COMPANY PROFILE / iPS CELLS & REGENERATIVE MEDICINE
Heartseed
The company that transplants allogeneic iPS cell-derived cardiac spheroids directly into the heart. It aims to file for approval in 2026, having parted ways with its partner Novo Nordisk in 2025
Heartseed is a biotech start-up spun out of Keio University. It forms ventricular cardiomyocytes made from iPS cells into small spheroids of about 1,000 cells each and transplants them into the hearts of patients with severe heart failure. Its lead pipeline product, HS-001, is transplanted by open-chest surgery at the same time as coronary artery bypass surgery. Analysis of the 10-patient Phase 1/2 trial (the LAPiS trial) is complete, and the company is targeting a marketing approval application within 2026. In September 2026 it also obtained the licence to market regenerative medicine products. It has no approved product yet, and almost all of its revenue has been milestone payments under its alliance with Novo Nordisk. That alliance was terminated in September 2025 at the partner's initiative, and the worldwide rights, including those outside Japan, have returned to Heartseed. 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.
- Heartseed 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. Heartseed in 30 seconds, and where it stands in iPS cells and regenerative medicine
TokyoEstablished in November 2015. A biotech start-up from Keio University
In terms of the three types of company in this field, Heartseed is an iPS cell & cell therapy company, and its treatment is of the kind in which the cardiomyocytes themselves are transplanted into the heart and made to engraft Sourced. The Annual Securities Report explains that its aim differs from approaches in which substances released by non-muscle cells help the heart (a paracrine effect). In June and August 2026 the company announced the results of the 10-patient trial. These were results from an open-label, uncontrolled study of 10 patients who also had coronary artery bypass surgery, and the figures compare each patient before transplant with the same patient 52 weeks later. Regulatory review is still ahead, and whether approval will be granted is not yet known. This article does not judge the merits of any product or whether a treatment is appropriate; it sets out the company's current state from primary sources.
2. The logo and how the name is written
A note on names: the company is Heartseed Inc. (its registered name is in Latin letters). It explains that the name reflects the resemblance of the spheroids to the seed of the balloon vine (English name: heartseed), and the hope that the spheroids will become a seed for the heart and save patients with severe heart failure. The product term for the spheroids is a registered trademark of the company (in Japanese). The development codes are HS-001 (open-chest delivery), HS-005 (catheter delivery) and HS-040 (from autologous iPS cells). Novo Nordisk, the partner until September 2025, is Novo Nordisk A/S of Denmark, which is the contracting party named in the filings.
Official site: https://heartseed.jp/3. Where the company sits in iPS cells and regenerative medicine
In terms of how it treats patients, Heartseed is of the type that transplants cells derived from allogeneic iPS cells (cells from a donor rather than the patient) into a damaged organ and makes them engraft. It makes cardiomyocytes specialised to the ventricular muscle from iPS cells, raises their purity, forms them into small spheroids, and injects them with a needle into the wall of the heart Sourced. Cuorips's cardiomyocyte sheet, by contrast, is a product that is "attached to the surface of the heart", so the aim and the method of delivery differ (see our Cuorips profile). This is not a comparison of which is better. For an explanation of iPS cells themselves, see our explainer on iPS cells in this series; for the difference between allogeneic and autologous cells, see our explainer on autologous and allogeneic cells.
4. Scale of the company
Heartseed is a small research-led company whose revenue has depended almost entirely on a single partner. Amounts are in Japanese yen, and in 2025 the fiscal year-end was changed from October to December Sourced.
