March 2023

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

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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

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