Advancing skin surgery with first-in-class personalized skin tissue therapeutics
Skin is the body’s largest organ. Every day around the world, patients require or demand surgical interventions to restore skin function in acute (burns and trauma) or elective indications (scar revisions, giant nevi or tumor resections, reconstructive and plastic surgery, etc.).
The current standard of care in burn, plastic and reconstructive surgery – autografting – is limited by donor site shortage and leads to permanent, debilitating, and disfiguring scars. Many patients require multiple corrective surgeries, psychosocial rehabilitation and intense home care.
CUTISS is redefining skin surgery by replacing autografting with denovoSkin™, our first-in-class, personalized skin tissue therapy that can be produced in large quantities and that regenerates in a scarless manner.
Clinical development program
denovoSkin™ is being clinically tested for burns and reconstructive indications in children and adults, receiving overwhelmingly positive feedback from leading medical experts and surgeons.
PHASE I CLINICAL TRIAL – SAFETY STUDY
A Phase I clinical trial for denovoSkin™ was completed with a five-year follow-up period in 2021, with 10 paediatric patients at the University Children’s Hospital Zurich, Switzerland. This study assessed the safety of the product in children and adults who underwent skin surgery due to burns or reconstructive surgeries. Each patient had a defined wound area treated with a single denovoSkin™ graft. The study was successfully completed, confirming the product’s safety in this first-in-human clinical trial.
PHASE II CLINICAL TRIALS – SAFETY AND EFFICACY STUDIES
Following the successful Phase I trial, denovoSkin™ is being further evaluated for its safety and efficacy in three randomized, controlled Phase II clinical trials. These trials follow a very similar design but differ in the patient population and indication: adult and adolescent burns, pediatric burns, and all ages reconstructive surgery. In those trials denovoSkin™ is compared to today’s standard of care, autografting, on every patient (intra-patient control). Long-term safety and efficacy readouts have been successful in demonstrating denovoSkin™’s donor site-sparing capacity and significant scar quality improvements, in comparison to autografting.
PHASE III CLINICAL TRIAL – SAFETY AND EFFICACY STUDY
A randomized, controlled Phase III clinical trial is being performed to confirm the product’s safety and efficacy. This trial has been approved in the EU and Switzerland and has started enrolling adult and adolescent burn patients under an orphan drug designation.
LIFE-SAVING BASIS TREATMENT
Under compassionate authorization, denovoSkin™ can be made available directly from CUTISS to a physician treating a patient in critical condition.
If you are a healthcare professional requesting more information regarding compassionate use, please contact CUTISS.
Clinical and scientific publications
March/April 2025
February 2025
Out of this World: Wound Healing on Earth and in Space
September 2024
Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial
November 2023
Nature Reviews Disease Primers - Abstract
