News

CUTISS has completed patient recruitment in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns. This randomized, controlled trial compares denovoSkin™ to the current standard of care, autografting, using an intra-patient control design. It is one of three Phase 2 trials designed to assess denovoSkin™ – a personalized, bioengineered skin graft – across different patient populations and indications. denovoSkin™ has also been used to treat children on a compassionate use basis where existing therapies are not sufficient or suitable. Severe burns in children are associated with lifelong consequences, including scarring and restricted growth. By generating clinical evidence in pediatric patients, this study supports the broader development of denovoSkin™ as a skin tissue therapy designed to reduce donor site burden and improve long-term scar outcomes. With recruitment now completed, the study moves into follow-up and data analysis. Results will contribute to the broader clinical development program of denovoSkin™, currently in Phase 3 for adolescents and adults. In February 2025, CUTISS announced positive long-term efficacy and safety readout in the Phase 2 clinical trials of denovoSkin™ in reconstructive surgery as well as in burns treatment (press release available here). Newsroom

CUTISS is making steady progress in the clinical development of denovoSkin™, its personalized, bio-engineered skin graft, as part of the ongoing Phase 3 clinical trial for the treatment of severe burns. The first enrolled patients have now been successfully grafted with denovoSkin™ at clinical sites in the Netherlands and Spain, with additional recruitment underway in France and Italy. There are eight sites involved in this confirmatory study in the EU. In parallel, the trial has also been approved in Switzerland by Swissmedic, with preparations in place to begin patient recruitment. We thank the clinical teams, surgeons, patients, collaborators, and stakeholders whose work and dedication is driving this important progress. Newsroom

CUTISS has been granted a new patent in the United States for a core element of its automated platform used to manufacture personalized, bio-engineered human skin grafts. The patent (US Patent No. 12,286,611), titled “Tissue culture vessel for preparation of compressed hydrogel skin grafts and related methods and systems,” protects a key component of the company’s automated tissue engineering process for denovoSkin™, currently in late-stage clinical development for skin surgery. This patent supports CUTISS’ broader strategy to industrialize personalized skin tissue therapy through standardization, reproducibility, and scalability. The company’s automation efforts have been commenced in collaboration with CSEM and INNOSUISSE and are now being advanced in collaboration with Tecan (read our partnership announcement here), a global leader in laboratory automation. The granting of this U.S. patent further strengthens our international intellectual property portfolio in the field of regenerative medicine and tissue bio-engineering. Newsroom Read Press release

CUTISS has received authorization from the European Medicines Agency (EMA) to commence the Phase 3 clinical trial for our lead product denovoSkin™ in adult & adolescent severe burn patients. Running across eight countries, including Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, and Spain, the Phase 3 confirmatory study will validate the efficacy and functionality of denovoSkin™ – a living, personalized bilayer bioengineered skin graft – in achieving wound closure and reducing scarring in patients with severe burns compared to standard of care. We are grateful to our entire CUTISS team, the clinical partners, all collaborators, patients, investors, and stakeholders who are making this pioneering work possible. Together, we continue to pave the way for transformative solutions in regenerative medicine and skin surgery. Newsroom Link to EMA page

A significant milestone in pediatric burn care in Italy has been achieved with the inauguration of the new pediatric burn center at Santobono Hospital in Naples, a new center of excellence at European level. Since 2021, Santobono has been the coordinating center in Italy for our Phase 2 clinical trial of denovoSkin™, the bioengineered autologous human skin tissue. Notably, Santobono was the first pediatric center in the world to perform a denovoSkin™ transplant in a neonate. We feel incredibly proud and honored to collaborate on this groundbreaking project with Dr. Marcello Zamparelli, underscoring our commitment to change the status quo in skin surgery and improve patient outcomes with cutting-edge regenerative medicine.  The new facility will enable quicker interventions for patients and allow continuous control, monitoring, and verification of the therapies and innovative treatments they receive. Burns are the third leading cause of death in children. In Campania region of Italy, between 2022 and 2023, 120 young patients were treated. Of these, 70% had severe or very severe burns; 80% required surgical hospitalizations that lasted an average of 15 days. It is in this context that the new pediatric burn center at Santobono-Pausilipon has been inaugurated. This news and announcement has featured across Italian media including in RAI, La Presse Il Mattino, ANSA, and Naples Today. Newsroom Link to RAI reportage

