ¥560 million (January to December 2026, of which ¥10 million already paid) and an expansion of CLiC-1 at ¥600 million (March to July 2027). Both are to be funded by subsidies and the company's own funds | Sourced |
| Money (fundraising) | On 11 September 2026 the board resolved to raise about ¥3 billion in new shares and ¥1 billion through the first series of unsecured straight bonds, ¥4 billion in all, with JICVGI Opportunity Fund No. 1 Investment Limited Partnership as the subscriber. Payment for the new shares was completed on 28 September (619,700 shares at ¥4,841 each). We have not confirmed completion of payment for the bonds | Sourced |
| Technology brought in (licence) | Holds an exclusive licence to a patent owned by Osaka University (Patent No. 6938154, expiring 6 November 2035). At its founding it took over the human iPS cell-derived cardiac sheet business from CellCube, a company set up to commercialise Osaka University research | Sourced |
| Acquisitions of and investments in other companies | None stated in the Annual Securities Report. Its subsidiaries are Cuorips Healthcare Science, which handles raw materials for healthcare products (established December 2023), and iReheart Inc. in the United States (established June 2024); both were set up by the company itself | Could not be confirmed |
| Universities, research institutes and public funding | Osaka University (ran a joint research chair from June 2017 to the end of September 2025), Stanford University (December 2024), Niigata University (October 2023) and the Center for iPS Cell Research and Application (CiRA), Kyoto University (source of the clinical-grade iPS cell stock). Public funding is the Ministry of Economy, Trade and Industry (METI) subsidy for regenerative-medicine CDMO capacity (selected July 2025). We could not confirm the amount awarded | Sourced |
6. Track record so far
| When | What happened | What it means |
|---|---|---|
| From 2008 | A research group led by Yoshiki Sawa at Osaka University began joint research with Shinya Yamanaka of Kyoto University on treating severe cardiomyopathy with human iPS cells | The academic starting point of the product |
| March and June 2017 | Cuore Inc. was established and took over the business from CellCube; in June it changed its name to Cuorips. It inherited the joint research chair with Osaka University | University technology was moved into a company |
| September 2017 | Signed a joint research and development agreement with Daiichi Sankyo (combining cardiomyocyte purification technology with sheet-forming technology) | A pairing with a large pharmaceutical company. Its purpose was achieved with the approval, and it ended at the end of March 2026 |
| January 2020 | Osaka University's investigator-initiated clinical trial began, with the first transplant | Start of the trial that underpins the approval |
| August 2020 | The commercial cell culture and processing facility CLiC-1 (Minoh, Osaka) began operating | In-house manufacturing capability |
| March and June 2023 | Transplants in the trial reached eight patients in total. Listed on the TSE Growth market in June | The cases needed for the approval application were in place |
| May to December 2024 | VMaCS (a consortium for mass cell manufacturing) was launched, iReheart Inc. was established in the United States, and a joint research agreement was signed with Stanford University | Footholds for mass manufacturing and US expansion |
| April 2025 | Applied to the MHLW for marketing approval (application date 4 April). CLiC-1 obtained a manufacturing licence for regenerative medicine products | Approval application based on the trial data |
| October 2025 | Designated as an orphan regenerative medicine product (designation number (R7 Re) 37; R7 = Reiwa 7, i.e. 2025) | Qualifies for regulatory guidance and advice, and for a premium on the reimbursement price |
| 6 March 2026 | Received conditional and time-limited marketing approval from the MHLW (a subcommittee of the Pharmaceutical Affairs Council judged on 19 February that approval could be granted) | Approved in Japan as an iPS cell-derived regenerative medicine product |
| 22 July 2026 | The Central Social Insurance Medical Council (Chuikyo) endorsed a reimbursement price of ¥53.2 million | The price was set by the cost-accounting method |
| 1 September 2026 | Listed for insurance reimbursement (official gazette notice) | Use under insurance coverage became possible |
| 28 and 29 September 2026 | Payment for the new shares from the JICVGI fund was completed. On the 29th the first transplant after insurance listing was performed at Osaka Police Hospital | The first case after launch. Results have not been published |
The trial behind the approval (within what the primary sources say)
The approval is based on an investigator-initiated trial of eight patients. What follows comes from the MHLW's review materials, the jRCT and the Annual Securities Report. The comparison is not with another treatment or a placebo but with each patient's own condition before transplant, and the time points of assessment differ from one measure to another. The results do not guarantee any treatment effect or safety, and are not medical advice.
