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CUTISS granted European patent for skin tissue graft

CUTISS is pleased to announce that a tissue graft patent has been granted by the European Patent Office for the personalized bioengineered human skin tissue therapy developed by CUTISS. The patent (3174563) has been granted pursuant to Article 97(1) EPC to University of Zurich (UZH) where the founders of CUTISS worked at the time of the patent filing (2014), and is exclusively licensed to CUTISS. This patent strengthens the company’s intellectual property position in human tissue graft technologies. CUTISS’s first skin tissue therapy product denovoSkin is 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. The mention of the grant has been published in the European Patent Bulletin 22/24. Newsroom European patent bulletin 22/24

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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

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Sciences et Avenir: A machine produces personalized skin

The popular French science magazine Sciences et Avenir has published an article explaining the science behind our denovoSkin and denovoCast innovations, and the promise that this brings to patients suffering from severe skin burns and injuries. The journalist had visited CUTISS to see this for herself and to speak with our CEO Daniela and CIO Vincent. “Swiss researchers have succeeded in automating the manufacture of autologous skin, produced from the patient’s own cells. An innovation that will benefit burn victims in the future. Reportage from the laboratory of this promising start-up near Zurich, Switzerland.” The article was also published in the monthly edition of the magazine, February 2022. Newsroom Link to article

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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

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CUTISS opens R&D subsidiary in France and secures first grant

CUTISS opens subsidiary in France and secures first government grant to extend its Research and Development in regenerative medicine The subsidiary CUTISS Innovation, based at Sophia Antipolis, Europe’s leading technology park, will focus on R&D and innovation in regenerative medicine. A grant of EUR 300,000 from the Region Provence-Alpes-Cote d’Azur will contribute towards the installation of a CUTISS laboratory at the site near Nice. France and Switzerland, 25 January 2022 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has announced the opening of CUTISS Innovation, a wholly-owned subsidiary based at Europe’s largest leading technology park Sophia Antipolis, in the French department of Alpes Maritime. The company has also secured its first grant of EUR 300,000 from the Provence-Alpes-Côte d’Azur region that will be used to set up and launch the research laboratory. CUTISS Innovation will support and extend the company’s R&D activities, focusing on the development of innovative break-throughs and products in the field of skin pigmentation restoration, and the automation of personalized regenerative medicine. As part of this, the company will work in close collaboration with dermatology stakeholders, clinics, and specialists, notably with Professor Thierry Passeron, Head of the Dermatology Unit at the Nice University Hospital and Team Leader of the Molecular Medicine Mediterranean Center. Vincent Ronfard, Chief Innovation Officer at CUTISS AG and Director of CUTISS Innovation, commented: “We are excited to establish our presence in this hotspot for innovation and dermatology which will enable our research team to push the boundaries in regenerative medicine. We are extremely grateful for the support we have received so far, particularly from the regional government who awarded the grant, and from Team Côte d’Azur and Sophia Antipolis Technopole.” The CUTISS Innovation laboratory is planned to be operational during Q2 2022, following the transfer of technology and recruitment of key professionals. As part of the company’s implantation in the region, CUTISS was accompanied by Team Côte d’Azur, which helped the company establish contacts with stakeholders, including leading dermatology specialists from both the university hospital and the private sector. About CUTISS AG 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 Children’s Hospital and a member of the accelerator Wyss Zurich. 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. Media contacts CUTISS: 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 as pdf

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Swissmedic grants CUTISS certificates of Good Manufacturing and Distribution Practices

CUTISS’s first onsite manufacturing facility in Schlieren, Zurich, has received the certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from the regulator Swissmedic, the Swiss Agency for Therapeutic Products. The GMP and GDP certifications authorizes the collection, manufacturing, testing, storage, release, and distribution of Transplant Products (TpP), Gene Therapy (GT) and Genetically Modified products (GM) for human use. This important milestone completes the expansion of CUTISS’ facilities, led by Kathi Mujynya and her Operations team. The state-of-the-art manufacturing facility is fully equipped for the 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 facility in Schlieren is expected to become fully operational in Q1-Q2 2022. Until now, the company’s products have been manufactured at the GMP facility of Wyss Zurich Regenerative Medicine Technologies Platform, University of Zurich. Newsroom

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Swiss RTS television reportage for T.T.C.

Swiss national television RTS came to CUTISS recently to find out about the denovoSkin, and to hear from our CIO Vincent about the promising potential of automation to scale up skin tissue bioengineering. The CUTISS segment was broadcast as part of RTS’s business program T.T.C. (Toutes taxes comprises) and is available on playback (in French) using the link below. https://www.youtube.com/watch?v=fK0Nmza1ECs Newsroom LInk to program

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RSI La 1, Come va? episode on skin

The Swiss national television channel RSI La 1 recently came to our offices to take a closer look at our work to develop denovoSkin, the personalized, bioengineered skin graft for children and adults suffering from large skin defects, such as severe burns. The interview with Daniela Marino was part of their monthly program Come va?, the popular science show exploring current health and medical topics, and this month’s episode focused on our body’s largest organ: skin. The episode is available on playback (in Italian) with the link below. Newsroom LInk to episode

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