This collaboration marks a critical step in the industrialisation of CUTISS’ pioneering automation platform for the manufacturing of personalised skin tissue therapies.

The partnership will enable the transition of CUTISS’ automated manufacturing solution from engineering development to industrial-grade production. It will also support CUTISS’ mission to bring its lead product denovoSkin – the personalised, bioengineered human skin graft – to market at scale and to expand the platform’s potential into new areas of regenerative medicine.

Dr. Daniela Marino, CEO of CUTISS, said: “This collaboration reaffirms our leading role in tissue therapeutics and our commitment to take denovoSkin to the global market. As a late-stage clinical biotech we strongly believe that denovoSkin has the potential to revolutionise skin surgery globally and across numerous indications. Tecan’s expertise and global infrastructure will strengthen our industrial capabilities, enabling the rapid scale-up of our automated tissue therapy platform. We are proud to work alongside such a strong industrial leader with Swiss roots and international presence.”

Dr. Achim von Leoprechting, CEO of Tecan, stated: “We are pleased to partner with CUTISS in industrialising the world's first automated manufacturing platform for personalised skin tissue therapy, addressing unmet medical needs. This collaboration perfectly aligns with Tecan's purpose of improving people's lives and health by empowering customers to scale healthcare innovation globally, from life science to the clinic.”

Dr. Vincent Ronfard, Chief Innovation Officer of CUTISS, added: “The CUTISS automation platform is a first-of-its-kind in personalised tissue manufacturing. Together with Tecan we are paving the future of tissue engineering automation.”

denovoSkin in late-stage Phase 3 clinical trials

As a personalised, bioengineered human skin graft, denovoSkin is designed for patients undergoing skin surgery for severe skin injuries (such as burns) or reconstructive procedures. It aims to replace the current standard of care, autografting, and to significantly improve patient outcomes.

The Phase 3 confirmatory study in adolescent and adult severe burn patients is taking place in Switzerland and the European Union across 8 sites. denovoSkin is also accessible under compassionate use. It has been granted Orphan Drug Designation (ODD) for the treatment of burns from Swissmedic, EMA, and the FDA.

denovoSkin is unique because it is bilayer, composed of both dermis and epidermis. In clinical trials and long-term follow-ups to date, it has been shown to grow with the patient and regenerate in a scarless manner, to mature quickly, safely restore skin function, and significantly reduce the need for scar care and follow-up corrective surgeries.

Beyond being life-saving and life-changing, denovoSkin is also cost-effective and offers attractive unit economics.

Scaling up with first-in-class automated production

CUTISS is working to scale-up the production of denovoSkin through automation. The company has already developed a first-in-class automation platform for the scalable production of personalised tissue therapy – a patented, fully-closed, end-to-end system that enables decentralised production, cost-effective scale-up, and high return on investment.

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