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CUTISS and Tecan partner to advance the automation of bioengineered human skin tissue manufacturing

Switzerland – 14 April 2025 – CUTISS, a late-stage clinical biotech at the forefront of tissue therapeutics and regenerative medicine, today announced a strategic partnership with Tecan, a global leader in the development, production, and distribution of automation solutions for the life sciences and diagnostics sector. This collaboration marks a critical step in the industrialization of CUTISS’ pioneering automation platform for the manufacturing of personalized skin tissue therapies. The partnership will enable the transition of CUTISS’ automated manufacturing solution from engineering development to industrial-grade production. It will also support CUTISS’ mission to bring its lead product denovoSkin™ – the personalized, bioengineered human skin graft – to market at scale and to expand the platform’s potential into new areas of regenerative medicine. Dr. Daniela Marino, CEO of CUTISS, said: “This collaboration reaffirms our leading role in tissue therapeutics and our commitment to take denovoSkin™ to the global market. As a late-stage clinical biotech we strongly believe that denovoSkin™ has the potential to revolutionize skin surgery globally and across numerous indications. Tecan’s expertise and global infrastructure will strengthen our industrial capabilities, enabling the rapid scale-up of our automated tissue therapy platform. We are proud to work alongside such a strong industrial leader with Swiss roots and international presence.” Dr. Achim von Leoprechting, CEO of Tecan, stated: “We are pleased to partner with CUTISS in industrializing the world’s first automated manufacturing platform for personalized skin tissue therapy, addressing unmet medical needs. This collaboration perfectly aligns with Tecan’s purpose of improving people’s lives and health by empowering customers to scale healthcare innovation globally, from life science to the clinic.” Dr. Vincent Ronfard, Chief Innovation Officer of CUTISS, added: “The CUTISS automation platform is a first-of-its-kind in personalized tissue manufacturing. Together with Tecan we are paving the future of tissue engineering automation.” denovoSkin™ in late-stage Phase 3 clinical trials As a personalized, bioengineered human skin graft, denovoSkin™ is designed for patients undergoing skin surgery for severe skin injuries (such as burns) or reconstructive procedures. It aims to replace the current standard of care, autografting, and to significantly improve patient outcomes. The Phase 3 confirmatory study in adolescent and adult severe burn patients is taking place in Switzerland and the European Union across 8 sites. denovoSkin™ is also accessible under compassionate use. It has been granted Orphan Drug Designation (ODD) for the treatment of burns from Swissmedic, EMA, and the FDA.  denovoSkin™ is unique because it is bilayer, composed of both dermis and epidermis. In clinical trials and long-term follow-ups to date, it has been shown to grow with the patient and regenerate in a scarless manner, to mature quickly, safely restore skin function, and significantly reduce the need for scar care and follow-up corrective surgeries. Beyond being life-saving and life-changing, denovoSkin™ is also cost-effective and offers attractive unit economics. Scaling up with first-in-class automated production CUTISS is working to scale-up the production of denovoSkin™ through automation. The company has already developed a first-in-class automation platform for the scalable production of personalized tissue therapy – a patented, fully-closed, end-to-end system that enables decentralized production, cost-effective scale-up, and high return on investment.  About CUTISS CUTISS (www.cutiss.com) is a late-stage clinical biotech at the forefront of tissue engineering therapy and regenerative medicine. The lead product – denovoSkin™ – is a bio-engineered, personalized human skin graft that promises to transform skin surgery with significant benefits to patients around the world. Currently in Phase III clinical trials in Europe, denovoSkin™ has received Orphan Drug Designation from Swissmedic, the European Medicines Agency (EMA), and the US FDA for the treatment of burns. CUTISS is also pioneering the development of the world’s first automated platform for large-scale skin tissue production, advancing breakthrough programs in skin pigmentation restoration and expanding the horizons of tissue engineering. To date, the project has benefited from public funding support including from Innosuisse, Switzerland’s innovation agency, and the European Union Horizon 2020. The company was established in 2017 as a spin off from the Tissue Biology Research Unit at the University of Zurich, and is headquartered in Zurich, Switzerland. About Tecan Tecan (www.tecan.com) improves people’s lives and health by empowering customers to scale healthcare innovation globally from life science to the clinic. Tecan is a pioneer and global leader in laboratory automation. As an original equipment manufacturer (OEM), Tecan is also a leader in developing and manufacturing OEM instruments, components and medical devices that are then distributed by partner companies. Founded in Switzerland in 1980, the company has 3,300 employees, with manufacturing, research and development sites in Europe, North America and Asia, and maintains a sales and service network in over 70 countries. In 2024, Tecan generated sales of CHF 934 million (USD 1,062 million; EUR 984 million). Registered shares of Tecan Group are traded on the SIX Swiss Exchange (TECN; ISIN CH0012100191). Media contacts CUTISS – European and international mediaCabinet Privé de Conseils (Switzerland)Toomas Kull kull@cpc-pr.com | +41 767 480 174 Newsroom Press release (PDF)

