Periodic Reporting for period 2 - denovoSkin (Personalized, bio-engineered skin grafts for the permanent treatment of skin defects)
Periodo di rendicontazione: 2019-10-01 al 2020-12-31
Every year in the world, more than 50M patients suffer from skin defects (e.g. burns, excision, etc.) and need surgical intervention to restore skin function. Standard of care, skin autografting, very often leaves these patients with permanent and disfiguring scars. Indeed, they may also impair movement and growth, and require several follow-up surgeries, intense homecare and psychosocial rehabilitation. Hence, scars significantly affect patient’s quality of life, along with the economic burden for the health-care system. Furthermore, in the case of large wounds, donor site shortage represents a real clinical issue. The safe and sustainable supply of tissues and cells is an essential pillar in modern healthcare and a priority for national and EU-level health authorities alike. Indeed, transplantation and application of human tissues and cells is a life-saving therapy for hundreds of thousands of EU citizens every year (in the EU alone, more than 140K people suffer from severe burns).
To address these problems Cutiss has developed denovoSkin™, the first hydrogel-based, autologous, permanent and safe bio-engineered, skin graft that is expected to minimize scar formation and ensure patient safety while lowering costs to national healthcare systems. denovoSkin™ is a patented, personalized, autologous bio-engineered human skin graft classified as Advanced Therapy Medical Product (ATMP). It is engineered to yield large quantities of skin graft surface starting-off from a stamp-sized skin biopsy of the patient, thus solving the donor site shortage issue. The work in Phase 2 of the SME instrument aims at enabling the production automation of denovoSkin™ to meet large-scale demand and maximise profitability while maintaining safety. Within the scope of the SME-I project, the main goal is to design, develop and integrate an automated and closed system for (skin) graft formation, with the ability of simultaneously fabricate enough skin grafts to treat at least 35% of the total body surface area of an adult patient (approx. 5000 cm^2).
To address these problems Cutiss has developed denovoSkin™, the first hydrogel-based, autologous, permanent and safe bio-engineered, skin graft that is expected to minimize scar formation and ensure patient safety while lowering costs to national healthcare systems. denovoSkin™ is a patented, personalized, autologous bio-engineered human skin graft classified as Advanced Therapy Medical Product (ATMP). It is engineered to yield large quantities of skin graft surface starting-off from a stamp-sized skin biopsy of the patient, thus solving the donor site shortage issue. The work in Phase 2 of the SME instrument aims at enabling the production automation of denovoSkin™ to meet large-scale demand and maximise profitability while maintaining safety. Within the scope of the SME-I project, the main goal is to design, develop and integrate an automated and closed system for (skin) graft formation, with the ability of simultaneously fabricate enough skin grafts to treat at least 35% of the total body surface area of an adult patient (approx. 5000 cm^2).
From the beginning of the project, Cutiss has been reviewing in details the current (manual) production method and assessed its feasibility for automation. The company has selected a modular approach to ensure flexibility and efficiency of the entire process. The modular design consists of 5 different modules (Biopsy Kit, Cell isolation, Cell expansion keratinocytes & fibroblasts, Post-processing keratinocytes & fibroblasts and Tissue formation). A first proof-of-concept prototypes of the biopsy kit, the automated cell isolation as well as the tissue formation device have been developed and will serve as a basis to further improve the design and concept of the devices. In parallel to this development activity, Cutiss is also currently evaluating the reduction in production time offered by the new modular system compared to the current manufacturing process. During this period, as part of the analysis of its go-to-market strategy Cutiss has also evaluated in detail the reimbursement trajectory for denovoSkin™ and successfully identified the steps and requirements to achieve reimbursement in the European markets targeted.
The current project will make denovoSkin™ producible at industrial scale, solving the problems associated with the lack of dermis of current standard treatment, leading for a better functional and aesthetic outcome as well as with the donor site shortage challenge. The automation process of denovoSkin™ manufacturing will ensure the respect of the highest quality standards, allowing easier transferability and regulatory pathway and shorten production time by up to 30%. It will also allow to cut production costs by 50% due to less manpower and optimization of the processes and logistics . Production efficiency will be also improved thanks to less variability and more robustness. Successful development of the project will allow Cutiss to replicate the production line all over the world by assuring a real delivery to patient worldwide while providing optimal logistics and quality of product to patients.