Cutiss
CUTISS is a late-stage clinical Swiss biotech developing personalized bioengineered bilayer skin grafts (denovoSkin™) for severe burns and reconstructive surgery, supported by the denovoCast™ automation platform and a vitiligo device (VitiCell®), serving burn centers and reconstructive surgery hospitals.
- Company typePrivate
- Founded2017
- HeadquartersZürich, Switzerland
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Cutiss does
CUTISS AG is a late-stage clinical TechBio company, spun out of the University of Zurich's Tissue Biology Research Unit in 2017, that develops personalized bioengineered skin grafts for patients requiring skin surgery. Its lead product, denovoSkin™, is a living, bilayer (dermal and epidermal) human skin graft produced from a small patient biopsy and expanded to cover large wound areas, with demonstrated near-scarless regeneration, donor-site sparing, and the ability to grow with pediatric patients. The product is classified as an Advanced Therapy Medicinal Product (ATMP) and has received Orphan Drug Designation from Swissmedic, the EMA, and the FDA for the treatment of burns. The company operates a GMP-certified manufacturing facility in Zurich-Schlieren and is currently running a Phase 3 confirmatory study in adolescent and adult severe burn patients across more than 20 specialized hospitals in Switzerland and 8 EU member states.
The company's strategic moat rests on three reinforcing layers. First, a proprietary tissue-engineering process — including automated cell isolation, expansion, and skin-tissue formation — protected by multiple granted U.S. patents and embodied in the denovoCast™ automation platform, which is being industrialized through a strategic partnership with Tecan. Second, a regulatory moat via Orphan Drug Designation across three jurisdictions and an exclusive global license from IBSA Pharma to commercialize VitiCell®, an MDD CE-marked medical device for autologous cell grafting in vitiligo and hypochromatic post-traumatic scars. Third, a distribution moat built through clinical trial site relationships, compassionate-use engagements with leading U.S. centers such as Massachusetts General Hospital and Shriners Children's Boston, and a collaboration agreement with the Dutch burn center Rode Kruis Ziekenhuis to establish a future international production facility in the Netherlands.
CUTISS is a privately held, pre-revenue company that has raised over CHF 130 million across multiple funding rounds, including a CHF 56 million Series C closed in September 2025. Its go-to-market is enterprise field sales targeting hospital procurement channels for ATMPs, with planned future channels through specialized burn centers and reconstructive surgery departments in Switzerland, the EU, and the United States. The leadership team is led by CEO and co-founder Dr. Daniela Marino; in June 2026, former Tecan Group CEO Dr. Achim von Leoprechting was elected Chairman, succeeding co-founder Prof. Martin Meuli, signaling a deliberate shift toward commercial-scale operating discipline ahead of the expected end-2026 Phase 3 readout and subsequent regulatory submissions.
Cutiss firmographics
Firmographics- Name
- Cutiss
- Legal name
- CUTISS AG
- Website
- https://cutiss.swiss
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- CUTISS is a late-stage clinical Swiss biotech developing personalized bioengineered bilayer skin grafts (denovoSkin™) for severe burns and reconstructive surgery, supported by the denovoCast™ automation platform and a vitiligo device (VitiCell®), serving burn centers and reconstructive surgery hospitals.
- Ownership category
- akta.pro rank
Cutiss industry classification
Industry- Product category
- Regenerative Medicine / Tissue Engineering
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)
- SIC
- Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Wound Healing & Skin Regeneration (advanced dressings, skin substitutes) (HLAAAGAG)
- akta.pro secondary industries
- Wound Closure & Securement (Sutures, Staples, Tissue Adhesives, Skin Closure Strips) (HLAHALAD), Drug Product Fill-Finish & Aseptic Manufacturing Services (HLAAAKAB)
Keywords
Where Cutiss is headquartered
LocationHeadquarters
- HQ city
- Zürich
- HQ country
- Switzerland
- HQ region
- Europe
Offices3 records
Markets served
Cutiss business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Operations, Personnel, Supply Chain, Infrastructure, Marketing or Sales
Revenue model
- denovoSkin Product Sales: Once regulatory approval is obtained, the company will generate revenue through the sale of denovoSkin as an ATMP (Advanced Therapy Medicinal Product) to hospitals and burn centers for treatment of severe burns and reconstructive surgery. Revenue will be derived from hospital procurement channels.
- VitiCell Commercialization: CUTISS holds exclusive global rights to commercialize VitiCell, an MDD CE-marked medical device for skin re-pigmentation. Revenue will be generated upon EU MDR CE marking approval through dermatology and hospital channels.