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Positive Phase 2 trial readout for long-term efficacy & safety of denovoSkin™ in reconstructive skin surgery and in burns

denovoSkin™ seeks to redefine skin surgery and significantly improve patient outcomes in burn treatment and reconstructive procedures. Positive Phase 2 data from a 1-year follow-up in reconstructive skin surgery and a 2-year follow-up in severe burns treatment confirms safety and efficacy. denovoSkin™ can significantly spare donor sites and improve scar quality when compared to standard of care treatment. Switzerland – 12 February 2025 – CUTISS AG, a life sciences company at the forefront of tissue engineering therapy and regenerative medicine, announced positive long-term efficacy and safety readout in the Phase 2 clinical trials of denovoSkin™ in reconstructive surgery as well as in burns treatment. The data reaffirm the role of denovoSkin™, an autologous, bio-engineered dermo-epidermal skin graft, in reducing the need for donor site harvesting and minimizing scarring, leading to improved patient outcomes following skin surgery compared to autografting which is today’s standard of care. “denovoSkin™ has the potential to revolutionize skin surgery beyond burns, and the latest data show that our product can also be used for elective reconstructive surgery indications,” said Dr. Daniela Marino, CEO of CUTISS. “The robust 1-year data in reconstructive procedures and the solid 2-year data in burns demonstrate denovoSkin™’s versatility and its ability to deliver superior outcomes, surpassing traditional methods.” “The impact of living with scars is frequently underestimated. Patients often face limitations in movements because of a scar that doesn’t stretch, requiring repeated surgeries that pose a constant burden for the patient and society,” commented Prof. Dr. Esther Middelkoop, Prof. of Skin Regeneration and Wound Healing at the Amsterdam University Medical Center. “Patients treated with denovoSkin™ for reconstruction perceived a remarkably fast maturation and good skin quality. The treated areas were particularly pliable, with texture and function comparable to normal skin. Unlike autografting, treatment with denovoSkin™ is less invasive and results in better skin quality. This could benefit many patients who are dealing with problematic wounds and scars today.” Growing need in reconstructive skin surgery Reconstructive skin surgery is needed for patients requiring scar revision, cancer resection, plastic and trauma surgery, as well as the removal of giant congenital nevi in children, for example. Demand for plastic and reconstructive surgeries continues to grow, with 6.8 million reconstructive procedures performed in the U.S. in 2023, according to the American Society of Plastic Surgeons (ASPS). denovoSkin™ promises improved patient outcomes and quality of life The current standard in skin surgery – autografting – often faces donor site shortages[1] and results in scarring, which requires ongoing maintenance, limits mobility and growth, and may necessitate follow-up corrective surgeries, particularly in children. While denovoSkin™ clearly offers the key advantage of sparing donor sites and eliminating the need for large-scale skin harvesting, these Phase 2 data readouts also demonstrate that denovoSkin™ provides patients with significant improvements in terms of skin pliability, flexibility, relief, and overall scar quality when compared to standard of care in an intra-patient control setting. Phase 2 clinical trials progressing, Phase 3 trial authorized and starting in the E.U. The positive 1-year efficacy and safety data in the Phase 2 trial in reconstructive skin surgery in children and adults follows the announcement of a positive interim readout in July 2024, and the successful treatment of the first U.S. patient on a compassionate-use basis for complex post burn reconstructive procedures. The positive 2-year long term follow-up data in burns follows the announcement of positive efficacy and safety readout in February 2024 in adolescent and adults, as well as several compassionate study reports. denovoSkin™’s Phase 2 clinical trials have a total follow-up period of three years. Meanwhile, CUTISS is advancing into Phase 3 trials in the E.U. for burn patients, having received authorization from the European Medicine’s Agency (EMA) in December 2024. With continued success, denovoSkin™ is set to redefine the future of skin surgery, offering advanced solutions that restore the skin’s function and cosmesis[2] with minimal donor site harvesting. The full clinical development program can be viewed online here. About CUTISS Established in 2017 as a spin-off of the Tissue Biology Research Unit of the University of Zurich, CUTISS is at the forefront of tissue engineering therapy and regenerative medicine. Our lead product, denovoSkin™, a bio-engineered, personalized skin graft, promises to transform skin surgery. Currently in phase III clinical trials in Europe, denovoSkin™ has received Orphan Drug Designation from Swissmedic, the European Medicines Agency (EMA), and the US FDA for the treatment of burns. Moreover, CUTISS is pioneering the development of the world’s first automated platform for large-scale skin tissue production, advancing breakthrough programs in skin pigmentation restoration and expanding the horizons of tissue engineering. For more information: www.cutiss.com. Media contacts CUTISS – European and international mediaCabinet Privé de Conseils (Switzerland)Toomas Kull kull@cpc-pr.com | +41 767 480 174 CUTISS – US mediaInizio Evoke CommsDanielle Cantey Danielle.cantey@inizioevoke.com | +1 (619) 826-4657 [1] Donor site shortages refer to the limited availability of healthy skin for grafting, particularly in patients with extensive burns or insufficient viable tissue. [2] Cosmesis refers to the aesthetic outcome of a medical procedure, particularly in minimizing visible scarring and improving skin appearance. Newsroom press release (PDF)

