March 2026

A new peer-reviewed publication reports 1-year results from a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial evaluating denovoSkin™ in reconstructive surgery in patients of all ages. The study evaluated denovoSkin™ against autologous split-thickness skin grafts (STSG) in 23 patients with full-thickness skin defects requiring planned elective reconstruction. According to the publication, denovoSkin™ demonstrated significantly better scar quality than STSG at 3 months, with benefits maintained at 12 months. Elasticity parameters also consistently favored denovoSkin™, and significant donor site sparing was also demonstrated. The authors conclude that denovoSkin™ is a safe and effective treatment for full-thickness skin defects and provides favorable skin quality over 12 months.  The study was conducted across sites in Italy, the Netherlands and Switzerland. denovoSkin™ was manufactured under GMP conditions, first at Wyss Zurich and thereafter at CUTISS in Schlieren, Switzerland.  This publication adds to the growing body of clinical evidence supporting denovoSkin™ as a personalized, bio-engineered dermo-epidermal skin graft for the treatment of acute and elective full-thickness skin defects. The paper, published in the Journal of Tissue Engineering, is titled “Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in reconstructive surgery: 1-year results of a prospective, randomized, intra-patient controlled, multicenter phase II clinical trial” and can be found online here. Our clinical development pipeline is available here. Newsroom Publication

CUTISS has been granted a new patent in the United States for a disposable system and method used in the preparation of compressed hydrogels for tissue engineering applications. The patent (U.S. Patent No. 12,564,662 B2), titled “Disposable system and method for preparing a compressed hydrogel”, protects a fully disposable system for casting, polymerizing and compressing a hydrogel, as well as methods for producing a scaffold for the generation of artificial tissue products, including skin grafts. The patent was granted on March 3, 2026, and is assigned to CUTISS AG, Schlieren. The patented invention relates to a core part of the tissue engineering process by enabling the preparation of compressed hydrogels in a fully disposable format. According to the patent, this approach is designed to reduce contamination risk, simplify workflow, lower production complexity and support improved quality and scalability in graft manufacturing. This new U.S. patent further strengthens CUTISS’ intellectual property portfolio in regenerative medicine and tissue bioengineering. It also supports the company’s broader strategy to industrialize personalized skin tissue therapy through robust, standardized and scalable manufacturing approaches for denovoSkin™, CUTISS’ lead product currently in late-stage clinical development in Switzerland and the European Union. denovoSkin™ is currently in Phase 3 clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA. Newsroom

A new peer-reviewed report in the Journal of Burn Care & Research describes the compassionate use of denovoSkin™ in a pediatric patient with extensive burn injuries treated at Massachusetts General Hospital (Boston, USA). The publication details reconstructive procedures including contracture release and treatment of unstable scars, reporting high engraftment rates, durable healed skin, and handling characteristics comparable to full-thickness autografts. This report provides additional clinical detail following the first U.S. compassionate use announced in 2024 and the abstract presented in 2025. In parallel, CUTISS continues to advance denovoSkin™ in an ongoing Phase 3 clinical trial in the European Union (8 countries) and Switzerland for adult and adolescent patients with severe burns. Our clinical development pipeline is available here. The published report can be accessed online here. Newsroom Report