| Item | Details | Category |
|---|---|---|
| Trial | Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheets for ischaemic cardiomyopathy. Investigator-initiated trial, jRCT2053190081 (coordinated by Shigeru Miyagawa of Osaka University Hospital). On the jRCT the phase is listed as 1 and the status as study completed. The Annual Securities Report calls it the CVSC0005 study | Sourced |
| Design and numbers | Open-label, no control group, multicentre. Eight patients were transplanted (3 in the earlier Cohort A, 5 in the later Cohort B). The efficacy analysis also covered eight patients | Sourced |
| Who was enrolled | Patients with severe heart failure from chronic ischaemic cardiomyopathy, NYHA class III to IV, whose condition was feared to worsen despite at least three months since maximal drug therapy or standard surgery or catheter treatment. Resting left ventricular ejection fraction (LVEF) of 35% or less | Sourced |
| Primary endpoint | The number of patients whose echocardiographic LVEF 26 weeks after transplant was assessed as improved compared with before transplant | Sourced |
| Primary endpoint result | Improvement in 2 of 8 patients. The review materials concluded that efficacy could be inferred even from a small number of cases, citing improvement or maintenance in secondary endpoints other than the primary one (heart size as measured by LVESVI and LVEDVI, NYHA class, exercise tolerance and others) | Sourced |
| Secondary assessment at 52 weeks | NYHA class improved in 8 of 8 patients, and six-minute walk distance and peak oxygen uptake (peak VO2) each improved in 4 of 8 (the company's account). In the overall assessment by the efficacy and safety evaluation committee, all 8 patients were rated effective | Sourced |
| Safety | Adverse events occurred in 7 of 8 patients and serious adverse events in 5 of 8. No adverse event leading to death, no adverse drug reaction to the product and no event whose causal link to the product could not be ruled out was recognised. All patients were alive at the data cut-off. Patients take immunosuppressants (three drugs) for 90 days after transplant | Sourced |
| The reviewers' view | The Pharmaceuticals and Medical Devices Agency (PMDA) judged that a certain level of efficacy can be expected and, because the small, open-label study gives limited information, said that efficacy and safety would continue to be evaluated after approval through a survey of all cases | Sourced |
7. Plans ahead
(29 September 2026)Osaka Police Hospital. Later case numbers are not published
(during 2026)Nakanoshima Qross. CLiC-1 expansion is scheduled for March to July 2027
| Planned or in-development item | Where it stands (company's account) | Category |
|---|---|---|
| Reheart (Japan) | During the 7-year conditional and time-limited approval the company will conduct a post-marketing survey of all cases (75) and apply for full approval on that basis. It plans to handle sales and promotion itself, and is securing and expanding the number of registered hospitals able to perform the transplant | Not yet confirmed |
| Reheart (overseas) | Aims to sell in Indonesia, Australia, Singapore, the Middle East, Europe and elsewhere, and is working on ties with overseas hospitals and preparing to consult regulators. No approval or sales to date (an MHLW document of November 2025 states that it is not approved overseas) | Not yet confirmed |
| Second-generation cardiac sheet (United States) | An improved product for the US market is under development. The company has run animal experiments with Stanford University, transplanting into pigs with myocardial infarction. At the pre-IND meeting with the FDA it obtained broad agreement on its policy, including an outline of the plan for a first-in-human study, and it is preparing the IND application | Not yet confirmed |
| Catheter-based therapy (with Asahi Intecc) | For heart disease milder than Reheart's target. Delivers iPS cell-derived cells to the heart by catheter. Proof of concept has been established in small animals and experiments are under way in large animals. No human study yet | Not yet confirmed |
| In-body regeneration factor inducers (YS series) | Small-molecule compounds (oxime derivatives) that induce regeneration factors in the body. Targets include liver disease. At the stage of evaluating efficacy in animal models, aiming to prepare for an investigator-initiated trial. Talks continue with pharmaceutical companies on partnering and out-licensing | Not yet confirmed |
| iPS cell-derived mesenchymal stem cells (MSCs) | Research on applications in liver disease, critical limb ischaemia, knee osteoarthritis and others. Listed among the purposes of the September 2026 fundraising, but there is no disclosure on the stage of development | Not yet confirmed |
| Large-scale cell culture (VMaCS) | Developing an integrated system covering culture, harvest, filling and dispensing, freezing and storage. Plans to install a pilot-scale plant at Nakanoshima Qross and later to run commercial-level demonstrations in its own facility. 14 members as of the end of March 2026 | Not yet confirmed |
None of the following appears in the primary sources, or the company has not disclosed it Not yet confirmed.
