CUTISS reports positive Phase 2 results for reconstructive skin surgery

Following the successful completion of the phase I clinical trial, denovoSkin is further evaluated for its safety and efficacy in three parallel phase II clinical trials. These trials are very similar in their design, but differ in the patient population and indication. In all three phase II clinical trials, denovoSkin is compared to today’s standard of care, the transplantation from one location to another on the same individual (autologous split-thickness skin). For this, two comparable wound areas are selected, and one of the areas is treated with a maximum of one denovoSkin graft, and the other area with the standard of care. During the study visits, the two areas are analyzed and compared, for a total of 3 years.

CUTISS has now announced a positive Phase 2 interim analysis on efficacy for denovoSkin in pediatric, adolescent and adult patients. Daniela Marino, CEO of CUTISS, said: “We are thrilled with this first positive assessment of efficacy from the Phase 2 trial in reconstructive surgery. These results confirm CUTISS’s mission to provide access to denovoSkin™ beyond burns, improve patient outcomes, and change the status quo in skin surgery.” The Phase 2 full data analysis with the one year follow up will be available in early 2025.

The 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.

(Press release / SK)
Picture: Daniela Marino, CEO CUTISS