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CUTISS continues collaboration with Santobono Hospital in Naples to transform pediatric burn care

A significant milestone in pediatric burn care in Italy has been achieved with the inauguration of the new pediatric burn center at Santobono Hospital in Naples, a new center of excellence at European level. Since 2021, Santobono has been the coordinating center in Italy for our Phase 2 clinical trial of denovoSkin™, the bioengineered autologous […]

CUTISS continues collaboration with Santobono Hospital in Naples to transform pediatric burn care Read More »

Inauguration of CUTISS Innovation

We’re proud to announce the recent inauguration of CUTISS Innovation, the French subsidiary of CUTISS AG, at the renowned Sophia Antipolis technology park in France. CUTISS Innovation is supporting and extending our R&D activities in regenerative medicine, including skin pigmentation, aging and healing. The Provence-Alpes-Côte d’Azur region is renowned as an innovation and dermatology hotspot,

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CUTISS awarded CHF 2.5M grant for automation program

CUTISS is delighted to announce that Innosuisse, the Swiss Innovation Agency, has awarded the company a CHF 2.5 million grant to advance our pioneering automation program. This grant will support the industrialization of denovoCast™, the world’s first machine that can bio-engineer large, personalized skin tissue grafts, in a fully closed way. This is yet another

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Case report: Youngest patient ever treated with denovoSkin – a neonatal case

The paper published in Burns Open has presented the case of a four day-old neonate suffering from life threatening burns, involving 40% total body surface area burn. The patient received 260 cm2 of denovoSkin, covering 20% TBSA, as part of a clinical trial sub-study in Italy. The management of such cases represents an unprecedented challenge.

Case report: Youngest patient ever treated with denovoSkin – a neonatal case Read More »

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)

Swissmedic grants CUTISS certificates of Good Manufacturing and Distribution Practices Read More »

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.

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

First ever compassionate use of denovoSkin delivers proof of principle

The latest edition of Burns Open, the peer reviewed international journal, has published the case report of the first ever compassionate use of denovoSkin in a child patient.

The patient had experienced a 95% total body surface area (TBSA) deep flame burn, and 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 denovoSkin reported:

– Ease of handling and application
– Excellent engraftment rates (80 – 90%) over dermal substitutes as well as over allodermal remnants
– Soft and solid, close to natural skin coverage, after a maturation process

As such, the reported case has delivered the clinical proof of principle that denovoSkin has the potential to help substantially in severe and acute burns.

It must be noted that, despite the promising skin grafting and healing process, the patient sadly died from multiple organ failure unrelated to the grafts. We believe that in the future, if denovoSkin can be applied sooner and in greater quantities in such disastrous cases, then it could lead to life-saving outcomes.

As the authors in the report conclude, 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 full report case can be read online, see link below.

denovoSkin has Orphan Drug Designation for the treatment of partial and full thickness burn wounds by Swissmedic, EMA, and FDA. It is currently in Phase II clinical trials comparing denovoSkin to conventional split-thickness skin grafts.

First ever compassionate use of denovoSkin delivers proof of principle Read More »

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