Advanced therapy accessibility: Why scalability is the hard part

Healthcare innovation doesn’t scale on science alone. For advanced therapy to deliver its full potential, industrialization and automation must become part of the solution. This principle has been at the core of our work to bring denovoSkin™ from the laboratory to patients worldwide.

From innovation to industrialization

CUTISS was founded to address one of the most pressing challenges in burn and reconstructive surgery: the lack of effective, personalized skin replacement solutions.

We developed denovoSkin™, a bioengineered, autologous dermo-epidermal skin tissue therapy that can drastically reduce donor site harvesting, regenerate with minimal scarring, grow with the patient, and reduce the need for multiple corrective surgeries. Today, denovoSkin™ is in Phase 3 clinical trials in Europe.

The production of denovoSkin™ currently relies on highly skilled manual processes. Yet from the outset, we knew that to enable broader patient access and integration into healthcare systems, we needed to build a fully closed, automated, GMP-compliant manufacturing solution.

Building the platform

Over several years, we invested in developing a proprietary automation platform in collaboration with Swiss engineering partners such as CSEM and Zühlke, supported by Innosuisse and EU funding. The result is one of the first closed, end-to-end systems for personalized skin tissue production.

However, moving from laboratory-scale automation to industrial production requires additional expertise.

Strategic partnership with Tecan

This year, we entered into a strategic partnership with Tecan, a global leader in laboratory automation and diagnostics, marking a critical step in our industrialization pathway. (You can read about our announcement here)

Tecan brings extensive experience in adapting laboratory technologies into regulated manufacturing environments. Together, we will advance our proprietary platform towards full industrial deployment, enabling denovoSkin™ production at scale and preparing for global commercial readiness.

The partnership demonstrates the interest of industry for advanced therapy as well as the broader potential for industrializing personalized regenerative medicine. The successful automation of living tissue production can serve as a blueprint for other cell and tissue therapies.

A defining challenge for regenerative medicine

As we advance denovoSkin™ towards commercialization, we remain focused on building not only a product, but the platform and infrastructure required to bring personalized regenerative medicine into everyday clinical practice.

The industrialization of advanced therapy is one of the defining challenges of our field. We are proud to contribute to this transformation.

Scroll to Top

Would you like to contact us as a journalist?

©WyssZurich

This website uses cookies to ensure you get the best experience on our website.