Cutiss AG

Our solution –
Personalized, bio-engineered, 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). 

Cutiss AG

Our solution –
Personalized, bio-engineered, 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.

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Cutiss AG

Technology

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.

©Susanne Staubli University Children's Hospital Zurich
@Susanne Staubli University Children's Hospital Zurich
Cutiss AG

Potential

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.

 

©Wyss Zurich
©WyssZurich
Cutiss AG

Automated Manufacturing

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.

Cutiss AG

For Professionals

Our Publications

2022

Two medical reports are currently in preparation

2021

First time compassionate use of laboratory engineered autologous Zurich skin in a massively burned child
more

2021

Expanding into the future: Combining a novel dermal template with distinct variants of autologous cultured skin substitutes in massive burns
more

2019

A Cultured Autologous Dermo-epidermal Skin Substitute for Full-Thickness Skin Defects: A Phase I, Open, Prospective Clinical Trial in Children
more

2017

The Effect of Wound Dressings on a Bio-Engineered Human Dermo-Epidermal Skin Substitute in a Rat Model
more

2016

Factors affecting the mechanical behavior of collagen hydrogels for skin tissue engineering
more

2014

Bioengineering dermo-epidermal skin grafts with blood and lymphatic capillaries
more

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.

Medical Conferences

December 19th

1x talk:
Scar Revision Using Skin Substitutes - Esther Middelkoop (Plastic, Reconstructive & Hand Surgery, Amsterdam Movement Sciences, AUMC, Vrije Universiteit Amsterdam)

March 19th

2x talks:
denovoSkin use in burns - Esther Middelkoop & denovoSkin use in compassionate burns – Clemens Schiestl (KISPI)

April 7th – 9th

Exhibition/Booth
1 talk:
denovoSkin use in compassionate burns – Clemens Schiestl

May 28th – 30th

Exhibition/Booth
2x talks:
denovoSkin use in burns – Esther Middelkoop

June 14th – 18th

Exhibition/Booth

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