Actual numbers of transplants and sales after insurance listing (beyond the first case) / annual manufacturing capacity / when a US trial will start / when approval overseas may come / when trials of the catheter therapy and the YS series will start / when the application for full approval will be filed. The MHLW's insurance-coverage document (Chuikyo General Assembly Document 2, 22 July 2026) does contain projections made for price setting: an estimated number of eligible patients (first year) of 690, a number of patients using the product (year 10, at peak) of 96, and projected sales (year 10) of ¥5.11 billion. These are projections in the pricing document and not the company's earnings guidance, and the document does not show the basis for the figures behind them, so we give them only for reference and do not mix them with other numbers.
8. What the company is aiming for in iPS cells and regenerative medicine
This section includes things the company does not say directly. We set them out as inferences within what the primary sources support, with the evidence for each.
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| The goal is to move from a one-product cardiac sheet company to a company with a cell manufacturing base | Its management strategy sets out, alongside expanding revenue from Reheart, next growth drivers such as the catheter therapy and the YS series, establishing large-scale culture technology, and the CDMO business. The company itself writes that this differs from the strategy of a conventional drug-discovery biotech | Inference |
| Domestic sales are likely to ramp up slowly | Transplant is open-chest surgery under general anaesthesia and requires registered hospitals able to perform it. The full-year forecast also has sales weighted to the third quarter onwards, and the pricing document projects 690 estimated eligible patients in the first year against 96 patients using the product in year 10 | Inference |
| Overseas, it is exploring several regions in parallel, built around an improved product for the United States | It describes joint research with Stanford University and a pre-IND meeting with the FDA for the US, and ties with hospitals in Asia, the Middle East and Europe. It also discloses that it has received many overseas enquiries | Inference |
| It aims for profitability not on Reheart alone but together with CDMO work and the joint research funds it receives | It states that it will slow the rate at which cash falls by securing stable revenue from the CDMO business even without a marketed product and by receiving joint R&D funds from joint research partners | Inference |
| Its policy is to keep manufacturing in-house | It owns the manufacturing facility CLiC-1 and plans ¥1,160 million of investment in the expansion and the pilot plant (¥560 million plus ¥600 million) Our calculation. It will continue to manufacture and sell the product itself even though the joint research with Daiichi Sankyo has ended | Inference |
The reading that sales will start slowly rests on the company's own numbers, which already say so. The revenue forecast for the year ending March 2027 is ¥540 million; divided by the reimbursement price of one Reheart (¥53.2 million), that is equivalent to about 10 units Our calculation. However, the forecast also includes revenue from the CDMO business and other sources, and the split of how much comes from Reheart has not been disclosed. The calculation is therefore not a volume forecast for Reheart; it is only a rough sense of the scale of the forecast, expressed in units of the price. Taken together with the projections in the pricing document (96 patients and ¥5.11 billion in year 10), we think the most natural reading is that the company assumes a launch with small case numbers for the first few years Not yet confirmed. This inference says nothing about the merits of the product or whether it will be widely adopted.
9. Partnership map
How to read the figure: Cuorips draws technology and clinical know-how from universities (Osaka University, Stanford University and others), works with operating companies (Asahi Intecc, Daiichi Sankyo), and manufactures in its own facility. The raw material, iPS cells, comes from the clinical-grade stock provided by CiRA at Kyoto University, which Cuorips differentiates into cardiomyocytes Sourced.