| Metric (non-consolidated, ¥ thousands) | FY ended Oct 2023 | FY ended Oct 2024 | Nov 2024 to Dec 2025 (14 months) | Jan to Jun 2026 |
|---|---|---|---|---|
| Revenue | 344,725 | 873,610 | 3,026,500 | 467,370 |
| Ordinary profit (loss) | −1,456,584 | −818,581 | 288,985 | −551,683 |
| Net profit (loss) for the period (interim) | −1,473,500 | −812,725 | 190,608 | −554,307 |
| Cash flow from operating activities | −797,930 | −1,343,039 | 1,080,526 | −529,128 |
| Cash and cash equivalents at period-end | 4,588,118 | 5,297,166 | 6,836,009 | 6,335,462 |
| Employees (people, at period-end) | 39 | 39 | 43 | - |
Of the ¥3,026,500 thousand in revenue for the 14 months ended December 2025, ¥3,025,000 thousand (99.95% Our calculation) came from Novo Nordisk, recognised as development milestones were achieved. Operating cash flow was positive because of the collection of the related receivable (a decrease in accounts receivable of ¥768,250 thousand). The company explains that the ¥467,370 thousand of revenue in January to June 2026 is also milestone income recognised in the first quarter under the pre-termination agreement. The forecast for revenue in the year ending December 2026 is ¥467 million, all of it already booked in the first half. In other words, now that the alliance has ended, new revenue is hard to foresee until product sales begin (or a new alliance is signed). The company has no interest-bearing debt, and explains that cash and deposits make up about 90% of total assets.
The year ended December 2025 was an irregular 14-month year because of the change of fiscal year-end, so it cannot be compared simply with the previous (12-month) year. The profit (ordinary profit of ¥289 million) came from one-off milestone income under the contract with Novo Nordisk and does not show that the business has become profitable on its own. The full-year forecast for the year ending December 2026 is an operating loss of ¥2,207 million, an ordinary loss of ¥2,155 million and a net loss of ¥2,158 million Not yet confirmed.
5. Resources committed to iPS cells and regenerative medicine
Heartseed is a company focused on a single line of myocardial regenerative medicine, so the company's overall figures are the scale of 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) | 43 employees (2 temporary staff not included, 31 December 2025), average age 45.0, of whom 28 work in R&D. The Annual Securities Report describes President and Representative Director Keiichi Fukuda as having continued his research as a cardiologist at Keio University. He holds 13.74% of the shares in issue (the largest shareholder as of 30 June 2026) | Sourced |
| People (sites) | Head office in Minato-ku, Tokyo. Research space at a research base in Kawasaki (the Kawasaki Business Incubation Center), expanded in 2020. It has no manufacturing facilities and uses outside contract manufacturers | Sourced |
| Money (R&D expense) | R&D expense for the 14 months ended December 2025 was ¥2,032,919 thousand (73.8% of selling, general and administrative expenses), mainly commissioned R&D. For January to June 2026 it was ¥779,927 thousand | Sourced |
| Money (funds) | Cash and cash equivalents were ¥6,335 million at the end of June 2026. On 14 August 2026 it signed a special overdraft agreement with Sumitomo Mitsui Banking Corporation (¥2 billion, one year, unsecured and unguaranteed, floating rate). It raised ¥381 million in the year ended December 2025 through the exercise of stock acquisition rights | Sourced |
| Money (manufacturing facilities) | No investment in its own manufacturing facilities is stated in the Annual Securities Report (it states that it does not carry out production). Manufacture of the trial product is outsourced to Nikon Cell Innovation Co., Ltd. | Could not be confirmed (own facilities) |
| Investment in and acquisition of other companies | No subsidiaries or affiliates are stated in the Annual Securities Report (it states that it has no related companies). No acquisition of or investment in other companies is stated either | Could not be confirmed |
| Technology brought in (licences) | From Keio University, patents on purification of cardiomyocytes and others, by transfer or exclusive licence (from 2016). From iPS Academia Japan, a non-exclusive licence of the basic iPS cell patents (2019). The consideration is royalties tied to sales and similar; the rates are not disclosed | Sourced |
