Advancing skin surgery with first-in-class personalized skin tissue therapeutics

Skin is the body’s largest organ. Every day around the world, patients require or demand surgical interventions to restore skin function in acute (burns and trauma) or elective indications (scar revisions, giant nevi or tumor resections, reconstructive and plastic surgery, etc.).

The current standard of care in burn, plastic and reconstructive surgery – autografting – is limited by donor site shortage and leads to permanent, debilitating, and disfiguring scars. Many patients require multiple corrective surgeries, psychosocial rehabilitation and intense home care.

CUTISS is redefining skin surgery by replacing autografting with denovoSkin™, our first-in-class, personalized skin tissue therapy that can be produced in large quantities and that regenerates in a scarless manner.

Clinical development program

denovoSkin™ is being clinically tested for burns and reconstructive indications in children and adults, receiving overwhelmingly positive feedback from leading medical experts and surgeons.

Phase I
Phase II
Phase III

PHASE I CLINICAL TRIAL – SAFETY STUDY

A Phase I clinical trial for denovoSkin™ was completed with a five-year follow-up period in 2021, with 10 paediatric patients at the University Children’s Hospital Zurich, Switzerland. This study assessed the safety of the product in children and adults who underwent skin surgery due to burns or reconstructive surgeries. Each patient had a defined wound area treated with a single denovoSkin™ graft. The study was successfully completed, confirming the product’s safety in this first-in-human clinical trial.

PHASE II CLINICAL TRIALS – SAFETY AND EFFICACY STUDIES

Following the successful Phase I trial, denovoSkin™ is being further evaluated for its safety and efficacy in three randomized, controlled Phase II clinical trials. These trials follow a very similar design but differ in the patient population and indication: adult and adolescent burns, pediatric burns, and all ages reconstructive surgery. In those trials denovoSkin™ is compared to today’s standard of care, autografting, on every patient (intra-patient control). Long-term safety and efficacy readouts have been successful in demonstrating denovoSkin™’s donor site-sparing capacity and significant scar quality improvements, in comparison to autografting.

PHASE III CLINICAL TRIAL – SAFETY AND EFFICACY STUDY

A randomized, controlled Phase III clinical trial is being performed to confirm the product’s safety and efficacy. This trial has been approved in the EU and Switzerland and has started enrolling adult and adolescent burn patients under an orphan drug designation.

LIFE-SAVING BASIS TREATMENT

Under compassionate authorization, denovoSkin™ can be made available directly from CUTISS to a physician treating a patient in critical condition.

If you are a healthcare professional requesting more information regarding compassionate use, please contact CUTISS.

Clinical and scientific publications

March/April 2025

Pediatric Compassionate Use of a Novel, Autologous, Engineered, Hydrogel Skin Graft with Keratinocytes and Fibroblasts
Matthew Supple, Robert Sheridan, Jeremy Goverman, 846 Pediatric Compassionate Use of a Novel, Autologous, Engineered, Hydrogel Skin Graft with Keratinocytes and Fibroblasts, Journal of Burn Care & Research, Volume 46, Issue Supplement_1, March/April 2025, Page S288.
more

February 2025

R&D
Out of this World: Wound Healing on Earth and in Space
Nathan C Balukoff, Garrett Houk, Tammy Gonzalez, Yael Berton, Vincent Ronfard, Irena Pastar, Marjana Tomic-Canic
more

September 2024

Journal of Burn Care & Research:
Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial
Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Böttcher-Haberzeth S. Journal of Burn Care & Research. 2024 Sept.
more

November 2023

Scars
Nature Reviews Disease Primers - Abstract

Jeschke M, Wood F, Middelkoop E, Bayat A., Teot L, Ogawa R, Gauglitz G. nature reviews disease primers. 2023 Nov;(9): 64
more

April 2023

Life threatening non-accidental burns, pandemic dependent telemedicine, and successful use of cultured Zurich Skin in a neonate – A case report.
Schiestl C, Zamparelli M, Meuli M, Hartmann-Fritsch F, Cavaliere A, Neuhaus K, Reichmann E, Böttcher-Haberzeth S. Burns Open. 2023 Apr;7(2):28-32.
more

July 2021

First time compassionate use of laboratory engineered autologous Zurich skin in a massively burned child
Moiemen N, Schiestl C, Hartmann-Fritsch F, Neuhaus K, Reichmann E, Löw A, Stenger C, Böttcher-Haberzeth S, Meuli M. Burns Open. 2021 Jul;5(3):113-117.
more

July 2021

Expanding into the future: Combining a novel dermal template with distinct variants of autologous cultured skin substitutes in massive burns
Schiestl C, Meuli M, Vojvodic M, Pontiggia L, Neuhaus D, Brotschi B, Reichmann E, Böttcher-Haberzeth S, Neuhaus K. Burns Open. 2021 Jul;5(3):145-153.
more

July 2021

Assessment of Non-cultured Autologous Epidermal Cell Grafting Resuspended in Hyaluronic Acid for Repigmenting Vitiligo and Piebaldism Lesions: A Randomized Clinical Trial.
Bertolotti A, Leone G, Taïeb A, Soriano E, Pascal M, Maillard H, Van Geel N. Acta Derm Venereol. 2021 Jul;101: adv00506
more

July 2019

A Cultured Autologous Dermo-epidermal Skin Substitute for Full-Thickness Skin Defects: A Phase I, Open, Prospective Clinical Trial in Children
Meuli M, Hartmann-Fritsch F, Hüging M, Marino D, Saglini M, Hynes S, Neuhaus K, Manuel E, Middelkoop E, Reichmann E, Schiestl C. Plast Reconstr Surg. 2019 Jul;144(1):188-198.
more

November/
December 2017

The Effect of Wound Dressings on a Bio-Engineered Human Dermo-Epidermal Skin Substitute in a Rat Model
Hüging M, Biedermann T, Sobrio M, Meyer S, Böttcher-Haberzeth S, Manuel E, Horst M, Hynes S, Reichmann E, Schiestl C, Hartmann-Fritsch F. J Burn Care Res. 2017 Nov/Dec;38(6):354-364
more

May 2017

Factors affecting the mechanical behavior of collagen hydrogels for skin tissue engineering
Pensalfini M, Ehret A, Stüdeli S, Marino D, Kaech A, Reichmann E, Mazza E. J Mech Behav Biomed Mater. 2017 May;69:85-97
more

January 2014

Bioengineering dermo-epidermal skin grafts with blood and lymphatic capillaries
Marino D, Luginbühl J, Scola S, Meuli M, Reichmann E. Sci Transl Med. 2014 Jan 29;6(221)
more
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