Press release

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 »

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

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

CUTISS develops world’s first machine to produce personalized human tissue

CUTISS develops world’s first machine to produce personalized human skin tissue therapy A world-first innovation in tissue engineering and regenerative medicine that can lead to life-saving and life-changing medical treatments for millions of people with severe skin injuries Over 11 million people annually suffer from severe burns needing surgery Significant milestone in the company’s automation program to addresses scale-up challenges when bio-engineering skin tissues and grafts The denovoCast machine has been developed in collaboration with Swiss innovation partner CSEM, with funding from InnoSuisse and EU Horizon 2020 Switzerland, 24 June 2021 – CUTISS AG, a Swiss clinical-stage life sciences company focused on skin regenerative medicine and tissue engineering, has unveiled the world’s first automated machine to produce customized skin tissue grafts for adults and children with severe skin injuries, such as deep burns. Developed in collaboration with the leading Swiss research center CSEM, the denovoCast machine demonstrates the feasibility of automating the bio-engineered skin manufacturing process, and seeks to revolutionize the current available treatments for severe skin defects. Daniela Marino, CEO of CUTISS, commented: “Every year over 11 million people suffer from severe burns which require surgery. Skin is our largest organ, so how do you produce enough skin quickly and affordably to treat these patients? Together with our partner CSEM, we used technological solutions to develop the denovoCast machine and automate the production of denovoSkin, our personalized skin tissue treatment.” Vincent Revol, Head Research and Business Development for Life Science Technologies, CSEM, said: “Automated manufacturing of cell products in closed systems is a must for all regenerative therapies trying to enter the market today because it reduces dramatically the risk of microbial contamination while ensuring standardized quality and lower production costs. Knowing that our work may impact the lives of millions of patients is a unique source of motivation for the whole team.” Significant need for patients with severe burns When patients suffer from disastrous large and deep burns, the ability to quickly, affordably and consistently provide large quantities of skin grafts is essential. Survival of major burns is closely related to how fast definitive wound closure is achieved. Speeding and scaling up the culturing process of bio-engineered, personalized skin grafts can be a game changer and crucial for saving more lives of patients with major burns, sparing patient healthy skin donor sites. Annually, 11 million patients suffer from severe burns and require skin surgery to restore skin function. The EU and US markets for severe burns is estimated to be over $2 billion and for burn scar reconstruction is estimated over $5 billion. The current standard of care – autografting – is often scarce due to donor site shortages, produces skin that is too thin and results in permanent painful, debilitating, disfiguring scars that frequently require follow up corrective surgeries. denovoSkin aiming to transform skin surgery The denovoCast machine produces a particular type of skin tissue called denovoSkin, a bio-engineered and personalized dermo-epidermal skin graft developed by CUTISS. It is an innovative process involving the growth of new skin using the body’s own tissue as the template. The denovoSkin, which is in Phase IIb clinical trials in the European Union and also accessible on a compassionate use basis, has unique features that promise to surpass any current medical treatment for large and deep skin injuries, with potentially life-saving and life-changing outcomes. It promises to grow with the patient, limit scarring, and drastically reduce the number of follow up corrective surgeries required, particularly in children. denovoCast machine greatly improves output and quality of skin tissue The process for bio-engineering the denovoSkin has so far been manual, lengthy, and requiring a costly clean room, and highly trained personnel. The denovoCast machine automates tissue formation in a fully closed process, requiring no manual intervention. It ensures consistent reproducible quality, enables the simultaneous cultivation of multiple skin grafts, and is expected to reduce production times by more than 30%. Vincent Ronfard, Chief Innovation Officer of CUTISS, remarked: “By scaling up the production of skin grafts with this ground breaking technology, we can potentially reach many patients in need of life-saving and life-changing treatment. This technology has potential applications for regenerative medicine for other tissues and organs.” Gilles Weder, Team Leader Life Microtechnologies of CSEM, said: “Innovation in regenerative medicine is challenging in a highly regulated environment. CSEM and CUTISS bring together the disciplines of biology, engineering and clinical practice to meet this challenge. For denovoCast we validated our approach with patient cells throughout all stages of the development process to ensure a successful transfer from the lab to the clinic.” The operational denovoCast machine will now undergo research-grade testing at CUTISS to demonstrate its effectiveness and efficiency in research and clinical settings according to (Good Manufacturing Practice) GMP rules. Images for denovoCast and denovoSkin can be accessed here. Swiss and EU funding for automation program CUTISS’s automation program and the development of the denovoCast were possible thanks to funding from the Swiss Innovation Promotion Agency InnoSuisse and the European Union’s Horizon 2020 research and innovation program. As part of CUTISS’s overall automation program, there are two other machines upstream of denovoCast: a cell isolation device (developed by CUTISS) and a cell expansion device (tested by CUTISS). Under the framework of the EU SME instrument H2020 grant program, the cell isolation device and the cell expansion devices were developed and tested in collaboration with innovation service provider Zühlke and healthcare company Terumo, respectively. 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 revolutionise 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

