Our solution –
dermo-epidermal skin grafts
After more than 15 years of research (Tissue Biology Research Unit, University Children’s Hospital Zurich), our lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments.
denovoSkin™ is a personalized human skin graft that can now be bio-engineered in large quantities, starting from a small, post stamp-sized piece of healthy skin. It promises to grow with the patient, limit scarring, and drastically reduce the number of follow up corrective surgeries required, particularly in children. denovoSkin™ received a Swissmedic, EMA and FDA Orphan drug designation for the treatment of burns.
denovoSkin™ is in Phase IIb clinical trials in Switzerland and the European Union and also accessible on a compassionate use basis (with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA).
Our solution –
dermo-epidermal skin grafts
After more than 15 years of research (Tissue Biology Research Unit, University Children’s Hospital Zurich), CUTISS AG can now bio-engineer large quantities of individually customized human skin grafts, denovoSkin™, starting off from a very small piece of healthy patient’s skin. Because of its intrinsic characteristics, denovoSkin™ is expected to result in a minimally scarring outcome after transplantation. denovoSkin™ received a Swissmedic, EMA and FDA Orphan drug designation for the treatment of burns.
To bio-engineer denovoSkin™, a small biopsy of healthy skin is harvested from the patient. The biopsy is processed to isolate epidermal and dermal cells. The cells are expanded in vitro, and thereafter used in combination with a hydrogel to create a dermo-epidermal skin graft. denovoSkin™ is now ready to be transplanted on the patient’s wounds. The safety trials for denovoSkin™ have been completed. The efficacy trials are currently being conducted at various hospitals in Switzerland and the EU and are supported by Wyss Zurich.
denovoSkin™ has a large potential. It could be of great benefit for patients with burns, traumas, that undergo reconstructive or plastic procedures, as well as for patients with chronic ulcers or congenital malformations that lead to skin-related problems.
denovoSkin™ is a patented, personalized, autologous bio-engineered human skin graft classified as Advanced Therapy Medicinal Product (ATMP). It is engineered in large quantities starting-off from a stamp-sized skin biopsy of the patient, thus solving the donor site shortage issue. Moreover, because of its dermo-epidermal structure, denovoSkin™ leads to minimal scarring after transplantation.
Its outstanding performance could considerably reduce or even avoids further corrective interventions, allowing for considerable savings. denovoSkin™ is also granted with Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA.
Skin is our largest organ. The bio-engineering of personalized skin tissue therapy faces scale up challenges. At CUTISS we work on the translation of the current manual process into an automated, fully closed one. The three automates were developed 2020 in collaboration with Zühlke Engineering and CSEM, supported by H 2020 EU and Innosuisse grants Automated skin tissue production, first in class, is expected to among others, decrease production costs and time, ensure robustness of the process and allow for the de-centralization of manufacturing.
Clinical Phase I results
Are you a Health Professional? A surgeon or a doctor?
The results of our phase I clinical trials have been summarized in the Plastic and Reconstructive Surgery Journal in July 2019.
“A Cultured Autologous Dermo-epidermal Skin Substitute for Full-Thickness Skin Defects: A Phase I, Open, Prospective Clinical Trial in Children”
Copyright © 2019 by the American Society of Plastic Surgeons
To receive the summary please fill in the request form. Thereafter we will send you the document link within a working day.
Scar Revision Using Skin Substitutes - Esther Middelkoop (Plastic, Reconstructive & Hand Surgery, Amsterdam Movement Sciences, AUMC, Vrije Universiteit Amsterdam)
denovoSkin use in burns - Esther Middelkoop & denovoSkin use in compassionate burns – Clemens Schiestl (KISPI)
April 7th – 9th
denovoSkin use in compassionate burns – Clemens Schiestl
May 28th – 30th
denovoSkin use in burns – Esther Middelkoop
June 14th – 18th