CUTISS Raises €57.9M Series C to Advance Phase 3 Trial of Personalized Skin Graft Therapy
核心洞察
CUTISS (搜索) secured €57.9 million in Series C funding, bringing total capital raised to over €129.3 million to advance its personalized bioengineered skin graft denovoSkin through Phase 3 trials.
The company's denovoSkin therapy has received Orphan Drug Designation from Swissmedic (搜索), EMA, and FDA for burn treatment, with first Phase 3 data expected by end of 2026.
CUTISS (搜索) signed a strategic collaboration with Rode Kruis Ziekenhuis (搜索) burn center, which invested in the round and will potentially host the company's first international production facility.
Swiss biotech company CUTISS (搜索) has closed a €57.9 million Series C funding round to advance its personalized bioengineered skin graft therapy through Phase 3 clinical trials. The funding brings the company's total capital raised to over €129.3 million since its 2017 launch as a University of Zurich spin-off.
The investment will primarily support the ongoing Phase 3 clinical trial of denovoSkin, a personalized skin graft designed for patients undergoing surgery for burns (搜索), reconstruction, or plastic procedures. The trial is currently recruiting patients across Switzerland and eight EU member states, with the first dataset expected by the end of 2026.
Strategic Partnership Unlocks Funding Momentum
The funding round was co-led by long-standing investor Giammaria Giuliani's family office and a U.S. family represented by Shiloh Advisors AG. A key development was the strategic investment from Rode Kruis Ziekenhuis (搜索) (RKZ), one of Europe's leading burn centers and a clinical trials partner for CUTISS (搜索).
"Once the burn unit hospital in the Netherlands invested, it sent a strong signal," said Dr. Daniela Marino, CEO and co-founder of CUTISS (搜索). "They saw that Phase 3 was happening, the timing was clear, and the product was truly on track. That investment unlocked the rest—suddenly, the other investors who had been hesitating for so long felt the FOMO."
The collaboration with RKZ extends beyond investment, laying groundwork for CUTISS (搜索)'s first international commercial production facility in the Netherlands, pending regulatory approval of denovoSkin.
Orphan Drug Status Across Multiple Jurisdictions
denovoSkin has received Orphan Drug Designation from Swissmedic (搜索), the European Medicines Agency (搜索), and the U.S. FDA for burn treatment. The therapy is a bilayer bioengineered skin graft composed of both dermis and epidermis, designed to drastically spare donor sites while restoring skin function in a near-scarless manner.
Long-term follow-up data has shown that denovoSkin matures quickly, safely restores skin function, and grows with the patient. According to Marino, the product's versatility extends beyond burns (搜索): "Each time, the product is freshly prepared for the individual patient. If the wound bed is well prepared, it doesn't really matter why the wound is there—whether from burns or reconstruction."
The Phase 3 trial includes almost 20 sites and focuses on adolescent and adult patients with severe burns (搜索). Previous Phase 2 trials demonstrated consistent outcomes across various reconstructive cases, from scar revisions to tumor resections to gender reassignment surgery.
Scaling Production Through Automation
CUTISS (搜索) is simultaneously scaling its manufacturing capabilities through a fully automated platform developed in partnership with Swiss-American company Tecan (搜索). The patented, fully-closed, end-to-end system enables decentralized production and cost-effective scale-up of personalized tissue therapies.
"Tecan (搜索) was a real jackpot for us in the first quarter," Marino noted. "Up to now, our machines were developed as prototypes with engineers. But what we need are real, deployable devices—and with Tecan, we're moving very quickly toward that finish line."
Expanding Portfolio with Vitiligo Treatment
Beyond denovoSkin, CUTISS (搜索) holds exclusive global commercialization rights for VitiCell (搜索), a CE-marked medical device developed by IBSA Pharma (搜索) for vitiligo (搜索) treatment. The device enables autologous cell grafting for skin re-pigmentation, allowing clinicians to isolate melanocytes (搜索) from pigmented skin and apply them to depigmented lesions within an hour.
"It's still personalized, still cell therapy, and a perfect addition to our approach," Marino explained. The company plans to launch VitiCell (搜索) once EU MDR certification is granted, targeting a market of over one million skin surgeries performed annually in Europe.
Market Positioning in Growing Sector
CUTISS (搜索) positions itself as a leader in the expanding tissue engineering field. According to Marino, the company is "the only company with a product already in Phase 3 and machines close to being market-ready" in this sector.
The funding round included new investors ranging from family offices to industry players, as well as Swisspreneur (搜索), an investor collective supporting Swiss innovation. "We're proud that Swisspreneur participated in the latest funding round of CUTISS (搜索), a pioneering Swiss biotech company," said Silvan Krähenbühl, speaking on behalf of Swisspreneur.
Nadine Vieleers, CEO of Rode Kruis Ziekenhuis (搜索), emphasized the clinical significance: "As a clinical institution dedicated to advancing burn care, we're committed to support CUTISS (搜索) and the development of denovoSkin. We're excited to continue our closer collaboration, and the agreement we've signed sets out our vision for bringing their revolutionary skin tissue therapy to our patients as a priority."