Bio-engineered skin grafts developed by researchers at the University of Zurich are being used to treat victims of severe burns, including those injured in the recent fire disaster in Crans-Montana. The incident resulted in 40 deaths and left over 100 people injured, with many suffering burns on more than 60 percent of their bodies.
Specialized centers at the University Children's Hospital Zurich and University Hospital Zurich are providing care for several patients from the disaster. Standard procedures involve stabilizing patients, removing dead skin to prevent infection, and covering wounds with temporary materials before performing autografting. However, these methods have limitations due to a shortage of healthy donor skin and issues such as scarring and lack of elasticity, especially in children.
Research into advanced bilayer skin grafts began at the University of Zurich 25 years ago. Between 2001 and 2016, work at the Tissue Biology Research Unit led to a promising substitute that includes both epidermal and dermal cells. This approach allows for elastic grafts that can grow with pediatric patients.
Biotechnologist Daniela Marino, now CEO of Cutiss—a spin-off company founded in 2017—explained: "We developed a living human skin tissue graft that is cultivated in the laboratory from a small skin biopsy the size of a post-stamp taken from the patient." She added: "The key point is that it is a personalized bilayer graft." Marino emphasized there is no risk of rejection since each graft uses the patient's own cells.
Cutiss can currently produce multiple skin grafts measuring up to 50 square centimeters within four weeks. Their product, denovoSkin, is undergoing late-stage clinical development for use in burn treatment and reconstructive surgery for both children and adults. A Phase 3 clinical trial began in spring 2025 across eight EU countries and Switzerland, involving twenty burn centers including University Hospital Zurich.
Marino commented on regulatory progress: "Our product is an advanced therapy, and now we need Phase-3 data before we can proceed with the full regulatory approval process in different geographies, including Switzerland."
In addition to ongoing trials, denovoSkin has been used under compassionate use protocols in eight individual cases over the past decade. Following the Crans-Montana disaster, biopsies from some burn victims have been sent to Cutiss for bio-engineering denovoSkin grafts.
Producing living personalized tissue requires specialized infrastructure and standardized processes. To address scalability challenges, Cutiss has developed automated manufacturing systems with Tecan as an industry partner.
Since its founding as a UZH spin-off specializing in regenerative medicine and tissue engineering, Cutiss has moved through various research phases supported by EU funding. Clinical applications began after initial success treating pediatric patients between 2014 and 2016 during Phase 1 studies at University Children’s Hospital Zurich. Further safety and efficacy testing continues through ongoing clinical trials.
Research efforts also continue at UZH into future generations of bilayer skin grafts incorporating blood vessel formation and pigmentation capabilities.
