CUTISS AG’s denovoSkin performed well in a Phase 2 clinical trial of patients undergoing reconstructive skin surgery for various conditions, according to an interim analysis of the data.
The full data analysis with the one year follow up will be available in early 2025.
DenovoSkin is a personalized, bio-engineered dermo-epidermal human skin graft, created from a small biopsy of the patient’s healthy skin and expanded to produce large quantities of new skin. It aims to significantly reduce the need for healthy skin harvesting, significantly reduce scarring, as well as reduce the need for follow-up corrective surgeries.
“We are thrilled with this first positive assessment of efficacy from the Phase 2 trial in reconstructive surgery,” says Dr. Daniela Marino, CEO of CUTISS, in a news release. “These results confirm CUTISS’s mission to provide access to denovoSkin beyond burns, improve patient outcomes, and change the status quo in skin surgery.”
In early 2024, CUTISS AG announced positive one-year follow-up data from its Phase 2 clinical trial of denovoSkin in adult and adolescent severe burn patients. Following the announced positive primary endpoint in Q1 2023, the one-year readout evaluated long term safety and scar quality. The Phase 2 data demonstrate that denovoSkin can safely cover severe burn wounds, significantly sparing patients’ healthy donor sites while improving overall scar quality when compared to standard of care intra-patient. Stay tuned.
