May 2025

CUTISS has completed an interim analysis in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns, with positive results. The randomized, controlled trial enrolled 12 pediatric patients, comparing denovoSkin™ to the current standard of care (autografting) using an intra-patient control design. The results from the interim analysis confirm a favorable safety profile and show positive signals of efficacy, supporting the continued development of denovoSkin™ for use in pediatric burn care. Children with extensive burns are particularly vulnerable to complications related to scarring, such as impaired growth and mobility, and visible disfigurement. The findings of this study, together with the results obtained in several pediatric compassionate burn patients, represent an important step in pediatric skin surgery, aiming to offer a personalized, donor site-sparing solution that also addresses the lifelong impact of scarring on quality of life. The 1 year analysis of the trial will follow; the trial has a total of 3 years of follow-up. In parallel, CUTISS is advancing denovoSkin™ in a Phase 3 clinical trial for adolescents and adults with severe burns in the E.U. and Switzerland, as detailed in our news on 6 May 2025. Newsroom Read News from 6 may 25

The abstract published in the Journal of Burn Care & Research (March/April 2025) by the American Burn Association (57th annual meeting) describes the compassionate use of denovoSkin™ in reconstructive surgery for a three-year-old child with 90% total body surface area (TBSA) burn injuries at Massachusetts General Hospital, a leading U.S. burn center. The treatment was carried out under a compassionate use exemption from the U.S. FDA. The case involved contracture release surgeries and treatment of non-healed wounds and unstable scars. The denovoSkin™ grafts demonstrated an engraftment rate greater than 95%, with the resulting skin described as durable and manageable, comparable to traditional full-thickness autografts but with advantages over conventional cultured epidermal autografts (CEAs). The authors conclude that this use of denovoSkin™ introduces a new treatment paradigm in both acute and reconstructive burn surgery, especially for patients with extensive injuries and limited donor skin. This case report adds to the growing body of clinical experience supporting denovoSkin™ as a potential breakthrough in skin tissue therapy, including in pediatric reconstructive care under extreme conditions. As the paper’s authors note: “The development of an autologous, full-thickness skin replacement remains the holy grail for the treatment of full thickness skin loss from burns, wounds, and trauma.” The abstract can be read online here: Burn Care & Research  Full citation: Matthew Supple, Robert Sheridan, Jeremy Goverman, 846 Pediatric Compassionate Use of a Novel, Autologous, Engineered, Hydrogel Skin Graft with Keratinocytes and Fibroblasts, Journal of Burn Care & Research, Volume 46, Issue Supplement_1, March/April 2025, Page S288. Newsroom Read Article

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