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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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CUTISS’s skin tissue graft is granted US patent

We are pleased to announce that a tissue graft patent has been granted by the United States Patent and Trademark Office (USPTO) for the personalized bioengineered human skin tissue therapy developed by CUTISS. The patent (U.S. Patent no. 10,953,140 B2) has been granted to University of Zurich (UZH) where the founders of CUTISS worked at …

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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.

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.

UZH article “From Lab to Life”

Fabienne Hartmann-Fritsch still feels most at home in the lab, even though she now spends more time in front of her PC than inspecting Petri dishes. In 2017, the biologist founded the spin-off CUTISS together with four other UZH scientists. Once clinical trials are complete, the spin-off plans to roll out personalized skin tissue therapy on the market – in other words, customized human skin grown in the lab. During her doctoral studies at the University Children’s Hospital Zurich, Hartmann-Fritsch started specializing in planning and executing clinical research projects involving humans and dealing with the legal framework. The transition from pure research to (communications) management was an easy one for her. “It’s immensely gratifying to now be able to apply the results of years’ worth of lab work,” she says. The innovative product that is supposed to increase the quality of life of people suffering from skin defects is called denovoSkin. In the second trial phase, the researchers will now test the safety and effectiveness of the skin replacement in various clinics. For Hartmann-Fritsch, this means extensive talks with medics, sponsors and the authorities.

Text: Alice Werner
Picture: Frank Brüderlin

©EBA

EBA 2019 Helsinki

CUTISS AG is present with a booth at the EBA 2019 in Helsinki. Further information about the congress, also for the upcoming events of the EBA can be found under “Learn more”

csem final

CSEM article on Innosuisse Grant

Swiss researchers want to develop the first-ever automated machine to bioengineer personalised skin grafts for therapy. The denovoCast project, a collaboration between life science start-up Cutiss AG and CSEM, has been awarded a grant of more than CHF 800’000 by Innosuisse.

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