| Technology licensed out | In May 2021 it signed an exclusive worldwide alliance and licence agreement with Novo Nordisk (up to US$598 million in upfront payment and milestones combined, plus royalties on overseas sales). On 29 September 2025 the partner gave notice of termination, and the rights reverted to Heartseed. In September 2023 it also licensed out to a biotech company its intellectual property on removing undifferentiated iPS cells by fatty acid synthesis inhibition | Sourced |
| Universities and public funding | Keio University (the source of the technology) and Shinshu University Hospital (first patient in the EMERALD trial). Under subsidy projects of AMED (the Japan Agency for Medical Research and Development): an evaluation platform for allogeneic iPS cell-derived cardiac spheroids (FY2018 to FY2020) and development of base technology for autologous iPS cell-derived cardiac spheroids (selected September 2023). Non-operating income of ¥58,511 thousand in the year ended December 2025 came mainly from AMED subsidy projects | Sourced |
6. Track record so far
| When | What happened | What it means |
|---|---|---|
| November 2015 | Established as a biotech start-up from Keio University | The research of Keiichi Fukuda and colleagues was the starting point |
| 2016 | Patents on cardiomyocyte purification and production of high-quality iPS cells transferred from Keio University. Joint research agreement signed | Transfer of technology |
| March 2020 | Capital and business alliance with Itochu Chemical Frontier and Medipal Holdings | A base of funding and distribution |
| May 2021 | Exclusive worldwide alliance and licence agreement with Novo Nordisk | Alliance with a large pharma company |
| February 2023 | Dosing of the first patient in the domestic Phase 1/2 trial of HS-001 (the LAPiS trial) completed | Start of clinical validation |
| July 2024 | Listed on the TSE Growth market. In the LAPiS trial, review by the safety evaluation committee of the low-dose group (5 patients) was completed and the trial moved on to the high-dose group | - |
| January 2025 | Dosing of all 10 patients in the LAPiS trial completed | Enrolment in the trial completed |
| 29 September 2025 | Novo Nordisk gave notice of termination of the licence agreement, citing a focus on its core business areas and a review of strategy in other areas. The rights and intellectual property revert | Lost the partner, but the rights are back in-house |
| From November 2025 | The 30-day review of the clinical trial notification for HS-005 (catheter delivery) was completed (November). In January 2026 the 52-week follow-up of all 10 patients in the LAPiS trial was completed | Preparation for the next trial; follow-up completed |
| 1 June 2026 | Announced completion of the LAPiS analysis, including image reading by a third-party body. Said no safety concerns were found that would affect the policy for a marketing approval application, and that it is aiming to apply for approval within 2026 | Moved into application preparation |
| 12 June 2026 | Announced that the first patient in the EMERALD trial of HS-005 (heart failure from dilated cardiomyopathy) had been treated (late March 2026, Shinshu University Hospital). The independent data safety monitoring committee approved continuing the trial based on data for four weeks after dosing | The first trial of catheter delivery of iPS cell-derived cardiac spheroids |
| 14 to 17 August 2026 | ¥2 billion special overdraft agreement with Sumitomo Mitsui Banking Corporation. Applied to the Tokyo Metropolitan Government for the licence to market regenerative medicine products | Building the set-up for commercialisation |
| 29 August 2026 | Presented the 52-week topline results of the LAPiS trial in an invited lecture at the European Society of Cardiology Congress (ESC Congress 2026) | Public presentation at an international congress |
| 28 September 2026 | Obtained the licence to market regenerative medicine products from the Tokyo Metropolitan Government | Part of the set-up needed to sell after approval |
Trial results (the company's announcement, within what the primary sources say)
What follows are the 52-week topline results of the LAPiS trial, which Heartseed published on 31 August 2026. The trial was open-label, uncontrolled and dose-escalating, with 10 patients; the figures compare each patient before transplant (week 0) with week 52, and the company's materials note them as read by the study site. As of writing, we have not been able to confirm an evaluation by regulators or a peer-reviewed paper. The results do not guarantee any treatment effect or safety, and are not medical advice.
