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.


CUTISS is a Swiss clinical-stage, pioneering life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first-in-class personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries globally.

The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently transitioning towards phase III clinical trials in Europe, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA.

CUTISS is also developing the world’s first machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine, aesthetic and other applications outside of the medicine. 

Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 92 million from private investors, family offices and public bodies.

Media contacts

Cabinet Privé de Conseils (Switzerland)

Toomas Kull | +41 767 480 174

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