10. Technologies, products and services
| Item | Details (from the Annual Securities Report and public materials) |
|---|---|
| Reheart (cardiomyocyte sheet) | An allogeneic cell product made by differentiating iPS cells from a healthy donor into cardiomyocytes and processing them into a sheet. It targets severe heart failure due to ischaemic cardiomyopathy that does not respond adequately to standard care, including drug therapy and invasive treatment. Transplant is under general anaesthesia, followed by 90 days of immunosuppressants. Insurance coverage applies only when the optimal-use guidelines of the relevant medical societies are followed |
| Features of the manufacturing process | Expanded iPS cells are differentiated into cardiomyocytes, remaining undifferentiated cells are removed to raise purity, and the cells are cryopreserved. They are thawed to match the transplant schedule, formed into a sheet and delivered to the hospital. Forming the sheet takes a few days |
| Transport | The sheet is embedded in gelatin gel, which the company says keeps the sheet's shape and the cells alive for about two days of transport at ambient temperature. At the hospital the gel is melted and washed off, and the sheet can then be transplanted |
| Cell processing facility CLiC-1 | Minoh, Osaka. A facility whose capacity was raised by a locally controlled design with several clean booths of the same cleanliness side by side. The company says it holds patents in Japan, the United States and Europe. It handles everything from process development to commercial production |
| CDMO (contract development and manufacturing) | Uses its know-how in culture and differentiation of iPS cells and purification of cardiomyocytes to support process development and to carry out contract manufacturing. It describes as a strength its willingness to take on small-volume manufacturing that large companies' big facilities do not cater for. Accounts for almost all revenue in the year ended March 2026 |
In this company's product, the materials and processes that matter are those outside the cells Sourced. The first is embedding in gelatin gel. A sheet of cells is thin and fragile, so the design wraps it in gel for ambient-temperature transport and has the hospital melt the gel away. The company says this reduces the burden on hospitals compared with shipping frozen cells. The second is cryopreservation and thawing. Differentiated cardiomyocytes are frozen in advance and thawed to match the transplant schedule before being made into a sheet, which delivers the advantage of allogeneic cells: they can be made ahead of time. The third is control of cleanliness. A product made of living cells cannot be terminally sterilised, so keeping the manufacturing environment itself clean is a precondition of quality. The Annual Securities Report explains that CLiC-1's arrangement of side-by-side clean booths is meant to raise manufacturing capacity, but control of cleanliness remains the premise.
Beyond that, the integrated mass manufacturing system from culture through harvest, filling and dispensing, freezing and storage that VMaCS is aiming for is an area where makers of materials and equipment, such as culture vessels, culture media, cryopreservation solutions and dispensing equipment, would come in. The company has said it intends to avoid monopoly by any single company, and which materials or equipment will be adopted has not been announced.
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| Approval is conditional and time-limited | The period is 7 years, during which a survey of all cases (75) must be carried out and a new application for full approval made. The company states that if approval is revoked or full approval is not obtained, an impairment of fixed assets is possible | Sourced |
| The underlying trial is small | Eight patients, open-label, no control group. The primary endpoint improved in 2 of 8. The PMDA itself says that continued evaluation after launch is needed because the information is limited | Sourced |
| Long-term safety data | No adverse drug reactions to the product were recognised in the trial, but serious adverse events occurred in 5 of 8 patients. The company states that it cannot rule out harm from causes that could not be foreseen at the time of approval. The burden of taking immunosuppressants for 90 days, including infection, is also a premise | Sourced |
| Drug pricing system and cost containment | The reimbursement price was set at ¥53.2 million, but the company states that future price cuts are possible. Insurance coverage is limited to cases that follow the relevant societies' optimal-use guidelines | Sourced |
| Continuing losses and funding | Net loss of about ¥1.02 billion for the year ended March 2026 and operating cash outflow of about ¥1.06 billion. The company states that it may need to raise funds, for example by issuing shares, until it secures a stable source of revenue. It resolved to raise ¥4 billion in September 2026, but the bonds are debt that must be repaid | Sourced |
| Concentration of manufacturing | Reheart is made mainly at CLiC-1 in Minoh, Osaka, a single site. The company states that disasters, power cuts or difficulty obtaining raw materials could affect it | Inference |
| Dependence on particular suppliers | It has secured enough iPS cells for the time being, but the company states that some raw materials and supplies can be provided only by specific suppliers | Sourced |
| Small organisation | With 51 consolidated employees it is handling sales, distribution, post-marketing surveys, US expansion and several development candidates at once. The company itself describes it as a small organisation | Sourced |
| Directors' concurrent posts and the hospital of the first case | Dr Sawa, Chief Medical and Scientific Officer, is also Director General of Osaka Police Hospital, where the first case was performed (the company discloses directors' concurrent posts). Whether early cases end up concentrated in particular hospitals is something that later disclosures will show | Inference |
12. Glossary
- iPS cell
- Induced pluripotent stem cell. A cell made by introducing factors into a body cell, which can then be turned into many types of cell.