| Measure (week 0 → week 52) | Low dose: 50 million cells (n=5) | High dose: 150 million cells (n=5) |
|---|---|---|
| LVEDVI (left ventricular end-diastolic volume index, a measure of heart enlargement), mean | 141.1 → 122.2 mL/m² (maintained or reduced in 4 of 5) | 134.5 → 119.2 mL/m² (maintained or reduced in 4 of 5) |
| LVEF (left ventricular ejection fraction), mean | 25.0 → 31.0% (maintained or raised in 4 of 5) | 22.7 → 31.2% (maintained or raised in 5 of 5) |
| KCCQ-OS (quality of life and symptoms), mean | 66.0 → 62.7 points (maintained or increased in 2 of 5) | 75.8 → 95.5 points (maintained or increased in 5 of 5) |
| Six-minute walk distance, mean | 374.5 → 371.5 m (increased in 2 of 4; one value missing) | 462.6 → 500.2 m (increased in 4 of 5) |
| NYHA class | Maintained or improved in 5 of 5 | Maintained or improved in 5 of 5 |
| Safety (the primary endpoint is at week 26) | No ventricular arrhythmia lasting 30 seconds or more, or requiring treatment. One patient had herpes zoster during the period of combined use of three immunosuppressants (it resolved with treatment). The company states that no safety concerns were found that would affect the policy for a marketing approval application | |
The Annual Securities Report states that all patients also had coronary artery bypass surgery (CABG), and that differences in cardiac function improvement by transplant site and by whether CABG was performed will be examined in future analysis. The immunosuppression is designed to start with three drugs immediately after transplant, at lower doses than for heart transplantation, and from week 26 to continue with one drug at a very low dose Sourced.
7. Plans ahead
14 patients planned7 each for dilated cardiomyopathy and ischaemic heart disease. The first patient had dilated cardiomyopathy
held by the companyWhether to find a new partner or go it alone will be considered
| Planned or in-development item | Where it stands (company's account) | Category |
|---|---|---|
| HS-001 (allogeneic iPS cell-derived cardiac spheroids, open-chest delivery) | Analysis of all 10 LAPiS patients is complete, including image reading by a third-party body; the efficacy data are to be used in the marketing approval application. The trial has been notified to the PMDA as the "main trial" (see the glossary). In discussion with a target of a marketing approval application within 2026, and a target of starting domestic sales within 2027. As of 1 October 2026 we found no disclosure showing that the application has been filed | Not yet confirmed |
| HS-005 (the same, catheter delivery) | A domestic Phase 1/2 company-sponsored trial (the EMERALD trial): 7 patients each with ischaemic heart disease and dilated cardiomyopathy and severe heart failure, 14 in all. The high dose (150 million cells) is divided among up to 15 sites, and the primary endpoint is safety at week 26. The company describes it as the world's first trial of catheter delivery of iPS cell-derived cardiac spheroids. The first patient with dilated cardiomyopathy has been dosed, and the first patient with ischaemic heart disease has been decided. ClinicalTrials.gov (NCT07347197) still shows "not yet recruiting", so it may be behind on updates | Not yet confirmed |
| HS-040 (autologous iPS cell-derived cardiac spheroids) | At the basic research stage. Because the patient's own cells are used, immune rejection is thought to be less of a concern, and applications are envisaged for patients using a ventricular assist device and for heart failure in children. Basic and non-clinical work is progressing with support from AMED subsidy projects. In November 2023 the company announced that it had stably made high-purity cardiomyocytes from iPS cell lines from several donors made by I Peace | Not yet confirmed |
| Overseas expansion | It holds worldwide rights to both HS-001 and HS-005, and receives at no extra cost the know-how and intellectual property that Novo Nordisk obtained during the alliance. Overseas, it is at the stage of considering manufacturing technology development and trial design for a global trial, and will consider later whether to secure a new partner to entrust the work to or to proceed itself | Not yet confirmed |
None of the following appears in the primary sources, or the company has not disclosed it Not yet confirmed.
The actual date of the approval application and the expected timing of approval / the selling price of HS-001 and the expected number of eligible patients / commercial manufacturing capacity and the terms of any commercial contract with a CDMO / when overseas trials will start / whether there is a new partner / the results of the EMERALD trial. The LAPiS results are the company's announcement, and we have not yet been able to confirm an evaluation of efficacy and safety by regulators or a peer-reviewed paper. This article does not use figures from press reports or market-size estimates.
