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CUTISS closes CHF 56M Series C round and signs agreement with leading European burn center

Switzerland, 10 September 2025 – CUTISS, a late-stage clinical TechBio at the forefront of tissue therapeutics and regenerative medicine, has announced the closing of its Series C round for a total of CHF 56M with existing and new investors, bringing total funds raised to more than CHF 125M. The proceeds will be used to progress with the Phase 3 trial of the lead product denovoSkin™, which started earlier this year, and to prepare for its commercialization. The funds will also advance the industrialization and clinical readiness of the world’s first automated manufacturing platform for personalized tissue therapy, a key component for bringing denovoSkin™ to market at scale. Dr. Daniela Marino, CEO and co-founder of CUTISS, stated: “The successful closing and partnerships demonstrates confidence in our vision and ability to bring transformative skin therapies to patients. We’re grateful for the continued trust of existing investors and warmly welcome new investors on board, including key strategic ones.” CUTISS has also signed a collaboration agreement with its new investor Rode Kruis Ziekenhuis (RKZ), which could see the creation of CUTISS’ first international commercial production facility in the Netherlands, once denovoSkin™ is commercially approved. RKZ is a leading EU clinical trials center, participating in the Phase 2 and Phase 3 trials for denovoSkin™.   “The agreement with RKZ sets the stage for our future expansion with the potential to revolutionize the skin surgery market in Europe and globally,” continued Dr. Marino. Nadine Vieleers, CEO Rode Kruis Ziekenhuis / Burn Center Beverwijk, commented: “As a clinical institution dedicated to advancing burn care, we’re committed to support CUTISS and the development of denovoSkin™. We’re excited to continue our closer collaboration, and the agreement we’ve signed sets out our vision for bringing their revolutionary skin tissue therapy to our patients as a priority.” The Series C co-lead investors – the family office of Giammaria Giuliani, a longstanding lead investor, and a US family represented by Shiloh Advisors AG – were joined in 2025 by new investors ranging from family offices to industry players, as well as an investor collective at Swisspreneur. Silvan Krähenbühl, speaking on behalf of Swisspreneur, commented: “We’re proud that Swisspreneur participated in the latest funding round of CUTISS, a pioneering Swiss biotech company. Their mission to revolutionize skin regeneration is exactly the kind of bold innovation we love to support, and we’re excited for the next phase in the journey ahead.”  In April 2025, CUTISS announced a strategic partnership with Tecan to enable the transition of CUTISS’ automated manufacturing solution from engineering development to industrial-grade production. Monica Manotas, Tecan CEO, commented: “Our ongoing partnership with CUTISS to industrialize skin tissue therapy highlights our commitment to advancing automation in high-growth areas such as cell biology and personalized medicine. Tecan’s expertise and technologies deliver precision and reproducibility at scale, enabling customers to transform research breakthroughs into real-world solutions to improve people’s lives and health.” denovoSkin™ is human, living skin – on demand The personalized (autologous), bioengineered skin graft denovoSkin™ is designed for patients undergoing skin surgery for burns, reconstructive and plastic procedures. denovoSkin™ is bilayer, composed of both dermis and epidermis. Long-term follow-ups to date have shown that it drastically spares donor sites, matures quickly, safely restores skin function, regenerating in a near-scarless manner, and growing with the patient. As a result, it has the potential to significantly reduce healthy skin harvesting and scar care (including follow-up corrective surgeries), and improve quality of life. The Phase 3 confirmatory study in adolescent and adult severe burn patients is recruiting in Switzerland, and the European Union across 8 member states. The first data set from this trial is expected at the end of 2026. denovoSkin™ has also been accessible under named-patient basis (compassionate use). It has Orphan Drug Designation (ODD) for the treatment of burns from Swissmedic, EMA, and the FDA, which also provides fast-track regulatory pathways and extended market exclusivity. 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 de-centralized production, cost-effective scale-up, and high return on investment. Platform industrialization is now ongoing. VitiCell® offers personalized treatment for patients with skin pigmentation disorders CUTISS has exclusive rights to globally commercialize VitiCell®, an MDD CE-marked medical device developed by IBSA Pharma. The device enables autologous cell grafting for skin re-pigmentation, offering a personalized treatment option for patients with vitiligo. In the future, patients treated with denovoSkin™ may also benefit from this therapy. CUTISS will launch VitiCell® once the EU MDR CE marking is granted. 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™ is a bio-engineered, personalized skin graft, that promises to transform skin surgery. Currently in Phase 3 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. www.cutiss.com Media contacts CUTISS: CPC PR | Toomas Kull | kull@cpc-pr.com | +41 767 480 174 RKZ: Sandra de Jong | sfmdejong@rkz.nl | +31 653447246 Newsroom Press release (PDF)