Go-to-market motion2 records
Distribution channels4 records
Marketing channels7 records
Cutiss product offering
Product offeringCore offering
CUTISS develops and manufactures personalized, bioengineered dermo-epidermal (bilayer) human skin grafts (denovoSkin™) classified as Advanced Therapy Medicinal Products (ATMPs), produced from a small patient biopsy and expanded to cover large wound areas for treatment of severe burns and reconstructive surgery. The company operates in-house GMP-certified manufacturing in Zurich and is industrializing a patented closed automation platform (denovoCast™) to enable decentralized, scalable production. CUTISS also holds exclusive global rights to commercialize VitiCell®, a CE-marked medical device for autologous cell grafting in vitiligo patients.
Product overview
CUTISS is a late-stage clinical TechBio company pioneering skin tissue therapeutics and bioengineering. The company's core product is denovoSkin™, a personalized, bio-engineered bilayer (dermal-epidermal) human skin graft for burns and reconstructive surgery. Supporting the core product is denovoCast™, an automation platform for scalable, decentralized production of personalized skin tissue. Additionally, CUTISS commercializes VitiCell®, a CE-marked medical device for skin re-pigmentation in vitiligo patients, licensed from IBSA Pharma. The company operates in-house GMP manufacturing capabilities and is industrializing its automation platform in partnership with Tecan for large-scale production.
Differentiator
Problem solved
Functional benefit
Brands
- denovoSkin: Personalized bio-engineered dermo-epidermal skin graft for treatment of burns and reconstructive surgery. A living, bilayer skin graft composed of both epidermis and dermis that can be produced from a small patient biopsy.
- VitiCell
- denovoCast
Products and services
- denovoSkin™ Personalized, bioengineered dermo-epidermal (bilayer) human skin graft composed of both dermis and epidermis, manufactured from a small biopsy of the patient's own healthy skin and expanded to produce large quantities of new skin. Classified as an Advanced Therapy Medicinal Product (ATMP) for the treatment of severe burns and reconstructive surgery indications, demonstrating near-scarless regeneration, donor site sparing, and growth with pediatric patients.
- VitiCell® MDD CE-marked medical device for autologous cell grafting enabling skin re-pigmentation in patients with stable vitiligo and hypochromatic post-traumatic scars. CUTISS holds exclusive global rights to commercialize VitiCell® licensed from IBSA Pharma.
- denovoCast™ First-in-class, patented, fully-closed, end-to-end automation platform enabling decentralized production and cost-effective scale-up of personalized skin tissue therapy. Modules include cell isolation, cell expansion, and skin tissue formation, supporting the manufacturing of large personalized skin grafts.
Quantifiable outcome
- Significantly better scar quality than standard of care (STSG) at 3 months, maintained at 12 months
- +3 more outcomes
Companies that use Cutiss
Customer profileNamed customers3 records
Segments3 records
Ideal customer profiles2 records
Cutiss technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Cutiss partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core, major and supporting.
- Rode Kruis Ziekenhuis (RKZ) / Red Cross BeverwijkcoreCollaboration agreement signed with RKZ, one of the EU's leading burn centers. RKZ participated in Phase 2 and Phase 3 trials. The agreement sets the stage for establishing CUTISS' first international commercial production facility in the Netherlands once denovoSkin is approved.
- TecancoreStrategic partnership to industrialize CUTISS' automated manufacturing solution from engineering development to industrial-grade production. Tecan, a global leader in laboratory automation with Swiss roots, is transitioning CUTISS' denovoCast automation platform to production scale. This collaboration supports bringing denovoSkin to market at scale and expanding into new areas of regenerative medicine.
- IBSA PharmamajorCUTISS received exclusive global rights to commercialize VitiCell, an MDD CE-marked medical device developed by IBSA Pharma for skin re-pigmentation/autologous cell grafting for vitiligo treatment.
- CSEMsupportingCollaboration on automation platform development for skin tissue manufacturing. Initial automation development conducted with CSEM and Innosuisse support.
- Massachusetts General HospitalmajorLeading US burn center that performed the first U.S. compassionate use of denovoSkin in pediatric reconstructive surgery (2024) and published peer-reviewed case report. Authorized by FDA under single patient IND application.
- Shriners Children's Hospital BostonsupportingCollaborated on first U.S. compassionate use case for pediatric burn reconstructive surgery alongside Massachusetts General Hospital.
Scale indicators7 records
Recent moves8 records
Expansion highlights7 records
Cutiss competitors and assessment
Company assessmentDirect peers
- Organogenesis Holdings: Commercial-stage regenerative medicine company marketing Apligraf and Dermagraft - leading living cell-based skin substitutes for wounds and burns. Directly comparable as a competitor in the bioengineered skin substitute category, though focused on allogeneic off-the-shelf products rather than personalized autologous grafts.