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 first priority is to obtain conditional and time-limited approval in Japan and start earning revenue | The management policy states that, after completing the LAPiS trial, the company will aim for conditional and time-limited approval in Japan and put in place a set-up that generates sales revenue. In 2026 it applied for and obtained the marketing licence, and describes this as moving into the phase of building a set-up for commercialisation and launch | Sourced |
| The eventual shape of treatment is to widen from HS-001 to HS-005, which is less burdensome for the body | After demonstrating efficacy with HS-001, the Annual Securities Report says the company is considering developing HS-005 globally as a next-generation product. The target extends from ischaemic heart disease to dilated cardiomyopathy | Inference |
| The policy is to own no manufacturing facilities and leave production to outside CDMOs | The company explains that it does not carry out production, has completed the transfer of manufacturing technology to a CDMO, and is "asset-light". No investment in its own manufacturing facilities is stated | Inference |
| Overseas, it is likely to look again for a large partner | While keeping the worldwide rights, it says it will either secure a new partner and entrust overseas development to it, or proceed itself. Under the earlier arrangement, Novo Nordisk bore the cost of overseas development, manufacturing and sales | Inference |
| Revenue for now is close to zero until product sales begin | The revenue forecast for the year ending December 2026 is ¥467 million (already booked in the first half), with an operating loss of ¥2,207 million expected. All of past revenue came from Novo Nordisk | Inference |
The reading that "overseas it will look for a partner again" rests on how the contract framework has changed with the termination. Under the contract with Novo Nordisk, Heartseed carried forward clinical development in Japan, while Novo Nordisk held the rights, and bore the costs, of development, manufacturing and sales outside Japan; Heartseed could receive up to US$598 million in upfront payment and milestones combined Sourced. Now that the contract has ended and the rights have returned, the primary sources do not allow us to tell whether the company can fund overseas trials and manufacturing on its own. The reference figures are cash of ¥6,335 million at the end of June 2026, a half-year operating loss of ¥621 million, and an overdraft facility of ¥2 billion Sourced. From this we think it natural that the company lists securing a new partner as the first option for overseas Not yet confirmed. This inference says nothing about the merits of the company's policy or its prospects of success.
9. Partnership map
How to read the figure: Heartseed takes its technology from Keio University, leaves manufacturing, transport and trial operations to outside parties, and concentrates itself on development and regulatory affairs. It used to have a contract under which Novo Nordisk held the rights, and bore the costs, of development, manufacturing and sales outside Japan; with that ended, it now holds the worldwide rights alone, and its partners are mainly contractors for practical work and supporters of funding Sourced.
10. Technologies, products and services
| Item | Details (from the Annual Securities Report and public materials) |
|---|---|
| HS-001 | A treatment in which cardiomyocytes specialised to the ventricular muscle are made from allogeneic iPS cells, formed into cardiac spheroids (clumps of about 1,000 cardiomyocytes) and transplanted into the heart wall by open-chest surgery at the same time as coronary artery bypass surgery. Low dose 50 million cells, high dose 150 million cells |
| HS-005 | A treatment delivering the same spheroids from inside the heart by catheter. Developed with Japan Lifeline as a system of two catheters: a mapping catheter and a delivery catheter. An electrode at the tip of the delivery catheter shows, through changes in the electrocardiogram, that the needle has reached the heart muscle |
| Delivery device (SEEDPLANTER) | For open-chest delivery. The needle tip is rounded so as not to injure tissue, and has six side holes sized to the spheroids. A guide adapter fixed on the heart keeps angle and depth constant |
| Purification technology | The glucose and glutamine that all cells need are removed from the culture medium and lactate, which only cardiomyocytes can use, is added; undifferentiated iPS cells and others die and cardiomyocytes are selected. Cardiomyocyte purity is stated as 98% or higher |
| Cell banks and manufacturing | From an original iPS cell stock obtained from an outside body, master and working cell banks were made with the help of a CDMO and are maintained and managed by the company. Cardiomyocytes can be stored for a long time at ultra-low temperature, and are thawed to match the surgical schedule to make the spheroids. Manufacturing technology has been transferred to the CDMO |
In this company's product, what matters for materials and processes is the composition of the culture medium itself Sourced. In general, when target cells are made from iPS cells, contamination by non-target or undifferentiated cells raises concerns such as tumour formation. Heartseed explains that it can purify by a simple step of exchanging the culture medium, using the metabolic difference that only cardiomyocytes can survive on lactate: remove glucose and glutamine from the medium and add lactate. Compared with methods that add equipment to sort cells, the simpler step could be a strength in large-scale manufacture Not yet confirmed.
