Personalized, bio-engineered, dermo-epidermal skin grafts
We aim to give patients back more of their own skin to make them well again.
After more than 20 years of research and development, 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. The outcome is potentially life-saving and life-changing.
denovoSkin™ is in late stage clinical trials in Switzerland and the European Union and also accessible for compassionate use. denovoSkin™ has been granted Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA.
Personalized, bio-engineered, dermo-epidermal skin grafts
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 ongoing at various hospitals in Switzerland and the EU.
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 ongoing at various hospitals in Switzerland and the EU.
Potential
denovoSkin™ has a large potential. It could be of great benefit to patients with burns, skin traumas, those that undergo reconstructive or plastic procedures, as well as for patients with skin cancer or cutaneous congenital malformations.
denovoSkin™ is a patented, personalized, autologous bio-engineered human skin graft classified as Advanced Therapy Medicinal Product (ATMP) in the EU. It is engineered in large quantities starting from a stamp-sized skin biopsy of the patient, thereby addressing the issue of donor site shortages.
Moreover, because of its dermo-epidermal structure, denovoSkin™ promises to lead to minimal scarring after transplantation. This considerably reduces further corrective interventions and post-surgery home care, allowing also for considerable healthcare cost savings.
Automated Manufacturing
Skin is our largest organ – adults carry around 3.6 kilograms and 2 square meters of it. The bio-engineering of personalized skin tissue therapy faces scale up challenges.
At CUTISS we are working on the translation of the current manual manufacturing process into an automated, fully closed one.
Automation is expected to decrease production costs and time, ensure robustness of the process, and allow for the de-centralization of manufacturing.
We have developed our own unique approach to bioengineering human skin tissue composed of three modules: cell isolation (Semotiss™), cell expansion (Quantum®), and skin tissue formation (denovoCast™). Starting form a patient’s biopsy and working in sequence, the modules produce the personalized skin graft denovoSkin™.
Once clinical readiness is reached, CUTISS plans to make automated machines available to hospitals and burn centers around the world.
For Professionals
Our Publications
2022
2021
2021
2019
2017
2016
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 as soon as possible.
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
January 2023
Exhibition/Booth