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.^[46] 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.^[46] 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.^[48] This personalized therapy has successfully moved through Phase I and Phase II clinical trials, demonstrating safety, high expansion capacity, and superior scar quality.^[50] 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.^[46] 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.^[48]