The other point is cryopreservation. The design is to freeze purified cardiomyocytes as stock and thaw them to match the surgical schedule to make the spheroids, so the cryopreservation solution, survival after thawing and the spheroid-forming step all affect supply stability and cost. The specifications of the medium, freezing solution and forming equipment used have not been disclosed. See also our explainers in this series on cell manufacturing and cell banks, GMP, CDMO, and autologous versus allogeneic cells.
11. The risks this company carries
| Risk | Details | Category |
|---|---|---|
| The partner's departure and the loss of its revenue source | Novo Nordisk, the source of almost all revenue, terminated the alliance in September 2025. The upfront payment and milestones of up to US$598 million under the contract can no longer be received. The revenue forecast for the year ending December 2026 is ¥467 million (already booked in the first half), with an operating loss of ¥2,207 million expected | Sourced |
| The underlying trial is small | The LAPiS trial was open-label, uncontrolled and dose-escalating, with 10 patients (5 low dose, 5 high dose), combined with coronary artery bypass surgery. The figures in the company's announcement compare each patient with his or her own pre-transplant state. Evaluation by regulators is still to come | Sourced |
| Long-term safety | Because the transplanted cells remain in the body for a long time, the company states that safety, including tumour formation and arrhythmia, has to be confirmed through an accumulation of non-clinical studies and long-term follow-up. It also states that it cannot completely rule out safety concerns not anticipated in the trials | Sourced |
| Use of immunosuppressants | Because the cells are allogeneic, the design combines three immunosuppressants immediately after transplant and continues one at a low dose from week 26. One patient had herpes zoster during the period of combined use of three drugs (it resolved with treatment) | Sourced |
| Whether and when approval will be granted | An application within 2026 and domestic sales within 2027 are both targets. The regulator may ask for additional trials or materials, and delays in filing or non-approval are always possible | Inference |
| Reliance on outside manufacturing | Manufacture of the trial product is outsourced to a single company, Nikon Cell Innovation. Commercial manufacturing capacity and contract terms are not disclosed. Disasters or interruptions of supply could affect it | Inference |
| Emergence of competitors | The company states that competition in iPS cell research is intense worldwide and that, for example, a competitor reaching the market first could have a material effect on its business. In March 2026 conditional and time-limited approval was granted to a product using iPS cells (Interim Report) | Sourced |
| Funding outlook | Cash at the end of June 2026 was ¥6,335 million and the half-year operating loss was ¥621 million. It has secured a ¥2 billion overdraft facility, but building manufacturing and sales systems after approval, and overseas expansion, may need further funds | Inference |
| Small staff | With 43 employees it is pursuing the approval application, a sales set-up, a second trial and overseas expansion at the same time | Inference |
12. Glossary
- Cardiac spheroid
- A tiny clump of about 1,000 cardiomyocytes made from iPS cells. A registered trademark of Heartseed (in Japanese).
- Myocardial replacement (remuscularisation)
- A treatment that aims to make up for lost heart muscle with transplanted cardiomyocytes, directly raising the heart's contractile force.
- Allogeneic
- Using cells from another person (a donor) rather than from the patient. Drugs to suppress rejection are needed.
- Coronary artery bypass grafting (CABG)
- Surgery that connects a blood vessel to bypass a blocked coronary artery. In the LAPiS trial it is done at the same time as transplanting the spheroids.
- LVEF
- Left ventricular ejection fraction. An index of the share of blood the heart pumps out with each beat.
- LVEDVI
- Left ventricular end-diastolic volume index. The volume of the left ventricle when it is dilated, corrected for body size. A measure of heart enlargement.
- NYHA class
- A classification of the severity of heart failure symptoms from class I to IV.
- KCCQ-OS
- The overall summary score of a questionnaire that scores heart failure symptoms and quality of life. The higher the score, the better.
- 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.
- CDMO and CRO
- A CDMO is a company that develops and manufactures on commission; a CRO is a company that carries out clinical trial work on commission.
