Heartseed

What Heartseed does

Heartseed Inc. is a Tokyo-based, clinical-stage biotechnology company founded in 2015 by Keiichi Fukuda (Professor Emeritus of Cardiology at Keio University School of Medicine) to commercialize iPSC-derived cardiac regenerative medicine. The company develops allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroids (lead asset HS-001) transplanted into the myocardial layer using a proprietary delivery needle (SEEDPLANTER®), administered during open-heart surgery in conjunction with coronary artery bypass graft (CABG). The underlying platform integrates proprietary technologies across the full value chain: iPSC production, cardiomyocyte differentiation (achieving high efficiency across multiple donor iPS cell lines), a metabolic selection purification method achieving ~99% cardiomyocyte purity by removing undifferentiated pluripotent cells, and spheroid formulation that improves cell retention and viability relative to single-cell suspensions. A second pipeline asset, HS-005, adapts the same core spheroid technology to less-invasive catheter-based administration.

Heartseed serves end-stage heart failure patients with reduced left ventricular ejection fraction (HFrEF) — including dilated cardiomyopathy (DCM), old myocardial infarction (OMI), and dilated-phase hypertrophic cardiomyopathy (D-HCM) — for whom existing therapies only slow disease progression and heart transplantation remains the only definitive option. The company retains sole development rights in Japan with 50/50 cost/profit-sharing co-commercialization through Novo Nordisk, which holds exclusive worldwide (ex-Japan) rights to develop, manufacture, and commercialize HS-001 under a June 2021 agreement eligible for up to USD 598M in payments (including USD 55M upfront and near-term milestones) plus tiered high single-digit to low double-digit royalties on annual net sales outside Japan. Future revenue will come from milestone receipts, royalties, and Japan profit-sharing contingent on regulatory approval targeted by end of 2026.

The company is publicly listed on the Tokyo Stock Exchange Growth Market (securities code 219A, IPO July 30, 2024), has raised approximately 10.2 billion JPY cumulatively since founding across multiple venture rounds, operates a small team (11-50 employees) across offices in Tokyo (Minato-ku headquarters) and Kawasaki (R&D lab), and maintains research collaborations with Keio University, Shinshu University, Tokyo Women's Medical University, and Juntendo University Hospital. Heartseed is pre-revenue with the LAPiS Phase I/II trial of HS-001 fully enrolled (10 patients, first patient dosed December 2022) and HS-005 advancing through domestic Phase I/II corporate trial notification review.

Name

Heartseed

Legal name

Heartseed株式会社 (Heartseed Inc.)

Website

https://heartseed.jp

Company type

Public

Founded year

2015

Operating status

Ipo

Headcount range

11–50 employees

Short description

Heartseed Inc. is a Tokyo-based, clinical-stage biotechnology company founded in 2015 that develops iPSC-derived cardiomyocyte spheroid therapies (lead asset HS-001) for severe heart failure, partnered globally with Novo Nordisk and listed on the TSE Growth Market (code 219A).

Ownership category

akta.pro rank

Product category

Cardiac Regenerative Medicine

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

akta.pro primary industry

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

Keywords

• Cardiac regenerative medicine
• IPSC cardiomyocyte therapy
• Heart failure treatment
• Cell therapy development
• Biopharmaceutical research

Headquarters

HQ city

Tokyo

HQ country

Japan

HQ region

Asia

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Pre-revenue / Clinical Development Stage: Heartseed is currently pre-revenue, in clinical development stage with HS-001 lead asset in Phase I/II LAPiS trial. Company plans to seek regulatory approval by end of 2026.
2. Future Licensing Royalties from Novo Nordisk: Eligible to receive tiered high single-digit to low double-digit royalties of annual net sales outside Japan for HS-001 from Novo Nordisk partnership. Up to USD 598 million in total payments including USD 55 million upfront and near-term milestones.
3. Future 50/50 Profit/Cost Sharing in Japan: Heartseed retains sole development rights in Japan with Novo Nordisk co-commercialization, with profit and cost sharing on a 50/50 basis.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels8 records

Core offering

Heartseed develops allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroids (HS-001) as a cardiac remuscularization therapy for severe heart failure with reduced left ventricular ejection fraction (HFrEF). The lead asset is administered via intramyocardial injection during open-heart surgery using the proprietary SEEDPLANTER® delivery needle and guide adapter, with a next-generation HS-005 catheter-based candidate in development. Heartseed also develops complementary iPSC differentiation, metabolic selection purification, and spheroid manufacturing technologies that underpin the platform.

