Reconstructive skin surgery: positive Phase 2 interim analysis on efficacy for denovoSkin™ in pediatric, adolescent and adult patients

Switzerland, 9 July 2024 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced positive interim analysis on efficacy from the Phase 2 clinical trial of its lead product denovoSkin™ in patients undergoing reconstructive skin surgery due to various conditions.

Dr. 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. A total of 23 patients are included in this multicentric trial. The trial focuses on conditions that necessitate skin grafts (scars, traumatic injuries, congenital defects, surgical excisions, etc), aiming to provide solutions that reduce scarring and improve healing outcomes.

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.

Further details of CUTISS’s clinical trials can be found on the company’s website here.