Cellusion
Cellusion is a Tokyo-based regenerative medicine biotech developing iPS cell-derived corneal endothelial cell substitutes (CLS001) for bullous keratopathy treatment, targeting the global 13M+ patient waiting list for corneal transplants through a simple cell injection procedure.
- Company typePrivate
- Founded2015
- HeadquartersTokyo, Japan
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Cellusion does
Cellusion Inc. (株式会社セルージョン) is a Tokyo-based, privately held regenerative medicine biotechnology company founded in January 2015 as a spin-off from Keio University School of Medicine Department of Ophthalmology by Prof. Kazuo Tsubota, Prof. Shigeto Shimmura, and Prof. Shin Hatou. The company develops iPS cell-derived corneal endothelial cell substitutes (CECSi cells) for the treatment of bullous keratopathy, a progressive eye disease causing corneal swelling and vision loss, addressing a global treatment gap where approximately 13 million patients wait for corneal transplants versus only ~180,000 procedures performed annually. Its lead product CLS001 uses proprietary direct differentiation induction technology to convert allogeneic iPS cells into corneal endothelial replacement cells, which are administered via a simple cell injection into the anterior chamber of the eye — a procedure that general ophthalmologists can perform without the specialized training required for traditional corneal transplantation. The product targets three structural bottlenecks of conventional corneal transplantation: donor cornea scarcity, surgical skill requirements, and the need for eye bank infrastructure.
The company's business model combines direct commercialization in Japan, the US, and EU with regional licensing for Greater China through an exclusive 2022 deal with Celregen Therapeutics (Fosun Pharma subsidiary) valued at potentially over $100 million USD in milestones plus royalties. It operates an asset-light model using CDMO partners (Nikon CeLL innovation for domestic production, Minaris Regenerative Medicine for US manufacturing) and distribution alliances (Toho Holdings for Japanese pharmaceutical distribution, Toyo Seikan for the WellBag closed-system spheroid production technology). Revenue streams currently consist of Japanese government grants (AMED, NEDO) and potential licensing milestones, with first-in-human clinical trial safety data confirmed at Keio University Hospital in March 2023. In December 2025, the company divested its CLS001A program — including all associated IP, manufacturing processes, and contracts with Keio, iPS Academia Japan, and CiRA Foundation — to newly created Caksus Bio, Inc., founded by former CEO Shin Hatou. Cellusion has raised approximately 4.5 billion yen (~$33 million USD) cumulatively across Series A through C rounds (2020-2023), employs approximately 20-50 people, and has received regulatory milestones including FDA Orphan Drug Designation (December 2023) and MHLW clinical study plan approval (July 2021).
Cellusion firmographics
Firmographics- Name
- Cellusion
- Legal name
- 株式会社セルージョン
- Website
- https://cellusion.jp
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Cellusion is a Tokyo-based regenerative medicine biotech developing iPS cell-derived corneal endothelial cell substitutes (CLS001) for bullous keratopathy treatment, targeting the global 13M+ patient waiting list for corneal transplants through a simple cell injection procedure.
- Ownership category
- akta.pro rank
Cellusion industry classification
Industry- Product category
- Regenerative Medicine / Cell Therapy
- akta.pro primary industry
- Ophthalmic Regeneration (cornea/retina) (HLAAAGAK)
- akta.pro secondary industries
- Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL)
Keywords
Where Cellusion is headquartered
LocationHeadquarters
- HQ city
- Tokyo
- HQ country
- Japan
- HQ region
- Asia
Offices2 records
Markets served
Cellusion business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Product Sales (CLS001): Revenue from commercialization of iPS cell-derived corneal endothelial cell substitute (CLS001) for bullous keratopathy treatment. Regional commercialization rights retained for Japan, USA, and EU; licensed to partners for Greater China region.
- Licensing and Milestone Payments: Potential over $100 million USD including upfront payment, development milestones, and sales milestones as well as tiered royalties from Celregen license agreement for Greater China region.
- Government Grants: Funding from AMED (Japan Agency for Medical Research and Development) 'Strengthening Program for Pharmaceutical Startup Ecosystem' for global development and P1/P2 clinical trials.