- AVITA Medical: Markets the RECELL System, an autologous cell harvesting device for burns and soft tissue reconstruction. Closely comparable as a personalized, point-of-care skin regeneration technology serving the same burn center and reconstructive surgery customer base as CUTISS.
- Vericel Corporation: Develops and commercializes autologous cell therapies including Epicel (cultured epidermal autografts) for severe burns. A direct competitor in the personalized skin graft space for major burns, with established US commercial infrastructure that represents both a benchmark and a competitive threat.
- Polynovo Limited: Develops and commercializes NovoSorb biodegradable temporizing matrix for severe burns and reconstructive surgery. Direct comparator as an emerging skin substitute technology targeting the same burn center customer base with a different architectural approach (synthetic dermal scaffold vs. living bilayer).
Broad incumbents
- Integra LifeSciences: Large diversified medical device company with a significant regenerative tissue technologies portfolio including Integra Dermal Regeneration Template for burns and reconstructive surgery. Established incumbent serving the same surgical specialties with broader product breadth.
- Smith+Nephew: Global medical device company with advanced wound management and skin substitute offerings (including legacy Dermagraft rights via prior acquisitions). Broad incumbent competing in burn and reconstructive surgery with established hospital sales channels.
- MiMedx Group: Commercial-stage regenerative medicine company selling dehydrated human amnion/chorion membrane allografts for wound care and surgical recovery. Competes for similar hospital budgets in chronic wounds and surgical applications, though focused on placental tissue rather than personalized skin grafts.
- Mallinckrodt Pharmaceuticals (Stratatech): Through its Stratatech subsidiary, develops living skin substitute products including StrataGraft for severe burns. Comparable as a bioengineered skin substitute competitor targeting the same regulatory (orphan drug) and clinical pathway, but with allogeneic rather than autologous manufacturing.
- Convatec Group: Global medical products company with advanced wound care portfolio serving burn centers and wound clinics. Indirect competitor in adjacent advanced wound healing applications, representing both an opportunity for partnership and a competitive channel presence.
Others
- Tecan Group: Global leader in laboratory automation and a strategic manufacturing partner to CUTISS for industrializing the denovoCast platform. Included as a strategic ecosystem partner rather than competitor - represents both a key commercialization enabler and a concentration risk through partnership dependency.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks7 records
Key highlights7 records
Customer concentration
Cutiss social profiles
Digital presenceCutiss compliance and trust
Trust signalCompliance6 records
Cutiss financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cutiss leadership team
Management profileNumber of profiles
Profiles8 records
Cutiss subsidiaries and ownership
Company hierarchySubsidiaries1 record
Cutiss funding detail
Funding detailFunding overview
Funding rounds7 records
Investors9 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cutiss 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 Cutiss
What does Cutiss do?
CUTISS develops and manufactures personalized, bioengineered dermo-epidermal (bilayer) human skin grafts (denovoSkin™) classified as Advanced Therapy Medicinal Products (ATMPs), produced from a small patient biopsy and expanded to cover large wound areas for treatment of severe burns and reconstructive surgery. The company operates in-house GMP-certified manufacturing in Zurich and is industrializing a patented closed automation platform (denovoCast™) to enable decentralized, scalable production. CUTISS also holds exclusive global rights to commercialize VitiCell®, a CE-marked medical device for autologous cell grafting in vitiligo patients.
Is Cutiss a public or private company?
Cutiss is a private company. It is classified as venture growth investor backed and is currently operating.
When was Cutiss founded?
Cutiss was founded in 2017. It employs 11 to 50 people.
Where is Cutiss based?
Cutiss is headquartered in Zürich, Switzerland, in the Europe region.
How does Cutiss make money?
Two revenue lines are on record. denovoSkin Product Sales are the primary driver. The others are vitiCell Commercialization.
Who are Cutiss's main competitors?
Direct peers on record are Organogenesis Holdings, AVITA Medical, Vericel Corporation and Polynovo Limited. Broad incumbents are Integra LifeSciences, Smith+Nephew, MiMedx Group, Mallinckrodt Pharmaceuticals (Stratatech) and Convatec Group. Tecan Group is listed as an others.
Does Cutiss have an API?
No public API is recorded for Cutiss.
What industry is Cutiss in?
Cutiss's product category is Regenerative Medicine / Tissue Engineering. Its primary akta.pro industry code is HLAAAGAG, Wound Healing & Skin Regeneration (advanced dressings, skin substitutes), with a secondary code of HLAHALAD, Wound Closure & Securement (Sutures, Staples, Tissue Adhesives, Skin Closure Strips). Its NAICS code is 325414 and its SIC code is 2836.