- Allogeneic
- Using cells from another person (a donor) rather than from the patient. Drugs to suppress rejection are needed.
- Ischaemic cardiomyopathy
- A condition in which the blood vessels of the heart are narrowed or blocked, damaging the heart muscle and weakening its function.
- Conditional and time-limited approval
- A Japanese system that lets a regenerative medicine product go on the market early, with conditions and a time limit, when a small trial has confirmed safety and some efficacy can be expected. Efficacy is then confirmed after launch.
- Paracrine effect
- The way factors secreted by cells act on their surroundings and support the tissue.
- LVEF
- Left ventricular ejection fraction. An index of the share of blood the heart pumps out with each beat.
- NYHA class
- A classification of the severity of heart failure symptoms from class I to IV.
- Peak VO2
- Peak oxygen uptake. A measure of exercise tolerance showing how much oxygen the body can take in during exercise.
- CDMO
- Contract development and manufacturing organisation. A company that develops and manufactures drugs or cells on commission.
- GCTP
- Good Gene, Cellular, and Tissue-based Products Manufacturing Practice. Japan's standard for manufacturing control and quality control of regenerative medicine products.
- Reimbursement price
- The official price set under public health insurance for items such as regenerative medicine products.
- Pre-IND meeting
- A meeting in which a company consults the US FDA on its development plan before filing an Investigational New Drug (IND) application for a clinical trial.
13. References
- Cuorips Annual Securities Report (10th fiscal year, year ended March 2026, filed with the Kanto Local Finance Bureau on 24 June 2026) (in Japanese). History, business description, R&D pipeline, trial summary, management policy, risks, facilities, employees and financial statements. https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf
- Cuorips Official website, "ABOUT US" (officers, company profile, sites, history) (in Japanese). https://www.cuorips.co.jp/aboutus
- Cuorips Timely disclosure, "Receipt of conditional and time-limited marketing approval for human (allogeneic) iPS cell-derived cardiomyocyte sheets" (6 March 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2773076/00.pdf
- Cuorips Timely disclosure, "Decision on the reimbursement price of Reheart" (22 July 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2854477/00.pdf
- Cuorips Timely disclosure, "Notice on the insurance listing of Reheart" (1 September 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2880161/00.pdf
- Cuorips Timely disclosure, "Notice on the first transplant of the regenerative medicine product Reheart" (29 September 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2888716/00.pdf
- Cuorips Timely disclosure, "Notice on the issuance of new shares by third-party allotment" (11 September 2026) (in Japanese). Purpose of the fundraising and the current state of each development candidate. https://ssl4.eir-parts.net/doc/4894/tdnet/2884161/00.pdf
- Cuorips Timely disclosure, "Notice on completion of payment for the new shares issued by third-party allotment" (28 September 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2887916/00.pdf
- Cuorips Timely disclosure, "Supplementary explanatory material on the issuance of new shares by third-party allotment and of the first series of unsecured straight bonds" (11 September 2026) (in Japanese). Breakdown of the ¥4 billion total. https://ssl4.eir-parts.net/doc/4894/tdnet/2884162/00.pdf
- Cuorips Timely disclosure, "Notice on the upward revision of the full-year consolidated earnings forecast" (28 July 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2856809/00.pdf
- Cuorips Timely disclosure, "Notice on the relocation of the head office and partial amendment of the articles of incorporation" (26 May 2026) (in Japanese). https://ssl4.eir-parts.net/doc/4894/tdnet/2822780/00.pdf
- Ministry of Health, Labour and Welfare (MHLW) Central Social Insurance Medical Council (Chuikyo), General Assembly Document 11, Reference 2, "Conditional and time-limited approval of three regenerative medicine products" (8 April 2026) (in Japanese). Summary of the approval review for Reheart, trial design and results, safety evaluation and post-marketing survey. https://www.mhlw.go.jp/content/10808000/001687611.pdf