Go-to-market motion3 records
Distribution channels4 records
Marketing channels5 records
Cellusion product offering
Product offeringCore offering
Cellusion develops CLS001, an iPS cell-derived corneal endothelial cell substitute (CECSi cells) for the treatment of bullous keratopathy. The product uses allogeneic iPS cells differentiated into functional corneal endothelial replacement cells and is administered via a simple cell injection procedure into the anterior chamber of the eye, eliminating the need for donor corneas and traditional corneal transplant surgery.
Product overview
Cellusion is a regenerative medicine company developing a pipeline of iPS cell-derived corneal endothelial cell substitutes to address the global shortage of corneal donors. The lead product is CLS001 (also referred to as CLS001A), which consists of CECSi cells — corneal endothelial replacement cells derived from allogeneic iPS cells — for the treatment of bullous keratopathy. The company combines its proprietary cell differentiation technology with a simple cell injection delivery procedure to provide an alternative to traditional corneal transplantation. The CLS001A business was transferred to KaksusBio Inc. in December 2025.
Differentiator
Problem solved
Functional benefit
Products and services
- CLS001 iPS cell-derived corneal endothelial cell substitute (CECSi cells) for treating bullous keratopathy, a progressive eye disease causing corneal swelling and vision impairment. Uses allogeneic iPS cells differentiated into corneal endothelial replacement cells, administered via a simple injection into the anterior chamber of the eye.
Quantifiable outcome
- Short-term safety confirmed with no adverse events observed for 3 months after CLS001 transplantation
- +2 more outcomes
Companies that use Cellusion
Customer profileNamed customers1 record
Segments1 record
Ideal customer profiles4 records
Cellusion technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Cellusion partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered major, supporting and core.
- Caksus Bio, Inc. (カクサスバイオ)majorBusiness transfer recipient for CLS001A development. Caksus Bio assumed all intellectual property, research data, related contracts, and manufacturing processes for CLS001A as of December 2025. Founded by former Cellusion CEO Shin Hatou. Transfer included contracts with Keio University, iPS Academia Japan, and CiRA Foundation.
- Japan Agency for Medical Research and Development (AMED)supportingSelected for AMED 'Strengthening Program for Pharmaceutical Startup Ecosystem' supporting global development of CLS001 and P1/P2 clinical trials, with condition of receiving venture capital funding.
- J-Startup Program (METI)supportingSelected for J-Startup, a startup support program promoted by Ministry of Economy, Trade and Industry (METI) in public and private sectors to support global market expansion of promising startups.
- Minaris Regenerative Medicine LLC (Showa Denko Materials)coreBusiness alliance for CLS001 global development with Minaris performing process optimization for FDA requirements at their Allendale, New Jersey facility. Minaris is a global CDMO with over 20 years experience in regenerative medicine manufacturing.
- Celregen Therapeutics Ltd. (Fosun Pharma)majorExclusive license agreement for Greater China region (Mainland China, Hong Kong, Macau, Taiwan) for Celregen to develop, manufacture and commercialize CLS001. Cellusion retains rights for Japan, USA, and EU. Potential deal value over $100 million USD including upfront payment, development milestones, sales milestones and tiered royalties.
- Toyo Seikan Group Holdings, Ltd.supportingCapital and business alliance using Toyo Seikan's 'WellBag' closed spheroid formation system to solve CLS001 manufacturing issues. WellBag enables safe and uniform spheroid formation for clinical study and commercial production.
- Nikon CeLL innovation Co., Ltd.coreStrategic business alliance for development and production of CLS001 for commercialization. Nikon CeLL innovation operates a GCTP/GMP-compliant production facility (Shinsuna Plant, 7,500+ sqm) and has strategic alliance with Lonza for global operations.
- Toho Holdings Co., Ltd.coreCapital and business alliance with leading Japanese pharmaceutical wholesaler for distribution solutions including advanced logistics systems, provision of information to medical institutions, and collection of post-marketing safety information for CLS001.
