English – CUTISS

Switzerland, 14 February 2024 – CUTISS AG, a Swiss clinical-stage life science company focused on skin regenerative medicine and tissue engineering, has announced positive one-year follow-up data from its Phase 2 clinical trial of the lead product denovoSkin™, in adult and adolescent severe burn patients. Following the announced positive primary endpoint in Q1 2023, the one-year readout evaluated long term safety and scar quality.

Dr Daniela Marino, CEO of CUTISS, commented: “The latest data represent a pivotal moment in our mission.
It reinforces the evidence we have gathered so far that denovoSkin™ can be life-saving and can become a transformative treatment option for patients suffering from severe burns by improving overall scar quality and relief post grafting.”

The Phase 2 data and results thus far demonstrate that denovoSkin™, a living, personalized bilayer (with epidermis and dermis) bioengineered skin graft, can safely cover severe burn wounds, significantly sparing patients’ healthy donor sites while improving overall scar quality when compared to standard of care intra-patient.

Prof. Dr. MD, Martin Meuli, Chairman of CUTISS, added: “The accomplishments of the past decade have placed us in the midst of an important paradigm shift in burn treatment: from mortality, that used to be the primary concern, to areas that focus on the quality of life of burn survivors. Conceptually understanding the epidermis as “life” whereas dermis as “quality of life” is maybe simplistic, but nonetheless useful to understand the impact that denovoSkin™ can potentially have in burn surgery.”

The current treatment in severe burns and reconstructive surgery – autografting – commonly results in permanent painful, debilitating, disfiguring scars that frequently require follow up corrective surgeries, psychosocial rehabilitation and intense home care. With denovoSkin™, CUTISS is seeking to revolutionize the treatment of severe burns. The Phase 2 clinical trial in adult and adolescent burns has a long-term follow-up of three years (data will be available in 2025). A total of 15 patients were included in this trial.

The company is preparing for the next regulatory steps, aiming to make denovoSkin™ available to patients suffering from severe burns and skin injuries worldwide.

Further details of CUTISS’s clinical trials can be found on the company’s website here.

About CUTISS AG

CUTISS is a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries.

The lead product denovoSkin™ promises to take skin surgery to the next level and revolutionize current treatments. It is a bio-engineered and personalized dermo-epidermal human skin graft, currently in Phase II 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 machines that can automate the entire production process of the personalized skin graft. The company’s knowledge in skin bio-engineering and biology offers several growth opportunities in regenerative medicine.

Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 65 million from private investors, family offices and public bodies.

Media contacts

Cabinet Privé de Conseils (Switzerland)
Toomas Kull kull@cpc-pr.com | +41 767 480 174

Discover CUTISS’s strides in developing the personalized skin tissue therapy denovoSkin™, as seen on TeleZüri’s CheckUp. The segment shares a patient’s remarkable recovery story, demonstrates how our pioneering skin graft technology can positively impact patients’ lives, and includes insights from CEO Dr. Daniela Marino. Watch the reportage to see the significant advancements denovoSkin™ brings to treating severe burns and enhancing patient outcomes.

The popular and influential Brazilian science magazine Superinteressante interviewed our CEO Daniela Marino about our development of denovoSkin™.

The article describes the ways in which denovoSkin™ could revolutionize skin surgery and benefit patients worldwide.

“We’re moving towards the last stage of development, and we hope to bring the technology to patients soon,” said Daniela in the interview.

You can read the full article using the link below.

Switzerland, 07 November – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the successful completion of patient recruitment for the Phase 2 clinical trial of its lead product, denovoSkin™, in reconstructive surgery for both children and adults.

This Phase 2 clinical trial evaluates the safety and efficacy of denovoSkin™, a personalized, bio-engineered dermo-epidermal skin substitute in reconstructive surgery. The study has a follow-up period of a total of 3 years. Clinical outcome data are expected to become available in the next 12 months.

The trial is being conducted across multiple hospitals in Switzerland, Italy, and the Netherlands, encompassing patients from 1 year of age who require reconstructive skin surgery due to various conditions. A total of 20 patients were included in this trial.

Dr. Daniela Marino, Chief Executive Officer and co-founder at CUTISS, said: “The end of recruitment for this pivotal clinical trial underscores our commitment to advancing the field of skin regenerative medicine beyond burns. We are eager to move to the next development phase and to analyze clinical outcome data during 2024.”