- Main trial (pivotal trial)
- A trial notified on the PMDA's website as the final stage of domestic development, after which an approval application is expected.
- Asset-light
- Running a business lightly by leaving factories and other assets to outside parties instead of owning them.
13. References
- Heartseed Annual Securities Report (10th fiscal year, November 2024 to December 2025, filed with the Kanto Local Finance Bureau on 26 March 2026) (in Japanese). History, business description, pipeline, trial summaries, management policy, risks, material contracts and R&D activities. https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf
- Heartseed Interim Report (first half of the 11th fiscal year, January to June 2026, August 2026) (in Japanese). Results of operations, major shareholders and R&D activities. https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100YX0K/00.pdf
- Heartseed Second-quarter (interim) results briefing materials for the year ending December 2026 (August 2026) (in Japanese). Progress against development targets, pipeline and balance sheet. https://ssl4.eir-parts.net/doc/219A/ir_material_for_fiscal_ym/210915/00.pdf
- Heartseed Press release, "52-week topline results of the Phase 1/2 trial (LAPiS) of allogeneic iPS cell-derived cardiac spheroids (HS-001) presented in an invited lecture at ESC Congress 2026" (31 August 2026) (in Japanese). https://heartseed.jp/news/assets/2026/08/b8af9c4bbc2cb3583655085e2067640f1b13730b.pdf
- Heartseed Timely disclosure, "Analysis results of the Phase 1/2 trial (LAPiS) of allogeneic iPS cell-derived cardiac spheroids (HS-001)" (1 June 2026) (in Japanese). https://ssl4.eir-parts.net/doc/219A/tdnet/2827696/00.pdf
- Heartseed Timely disclosure, "First patient treated in the Phase 1/2 company-sponsored trial of myocardial regenerative medicine HS-005 (catheter delivery)" (12 June 2026) (in Japanese). https://ssl4.eir-parts.net/doc/219A/tdnet/2834857/00.pdf
- Heartseed Timely disclosure, "Notice of conclusion of a special overdraft agreement" (14 August 2026) (in Japanese). https://ssl4.eir-parts.net/doc/219A/tdnet/2873646/00.pdf
- Heartseed Timely disclosure, "Notice of application for a licence to market regenerative medicine products" (17 August 2026) (in Japanese). https://ssl4.eir-parts.net/doc/219A/tdnet/2875044/00.pdf
- Heartseed Timely disclosure, "Notice of obtaining a licence to market regenerative medicine products" (28 September 2026) (in Japanese). https://ssl4.eir-parts.net/doc/219A/tdnet/2887710/00.pdf
- U.S. National Library of Medicine ClinicalTrials.gov NCT04945018 (LAPiS trial, Phase 1/2 of HS-001). https://clinicaltrials.gov/study/NCT04945018
- U.S. National Library of Medicine ClinicalTrials.gov NCT07347197 (EMERALD trial, Phase 1/2 of HS-005). https://clinicaltrials.gov/study/NCT07347197
- Heartseed Official website (source of the logo). https://heartseed.jp/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name, establishment (November 2015), head office, listing (TSE Growth 219A, July 2024), change of fiscal year-end | Sourced | References 1 and 12 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://heartseed.jp/ |
| 43 employees, 28 in R&D, average age 45.0 | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf |
| Revenue, profit and cash flow (year ended October 2023 to January to June 2026) | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100YX0K/00.pdf |
| 99.95% of revenue from Novo Nordisk (¥3,025,000 thousand of ¥3,026,500 thousand) | Our calculation | Reference 1 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf Our own calculation |
| Earnings forecast for the year ending December 2026 (operating loss of ¥2,207 million and others), cash and deposits at about 90% of assets, no interest-bearing debt | Not yet confirmed | Reference 3 https://ssl4.eir-parts.net/doc/219A/ir_material_for_fiscal_ym/210915/00.pdf |
| R&D expense (¥2,032,919 thousand, 73.8% of SG&A) and ¥779,927 thousand in January to June 2026 | Sourced | References 1 and 2 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100YX0K/00.pdf |
| Special overdraft agreement (¥2 billion, Sumitomo Mitsui Banking Corporation) | Sourced | Reference 7 https://ssl4.eir-parts.net/doc/219A/tdnet/2873646/00.pdf |
| Patents brought in from Keio University and iPS Academia Japan | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf |
