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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 launches Series C financing round to advance the development of its personalized skin technology, paving the way towards commercialization

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™ 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 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 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 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. 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, aesthetic and other applications beyond 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 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 French version of the press release > Newsroom Link to Press Release

CUTISS launches Series C financing round to advance the development of its personalized skin technology, paving the way towards commercialization Read More »

CUTISS recognized as leading biotech in TOP100 Swiss Startup Award

In this year’s 13th 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 1st 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. Newsroom Link to article

CUTISS recognized as leading biotech in TOP100 Swiss Startup Award Read More »

GEN interview

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. Newsroom Link to article

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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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CUTISS announces positive Phase 2 clinical trial results for 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 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 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  Newsroom Press release as PDF

CUTISS announces positive Phase 2 clinical trial results for denovoSkin™ Read More »

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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Fierce Biotech interview

The leading industry media Fierce Biotech reported on the news that CUTISS sent human skin cells into space, for advanced R&D testing on the International Space Station. Our Chief Innovation Officer Vincent Ronfard explained in his interview the reasons for conducting such experiments and what we hope to achieve. The initial round of experiments will look at different dimensions of wound healing. One set of cultures contains wounded tissue, and we will focus on how long it takes a wound to close in microgravity. The second set will be used to study how extracellular matrix formation and collagen production differs between space and Earth. The projects will remain on the space station for four weeks before they’re returned. When asked what was it that provoked CUTISS to take this step into space-based research, Vincent replied: “There are two ways of research: One is very organized, but you’re always in the mainstream, and the other is that you’re opportunistic and you say, ‘Okay, let’s try’. When you don’t set too many boundaries, you may find new things that are important.” You can read the full article using the link below. Newsroom Link to article

Fierce Biotech interview Read More »

Advanced testing of human skin cells on the International Space Station to push the boundaries of innovation in regenerative medicine

As part of the company’s R&D in regenerative medicine, CUTISS will observe the effects of space on skin cells and tissue culture. Research implications towards human safety in space travel and new discoveries in regenerative medicine and tissue engineering on Earth. Four-week mission conducted in collaboration with SpacePharma which specializes in space-based experiments and micro-lab technologies. Micro-lab containing CUTISS’s experiment travelled to the ISS on SpaceX’s 27th commercial resupply mission (CRS-27) for NASA. Switzerland, 15 March 2023 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the start of an advanced research and development mission on board the International Space Station (ISS), leveraging the state-of-the-art micro-lab technology developed and provided by the Swiss spacetech company SpacePharma. Daniela Marino, co-founder and CEO of CUTISS, commented: “We are thrilled to launch this advanced research and development mission with SpacePharma on board the International Space Station, enabling us to push the boundaries of innovation in regenerative medicine and tissue engineering. We are excited by the potential of this research to improve the safety of space travel as well as the likelihood of making scientific discoveries for the benefit of people on Earth.” Yossi Yamin, co-founder and CEO of SpacePharma, stated: “We are discovering new and exciting ways to help humanity in novel medical and pharmacological solutions that can be researched and developed only under micro-gravity conditions in space. SpacePharma is proud to enable such advanced research for pharma and medical players and we are especially excited about this important collaboration with CUTISS that we believe may change scarring treatments for us all.” In space, humans are known to be impacted by microgravity and space radiation, leading to changes in the structure and function of cells. Skin, like other organs, experiences changes in physical properties such as thickness and levels of hydration, and also biological properties that can impact wound healing. Building on CUTISS’s expertise in skin biology and tissue bioengineered, the company will observe the biological processes and cell behavior of skin tissue in the space environment, in comparison to Earth’s. Studying the effects of space on skin tissue and cell culture is important for developing strategies to protect astronauts during spaceflight, understanding how exposure to the space environment can affect human health, as well as developing potentially new and innovative medical treatments and technologies that can benefit people on Earth. Vincent Ronfard, Chief Innovation Officer of CUTISS, said: “As we embark on this research and development mission in space, we are excited to leverage our expertise in skin biology and tissue bioengineering and to combine it with SpacePharma’s cutting-edge technology. We look forward to observing the experiment in space and continuing our research and analysis after the lab returns to Earth.” With the SpacePharma micro-lab plugged into the ISS’s electrical and monitoring systems, CUTISS will observe in vitro the cultivation of human skin cells (keratinocytes and fibroblasts) in 2D or 3D culture systems to assess their ability to produce extracellular matrices, and also look at the cells’ properties, such as their ability to migrate and to divide. The aim is to deepen our understanding of fundamental biological processes and potentially support the development of new therapies, devices and tools for wound healing, aging, and scarring. Collaboration with cutting-edge spacetech company SpacePharma To fulfill this space mission, CUTISS has collaborated with the Swiss company SpacePharma which develops micro-laboratories for advanced R&D in space under micro-gravity conditions. These remotely controlled, fully automated labs are based on lab-on-a-chip (LOC) technology, in other words a microfluidic device that carries living cells in a nutrient-rich growth medium. With the micro-lab safely onboard the ISS, it will be connected to the station’s power and monitoring systems by NASA astronaut Dr Warren Hoburg. The data from the micro-lab will be transmitted back to Earth and overseen in real-time by the CUTISS scientific team. SpacePharma’s micro-labs technology enables the collection of unprecedented results that cannot be obtained on terrestrial setting and the CUTISS team has worked closely with SpacePharma’s mission experts to define solid preflight protocols. For SpacePharma, this is the company’s eighth flight to orbit, sixth mission to ISS, and thirtieth experiment for a commercial client. Return to Earth in about one month The ISS orbits at an average altitude of 408 kilometers above Earth. At the end of the mission, in approximately four weeks, the miniaturized lab will come back to Earth in the Dragon spacecraft near the Florida coastline. CUTISS’s cells will then be returned to company headquarters in Zurich, Switzerland, for more detailed analysis of the results of the experiments.  Research in microgravity: a new frontier Microgravity is a disruptive opportunity for several major sectors: pharmaceuticals, biotechnology, material/chemical science and nutrition. It provides companies and researchers with the ability to accelerate discovery processes for new drugs and vaccines, develop new crystals and materials and accelerate the study of human genome and origin of diseases. The potential scientific, technological and commercial benefits of microgravity research to humankind are substantial, and will revolutionize traditional Earth-bound processing methods. About the CRS-27 mission The SpacePharma micro-lab containing CUTISS’s experiment traveled to the International Space Station on SpaceX’s 27th commercial resupply mission (CRS-27) for NASA. Liftoff of the SpaceX Dragon cargo spacecraft on a Falcon 9 rocket took place on March 14, from Launch Complex 39A at NASA’s Kennedy Space Center in Florida. SpaceX’s Dragon has delivered new science investigations, supplies, and equipment for the international crew. About CUTISS 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

Advanced testing of human skin cells on the International Space Station to push the boundaries of innovation in regenerative medicine Read More »

BioVoice CUTISS interview with Dr. Daniela Marino

Following our presence at Arab Health 2023 we had the opportunity to speak with BioVoice, the top Indian bioscience news magazine. In the interview, our CEO Daniela Marino shared the progress that CUTISS has been making in bioengineering the personalized skin graft denovoSkin, the commercial plans around skin pigmentation, and the exciting innovations in regenerative medicine. You can read the interview in the pdf below, or directly online here. Newsroom Interview (PDF)

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