Press release

CUTISS announces first closing of CHF 25M in Series C funding round

Switzerland, 17 May 2024 – CUTISS AG, a Swiss pioneering life sciences company specializing in skin regenerative medicine and tissue engineering, is glad to announce the first closing of CHF 25 million in its Series C funding round. This milestone demonstrates strong investor confidence in CUTISS’ mission and progress to transform skin surgery. The Series C round is co-led by the family office of Giammaria Giuliani, a longstanding lead investor, and a new co-lead investor, a US family represented by Shiloh Advisors AG. This first closing allows CUTISS to enter Phase 3 clinical trials for its personalized skin therapy denovoSkin™, which recently announced positive results in Phase 2. Additionally, funds will be used to advance the industrialization and clinical readiness of the automated machine for bioengineering denovoSkin™, and to finalize pre-launch activities for the commercialization of VitiCell®, a medical device for Vitiligo treatment in-licensed from IBSA Pharma. Dr. Daniela Marino, CEO and co-founder of CUTISS, commented: “Securing the first CHF 25 million in our Series C funding round is a pivotal achievement for CUTISS. We deeply appreciate the trust and support of our existing and new investors. This funding will enable us to continue working at speed to reach our critical development milestones and bring our life-changing treatments to patients in need. The recent positive Phase 2 clinical trial results for denovoSkin™ have fueled our determination to innovate further in regenerative medicine.” The company continues to welcome new investors to join its journey towards commercialization. CUTISS is committed to change the status quo in skin surgery, advancing its groundbreaking technologies and improving outcomes for patients with severe skin injuries and defects. The Series C round of fundraising is ongoing, and we invite additional investors to support our mission. To date, CUTISS has raised a total of CHF 92 million from private investors, family offices, and public bodies, including contributions from Giammaria Giuliani (of GG1978, Giuliani Pharma, Royalty Pharma, HBM, Rothschild&Co), Zürcher Kantonalbank (ZKB), the Wyss Foundation, Yellowstone Holding, Lichtsteiner Foundation, and Cherry Bay Capital Group. The company has also received grants from the European Union, Innosuisse, and Wyss Zurich. About CUTISS AG CUTISS is a Swiss clinical-stage, pioneering life sciences company focused on regenerative medicine and skin tissue engineering. It is developing the first-in-class personalized and automated skin tissue therapy offering life-saving and life-changing medical treatments for patients with severe skin injuries globally. 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 Europe, 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 outside of the 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 92 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 Link to press release

CUTISS announces first closing of CHF 25M in Series C funding round Read More »

Positive one-year follow-up data from Phase 2 trial of denovoSkin™

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  Newsroom View Press release in PDF

Positive one-year follow-up data from Phase 2 trial of denovoSkin™ Read More »

Recruitment completed for denovoSkin™ Phase 2 clinical trial in reconstructive surgery

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 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 Newsroom View Press release in PDF

Recruitment completed for denovoSkin™ Phase 2 clinical trial in reconstructive surgery Read More »

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 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 »

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 »

CUTISS to participate in Jefferies London Healthcare Conference 2022

Switzerland, 7 November 2022 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced that the company is invited to the upcoming Jefferies London Healthcare Conference, taking place November 15 – 17, 2022. Dr Daniela Marino, Chief Executive Officer and co-founder at CUTISS, will attend the conference and hold one-to-one meetings with registered members of the investor community which includes leading global executives, institutional investors, and private equity investors. The Jefferies Healthcare Conference is the largest healthcare-dedicated investor conference in Europe covering pharma, biotech, medtech and healthcare services. The past conference saw 550 companies and 3,000 attendees from Americas, Europe, Middle East, Africa, and Asia join the event. 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 55 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  Nick Miles miles@cpc-pr.com | +41 796 787 626 Newsroom Press Release

CUTISS to participate in Jefferies London Healthcare Conference 2022 Read More »

Recruitment completed for denovoSkin Phase 2 clinical trial, adult & adolescent patients