- Keio University (Department of Ophthalmology)coreCellusion was founded by Prof. Kazuo Tsubota, Prof. Shigeto Shimmura, and Prof. Shin Hatou from Keio University School of Medicine Department of Ophthalmology. Ongoing research collaboration with investigator-initiated clinical trials at Keio University Hospital.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
Cellusion competitors and assessment
Company assessmentEmerging players
- CorNeat Vision: CorNeat Vision (Israel) develops the EndoArt synthetic corneal implant as an alternative to donor cornea transplantation for endothelial dysfunction. It targets the same bullous keratopathy indication via a different (synthetic) modality.
- EyeYon Medical: EyeYon Medical develops cell-free synthetic corneal implants (EndoArt-style and other devices) for corneal edema and endothelial disease, competing in the same corneal blindness therapeutic space as Cellusion.
- Trefoil Therapeutics: Trefoil Therapeutics is developing engineered protein-based regenerative therapies (e.g., TTHX1114) for corneal endothelial dysfunction, representing a competing regenerative approach to Cellusion's iPSC-derived cell substitute.
- Bit Bio: Bit Bio is a UK-based company developing iPSC-derived cell therapies using a proprietary opti-ox differentiation platform, comparable to Cellusion as a fellow iPSC-derived cell therapy platform company, though operating across multiple therapeutic areas rather than focused on cornea.
Direct peers
- Aurion Biotech: Aurion Biotech is developing allogeneic cell therapies for corneal endothelial disease (bullous keratopathy), making it the most direct competitor to Cellusion's CLS001 with a similar mechanism (cell-based regeneration) and target indication.
Others
- iPS Academia Japan: iPS Academia Japan is a key iPS cell technology licensor and Cellusion's contracted supplier for iPSC lines. It is an enabling ecosystem participant upstream of Cellusion's differentiation process.
- Eversight: Eversight is a US-based eye bank network providing donor corneal tissue for transplantation. It represents the incumbent donor-cornea supply chain that Cellusion's off-the-shelf cell therapy is positioned to disrupt.
- SightLife: SightLife is a global eye bank and corneal tissue provider — the traditional supply infrastructure that Cellusion's iPSC-derived cell substitute is designed to bypass for bullous keratopathy treatment.
Broad incumbents
- Astellas Pharma: Astellas Pharma is a major Japanese pharma that built a regenerative medicine franchise including the Universal Cells acquisition (iPSC-derived cell therapy). Its regenerative medicine division management background is shared with Cellusion's COO, and it is a broad incumbent in adjacent regenerative medicine categories.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks5 records
Key highlights7 records
Customer concentration
Cellusion social profiles
Digital presenceCellusion financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cellusion leadership team
Management profileNumber of profiles
Profiles10 records
Cellusion subsidiaries and ownership
Company hierarchySubsidiaries1 record
Cellusion funding detail
Funding detailFunding overview
Funding rounds4 records
Investors14 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cellusion 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 Cellusion
What does Cellusion do?
Cellusion develops CLS001, an iPS cell-derived corneal endothelial cell substitute (CECSi cells) for the treatment of bullous keratopathy. The product uses allogeneic iPS cells differentiated into functional corneal endothelial replacement cells and is administered via a simple cell injection procedure into the anterior chamber of the eye, eliminating the need for donor corneas and traditional corneal transplant surgery.
Is Cellusion a public or private company?
Cellusion is a private company. It is classified as venture growth investor backed and is currently operating.
When was Cellusion founded?
Cellusion was founded in 2015. It employs 11 to 50 people.
Where is Cellusion based?
Cellusion is headquartered in Tokyo, Japan, in the Asia region.
How does Cellusion make money?
Three revenue lines are on record. Product Sales (CLS001) is the primary driver. The others are licensing and Milestone Payments and government Grants.
Who are Cellusion's main competitors?
Emerging players on record are CorNeat Vision, EyeYon Medical, Trefoil Therapeutics and Bit Bio. Aurion Biotech is listed as a direct peer. Others are iPS Academia Japan, Eversight and SightLife. Astellas Pharma is listed as a broad incumbent.
Does Cellusion have an API?
No public API is recorded for Cellusion.
What industry is Cellusion in?
Cellusion's product category is Regenerative Medicine / Cell Therapy. Its primary akta.pro industry code is HLAAAGAK, Ophthalmic Regeneration (cornea/retina), with a secondary code of HLAAABAE, Stem Cell Therapies (MSC/iPSC/HSC-derived).