CUTISS develops world’s first machine to produce personalized human tissue Read More »

CUTISS wins Top 100 Swiss Startup Award 2020

Zurich, Switzerland, September 10, 2020 – CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced it has won the Top 100 Swiss Startup Award 2020, granted by a jury of 100 leading startup experts and investors within the framework of an award ceremony yesterday evening in Zurich. In 2019, CUTISS achieved rank six out of 100 and in 2018, the Company reached rank five out of 100. The win of this leading Swiss Startup award is reflecting the significant progress CUTISS achieved in the last twelve months: Despite the Covid-19 pandemic, the Company continued its activities, onboarded additional study centers and closed an oversubscribed Series B financing round, raising funds of more than CHF 20 Million. In addition, in August CUTISS received a positive opinion from the Paediatric Committee of the European Medicines Agency on the Company’s proposed Paediatric Investigation Plan for denovoSkin™ and significantly advanced its automation program. Most recently, staff members moved into a new office at the Biotechnopark in Schlieren (Zurich), next to the Company’s production and R&D facilities. CUTISS currently employs 28 employees, of which eight joined the Company since September 2019. About the Top 100 Swiss Startup Award The TOP 100 Swiss Startup Award has become a benchmark in Switzerland’s startup ecosystem: In the last 10 years, the event has featured 397 startups that have created more than 8’700 jobs and raised CHF 4.2 billion. Forty-two exits and two IPOs top off the achievements so far. Each year since 2011, the 100 most innovative and promising Swiss startups are picked by a jury of 100 leading investors and startup experts. www.top100startups.swiss/ About CUTISS AG CUTISS is a Swiss Life Science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich; denovoSkin™ was well tolerated by all patients with no safety issue reported. Phase II studies are currently ongoing in Switzerland and the European Union and are partially funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ aims to improve life quality of elective (reconstructive treatments) patients as well and it can further be developed in terms of complexity by adding pigmentation. www.cutiss.swiss Contact CUTISS AG, CEO Dr. Daniela Marino, +41 44 244 36 60, info@cutiss.swiss Newsroom download press release as pdf

CUTISS wins Top 100 Swiss Startup Award 2020 Read More »

Logo CUTISS News final

CUTISS receives Positive Opinion from the Paediatric Committee of the EMA for denovoSkin™

Zurich, Switzerland, August 3, 2020 – CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced that it received a positive opinion from the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) for its proposed Paediatric Investigation Plan (PIP) for denovoSkin™. The positive opinion is based on the non-clinical program, as well as data from the phase I safety clinical trial and the plans for the current phase IIb efficacy trials running in children and adults. The PDCO’s positive opinion on CUTISS’ PIP endorsed the Company’s program for denovoSkin™ as acceptable for assessment of safety and efficacy for the use in children from birth  to less than 18 years of age. The relevance of a Paediatric Investigation Plan (PIP) A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when a marketing-authorisation holder wants to add a new indication, pharmaceutical form or route of administration for a medicine that is already authorised and covered by intellectual property rights. About CUTISS AG CUTISS is a Swiss Life Science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich; denovoSkin™ was well tolerated by all patients with no safety issue reported. Phase II studies are currently ongoing in Switzerland and the European Union and are partially funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ aims to improve life quality of elective (reconstructive treatments) patients as well and it can further be developed in terms of complexity by adding pigmentation. Contact CUTISS AG, CEO Daniela Marino, +41 76 230 80 46, info@cutiss.swiss, www.cutiss.swiss Newsroom download press release as pdf

CUTISS receives Positive Opinion from the Paediatric Committee of the EMA for denovoSkin™ Read More »

Logo CUTISS News final

Series B financing oversubscribed

CUTISS closes series B funding – Target of CHF 20 million oversubscribed

Zurich, Switzerland, June 29 2020 – CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced it has successfully closed its series B financing round. The fundraising aiming at CHF 20 million was eventually oversubscribed.
The proceeds will allow CUTISS to further progress denovoSkin™, the Company’s unique personalized skin technology to treat skin defects, i.e. due to burns. Upcoming key inflection points include the completion of the ongoing clinical phase II trials, the scale-up of the manufacturing at the Biotechnopark in Zurich-Schlieren, and the successful implementation of a prototype machine for the automated production of large quantities of skin from a small piece of healthy skin. It is CUTISS’ ambition to file for market authorization with denovoSkin™ in Switzerland and in the European Union in 2022.
Dr. Daniela Marino, Chief Executive Officer and Co-Founder of CUTISS AG, commented: “We feel very lucky and privileged that we have closed an oversubscribed series B financing round. We will invest these proceeds circumspectly, aiming at improving burn patients’ lives.”
Giammaria Giuliani, Co-Founder of Gisev Family office and Member of the Board of Directors of CUTISS, added: “It has been an honor acting as lead investor for this series B financing round. The support by the Wyss Foundation as well as new and existing private investors and family offices demonstrates the potential many investors see in CUTISS’ vision and strategy.”

