Positive from CUTISS’ Phase I and Phase II clinical studies

Established in 2017 as a spin-off from the University of Zurich (UZH) / University Children’s Hospital, CUTISS AG is a  Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering for patients with severe skin injuries. The lead product, denovoSkin is a bio-engineered and personalized dermo-epidermal human skin graft with Orphan Drug Designation for treating burns from Swissmedic, EMA, and the US Food and Drug Administration (FDA). CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft.

The Phase II study is study is performed in different countries and hospitals across Switzerland, Italy, and the Netherlands on 15 patients of ages 12 years and above who require a skin graft due to a major burn. The last patient transplant took place in August 2022. After about 12 months, the efficacy endpoint has been reached with high statistical significance, demonstrating the efficacy of denovoSkin. Patients will have yearly follow-up visits 2 and 3 years after transplantation. Further results and complete data analysis of the Phase 2 trial with the three-year follow-up will be available in 2025.

Furthermore, the Phase 1 clinical trial for denovoSkin completed the 5-year follow-up period, demonstrating the product’s safety. The Phase 1 trial included pediatric and adolescent patients requiring a skin graft due to a burn injury or reconstructive surgery.

“We are thrilled with the positive results from Phase 2 and the completion of Phase 1 clinical trial with five-year follow-up, which confirms the safety and efficacy of denovoSkin in adult and adolescent burn patients”, said Daniela Marino, CEO of CUTISS. “We are proud of the progress made this far and the hard work and dedication of the entire CUTISS team. We look forward to preparing for the next regulatory steps to bring this promising treatment to patients suffering from severe burns and skin injuries.”

(Press release/RAN)