PRESS RELEASE CUTISS completes recruitment for denovoSkin™ Phase 2 clinical trial in adult and adolescent burn patients Switzerland, 7 September 2022 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the completion of recruitment for the Phase 2 clinical trial of its lead product denovoSkin™ in adult and adolescent burn patients. The entire study lasts about 12 months per patient with yearly follow-up visits 2 and 3 years after transplantation. Clinical outcome data from ongoing patient follow-ups are expected to become available in Q1 2023. This Phase 2 clinical trial evaluates the safety and efficacy of denovoSkin™, a personalized, bio-engineered dermo-epidermal skin substitute (NCT03227146). The trial is conducted in hospitals across Switzerland, Italy, and the Netherlands in patients 12 years of age and older who require a skin graft due to a major burn. A total of 12 patients are included in this trial. Since the protocol allows up to 15 patients, 2 additional patients have been enrolled and treated in August. Dr. Fabienne Hartmann-Fritsch, Clinical Study Advisor and co-founder at CUTISS, stated: “We are very pleased to have completed the recruitment of patients for this ground-breaking clinical trial, a true milestone for the continued development of our lead product denovoSkin™. We now look forward to analyzing the clinical outcome data during 2023.” The personalized human skin graft denovoSkin™ that is bio-engineered in large quantities starting from a small, post stamp-sized piece of healthy skin of the patient, could take skin surgery to the next level and revolutionize current treatments. It promises to grow with the patient, limit scarring and drastically reduce the number of follow up corrective surgeries required. Dr. Daniela Marino, Chief Executive Officer and co-founder at CUTISS, commented: “In Switzerland and across Europe, this year’s particularly hot and dry summer resulted in several fire-related accidents and patients admitted to burn centers requiring skin surgery. After completing the technology transfer from Wyss Zurich, our new on-site manufacturing facility started activities in March 2022 which significantly increased our agility and capacity to produce denovoSkin™ for clinical trials as well as for patients on a compassionate use basis.”                                                                                                                                                   CUTISS is also conducting two other denovoSkin™ Phase 2 clinical trials in Switzerland, Italy, and the Netherlands: one for pediatric burns (under 12 years of age, NCT03229564), and one for reconstructive surgery of skin defects (from 1 years of age, NCT03394612). A clinical trial Phase 1 for denovoSkin™ involving children suffering from burns or skin defects requiring surgery was completed in 2021 with a 5 year follow up at the University Children’s Hospital in Zurich. Further details of CUTISS’s clinical trials can be found on the company’s website here. To see how CUTISS bioengineers denovoSkin™, its pioneer automated manufacturing program, and the promising impact that CUTISS’s product has on patients, please visit the company’s YouTube channel 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 55 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  Nick Miles miles@cpc-pr.com | +41 796 787 626 Newsroom Press release (PDF)

Recruitment completed for denovoSkin Phase 2 clinical trial, adult & adolescent patients Read More »

CUTISS starts onsite denovoSkin™ production and successfully exits Wyss Zurich accelerator