Product overview

Heartseed Inc. is a Tokyo-based biotechnology company offering a single platform of iPSC-derived cardiac regenerative medicine, anchored by its lead pipeline product HS-001 and the next-generation catheter-administered candidate HS-005, both built around the proprietary iPSC-derived cardiomyocyte spheroid technology and delivered using the dedicated SEEDPLANTER® administration needle/guide adapter. The portfolio is a unified remuscularization approach: HS-001 is the open-chest (intramyocardial injection) lead asset currently in the Phase I/II LAPiS trial for severe heart failure in Japan, while HS-005 extends the same core spheroid technology to a less-invasive catheter-based delivery route currently preparing for Phase I/II initiation. Underpinning both products are Heartseed's proprietary iPSC production, cardiomyocyte differentiation, and metabolic selection purification technologies developed internally and transferred from Keio University.

Differentiator

Problem solved

Functional benefit

Brands

• HS-001: Lead pipeline product — allogeneic iPSC-derived, highly purified ventricular cardiomyocyte spheroids developed for the treatment of severe heart failure (Phase I/II LAPiS trial in Japan).
• SEEDPLANTER®
• HS-005

Products and services

• HS-001 Allogeneic (donor-derived) iPSC-derived, highly purified ventricular cardiomyocyte spheroids developed as a cardiac remuscularization therapy (HS-001) for severe heart failure with reduced left ventricular ejection fraction (HFrEF), including dilated cardiomyopathy (DCM), old myocardial infarction (OMI), and dilated-phase hypertrophic cardiomyopathy (D-HCM). Administered via intramyocardial injection using the dedicated SEEDPLANTER® needle in the Phase I/II LAPiS trial in Japan.
• HS-005 Cardiac remuscularization therapy using iPSC-derived cardiomyocyte spheroids designed for less-invasive catheter-based administration (HS-005). Under domestic Phase I/II company-sponsored clinical trial preparation; designed to broaden access to the therapy beyond open-chest surgical delivery.
• SEEDPLANTER® Special administration needle and guide adapter developed by Heartseed for safe and efficient transplantation of cardiomyocyte spheroids (such as HS-001) into the myocardial layer of the heart. Registered trademark (#6932696).

Quantifiable outcome

• 65 million+ people globally affected by heart failure, with 1.2 million in Japan
• +3 more outcomes

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Twelve partnerships are on record, tiered core, minor and flagship.

• Tokyo Women's Medical University HospitalcoreImplementation/ SI/ Consulting Partner · 4 November 2025Clinical trial site for LAPiS Phase I/II study. Performed world's first HS-001 transplantation in December 2022. Dr. Hiroshi Shinnami (cardiovascular surgery) led first patient transplant. Dr. Yuki Ichihara presented initial results at ESC-HF 2024 congress.
• Catheter Delivery System Partner (undisclosed)coreOEM/ Whitelabel/ Licensing Partner · 11 September 2025Announced partnership for delivery catheter system for allogeneic iPS cell-derived cardiomyocyte spheroids. Enables HS-005 catheter-based administration development for global development by Novo Nordisk. Partner name not publicly disclosed at announcement.
• RAINBOW Inc.minorStrategic or Co-development Partner · 16 December 2024Heartseed CMO Takehiko Kaneko joined RAINBOW (Hokkaido University-launched biotech developing brain regeneration therapy for chronic-phase cerebral infarction) as outside director. RAINBOW initiated physician-led clinical trial for HUNS001 in December 2024.
• Juntendo University HospitalcoreImplementation/ SI/ Consulting Partner · 12 December 2024Clinical trial site for LAPiS Phase I/II study. Conducted first HS-001 transplantation of patient at their facility in December 2024.
• Stimuliver APSminorStrategic or Co-development Partner · 28 August 2024Heartseed COO Kikuo Yasui joined Stimuliver APS (Denmark-based biotech developing liver organoids from pluripotent stem cells for liver disease treatment) as Board Advisor. Heartseed-Stimuliver partnership leverages Yasui's expertise and Asian biotech ecosystem connections.
• I Peace, Inc.coreStrategic or Co-development Partner · 1 November 2023Collaboration with I Peace, a GMP cell CDMO in Palo Alto, to generate cardiomyocytes using multiple donor-derived iPS cell lines from I Peace's MyPeace personalized iPS cell banking service. Heartseed successfully produced high-purity cardiomyocytes (nearly 99%) from all 8 iPS cell lines with 4 different donors using its proprietary differentiation and Metabolic Selection purification methods. Advances autologous cardiac regenerative medicine.
• Albumedix Ltd (Sartorius)coreTechnology or Integration · 14 March 2023Albumedix supplies Recombumin® recombinant albumin as critical excipient in HS-001 final formulation. Recombumin supports formation of cardiomyocyte spheres and offers enhanced cell viability during transportation and distribution. Albumedix is part of Sartorius life science group.
• Shinshu UniversitycoreStrategic or Co-development Partner · 1 January 2023Joint research collaboration on cardiac regenerative medicine with Shinshu University (Department of Regenerative Medicine). Co-authored research results published in Circulation journal (April 2024). Professor Yuji Shibata presented pre-clinical research using primate models at JCC 2024 special session.
• Novo Nordisk A/SflagshipStrategic or Co-development Partner · 1 June 2021Global collaboration and license agreement signed June 1, 2021 for HS-001. Novo Nordisk received exclusive rights to develop, manufacture, and commercialize HS-001 worldwide except Japan. Heartseed retains sole Japan development rights with 50/50 profit and cost sharing for co-commercialization. Heartseed eligible for up to USD 598 million in payments including USD 55 million upfront and near-term milestones, plus tiered high single-digit to low double-digit royalties on annual net sales outside Japan.
• Medipal HoldingscoreStrategic or Co-development Partner · 10 March 2020Capital and business alliance with Medipal Holdings announced March 2020. Medipal Holdings is a major Japanese pharmaceutical wholesaler providing distribution expertise.
• Shibuya Corporation (澁谷工業)coreStrategic or Co-development Partner · 30 July 2018Japanese industrial company with life sciences division. Participated in 800 million yen third-party allocation in July 2018. Provides expertise in pharmaceutical manufacturing and medical device technologies.
• Keio University School of Medicine (Fukuda Laboratory)flagshipStrategic or Co-development Partner · 1 January 2015Founding technology partnership with Keio University Department of Cardiology (Fukuda Laboratory). Joint research agreement for manufacturing method of transplantable iPSC-derived regenerative cardiomyocytes signed May 2016. Multiple patents transferred from Keio University. Co-research with Shinshu University on cardiac regenerative medicine published in Circulation (April 2024).

