CUTISS raises additional CHF 31 million to support ongoing Phase 3 trials
The second tranche of the Series C round brings total funds raised to more than CHF 125 million. The proceeds will be used to progress with the Phase 3 trial of the lead product denovoSkin and to prepare for its commercialization. The funds will also advance the industrialization and clinical readiness of the world’s first automated manufacturing platform for personalized tissue therapy.
CUTISS’ personalized, bioengineered skin graft denovoSkin is designed for patients undergoing skin surgery for burns, reconstructive and plastic procedures. Long-term follow-ups to date have shown that it drastically spares donor sites, matures quickly, safely restores skin function, regenerating in a near-scarless manner, and growing with the patient. The Phase 3 confirmatory study in adolescent and adult severe burn patients started enrolling patients this year; it has a total of 2-year follow up period. The first data set is expected by end of 2026.
The funds from the Series C round will be used for the clinical trial and the industrialization of CUTISS’ manufacturing platform. In April 2025, CUTISS announced a strategic partnership with Tecan to enable the transition of CUTISS’ automated manufacturing solution from engineering development to industrial-grade production. The Series C co-lead investors – the family office of Giammaria Giuliani, a longstanding lead investor, and a US family represented by Shiloh Advisors AG – were joined in 2025 by new investors ranging from family offices to industry players, as well as an investor collective at Swisspreneur.
Agreement for first production center
Among the equity investors is Rode Kruis Ziekenhuis / Burn Center Beverwijk (RKZ). In addition to the investment CUTISS and RKZ have signed a collaboration agreement, which could see the creation of CUTISS’ first international commercial production facility in the Netherlands, once denovoSkin is commercially approved. The agreement is set on the possibility for CUTISS to open a center of excellence for denovoskin production in Beverwijk.
Dr. Daniela Marino, CEO and co-founder of CUTISS, stated: “The successful closing and partnerships demonstrates confidence in our vision and ability to bring transformative skin therapies to patients. We’re grateful for the continued trust of existing investors and warmly welcome new investors on board, including key strategic ones. The agreement with RKZ sets the stage for our future expansion with the potential to revolutionize the skin surgery market in Europe and globally.”
Nadine Vieleers, CEO Rode Kruis Ziekenhuis / Burn Center Beverwijk, commented: “As a clinical institution dedicated to advancing burn care, we’re committed to support CUTISS 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.”
Second product in the pipeline
The proceeds from the funding round will be also used to enable the market launch of VitiCell. CUTISS has exclusive rights to globally commercialize VitiCell, an MDD CE-marked medical device developed by IBSA Pharma. The device enables autologous cell grafting for skin re-pigmentation, offering a personalized treatment option for patients with vitiligo. In the future, patients treated with denovoSkin may also benefit from this therapy. CUTISS will launch VitiCell once the EU MDR CE marking is granted.
(Press release / SK)