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EMA authorizes Phase 3 clinical trial for denovoSkin™

CUTISS has received authorization from the European Medicines Agency (EMA) to commence the Phase 3 clinical trial for our lead product denovoSkin™ in adult & adolescent severe burn patients. Running across eight countries, including Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, and Spain, the Phase 3 confirmatory study will validate the efficacy and functionality of denovoSkin™ – a living, personalized bilayer bioengineered skin graft – in achieving wound closure and reducing scarring in patients with severe burns compared to standard of care. We are grateful to our entire CUTISS team, the clinical partners, all collaborators, patients, investors, and stakeholders who are making this pioneering work possible. Together, we continue to pave the way for transformative solutions in regenerative medicine and skin surgery. Newsroom Link to EMA page

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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 human skin tissue. Notably, Santobono was the first pediatric center in the world to perform a denovoSkin™ transplant in a neonate. We feel incredibly proud and honored to collaborate on this groundbreaking project with Dr. Marcello Zamparelli, underscoring our commitment to change the status quo in skin surgery and improve patient outcomes with cutting-edge regenerative medicine.  The new facility will enable quicker interventions for patients and allow continuous control, monitoring, and verification of the therapies and innovative treatments they receive. Burns are the third leading cause of death in children. In Campania region of Italy, between 2022 and 2023, 120 young patients were treated. Of these, 70% had severe or very severe burns; 80% required surgical hospitalizations that lasted an average of 15 days. It is in this context that the new pediatric burn center at Santobono-Pausilipon has been inaugurated. This news and announcement has featured across Italian media including in RAI, La Presse Il Mattino, ANSA, and Naples Today. Newsroom Link to RAI reportage

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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, and offers a rich ecosystem of world-leading public and private entities specializing in biotech and skin. The event was held on 5 October 2023 in the presence of the Mayor of Antibes, M. Jean Leonetti, and the Mayor of Biot, M. Jean-Pierre Dermit, alongside all our esteemed guests. Vincent Ronfard, our President of CUTISS Innovation and Chief Innovation Officer of CUTISS AG, remarked: “We are grateful to mark this occasion in the presence of our distinguished guests. The Sophia Antipolis technology park and the Provence-Alpes-Cote d’Azur region is the ideal hotspot for innovation in dermatology. We have already collaborated with leading private and public players across healthcare, biotechnology, and pharma, and look forward to establishing other joint research projects. Leveraging our experience to date, our goal is to innovate, develop and provide breakthrough solutions for various skin-related issues.” Since launching last year, the CUTISS Innovation team has been busy transferring technology, onboarding key professionals, and making the laboratory operational. You can watch the highlights from the event here  Newsroom Link to Highlights on Youtube

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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 stamp of quality approval for our ambitious and unique automation program, and we are grateful to Innosuisse and their continued support. Taking the denovoCast™ machine to clinical readiness CUTISS unveiled the first denovoCast™ machine in 2021, demonstrating the feasibility of automating the bio-engineered skin manufacturing process. The machine was developed in collaboration with Innosuisse and CSEM. Since then, the machine has undergone R&D testing at CUTISS and we are now ready to start the process of industrialization that will take denovoCast™ to clinical readiness at the service of adults and children with severe skin injuries, such as deep burns. Automation is key to scale up production of denovoSkin™ CUTISS is working to scale-up the production of denovoSkin™ through automation. The company has developed its 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 dermo-epidermal skin graft denovoSkin™. Newsroom

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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. The published paper is based on a one-year follow-up of the patient, and these results deliver further proof of concept that denovoSkin can be successfully applied in pediatric severe burns. Specifically, the case report has noted that: Clinically, denovoSkin grafted areas show a matured skin after 3–6 months with minimal or no detectable scarring, whereas conventional grafting was not yet matured and mostly associated with moderate to massive hypertrophic scarring. denovoSkin yields close to normal skin in terms of softness, elasticity, pliability, growth, and mechanical robustness. The full case report can be read online, see link below. Newsroom Link to Case Report

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CUTISS granted European patent for skin tissue graft

CUTISS is pleased to announce that a tissue graft patent has been granted by the European Patent Office for the personalized bioengineered human skin tissue therapy developed by CUTISS. The patent (3174563) has been granted pursuant to Article 97(1) EPC to University of Zurich (UZH) where the founders of CUTISS worked at the time of the patent filing (2014), and is exclusively licensed to CUTISS. This patent strengthens the company’s intellectual property position in human tissue graft technologies. CUTISS’s first skin tissue therapy product denovoSkin is 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. The mention of the grant has been published in the European Patent Bulletin 22/24. Newsroom European patent bulletin 22/24

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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) and Genetically Modified products (GM) for human use. This important milestone completes the expansion of CUTISS’ facilities, led by Kathi Mujynya and her Operations team. The state-of-the-art manufacturing facility is fully equipped for the manufacturing and testing of tissue-engineered products, notably for the personalized human skin tissue therapy denovoSkin which is currently in Phase 2 clinical trials. The facility in Schlieren is expected to become fully operational in Q1-Q2 2022. Until now, the company’s products have been manufactured at the GMP facility of Wyss Zurich Regenerative Medicine Technologies Platform, University of Zurich. Newsroom

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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 the time of the patent filing (2014), and is exclusively licensed to CUTISS. This patent strengthens the company’s intellectual property position in human tissue graft technologies in the US (in addition to other markets), and complements the existing patent covering the method and production process which is also granted across multiple markets. CUTISS’s first skin tissue therapy product denovoSkin is 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.

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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.

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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