CUTISS closes CHF 56M Series C round and signs agreement with leading EU burn center
Switzerland, 10 September 2025 – CUTISS, a late-stage clinical TechBio at the forefront of tissue therapeutics and regenerative medicine, has announced the closing of its Series C round for a total of CHF 56M with existing and new investors, bringing total funds raised to more than CHF 125M.
The proceeds will be used to progress with the Phase 3 trial of the lead product denovoSkin™, which started earlier this year, 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, a key component for bringing denovoSkin™ to market at scale.
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.
CUTISS has also signed a collaboration agreement with its new investor Rode Kruis Ziekenhuis (RKZ), which could see the creation of CUTISS’ first international commercial production facility in the Netherlands, once denovoSkin™ is commercially approved. RKZ is a leading EU clinical trials center, participating in the Phase 2 and Phase 3 trials for denovoSkin™
“The agreement with RKZ sets the stage for our future expansion with the potential to revolutionize the skin surgery market in Europe and globally,” continued Dr. Marino.
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.”
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.
Silvan Krähenbühl, speaking on behalf of Swisspreneur, commented: “We’re proud that Swisspreneur participated in the latest funding round of CUTISS, a pioneering Swiss biotech company. Their mission to revolutionize skin regeneration is exactly the kind of bold innovation we love to support, and we’re excited for the next phase in the journey ahead.”
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.
Monica Manotas, Tecan CEO, commented: “Our ongoing partnership with CUTISS to industrialize skin tissue therapy highlights our commitment to advancing automation in high-growth areas such as cell biology and personalized medicine. Tecan’s expertise and technologies deliver precision and reproducibility at scale, enabling customers to transform research breakthroughs into real world solutions to improve people’s lives and health.”
denovoSkin™ is human, living skin – on demand
The personalized (autologous), bioengineered skin graft denovoSkin™ is designed for patients undergoing skin surgery for burns, reconstructive and plastic procedures.
denovoSkin™ is bilayer, composed of both dermis and epidermis. 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. As a result, it has the potential to significantly reduce healthy skin harvesting and scar care (including follow-up corrective surgeries), and improve quality of life.
The Phase 3 confirmatory study in adolescent and adult severe burn patients is recruiting in Switzerland, and the European Union across 8 member states. The first data set from this trial is expected at the end of 2026.
denovoSkin™ has also been accessible under named-patient basis (compassionate use). It has Orphan Drug Designation (ODD) for the treatment of burns from Swissmedic, EMA, and the FDA, which also provides fast-track regulatory pathways and extended market exclusivity.
Scaling up with first-in-class automated production
CUTISS is working to scale-up the production of denovoSkin™ through automation. The company has already developed a first-in-class automation platform for the scalable production of personalized tissue therapy – a patented, fully-closed, end-to-end system that enables de-centralized production, cost-effective scale-up, and high return on investment. Platform industrialization is now ongoing.
VitiCell® offers personalized treatment for patients with skin pigmentation disorders
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.