We’re proud to announce the recent inauguration of CUTISS Innovation, the French subsidiary of CUTISS AG, at the renowned Sophia Antipolis technology park in France. CUTISS Innovation is supporting and extending our R&D activities in regenerative medicine, including skin pigmentation, aging and healing. The Provence-Alpes-Côte d’Azur region is renowned as an innovation and dermatology hotspot, and offers a rich ecosystem of world-leading public and private entities specializing in biotech and skin. The event was held on 5 October 2023 in the presence of the Mayor of Antibes, M. Jean Leonetti, and the Mayor of Biot, M. Jean-Pierre Dermit, alongside all our esteemed guests. Vincent Ronfard, our President of CUTISS Innovation and Chief Innovation Officer of CUTISS AG, remarked: “We are grateful to mark this occasion in the presence of our distinguished guests. The Sophia Antipolis technology park and the Provence-Alpes-Cote d’Azur region is the ideal hotspot for innovation in dermatology. We have already collaborated with leading private and public players across healthcare, biotechnology, and pharma, and look forward to establishing other joint research projects. Leveraging our experience to date, our goal is to innovate, develop and provide breakthrough solutions for various skin-related issues.” Since launching last year, the CUTISS Innovation team has been busy transferring technology, onboarding key professionals, and making the laboratory operational. You can watch the highlights from the event here  Newsroom Link to Highlights on Youtube

CUTISS is delighted to announce that Innosuisse, the Swiss Innovation Agency, has awarded the company a CHF 2.5 million grant to advance our pioneering automation program. This grant will support the industrialization of denovoCast™, the world’s first machine that can bio-engineer large, personalized skin tissue grafts, in a fully closed way. This is yet another stamp of quality approval for our ambitious and unique automation program, and we are grateful to Innosuisse and their continued support. Taking the denovoCast™ machine to clinical readiness CUTISS unveiled the first denovoCast™ machine in 2021, demonstrating the feasibility of automating the bio-engineered skin manufacturing process. The machine was developed in collaboration with Innosuisse and CSEM. Since then, the machine has undergone R&D testing at CUTISS and we are now ready to start the process of industrialization that will take denovoCast™ to clinical readiness at the service of adults and children with severe skin injuries, such as deep burns. Automation is key to scale up production of denovoSkin™ CUTISS is working to scale-up the production of denovoSkin™ through automation. The company has developed its own unique approach to bioengineering human skin tissue composed of three modules: cell isolation (Semotiss™), cell expansion (Quantum®), and skin tissue formation (denovoCast™). Starting form a patient’s biopsy and working in sequence, the modules produce the personalized dermo-epidermal skin graft denovoSkin™. Newsroom

The paper published in Burns Open has presented the case of a four day-old neonate suffering from life threatening burns, involving 40% total body surface area burn. The patient received 260 cm2 of denovoSkin, covering 20% TBSA, as part of a clinical trial sub-study in Italy. The management of such cases represents an unprecedented challenge. The published paper is based on a one-year follow-up of the patient, and these results deliver further proof of concept that denovoSkin can be successfully applied in pediatric severe burns. Specifically, the case report has noted that: Clinically, denovoSkin grafted areas show a matured skin after 3–6 months with minimal or no detectable scarring, whereas conventional grafting was not yet matured and mostly associated with moderate to massive hypertrophic scarring. denovoSkin yields close to normal skin in terms of softness, elasticity, pliability, growth, and mechanical robustness. The full case report can be read online, see link below. Newsroom Link to Case Report

CUTISS is pleased to announce that a tissue graft patent has been granted by the European Patent Office for the personalized bioengineered human skin tissue therapy developed by CUTISS. The patent (3174563) has been granted pursuant to Article 97(1) EPC to University of Zurich (UZH) where the founders of CUTISS worked at the time of the patent filing (2014), and is exclusively licensed to CUTISS. This patent strengthens the company’s intellectual property position in human tissue graft technologies. CUTISS’s first skin tissue therapy product denovoSkin is currently in Phase IIb clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. The mention of the grant has been published in the European Patent Bulletin 22/24. Newsroom European patent bulletin 22/24

CUTISS’s first onsite manufacturing facility in Schlieren, Zurich, has received the certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from the regulator Swissmedic, the Swiss Agency for Therapeutic Products. The GMP and GDP certifications authorizes the collection, manufacturing, testing, storage, release, and distribution of Transplant Products (TpP), Gene Therapy (GT) and Genetically Modified products (GM) for human use. This important milestone completes the expansion of CUTISS’ facilities, led by Kathi Mujynya and her Operations team. The state-of-the-art manufacturing facility is fully equipped for the manufacturing and testing of tissue-engineered products, notably for the personalized human skin tissue therapy denovoSkin which is currently in Phase 2 clinical trials. The facility in Schlieren is expected to become fully operational in Q1-Q2 2022. Until now, the company’s products have been manufactured at the GMP facility of Wyss Zurich Regenerative Medicine Technologies Platform, University of Zurich. Newsroom