Promising results from first compassionate use of CUTISS’ denovoSkin in Switzerland

Beginning of July, a new paper was published in a peer reviewed international journal describing the treatment of a 14-year-old who sustained deep flame burns involving 95% total body surface area burn. The paper is based on a one-year follow-up of the patient, who is doing well, and provides further proof of principle for denovoSkin use on massive burns over a long period of time.

The latest edition of Burns Open, the peer reviewed international journal, has published the case report of a 14-year-old who sustained deep flame burns involving 95% total body surface area burn (TBSA). As part of the treatment at the University Children’s Hospital Zurich, the patient received CUTISS’ denovoSkin grafts (12% TBSA) alongside other treatments. CUTISS denovoSkin is a bio-engineered and personalized dermo-epidermal human skin graft. The production process involves the growth of new skin using the body’s own tissue as the template. 

Four deliveries of 10 sheets each enabled us to cover about 12% of the patient‘s TBSA. Take rates were high (80–90%), irrespective of the wound bed preparation and early mobilisation of the patient. Notably, there was no difference in take rates irrespective of location. Take rates were high even in notoriously delicate areas with high shearing forces such as the proximal dorsal thigh.

Results remained consistent showing natural, robust surfaces, near normal elasticity, and no hypertrophic scarring. Assessing the patients‘ skin over a course of several months since grafting, there were no significant skin contraction and secondary reconstructive surgery had not been necessary.

Generally speaking, clinical assessments several months after application have shown that denovoSkin is maturing favourably, without instabilities or recurrent open wounds, and that hypertrophic scarring was not evident.

While the clinical evolution of this case will continue to be monitored and analysed, this paper provides very promising observations on the denovoSkin use in massive burns one year after its application on an adolescent.

The denovoSkin, which is accessible on a compassionate use basis and is as well in Phase IIb clinical trials in the European Union has unique features that promise to surpass any current medical treatment for large and deep skin injuries, with potentially life-saving and life-changing outcomes. It promises to grow with the patient, limit scarring, and drastically reduce the number of follow up corrective surgeries required, particularly in children.

To produce the denovoSkin, CUTISS is developing in collaboration with CSEM the denovoCast machine automating tissue formation in a fully closed process, requiring no manual intervention. It ensures consistent reproducible quality, enables the simultaneous cultivation of multiple skin grafts, and is expected to reduce production times by more than 30%.


Picture: CSEM