denovoSkin: bioengineered skin grafts for severe burn treatment

The Crans-Montana fire disaster killed 40 people and injured 116; 80 to 100 of the injured sustained severe burns, many affecting more than 60% of the skin surface. Several patients are being treated in Zurich. The University Children’s Hospital Zurich and University Hospital Zurich operate specialized burn centers.

Standard burn care includes intensive care stabilization, surgical removal of burned, dead skin, and wound coverage, often first with temporary biological or synthetic materials and later with autologous split-thickness skin grafts (autografting). While these procedures save lives, they can be constrained by:

• donor site shortage (not enough healthy skin to harvest)
• scarring, which may reduce function, require long-term care, and sometimes corrective surgery
• limited stretch in growing children, as autografts may not expand with the patient

To address these challenges, the University of Zurich initiated basic research on bilayer skin grafts about 25 years ago. Between 2001 and 2016, the Tissue Biology Research Unit (TBRU) at the University Children’s Hospital cultivated human skin cells in a special gel. A team led by TBRU Director Ernst Reichmann developed a skin substitute combining:

• epidermis (cells from the uppermost skin layer)
• dermis (supportive deeper layer to provide elasticity)

Clinical studies to date indicated that the dermal layer can contribute to elasticity and allow the graft to grow in pediatric patients.

Biotechnologist Daniela Marino helped develop the approach and co-founded the University of Zurich spin-off Cutiss in 2017 to bring the product, denovoSkin, into clinical use. “We developed a living human skin tissue graft that is cultivated in the laboratory from a small skin biopsy the size of a post-stamp taken from the patient,” says Daniela Marino, who is CEO of Cutiss. “The key point is that it is a personalized bilayer graft.” Since the patient’s own cells are used, the press release states there is no risk of rejection.

Marino also points to clinical evidence: “So far, long-term clinical data in both burns and reconstructive surgery, such as scar revisions and plastic surgery, show that the bilayer skin grafts safely close wounds and spare healthy skin for the patients while improving scar quality when compared to standard of care,” she says. Cutiss reports it can grow multiple 50-square-centimeter grafts within four weeks.

The treatment is in late-stage clinical development for burns and reconstructive skin surgery. A Phase 3 clinical trial that began in spring 2025 for severe burns in adults and adolescents is ongoing and enrolling patients across 20 burn centers in eight EU countries and Switzerland, including University Hospital Zurich. “Our product is an advanced therapy, and now we need Phase-3 data before we can proceed with the full regulatory approval process in different geographies, including Switzerland,” commented Daniela Marino.

Selected Crans-Montana patients may receive denovoSkin under physician discretion, based on biopsies sent to Cutiss. To support scalability, Cutiss is developing automated manufacturing systems in partnership with Tecan.

MEDICA-tradefair.com; Source: University of Zurich