- Ministry of Health, Labour and Welfare (MHLW) Central Social Insurance Medical Council (Chuikyo), General Assembly Document 2, "Insurance coverage of regenerative medicine products (scheduled for listing on 1 September 2026)" (22 July 2026) (in Japanese). Reimbursement price, pricing method and projected patient numbers. https://www.mhlw.go.jp/content/10808000/001726219.pdf
- Ministry of Health, Labour and Welfare (MHLW) Japan Registry of Clinical Trials (jRCT), jRCT2053190081, "Clinical trial of human (allogeneic) iPS cell-derived cardiomyocyte sheets for ischemic cardiomyopathy" (in Japanese). https://jrct.mhlw.go.jp/latest-detail/jRCT2053190081
- Cuorips Official website (top page; source of the logo). https://www.cuorips.co.jp/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name, English name, former company name, origin of the name, trademark of the product name | Sourced | References 1, 2 and 3 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://www.cuorips.co.jp/aboutus https://ssl4.eir-parts.net/doc/4894/tdnet/2773076/00.pdf |
| Head office address, incorporation, listing (TSE Growth, 27 June 2023), 51 employees and headcount by site | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://www.cuorips.co.jp/aboutus |
| Resolution to move the head office to Nakanoshima, Kita-ku, Osaka | Sourced | Reference 11 https://ssl4.eir-parts.net/doc/4894/tdnet/2822780/00.pdf |
| Revenue, losses, cash flow and net assets (years ended March 2024 to March 2026) and revenue from CDMO and consulting | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Earnings forecast for the year ending March 2027 (revenue of ¥540 million and others) | Not yet confirmed | Reference 10 https://ssl4.eir-parts.net/doc/4894/tdnet/2856809/00.pdf |
| Total R&D expense and the amount after deducting joint research funds received | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Joint research funds received of ¥336,207 thousand (the difference between the total and the amount after deduction) | Our calculation | Our own calculation (970,450 − 634,243) |
| Capital expenditure, and the plans for the ¥560 million pilot plant and the ¥600 million CLiC-1 expansion | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Combined ¥1,160 million for the pilot plant and the CLiC-1 expansion | Our calculation | Our own calculation (560 + 600) |
| The September 2026 fundraising (about ¥3 billion in new shares, ¥1 billion in bonds, ¥4 billion in all) and completion of payment | Sourced | References 7, 8 and 9 https://ssl4.eir-parts.net/doc/4894/tdnet/2884161/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2887916/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2884162/00.pdf |
| Exclusive licence to Osaka University's patent, the business transfer, the joint research chair, and relationships with Daiichi Sankyo, Asahi Intecc, Stanford University and Niigata University | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://www.cuorips.co.jp/aboutus |
| CiRA, Kyoto University, provides the clinical-grade iPS cell stock | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Selection for the METI regenerative-medicine CDMO subsidy (amount awarded could not be confirmed) | Sourced | References 1 and 10 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2856809/00.pdf |
| VMaCS (14 members) and what it is developing | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Receipt of conditional and time-limited approval (6 March 2026), indications, orphan regenerative medicine product designation | Sourced | References 1, 3 and 12 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2773076/00.pdf https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| 7-year approval period and post-marketing survey of all cases (75) | Sourced | References 3 and 12 https://ssl4.eir-parts.net/doc/4894/tdnet/2773076/00.pdf https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| Trial design (8 patients, open-label, no control group), primary endpoint and result (LVEF improved in 2 of 8) | Sourced | References 12 and 14 https://www.mhlw.go.jp/content/10808000/001687611.pdf https://jrct.mhlw.go.jp/latest-detail/jRCT2053190081 |
