Phase:  Preclinical Development /Conformity Assessment  

The regeneration of full thickness skin defects after plastic reconstructive surgery (i.e. scar excisions) or burn injury is only successful if both the epidermis and the dermis show adequate regeneration. Epidermal regeneration is a clinically established procedure nowadays, either through split skin transplantation (mesh graft) or application of cultured keratinocytes. The healing of these wounds is still complicated by the lack of a dermal component resulting in a poor functional and cosmetic outcome due to (hypertrophic) scar formation and contraction.

The Novomaix dermal regeneration matrix is intended to aid in the healing of full thickness skin defects. The Novomaix dermal regeneration matrix is intended to stimulate the regeneration of dermal tissue as a basis for the attachment of autologous split-skin mesh grafts or cultured keratinocyte sheets. The aim of the treatment is to achieve skin regeneration with less scarring and less wound contraction when compared to epidermal regeneration alone.

The last preclinical developments were finished in close cooperation with Prof. Middelkoop (Free University Amsterdam, Burn Wound Center Beverwijk) and the CE mark for Novomaix is expected in Q3-2012. 

In collaboration with burn wound centers in Switzerland, The Netherlands, and Germany a multicenter comparative study on dermal regeneration with Novomaix and other tissue engineered dermal replacements will be initiated in 2012 as part of the European project "EuroSkinGraft".

The project EuroSkinGraft deals with a novel generation of skin substitutes to clinically treat a broad spectrum of severe skin defects. EuroSkinGraft is coordinated by PD Dr. Ernst Reichmann, University of Zurich.  

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