denovoSkin™ positive safety & efficacy 1-year readout in Phase 2 trial for adolescent and adult burn patients

CUTISS is pleased to share that the 1-year results of the Phase IIb clinical trial evaluating denovoSkin™ in adolescent and adult burn patients have been published in eClinicalMedicine, part of The Lancet Discovery Science.

The prospective, randomized, controlled multicenter study compared denovoSkin™ to split-thickness skin grafts, the current surgical standard. The efficacy readout shows that denovoSkin™ demonstrated a markedly higher expansion capacity from a small biopsy, and a minimally scarring outcome, in sharp contrast to the intra-patient control. These outcomes support the potential of denovoSkin™ to safely reduce donor-site burden and improve long-term scar quality in severe burn care.

This publication represents a very important milestone for CUTISS and contributes robust clinical evidence to the field of personalized, bio-engineered skin replacement. The study was conducted in four burn centers across Switzerland, the Netherlands, and Italy, with manufacturing performed in CUTISS’ state-of-the-art GMP (Good Manufacturing Practice) facility in Zurich. The clinical follow-up for this Phase IIb study recently completed the 3-year follow up period.

You can access the published paper online here

Ongoing clinical development program

In parallel, CUTISS’ Phase IIb study on pediatric burns is ongoing and will soon hit the 1-year readout. The reconstructive Phase II clinical trial recently reached the 2-year follow-up readout, further expanding the clinical evidence base for denovoSkin™ in elective skin surgery. denovoSkin™ also continues to advance in its Phase III clinical trial in adolescents and adults across the EU and in Switzerland.