CUTISS

1. Executive Summary (Confidence: High)

CUTISS AG, established in 2017 as a spin-off from the University of Zurich, is a leader in regenerative medicine and tissue therapeutics. The company addresses the profound limitations of the current standard of care in skin surgery—autografting—which often leads to severe scarring and donor site shortages. Its primary product, denovoSkin, is a living, bioengineered bilayer (dermis and epidermis) skin substitute grown from a small biopsy of the patient's own healthy skin. This personalized therapy has successfully moved through Phase I and Phase II clinical trials, demonstrating safety, high expansion capacity, and superior scar quality. CUTISS is currently in late-stage Phase III trials for burn treatment in the EU and Switzerland and has raised over CHF 125 million to date, including a significant CHF 56 million Series C round in late 2025. Parallel to its clinical development, CUTISS is industrializing the world’s first automated manufacturing platform for personalized tissue therapy, denovoCast, through a strategic partnership with Tecan.