The innovative denovoSkin™ graft, bio-engineered from a small sample of the patient’s healthy skin, aims to transform the landscape of skin surgery. Its potential benefits include reduced scarring, a pivotal feature for reconstructive surgery.

Dr. Daniela Marino added: “Our team has worked diligently to reach this stage, and we are grateful for the trust and collaboration of our clinical partners and patients. As we progress, we remain dedicated to our mission of offering advanced solutions for skin surgery.”

In addition to this reconstructive surgery clinical trial, CUTISS has a Phase 2 study in recruitment for pediatric burns (under 12 years of age) with denovoSkin™, as well as an active Phase 2 study in burns for adult and adolescent patients (total follow-up period of 3 years). A Phase 3 clinical trial for denovoSkin™ in adult and adolescent burn patients is in the planning phase.

More details on CUTISS’s clinical trials and other developments can be found on the website here.

About denovoSkin™

Lead product denovoSkin™ is a personalized human skin graft that can 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.

Following the completion of a safety clinical Phase 1 trial with a 5-year follow up, CUTISS announced in April 2023 the positive results from the Phase 2 clinical trial of denovoSkin™ in adult and adolescent burn patients. The efficacy endpoint was reached with high statistical significance.

It has Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA.

About CUTISS AG

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

Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 67 million from private investors, family offices and public bodies.

Media contacts

Cabinet Privé de Conseils (Switzerland)

Toomas Kull kull@cpc-pr.com | +41 767 480 174

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

Round C to finance the continued development and path to commercialization of denovoSkin™ and Viticell®
Phase 2 clinical trial results for lead product denovoSkin™ reached efficacy endpoint with high statistical significance
VitiCell® is a CE marked medical device the treatment of skin pigmentation disorders

Switzerland, 18 September 2023 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the launch of its Series C for the next stage of the company’s development.

CUTISS seeks to raise the Series C with the participation of existing and new investors to take its personalized skin therapy denovoSkin™ into the final stages of development, having recently completed the recruitment in Phase 2 clinical trials with positive results. The company will also proceed to industrialize and get to clinical readiness the automated machine that can bioengineer denovoSkin™. Furthermore, CUTISS will finalize the pre-launch activities for the commercialization of VitiCell®, the medical device for the treatment of Vitiligo which has been in-licensed from IBSA Pharma.

The Series C is co-led by the family office of Giammaria Giuliani (lead investor in CUTISS’ previous rounds) and a US family (new investor) represented by Shiloh Advisors AG. The terms are set. Existing shareholders and new investors are called in to support CUTISS’ journey in its final steps to commercialization.

Dr Daniela Marino, CEO and co-founder of CUTISS, commented: “The opening of our Series C financing round is a significant step in our mission to develop and provide a life-saving and life-changing treatment for patients with severe skin injuries and defects. We are grateful for the continued support of our existing investors and the new investor from the US, and look forward to engaging with others. The recent positive Phase 2 clinical trial results for denovoSkin™ and the positive feedback from the medical community strongly motivate us to continue pushing the boundaries of innovation in the field of regenerative medicine.”

CUTISS has so far raised a total of CHF 67 million from private investors, family offices, and public bodies, including Giammaria Giuliani (Giuliani Pharma, GiSev, Royalty Pharma and HBM), Zürcher Kantonalbank (ZKB), the Wyss Foundation, Yellowstone Holding, and Lichtsteiner Foundation. CUTISS has also received funds granted by the European Union, Innosuisse and Wyss Zurich.

About denovoSkin™

It has Orphan Drug Designation for the treatment of burns from Swissmedic, EMA, and FDA.

About the automation program

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, cell expansion, and skin tissue formation. Starting form a patient’s biopsy and working in sequence, the modules produce the personalized dermo-epidermal skin graft denovoSkin™.

The denovoCast™ is the world’s first machine that can bio-engineer large, personalized skin tissue grafts, in a fully closed way. The machine has undergone R&D testing at CUTISS and the company is ready to start the process of industrialization. In May 2023, CUTISS announced that Innosuisse, the Swiss Innovation Agency, awarded a CHF 2.5 million grant to advance the pioneering automation program, and support the industrialization of the denovoCast™.