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Brigitte: featured in the ‘female makers’ section

German lifestyle magazine Brigitte has profiled our CEO Dr. Daniela Marino in its Macherinnen (female makers) section. Under the title “Meisterin der zweiten Haut” (Master of the second skin), the article retraces her journey from early research at Kinderspital Zürich to the founding of CUTISS and the development of our bio-engineered skin substitute, denovoSkin™. The feature highlights how denovoSkin™ is designed to permanently treat severe burns and large skin defects, sparing donor sites, reducing scarring, and growing with children – bringing new hope to “burn survivors”. You can read the full article as a PDF via the link below. Newsroom Article as PDF

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Phase 2 BC_interim analysis

Positive Phase 2 trial interim analysis on safety and efficacy for denovoSkin™ in pediatric burn patients

CUTISS has completed an interim analysis in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns, with positive results. The randomized, controlled trial enrolled 12 pediatric patients, comparing denovoSkin™ to the current standard of care (autografting) using an intra-patient control design. The results from the interim analysis confirm a favorable safety profile and show positive signals of efficacy, supporting the continued development of denovoSkin™ for use in pediatric burn care. Children with extensive burns are particularly vulnerable to complications related to scarring, such as impaired growth and mobility, and visible disfigurement. The findings of this study, together with the results obtained in several pediatric compassionate burn patients, represent an important step in pediatric skin surgery, aiming to offer a personalized, donor site-sparing solution that also addresses the lifelong impact of scarring on quality of life. The 1 year analysis of the trial will follow; the trial has a total of 3 years of follow-up. In parallel, CUTISS is advancing denovoSkin™ in a Phase 3 clinical trial for adolescents and adults with severe burns in the E.U. and Switzerland, as detailed in our news on 6 May 2025. Newsroom Read News from 6 may 25

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Case report: denovoSkin™ used under compassionate use in pediatric reconstructive burn surgery

The abstract published in the Journal of Burn Care & Research (March/April 2025) by the American Burn Association (57th annual meeting) describes the compassionate use of denovoSkin™ in reconstructive surgery for a three-year-old child with 90% total body surface area (TBSA) burn injuries at Massachusetts General Hospital, a leading U.S. burn center. The treatment was carried out under a compassionate use exemption from the U.S. FDA. The case involved contracture release surgeries and treatment of non-healed wounds and unstable scars. The denovoSkin™ grafts demonstrated an engraftment rate greater than 95%, with the resulting skin described as durable and manageable, comparable to traditional full-thickness autografts but with advantages over conventional cultured epidermal autografts (CEAs). The authors conclude that this use of denovoSkin™ introduces a new treatment paradigm in both acute and reconstructive burn surgery, especially for patients with extensive injuries and limited donor skin. This case report adds to the growing body of clinical experience supporting denovoSkin™ as a potential breakthrough in skin tissue therapy, including in pediatric reconstructive care under extreme conditions. As the paper’s authors note: “The development of an autologous, full-thickness skin replacement remains the holy grail for the treatment of full thickness skin loss from burns, wounds, and trauma.” The abstract can be read online here: Burn Care & Research  Full citation: Matthew Supple, Robert Sheridan, Jeremy Goverman, 846 Pediatric Compassionate Use of a Novel, Autologous, Engineered, Hydrogel Skin Graft with Keratinocytes and Fibroblasts, Journal of Burn Care & Research, Volume 46, Issue Supplement_1, March/April 2025, Page S288. Newsroom Read Article

