EMA authorizes Phase 3 clinical trial for denovoSkin™

CUTISS has received authorization from the European Medicines Agency (EMA) to commence the Phase 3 clinical trial for our lead product denovoSkin™ in adult & adolescent severe burn patients.

Running across eight countries, including Belgium, France, Germany, Italy, the Netherlands, Poland, Portugal, and Spain, the Phase 3 confirmatory study 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.

We are grateful to our entire CUTISS team, the clinical partners, all collaborators, patients, investors, and stakeholders who are making this pioneering work possible. Together, we continue to pave the way for transformative solutions in regenerative medicine and skin surgery.