CUTISS achieves full independence in its manufacturing capabilities with onsite facility. Increased agility and capacity in producing denovoSkin for current and future clinical trials and patients on compassionate basis. Successful transfer of technology and departure from Wyss Zurich Translational Center, a joint accelerator created by Hansjörg Wyss together with the University of Zurich and ETH Zurich (Swiss Federal Institute of Technology Zurich). Zurich, Switzerland – 08 March 2022 – CUTISS AG, a Swiss clinical-stage life sciences company focused on regenerative medicine and skin tissue engineering, has announced the start of production at the company’s new onsite manufacturing facility. This follows the certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)[1] from the regulator Swissmedic, the Swiss Agency for Therapeutic Products, in October 2021, and then the authorization to transfer the technology from Wyss Zurich to CUTISS. Kathi Mujynya, Chief Operating Officer at CUTISS, said: “This evolution represents a critical milestone for CUTISS. It centralizes our activities around the manufacturing of denovoSkin, increases our production capacities, and enables us to scale up the manufacturing process and take our automation program to the next level.” The CUTISS facility has commenced 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 state-of-the-art facility, located at the company’s headquarters at the Biotechnopark in Zurich-Schlieren, covers a surface area of 150 square meters and is comprised of several laboratories including a biobank and a histology lab. Until now, CUTISS’s products were manufactured at the GMP facility of Wyss Zurich Regenerative Medicine Technologies Platform, University of Zurich. Following the successful transfer of technology, CUTISS has become one of the first regenerative medicine companies to transfer out of this platform at Wyss Zurich. Professor Simon P. Hoerstrup, Founding Co-Director of the Wyss Zurich Translational Center, stated: “We are extremely pleased with the development of the project during its five years at Wyss Zurich, not least because it has all come out of our own development at the University of Zurich, our state-of-the-art technical and scientific platform facilities, and the Children’s Hospital Zurich. Starting as a research project, moving to preclinical implementation, and finally to clinical trials in a highly regulated environment – this is one of Wyss Zurich’s flagship projects. And finally, a successful technology transfer from Wyss Zurich’s Regenerative Medicine Technologies Platform to the startup was achieved with the construction of its own facility by CUTISS.” Dr Daniela Marino, Chief Executive Officer at CUTISS, commented: “We are very grateful to Wyss Zurich for their help and support throughout the last five years, enabling CUTISS to grow and arrive at this stage of development. Now, we are thrilled to have established and launched our own independent manufacturing capabilities, enabling us to scale up the development of our personalized skin tissue therapy and to meet the needs of patients with severe skin injuries.” Today’s announcement coincides with CUTISS’s five-year anniversary, having been established on 08 March 2017. A video of the manufacturing facility can be viewed 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 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. 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 March 2022. Headquartered at the Bio-Technopark in Zurich, it won the Top 100 Swiss Startup Award 2020, and has raised about CHF 50 million from private investors, family offices and public bodies. About Wyss Zurich The Wyss Zurich Translational Center is a joint accelerator of the University of Zurich and ETH Zurich (Swiss Federal Institute of Technology Zurich), which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. h.c. mult. Hansjörg Wyss. It was established to foster translational research focused on developing treatment protocols and clinical therapies, as well as novel technologies and intelligent systems, in the emerging fields of Regenerative Medicine, Robotics, and hybrid technologies thereof. Wyss Zurich unites world-leading experts from both institutions in multidisciplinary teams, pooling their knowledge and expertise. Media contacts Cabinet Privé de Conseils (Switzerland) Toomas Kull kull@cpc-pr.com | +41 767 480 174  Nick Miles miles@cpc-pr.com | +41 796 787 626 [1] Good Manufacturing Practice (GMP) standards and guidelines require that the manufactured medical products are of consistent high quality. Good Distribution Practice (GDP) refers to standards that ensure the quality and integrity of medicines throughout the supply chain. Newsroom press release as pdf

CUTISS starts onsite denovoSkin™ production and successfully exits Wyss Zurich accelerator Read More »