Scale indicators8 records

Recent moves9 records

Expansion highlights6 records

Emerging players

• Cynata Therapeutics: Australian clinical-stage biotech developing iPSC-derived mesenchymal stem cell (MSC) therapies using its Cymerus platform for inflammatory and cardiovascular conditions. Comparable as a peer in iPSC-derived cell therapy, though targeting different cell types than Heartseed.
• Help Therapeutics: Chinese clinical-stage biotech developing allogeneic iPSC-derived cardiomyocytes (HiCM-188) for heart failure, with preclinical and early clinical data. Emerging competitor pursuing the same iPSC-derived cardiomyocyte approach, primarily operating in China.

Direct peers

• Capricor Therapeutics: Clinical-stage biotech developing CAP-1002, an allogeneic cardiosphere-derived cell therapy for Duchenne muscular dystrophy-associated cardiomyopathy and other cardiac indications. Direct competitor in cardiac cell therapy with similar Phase II/III stage and delivery-based administration approach.
• Cytori Therapeutics: Clinical-stage cell therapy company developing adipose-derived regenerative cells (ADRCs/ECM-S) for heart failure and other cardiovascular indications. Comparable peer in cardiac cell therapy with similar therapeutic focus but different cell source.
• BlueRock Therapeutics: A Bayer-owned clinical-stage cell therapy company developing iPSC-derived cardiomyocytes for heart failure (BCRT-100, partnered with Sony). Most direct competitor to Heartseed, pursuing the same allogeneic iPSC-derived cardiomyocyte approach for cardiac remuscularization.
• Athersys: Clinical-stage company developing MultiStem cell therapy for acute myocardial infarction and other indications. Direct competitor in cardiac regenerative medicine, though using a multipotent adult progenitor cell platform rather than iPSC-derived cardiomyocytes.
• BioCardia: Clinical-stage company developing cardiac cell therapy delivery systems including the Helix transendocardial delivery catheter and CardiAMP cell therapy for heart failure. Highly comparable as a peer with both a delivery device and a cell therapy in cardiac regenerative medicine.
• Mesoblast: Commercial-stage cell therapy company with Revascor (rexlemestrocel-L) for chronic heart failure with reduced ejection fraction (HFrEF). Most advanced direct competitor targeting the same HFrEF indication via cell therapy, providing important read-through to Heartseed's commercial path.

Others

• Novo Nordisk A/S: Global pharmaceutical company and Heartseed's licensing partner for HS-001 (ex-Japan). Functions as a strategic partner/distributor for Heartseed's lead asset rather than a direct competitor, providing global commercial infrastructure for the cardiac remuscularization therapy.
• Sumitomo Mitsui Trust Investment: Lead investor in Heartseed's Series D round via Japan Co-Invest IV Limited Partnership. Functions as a financial partner and shareholder, not a direct competitor — included as a relevant ecosystem participant given its lead role in Heartseed's most recent funding round.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCZ88HHvk5Ogk8_rKALxKf9g
• LinkedInlinkedin.com/company/heartseed-inc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds6 records

Investors18 records

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M&A

Investments

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Frequently asked questions about Heartseed