The European Medicines Agency (EMA) authorizes Phase 3 clinical trial for denovoSkin™ in adult and adolescent severe burn patients.
04-12-2024 – Celebration at the end of this year for CUTISS AG as the team receives authorization from EMA for the Phase 3 clinical trial for CUTISS' lead product, denovoSkin™.
The trial will run across 8 countries within the European Union, including Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, and Spain. This phase will validate the efficacy and functionality of denovoSkin™ – a living, personalized bilayer bioengineered skin graft – in achieving wound closure and reducing scarring in patients with severe burns compared to standard of care.
Source: CUTISS AG