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CUTISS completes patient recruitment in Phase 2 pediatric burns trial

CUTISS has completed patient recruitment in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns. This randomized, controlled trial compares denovoSkin™ to the current standard of care, autografting, using an intra-patient control design. It is one of three Phase 2 trials designed to assess denovoSkin™ – a personalized, bioengineered skin graft – across different patient populations and indications. denovoSkin™ has also been used to treat children on a compassionate use basis where existing therapies are not sufficient or suitable. Severe burns in children are associated with lifelong consequences, including scarring and restricted growth. By generating clinical evidence in pediatric patients, this study supports the broader development of denovoSkin™ as a skin tissue therapy designed to reduce donor site burden and improve long-term scar outcomes. With recruitment now completed, the study moves into follow-up and data analysis. Results will contribute to the broader clinical development program of denovoSkin™, currently in Phase 3 for adolescents and adults. In February 2025, CUTISS 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 (press release available here). Newsroom

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CUTISS advances Phase 3 clinical trial of denovoSkin™

CUTISS is making steady progress in the clinical development of denovoSkin™, its personalized, bio-engineered skin graft, as part of the ongoing Phase 3 clinical trial for the treatment of severe burns. The first enrolled patients have now been successfully grafted with denovoSkin™ at clinical sites in the Netherlands and Spain, with additional recruitment underway in France and Italy. There are eight sites involved in this confirmatory study in the EU. In parallel, the trial has also been approved in Switzerland by Swissmedic, with preparations in place to begin patient recruitment. We thank the clinical teams, surgeons, patients, collaborators, and stakeholders whose work and dedication is driving this important progress. Newsroom

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Dutch media report on first baby treated in the Netherlands

Dutch media have reported on the treatment of the first baby with denovoSkin™, in the Netherlands, outside of clinical trials. The operation was performed by doctors and surgeons at the Burn Centre of the Maasstad Hospital in Rotterdam. Trauma and burn surgeon, Kees van der Vries, described the use of denovoSkin™ a “godsend”. “The baby has been successfully operated on and is recovering well. We are proud to have been able to use this treatment. It really makes a difference for patients with severe, large/extensive burns and contributes to a better quality of life. This innovative method offers promising prospects for the future of burn care.” CUTISS is already running clinical trials, including the ongoing Phase 3 study, in the Netherlands at the Brandwondencentrum Beverwijk. The English language media article is available in the NL Times here, and the original Dutch media article can be read in AD here. The Maasstad Hospital has also published its own article regarding the operation which can be found here. Newsroom Article NL Times

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BiotechTV: CUTISS featured in European biotech spotlight

As part of his European tour and trip to Switzerland, BiotechTV host Brad Loncar visited CUTISS to learn more about our work in personalized skin tissue therapy. In this interview, our CEO Dr. Daniela Marino shares insights into the development of denovoSkin™, its clinical progress, and the vision behind advancing skin surgery through bioengineering and automation. Watch the full feature on BiotechTV in the link below. Newsroom Watch feature

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CUTISS granted U.S. patent for automation technology in skin tissue therapy

CUTISS has been granted a new patent in the United States for a core element of its automated platform used to manufacture personalized, bio-engineered human skin grafts. The patent (US Patent No. 12,286,611), titled “Tissue culture vessel for preparation of compressed hydrogel skin grafts and related methods and systems,” protects a key component of the company’s automated tissue engineering process for denovoSkin™, currently in late-stage clinical development for skin surgery. This patent supports CUTISS’ broader strategy to industrialize personalized skin tissue therapy through standardization, reproducibility, and scalability. The company’s automation efforts have been commenced in collaboration with CSEM and INNOSUISSE and are now being advanced in collaboration with Tecan (read our partnership announcement here), a global leader in laboratory automation. The granting of this U.S. patent further strengthens our international intellectual property portfolio in the field of regenerative medicine and tissue bio-engineering. Newsroom Read Press release

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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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