About CUTISS AG
CUTISS is a Swiss Life Science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich. Phase II studies are currently ongoing in Switzerland and the European Union and are partially funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ aims to improve life quality of elective (reconstructive treatments) patients as well and it can further be developed in terms of complexity by adding pigmentation.

Contact
CUTISS AG, CEO Daniela Marino, +41 76 230 80 46, info@cutiss.swiss, www.cutiss.swiss

Series B financing oversubscribed Read More »

Logo CUTISS News final

Series B Financing Round successfully secured
with CHF 18.7 Mio.

CUTISS with successful series B financing round – funds raised so far sum-up to CHF 18.7 million

Zurich, Switzerland, June 4 2020 – CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced it has successfully secured its series B financing round. Funds raised so far sum-up to CHF 18.7 million. The financing round was led by Giammaria Giuliani (Gisev Family Office), seconded by the Wyss Foundation and supported by new and existing private investors and family offices. The series B financing round aiming at up to CHF 20 million in total is still ongoing; its final closing is expected for June 15 2020.

The proceeds will allow CUTISS to further progress denovoSkin™, the Company’s unique personalized skin technology to treat skin defects, i.e. due to burns. Upcoming key inflection points include the completion of the ongoing clinical phase II trials, the scale-up of the manufacturing at the Biotechnopark in Zurich-Schlieren, and the successful implementation of a prototype machine for the automated production of large quantities of skin from a small piece of healthy skin. It is CUTISS’ ambition to file for market authorization with denovoSkin™ in Switzerland and in the European Union in 2022.

In 2018, CUTISS raised CHF 11.2 million in a series A financing round that included Business Angels and Family Offices as well as Giammaria Giuliani (Gisev Family Office), Yellowstone Holding, and the Zürcher Kantonalbank (ZKB). In addition, a total of CHF 4 million were granted by Innosuisse and the European Commission (non-dilutive).

Dr. Daniela Marino, Chief Executive Officer and Co-Founder of CUTISS AG, commented: “We are thrilled and honored about the great interest our series B financing round has received from both private and professional investors, especially on the backdrop of the current challenging times. We thank our existing shareholders for their continued support and our new investors for their commitment and trust.”

About CUTISS AG
CUTISS is a Swiss Life Science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich. Phase II studies are currently ongoing in Switzerland and the European Union and are partially funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ aims to improve life quality of elective (reconstructive treatments) patients as well and it can further be developed in terms of complexity by adding pigmentation.

Contact
CUTISS AG, CEO Daniela Marino, +41 76 230 80 46, info@cutiss.swiss, www.cutiss.swiss

Series B Financing Round successfully secured
with CHF 18.7 Mio.
Read More »

Gérard Ber appointed as additional Board Member

CUTISS AG announces additional Member of the Board of Directors

Zurich, Switzerland, May 28 2020 – CUTISS AG, an innovative Swiss Life Science Company aiming to provide patients that suffer from large and deep skin defects with an automatically produced, personalized skin tissue therapy, denovoSkin™, today announced it has further enhanced its Board of Directors with Gerard Ber as newly elected, additional and independent Member of the Board.

At the recent Annual Shareholder Meeting 2020 of CUTISS, Dr. Gerard Ber was elected as additional and independent Member of the Board of the Company for a term of one year, thus further strengthening its Board of Directors. Gerard has been acting as Co-Founder, Chief Operating Officer and Member of the Board of Advanced Accelerator Applications, an innovative radiopharmaceutical Company based in France that was acquired by Novartis in 2018. Before, he held positions as Export Area Manager for Western Europe at OM Pharma Switzerland (Vifor Pharma) in Geneva and Director of Marketing and Commerce for CIS Bio International/ORIS in Paris. Today, Gerard is Life Science Entrepreneur and Member of the Board of Directors of, among others, Ymabs (New York). He studied Pharmacy at the University of Grenoble (France). Dr. Gerard Ber is a Swiss citizen.

Daniela Marino, CEO and Co-Founder of CUTISS AG, commented: “We are pleased and honored that Gerard Ber has accepted becoming an independent Member of our Board, thereby offering his valuable and broad know-how of the Life Science industry to our emerging Company.”

About CUTISS AG
CUTISS is a Swiss Life Science Company, spin-off of the University of Zurich, developing personalized skin graft technologies for the treatment of a large spectrum of skin defects. Its lead product candidate, denovoSkin™, has been tested in a phase I clinical trial on pediatric patients at the University Children’s Hospital in Zurich. Phase II studies are currently ongoing in Switzerland and the European Union and are partially funded by Wyss Zurich. denovoSkin™ has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In addition, denovoSkin™ aims to improve life quality of elective (reconstructive treatments) patients as well and it can further be developed in terms of complexity by adding pigmentation.

Contact
CUTISS AG, CEO Daniela Marino, +41 76 230 80 46, info@cutiss.swiss, www.cutiss.swiss

Gérard Ber appointed as additional Board Member 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.