| The contract with Novo Nordisk (up to US$598 million), the notice of termination of 29 September 2025 and the return of rights | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf |
| Contracting and joint development with Nikon Cell Innovation, Linical, SPLine and Japan Lifeline | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf |
| AMED subsidy projects (FY2018 to FY2020, selected September 2023) and non-operating income | Sourced | References 1 and 4 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://heartseed.jp/news/assets/2026/08/b8af9c4bbc2cb3583655085e2067640f1b13730b.pdf |
| Design of the LAPiS trial (10 patients; low dose 50 million cells, high dose 150 million cells) and primary endpoint | Sourced | References 1, 4 and 10 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://heartseed.jp/news/assets/2026/08/b8af9c4bbc2cb3583655085e2067640f1b13730b.pdf https://clinicaltrials.gov/study/NCT04945018 |
| 52-week topline results of the LAPiS trial (LVEF, LVEDVI, KCCQ-OS, six-minute walk and others) | Sourced | Reference 4 https://heartseed.jp/news/assets/2026/08/b8af9c4bbc2cb3583655085e2067640f1b13730b.pdf |
| Completion of the LAPiS analysis (1 June 2026) and the target of an approval application within 2026 | Sourced | Reference 5 https://ssl4.eir-parts.net/doc/219A/tdnet/2827696/00.pdf |
| Design of immunosuppression (three drugs, then one from week 26) and combination with CABG | Sourced | Reference 1 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf |
| Design of the EMERALD trial (14 patients), the first patient (dilated cardiomyopathy) and approval by the data safety monitoring committee | Sourced | References 1, 6 and 11 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://ssl4.eir-parts.net/doc/219A/tdnet/2834857/00.pdf https://clinicaltrials.gov/study/NCT07347197 |
| Application for (17 August 2026) and receipt of (28 September 2026) the licence to market regenerative medicine products | Sourced | References 8 and 9 https://ssl4.eir-parts.net/doc/219A/tdnet/2875044/00.pdf https://ssl4.eir-parts.net/doc/219A/tdnet/2887710/00.pdf |
| The target of starting domestic sales within 2027, progress of HS-040, and the overseas policy | Not yet confirmed | References 1 and 3 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://ssl4.eir-parts.net/doc/219A/ir_material_for_fiscal_ym/210915/00.pdf |
| Actual date of the approval application, selling price, commercial manufacturing capacity and start of overseas trials | Not yet confirmed | No outlook has been published. This article does not estimate them either |
| 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 |
| Purification technology (using lactate), manufacture of the spheroids, and features of the delivery devices | Sourced | References 1 and 4 https://ssl4.eir-parts.net/doc/219A/yuho_pdf/S100XUL5/00.pdf https://heartseed.jp/news/assets/2026/08/b8af9c4bbc2cb3583655085e2067640f1b13730b.pdf |
| The reading that the eventual shape of treatment is to widen from HS-001 to HS-005 | Inference | This article's interpretation of how the Annual Securities Report positions HS-005 |
| The reading that the policy is to own no manufacturing facilities and leave production to outside CDMOs | Inference | This article's interpretation of the statement that the company does not carry out production, and similar |
| The reading that overseas it is likely to look again for a large partner | Inference | This article's interpretation of the policy after the rights returned and the change in the contract framework |
| The reading that revenue for now is close to zero until product sales begin | Inference | This article's interpretation of the earnings forecast and the dependence on Novo Nordisk |
| The risks of reliance on outside manufacturing, the funding outlook and small staff | Inference | This article's interpretation of the manufacturing contractor, cash and the number of employees |
| The risk that whether and when approval will be granted is uncertain | Inference | This article's interpretation of the fact that the application is still at the target stage |
Last updated 1 October 2026 / Troy Technical
The figures in this article are based on Heartseed's Annual Securities Report, Interim Report, timely disclosures, results briefing materials and press releases, and on ClinicalTrials.gov. 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.