CUTISS’ denovoSkin first large scale transplantation delivers proof of principle

For the first time, CUTISS succeeded in transplanting 1,626 cm2 of denovoSkin in a child patient with 95 percent total body surface area deep flame burn. This achievement further validates that the company's bio-engineered skin graft has the potential to help substantially in severe and acute burns. 

The University of Zurich spin-off Cutiss has been demonstrating the possibilities of denovoSkin since its establishment. denovoSkin is a personalised, biotechnological skin transplantation products for the treatment of burns, skin defects and extensive scar corrections. The product has already been granted the Orphan Drug Designation for the treatment of partial and full-thickness burn wounds by Swissmedic, EMA, and FDA. 

A major milestone for the company comes after its first ever compassionate use of denovoSkin in a child patient. According to the results, the patient had experienced a 95% total body surface area (TBSA) deep flame burn. The use of a bio-engineered dermo-epidermal skin graft was therefore justified and permitted. A total of 1,626 cm2 of denovoSkin was transplanted onto the patient (approximately 20% TBSA). This first large-scale application of the skin graft also reported its ease of handling and application; excellent engraftment rates (80 - 90%) over dermal substitutes and over allo-dermal remnants, and it was soft and solid (close to natural skin coverage) after a maturation process. Therefore, the reported case has delivered the clinical proof of principle that denovoSkin can help substantially in severe and acute burns. 

As the authors in the report concluded, the prospect of scaling up denovoSkin to provide more rapid response and treatment for major burns would be “a paradigm shift in the care of such patients”. The latest edition of Burns Open, the peer-reviewed international journal, published the case report of the transplantation. The detailed report can be retrieved from the publisher's website.  

Ongoing clinical trials first successful results 
In the meantime, Cutiss is also seeing first successes in its ongoing phase II clinical trials held in three studies in Switzerland and the Netherlands targeting paediatric burn patients <12 years old Doctors in Naples have treated a newborn making it the youngest ever treated patient with a bio-engineered bi-layer skin graft in the world, according to the surgeon, to the best of his knowledge” as revealed by Daniela Marino, CEO and co-founder of Cutiss. This is also the first patient treated in the context of clinical trials. 

“Covid has significantly delayed clinical activities, especially in Italy; this first treated patient in Napoli marks an important, awaited milestone for CUTISS.”, says Marino. “We were not expecting to include such a small neonate, but we are extremely happy we could help in this case, and the results will give us important insights on skin regeneration processes in newborns.”