| 52-week secondary assessment (NYHA 8 of 8; six-minute walk distance and peak VO2 4 of 8 each) and safety (adverse events in 7, serious in 5) | Sourced | References 1 and 12 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| The PMDA's judgement (a certain level of efficacy can be expected; continued evaluation after launch) | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Method of transplant (under general anaesthesia) and 90 days of immunosuppressants | Sourced | Reference 12 https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| Reimbursement price of ¥53.2 million, Category C2, cost-accounting method, 10% marketability premium | Sourced | References 4, 5 and 13 https://ssl4.eir-parts.net/doc/4894/tdnet/2854477/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2880161/00.pdf https://www.mhlw.go.jp/content/10808000/001726219.pdf |
| Insurance listing date (1 September 2026) and the first transplant (29 September 2026, Osaka Police Hospital) | Sourced | References 5 and 6 https://ssl4.eir-parts.net/doc/4894/tdnet/2880161/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2888716/00.pdf |
| Projections in the pricing document (690 estimated eligible patients; 96 patients and ¥5.11 billion in year 10) | Not yet confirmed | Reference 13 https://www.mhlw.go.jp/content/10808000/001726219.pdf |
| Second-generation sheet for the US, pre-IND meeting, catheter therapy, YS series and MSC development status | Not yet confirmed | References 1 and 7 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://ssl4.eir-parts.net/doc/4894/tdnet/2884161/00.pdf |
| Overseas expansion plans (Indonesia, Australia and others) | Not yet confirmed | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf |
| Results of the post-marketing survey, the trend in transplant numbers, and the start date of a US trial | Not yet confirmed | No outlook has been published. This article does not estimate them either |
| Regenerative medicine market estimate quoted by the company (not used in this article) | Not yet confirmed | Reference 1 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf Not used, because it is an industry body's estimate and not the company's results |
| The three-type classification (large pharma / genome editing / iPS cell and cell therapy) | Our calculation | This article's own grouping. Company names are examples from this series |
| Action of the cardiac sheet (paracrine effect) | Sourced | References 1 and 12 https://ssl4.eir-parts.net/doc/4894/yuho_pdf/S100YIP2/00.pdf https://www.mhlw.go.jp/content/10808000/001687611.pdf |
| The reading that the goal is to move from a one-product cardiac sheet company to a company with a cell manufacturing base | Inference | This article's interpretation of the company's management strategy (next growth drivers, large-scale culture, CDMO) |
| The reading that domestic sales are likely to ramp up slowly | Inference | This article's interpretation of the full-year forecast, the securing of registered hospitals and the projections in the pricing document |
| The reading that overseas it is exploring several regions in parallel, built around an improved product for the US | Inference | This article's interpretation of the pre-IND meeting and the preparations for ties in each region |
| The reading that it aims for profitability together with CDMO work and joint research funds, not on Reheart alone | Inference | This article's interpretation of the management policy's statements on the cash burn rate |
| The reading that its policy is to keep manufacturing in-house | Inference | This article's interpretation of its ownership of CLiC-1 and the expansion plans |
| The reading that manufacturing concentrated at a single site could become a risk | Inference | This article's interpretation of the description of facilities and the risk statements |
| The reading that directors' concurrent posts and the hospital of the first case are something to check in future | Inference | This article's interpretation of the disclosure of directors' concurrent posts and the hospital where the first case was performed |
Last updated 1 October 2026 / Troy Technical
The figures in this article are based on Cuorips's Annual Securities Report and timely disclosures, public materials from the Ministry of Health, Labour and Welfare, and the Japan Registry of Clinical Trials (jRCT). No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of the primary sources, not statements made by the company. This article does not recommend any treatment or product and is not medical advice.