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Swissmedic grants CUTISS certificates of Good Manufacturing and Distribution Practices

CUTISS’s first onsite manufacturing facility in Schlieren, Zurich, has received the certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from the regulator Swissmedic, the Swiss Agency for Therapeutic Products. The GMP and GDP certifications authorizes the collection, manufacturing, testing, storage, release, and distribution of Transplant Products (TpP), Gene Therapy (GT) […]

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Journal of Wound Care: The future of bioengineering personalized skin

As part of the journal’s “Innovations in wound care” section, the latest edition features a guest editorial by our CEO Daniela Marino and CIO Vincent Ronfard. When patients suffer from large and severe skin injuries affecting more than 50% of the body, such as burns, then the current standard of care – autografting – presents

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Article TOP 100 Swiss Startup Award 2021

Article published by Isabelle Mitchell, Top 100 Swiss Startup Magazine 2021 on 08.09.2021 20:32 Last year’s winner is this year’s runner-up: The CUTISS team wins silver at the TOP 100 Swiss Startup Award 2021 for developing unique personalized skin technology to treat skin defects. CUTISS’s denovoSkin™ is a safe, effective, and accessible therapy for children

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Further proof of principle for denovoSkin on a massive burn with a one-year follow-up

The latest edition of Burns Open, the peer reviewed international journal, has published the case report of a 14-year-old who sustained deep flame burns involving 95% total body surface area burn (TBSA). As part of the treatment at the University Children’s Hospital Zurich, the patient received CUTISS’s denovoSkin grafts (12% TBSA) alongside other treatments.

The published paper is based on a one-year follow-up of the patient, who is doing well, and provides further proof of principle for denovoSkin use on massive burns over a long period of time. It also marks the first compassionate use of denovoSkin in Switzerland.

Specifically, the paper includes the following key points regarding denovoSkin:

• Four deliveries of 10 sheets each enabled us to cover about 12% of the patient‘s TBSA. Take rates were high (80–90%), irrespective of the wound bed preparation and early mobilisation of the patient.

• Results remained consistent showing natural, robust surfaces, near normal elasticity, and no hypertrophic scarring. Assessing the patients‘ skin over a course of several months since grafting, there were no significant skin contraction and secondary reconstructive surgery had not been necessary.

• Notably, there was no difference in take rates irrespective of location. Take rates were high even in notoriously delicate areas with high shearing forces such as the proximal dorsal thigh.

• Generally speaking, clinical assessments several months after application have shown that denovoSkin is maturing favourably, without instabilities or recurrent open wounds, and that hypertrophic scarring was not evident.

While the clinical evolution of this case will continue to be monitored and analysed, this paper provides very promising observations on the denovoSkin use in massive burns one year after its application on an adolescent.

The full report case can be read online, see link below.

denovoSkin promises to take skin surgery for burns to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase IIb clinical trials in Switzerland and the European Union, with Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA.

CUTISS is also developing the world’s first machine that can automate the entire production process of the personalized skin graft.

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swissinfo.ch: Swiss start-up develops world’s first ‘personalised skin’ machine

swissinfo.ch  “A Swiss company is offering hope to the more than 11 million people worldwide who suffer serious burns every year. The company is launching a revolutionary machine capable of generating skin that can be grafted in large quantities using a sample provided by the patient.” read more Photo: Copyright CSEM Newsroom LInk to article on

swissinfo.ch: Swiss start-up develops world’s first ‘personalised skin’ machine Read More »

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