IBSA Pharma and CUTISS complete license agreement for VitiCell

PRESS RELEASE  Two innovative biotechnology specialists, IBSA Pharma and CUTISS complete license agreement for VitiCell® Agreement grants CUTISS exclusive worldwide license to commercialize VitiCell®. VitiCell® is a CE marked medical device developed by IBSA for the treatment of skin pigmentation disorders. Strategic fit with CUTISS’s expertise in skin tissue bioengineering. Sophia-Antipolis (France) and Zurich (Switzerland), 2 February 2022 – IBSA Pharma SAS (“IBSA Pharma”), the French subsidiary of the multinational pharmaceutical company IBSA, and CUTISS AG (“CUTISS”), a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, announced today the start of an exclusive licensing agreement for the commercialization of VitiCell® worldwide. Under the non-disclosed terms of this agreement, CUTISS has received exclusive rights to globally commercialize VitiCell®, a biotechnological product developed and patented by IBSA Pharma. VitiCell® 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 indicated for skin re-pigmentation, for example in the case of non-evolving Vitiligo or hypochromatic post traumatic scars. The medical device was granted a CE mark as a class llb medical device in 2015. Fabrice Jover, General Manager of IBSA Pharma said: “Aware of the role of biotechnologies in the emergence of new therapies, with a shared vision on the potential of VitiCell® and CUTISS’s mission and expertise, this agreement aligns our two companies with the common goal of reaching more patients suffering from Vitiligo and hypochromatic post traumatic scars and who can therefore benefit from VitiCell®.” Massimiliano Licenziati, President of IBSA Pharma stated: “This agreement confirms the expertise of IBSA Pharma’s Biotechnology Department in the development of innovative and accessible biotechnology products designed for healthcare professionals and dedicated to unmet medical needs. We are delighted to collaborate with CUTISS to commercialize VitiCell® and improve the lives of patients suffering from skin pigmentation disorders. Together with CUTISS we have a common goal in developing innovative regenerative medicine therapies to improve the quality of life of patients.” Daniela Marino, CEO of CUTISS commented: “This license agreement is encouraging news for patients suffering from a loss of skin color. VitiCell®’s ability to restore skin color using patient’s own cells will benefit Vitiligo patients and patients with dyspigmented scars. Importantly, future patients treated with CUTISS’s promising denovoSkin™ therapy for burns and skin reconstructive indications may also benefit, since as of today, denovoSkin™ is colorless. We are excited by the excellent strategic fit of these two products and the opportunity for CUTISS to develop its commercial operations in a knowledgeable community of dermatology experts.” Positive news for patients suffering from skin pigmentation disorders Vitiligo is the most common skin pigmentation disorder with approximately 1-2% of the global population affected. It is an autoimmune disease resulting in discolored skin lesions in different areas of the body. Patients with stable Vitiligo and post-traumatic scars are eligible for treatment with VitiCell®. In the treatment procedure, the medical professional takes a sample of patient’s healthy, pigmented skin, and using the VitiCell® kit, prepares an autologous epidermal cell solution, further transplanted onto the prepared skin lesion. CUTISS will actively commercialize VitiCell® once the device’s existing EU MDD license is converted to the EU MDR[1] license. In the meantime, IBSA Pharma continues to make the product available to patients. This agreement is an excellent strategic fit with CUTISS’s expertise in skin tissue bioengineering and the company’s close relationships with key opinion leaders in dermatology. Furthermore, CUTISS also recently announced the opening of a R&D subsidiary at the Sophia Antipolis technology park on the Cote d’Azur in France. About IBSA Pharma (former Laboratoires Genevrier) IBSA Pharma is the French subsidiary of IBSA, an international pharmaceutical company based in Switzerland. Created in 1987 under the name of Laboratoires Genevrier, IBSA Pharma is located in Sophia-Antipolis, the first technology park in Europe, near Nice (France). IBSA Pharma is built on the four IBSA Group’s pillars: Person, Innovation, Quality and Responsibility. The common thread is bringing innovative and safe therapeutic alternatives to the greatest number of patients. IBSA Pharma is therefore committed to improving the quality of life of patients by offering products in their best galenic forms for optimal and proven effectiveness. Our approach is thus in line with a continuous philosophy of excellence and technological progress to contribute to the future improvement of health. In 1996, Laboratoires Genevrier proudly became the first European certified private cell therapy center, making it a true pioneer in biotechnology. The know-how is illustrated in the design and development of breakthrough technology health products. IBSA Pharma’s intellectual property and know-how is used for the development of medical devices for cell therapy, as well as medical devices adapted to pathologies that require long and expensive treatments, often disrupting the patient’s daily life. Today, IBSA Pharma has expanded into 8 therapeutic areas: Aesthetic Medicine, Dermatology, Pain and Inflammation, Osteoarticular, Reproductive Medicine, Uro-gynaecology, Endocrinology, Consumer Health. IBSA Pharma offers to patients and healthcare professionals alike more than 90 products to meet their evolving needs: drugs, medical devices, cosmetics, food supplements, biocides and cell therapy products, all manufactured in Europe under the highest quality standards. About CUTISS CUTISS is a Swiss clinical-stage life sciences company focused on skin regenerative medicine and 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 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. 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

IBSA Pharma and CUTISS complete license agreement for VitiCell Read More »

Scroll to Top

Newsletter

Would you like to contact us as a journalist?

©WyssZurich

This website uses cookies to ensure you get the best experience on our website.