About VitiCell®

VitiCell® is indicated for skin re-pigmentation, for example in the case of non-evolving Vitiligo or hypochromatic post traumatic scars. It is a medical device that makes autologous cellular grafting possible in an out-patient setting by a medical professional, be it at a hospital, private clinic or a dermatologist’s cabinet. VitiCell® is a biotechnological product developed and patented by IBSA Pharma. In February 2022, CUTISS announced that it received exclusive rights from IBSA Pharma to globally commercialize VitiCell®.

About CUTISS AG

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

Media contacts

Cabinet Privé de Conseils (Switzerland)

Toomas Kull kull@cpc-pr.com | +41 767 480 174

French version of the press release >

In this year’s 13^th edition of the TOP100 Swiss Startup Award, CUTISS has been recognized as a ‘most promising’ TOP 25 scale-up.

We are just as proud to say that CUTISS continues to place 1^st in the Biotech category, this year amongst the scale ups!

For this year’s listing, CUTISS was selected by a jury of 25 growth investors alongside other companies that are five to ten years old and therefore considered as ‘scale ups’. We want extend a big thank you to everyone on our team, our investors and supporters, and partners! Since our company’s founding in 2017, we continue to accomplish significant milestones.

CUTISS has featured consistently in the TOP100 awards. As a start-up (up to five years old) we won the award and placed 1st in 2020, we came 2nd in 2021, and in 2022 we placed 4th amongst the 100 contenders. CUTISS has consistently ranked first amongst biotechs.

Further details about the awards and rankings are available in the link below.

Genetic Engineering & Biotechnology News (GEN), the leading life sciences publication, recently interviewed our CEO Daniela Marino.

The article reports on CUTISS’s progress with denovoSkin™ and the clinical trials, how the company plans to restore patients’ own skin pigmentation, the key role of automation to meet the scale up challenge, and CUTISS’s global ambitions.

“The product we are developing really can replace autografting—the current standard-of-care treatment—not only for severe burns patients but also for other reconstructive surgeries,” said Daniela in the interview.

You can read the full article using the link below.

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™.

CUTISS announces results from Phase 2 clinical trials for denovoSkin™ in adolescent and adult burn patients, and Phase 1 in children

Phase 2 clinical trial reaches efficacy endpoint with high statistical significance for lead product denovoSkin™ in adult and adolescent burn patients.
Phase 1 clinical trial of denovoSkin™ is completed with 5-year follow up demonstrating product safety in pediatric and adolescent patients in burn and reconstructive surgery.

Switzerland, 3 April 2023 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced positive results from the Phase 2 clinical trial of its lead product denovoSkin™, in adult and adolescent burn patients. The efficacy endpoint has been reached with high statistical significance, demonstrating efficacy of denovoSkin™ as a personalized, bio-engineered dermo-epidermal skin substitute for patients requiring a skin graft due to a major burn.

Furthermore, the Phase 1 clinical trial for denovoSkin™ completed the 5-year follow up period demonstrating the product’s safety. The Phase 1 trial included pediatric and adolescent patients requiring a skin graft due to a burn injury or reconstructive surgery.

Dr. Daniela Marino, CEO of CUTISS, said: “We are thrilled with the positive results from the Phase 2 and the completion of the Phase 1 clinical trial with five-year follow-up, which confirms the safety and efficacy of denovoSkin™ in adult and adolescent burn patients. We are proud of the progress made this far, and the hard work and dedication of the entire CUTISS team. We look forward to preparing for the next regulatory steps to bring this promising treatment to patients suffering from severe burns and skin injuries.”

The Phase 2 full data analysis with the three-year follow up will be available in 2025, with the last patient transplant having taken place in August 2022. A total of 15 patients are included in this trial.

Further details of CUTISS’s clinical trials can be found on the company’s website here.

About CUTISS AG

Established in 2017, the company is a spin-off from University of Zurich (UZH) / University Children’s Hospital and was a member of the accelerator Wyss Zurich until February 2022. Headquartered at the Bio-Technopark in Zurich-Schlieren, it won the Top 100 Swiss Startup Award 2020, and has raised over CHF 65 million from private investors, family offices and public bodies.

Media contacts

Cabinet Privé de Conseils (Switzerland)

Toomas Kull kull@cpc-pr.com | +41 767 480 174

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