May 2024

Quotidiano Nazionale: a technology that saves lives

The article from Italy’s Quotidiano Nazionale features an interview with our CEO and co-founder Daniela Marino. She discusses our pioneering work in creating bioengineered skin on demand. Daniela highlights the benefits of this technology and our approach which allows us to generate large amounts of skin from a small patient’s own skin sample. More than 60 patients have been treated, among them also an infant. The article also covers CUTISS’s collaborations, including with the Buzzi Pediatric Hospital in Milan, the fundraising efforts, and the significant impact of our innovation on burn victims and reconstructive surgery. For more details, read the full article here. Newsroom Link to article

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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 | +41 767 480 174  Newsroom Link to press release

CUTISS announces first closing of CHF 25M in Series C funding round Read More » life changing hope for burn victims, the premier online publication dedicated to the growing European technology ecosystem, writes about CUTISS’s breakthrough with denovoSkin, a bioengineered skin graft designed to grow with patients, improving quality of life and significantly reducing the need for follow-up surgeries. The innovative skin graft is derived from a small piece of the patient’s healthy skin and can be produced in large quantities. This advancement offers hope for burn victims and those needing reconstructive surgery. The article also discusses CUTISS’s efforts in automation and our participation in advanced research initiatives, including in space, to enhance our understanding of skin regeneration. For more details, read the full article here. Newsroom Link to article life changing hope for burn victims Read More »

CUTISS continues collaboration with Santobono Hospital in Naples to transform pediatric burn care

A significant milestone in pediatric burn care in Italy has been achieved with the inauguration of the new pediatric burn center at Santobono Hospital in Naples, a new center of excellence at European level. Since 2021, Santobono has been the coordinating center in Italy for our Phase 2 clinical trial of denovoSkin™, the bioengineered autologous human skin tissue. Notably, Santobono was the first pediatric center in the world to perform a denovoSkin™ transplant in a neonate. We feel incredibly proud and honored to collaborate on this groundbreaking project with Dr. Marcello Zamparelli, underscoring our commitment to change the status quo in skin surgery and improve patient outcomes with cutting-edge regenerative medicine.  The new facility will enable quicker interventions for patients and allow continuous control, monitoring, and verification of the therapies and innovative treatments they receive. Burns are the third leading cause of death in children. In Campania region of Italy, between 2022 and 2023, 120 young patients were treated. Of these, 70% had severe or very severe burns; 80% required surgical hospitalizations that lasted an average of 15 days. It is in this context that the new pediatric burn center at Santobono-Pausilipon has been inaugurated. This news and announcement has featured across Italian media including in RAI, La Presse Il Mattino, ANSA, and Naples Today. Newsroom Link to RAI reportage

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La Repubblica: denovoSkin™ applied in pediatric burns in Milano

The Italian daily newspaper La Repubblica writes about our lead product denovoSkin™ being used to treat a child in Milan, Italy.  The young child suffered severe burns over a large portion of his body due to a domestic accident. Traditional skin grafts were not a viable option due to his young age and the extent of the injuries. This patient is now part of the ongoing pediatric clinical trial aimed at demonstrating the efficacy and safety of denovoSkin™ in young kids, who represent a particularly challenging demographic in burn surgery due to their delicate skin and rapid growth rates. A twin study in adolescents and adults has completed recruitment, and safety and efficacy has been recently demonstrated (read the press release here). A third study in reconstructive surgery has completed recruitment (read the press release here). In the article, Professor Gloria Pelizzo, who led the surgical team, noted the successful grafting of our personalized, bioengineered skin graft, highlighting the potential for denovoSkin™ to significantly improve outcomes in pediatric burn treatment. We extend a big thank you to Italian patients, surgeons and investors for being part of CUTISS’ journey. Newsroom Link to article

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