Heartseed
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).
- Company typePublic
- Founded2015
- HeadquartersTokyo, Japan
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
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.
Heartseed firmographics
Firmographics- 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
Heartseed industry classification
Industry- Product category
- Cardiac Regenerative Medicine
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- akta.pro primary industry
- Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis) (HLAAAGAJ)
Keywords
Where Heartseed is headquartered
LocationHeadquarters
- HQ city
- Tokyo
- HQ country
- Japan
- HQ region
- Asia
Offices3 records
Markets served
Heartseed business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- 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.
- 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.
- 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
Heartseed product offering
Product offeringCore 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
Companies that use Heartseed
Customer profileSegments3 records
Ideal customer profiles2 records
Heartseed technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature7 records
Heartseed partnerships and signals
Strategic signalPartnerships
Twelve partnerships are on record, tiered core, minor and flagship.
- Tokyo Women's Medical University HospitalcoreClinical 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)coreAnnounced 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.minorHeartseed 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 HospitalcoreClinical trial site for LAPiS Phase I/II study. Conducted first HS-001 transplantation of patient at their facility in December 2024.
- Stimuliver APSminorHeartseed 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.coreCollaboration 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)coreAlbumedix 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 UniversitycoreJoint 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/SflagshipGlobal 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 HoldingscoreCapital 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)coreJapanese 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)flagshipFounding 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
Heartseed competitors and assessment
Company assessmentEmerging 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
Heartseed social profiles
Digital presenceHeartseed compliance and trust
Trust signalCompliance2 records
Heartseed financial estimates
Financial estimateRevenue estimate
Valuation estimate
Heartseed leadership team
Management profileNumber of profiles
Profiles10 records
Heartseed funding detail
Funding detailFunding overview
Funding rounds6 records
Investors18 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Heartseed M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Heartseed
What does Heartseed do?
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.
Is Heartseed a public or private company?
Heartseed is a public company. It is classified as public and is currently ipo.
When was Heartseed founded?
Heartseed was founded in 2015. It employs 11 to 50 people.
Where is Heartseed based?
Heartseed is headquartered in Tokyo, Japan, in the Asia region.
How does Heartseed make money?
Three revenue lines are on record. Pre-revenue / Clinical Development Stage is the primary driver. The others are future Licensing Royalties from Novo Nordisk and future 50/50 Profit/Cost Sharing in Japan.
Who are Heartseed's main competitors?
Emerging players on record are Cynata Therapeutics and Help Therapeutics. Direct peers are Capricor Therapeutics, Cytori Therapeutics, BlueRock Therapeutics, Athersys, BioCardia and Mesoblast. Others are Novo Nordisk A/S and Sumitomo Mitsui Trust Investment.
Does Heartseed have an API?
No public API is recorded for Heartseed.
What industry is Heartseed in?
Heartseed's product category is Cardiac Regenerative Medicine. Its primary akta.pro industry code is HLAAAGAJ, Cardiovascular & Vascular Regeneration (vascular grafts, angiogenesis). Its NAICS code is 334510.