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Schweizer Monat: entrepreneurship series, interview focus on CUTISS

Our CEO Daniela Marino has been featured in a new entrepreneurship series launched by Schweizer Monat, the Swiss monthly magazine. In her video interview, she discusses the challenges and rewards of leading CUTISS and our mission to transform skin surgery with denovoSkin™, the bio-engineered skin graft which promises to grow with the patient, minimize scarring and improve quality of life, particularly for children. Daniela also shares candid insights on what it takes to innovate in the biotech space, the importance of resilience, and how balancing her professional and personal life keeps her grounded. You can watch and listen to the interview, in German, here.   Newsroom Video Interview

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Handelszeitung: reportage on the U.S. patient and our latest developments

“The start-up hype of recent years has seen many young entrepreneurs come and go. One who has not only made headlines but also delivered results is Daniela Marino.” Thus reads the opening line of the article published in Switzerland’s business newspaper HandelsZeitung. The article was published on the back of our news in October 2024, announcing the first reconstructive surgery that was done under compassionate use and the first U.S. patient treated with denovoSkin™. Having interviewed Jeremy Goverman M.D. at Massachusetts General Hospital and our CEO Daniela Marino,  the journalist recounts the challenges that we overcame in transporting the personalized skin grafts from Schlieren to Boston, and the wonderful positive outcomes that the surgeons are seeing with the young patient in question. “Daniela and her team are trying to do something that no one else in burn medicine is daring to do. She is developing real skin, not just a substitute,” Jeremy Goverman M.D. is quoted as saying. The link to the article, in German, is available here or on PDF. Newsroom Article (PDF)

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EMA authorizes Phase 3 clinical trial for denovoSkin™

CUTISS has received authorization from the European Medicines Agency (EMA) to commence the Phase 3 clinical trial for our lead product denovoSkin™ in adult & adolescent severe burn patients. Running across eight countries, including Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, and Spain, the Phase 3 confirmatory study will validate the efficacy and functionality of denovoSkin™ – a living, personalized bilayer bioengineered skin graft – in achieving wound closure and reducing scarring in patients with severe burns compared to standard of care. We are grateful to our entire CUTISS team, the clinical partners, all collaborators, patients, investors, and stakeholders who are making this pioneering work possible. Together, we continue to pave the way for transformative solutions in regenerative medicine and skin surgery. Newsroom Link to EMA page

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Panorama: Switzerland as a hub for innovation, featuring CUTISS

Panorama, one of Italy’s leading weekly magazines covering current affairs, culture, and technology, has highlighted Switzerland’s emergence as a global leader in biotechnology, artificial intelligence, and cutting-edge innovation, calling it a “new Silicon Valley”. The article highlights the country’s commitment to advancing science and technology and its ability to foster groundbreaking companies that shape the future of healthcare and beyond. CUTISS is proudly featured as an example of innovation in regenerative medicine and skin tissue engineering. The piece emphasizes our pioneering work in developing the world’s first machine capable of bioengineering personalized human skin grafts, the denovoSkin™, for patients suffering from severe skin injuries. Read the full article in Panorama HERE Newsroom Link to article

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The Boston Globe reports on first U.S. patient treated with denovoSkin™

The Boston Globe reports on the news that Massachusetts General Hospital has completed the first U.S. application of denovoSkin™, the bi-layer bioengineered skin graft developed by CUTISS, on a young pediatric patient. The reconstructive surgery was performed by Dr. Jeremy Goverman under FDA compassionate use.   Dr. Goverman describes the full-thickness personalized skin graft as a step closer to the “Holy Grail” of reconstructive surgery, potentially transforming skin surgery for both pediatric and adult patients. Read the article here. Newsroom Link to article

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Reconstructive skin surgery: positive Phase 2 interim analysis on efficacy for denovoSkin™ in pediatric, adolescent and adult patients

Switzerland, 9 July 2024 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced positive interim analysis on efficacy from the Phase 2 clinical trial of its lead product denovoSkin™ in patients undergoing reconstructive skin surgery due to various conditions. Dr. Daniela Marino, CEO of CUTISS, said: “We are thrilled with this first positive assessment of efficacy from the Phase 2 trial in reconstructive surgery. These results confirm CUTISS’s mission to provide access to denovoSkin™ beyond burns, improve patient outcomes, and change the status quo in skin surgery.” The Phase 2 full data analysis with the one year follow up will be available in early 2025. A total of 23 patients are included in this multicentric trial. The trial focuses on conditions that necessitate skin grafts (scars, traumatic injuries, congenital defects, surgical excisions, etc), aiming to provide solutions that reduce scarring and improve healing outcomes. The denovoSkin™ is a personalized, bio-engineered dermo-epidermal human skin graft, created from a small biopsy of the patient’s healthy skin and expanded to produce large quantities of new skin. It aims to significantly reduce the need for healthy skin harvesting, significantly reduce scarring, as well as reduce the need for follow-up corrective surgeries. 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, 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

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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 kull@cpc-pr.com | +41 767 480 174  Newsroom Link to press release

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