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).
