Personalized, bio-engineered skin grafts for the permanent treatment of skin defects
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 scars. Scars are permanent and disfiguring, and can also be painful and highly debilitating. 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.

denovoSkin™ is a patented, personalized, autologous bio-engineered human skin graft classified as Advanced Therapy Medical Product (ATMP). It is engineered in large quantities starting-off from a stamp-sized skin biopsy of the patient, thus solving the donor site shortage issue. Moreover, because of its dermo-epidermal structure, denovoSkin™ leads to minimal scarrring after transplantation. Its outstanding performance could considerably reduce or even avoids further corrective interventions, allowing for considerable savings in terms of costs. denovoSkin™ is also granted with Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA.

So far, more than €17.5M have been invested over the last 16 years of research into the development and the clinical testing of denovoSkin™. To have denovoSkin™ fully projected at a European and global level we need a further investment of €3.57M to automate its production, de-risking the entire denovoSkin™ project by assuring a real delivery to patients worldwide while providing optimal logistics and quality of product.

The proposed work in Phase 2 of the SME instrument fits into our overall plan to reach the market by contributing the financial resources needed to plan a fast sound wider deployment of denovoSkin™ and its market uptake.