The regenerative medicine startup Cutiss has raised €18.8M (CHF 20M) to commercialize its personalized skin graft treatment for burn patients in Switzerland and the European Union around 2022.
This is the final closing of a Series B round announced earlier this month. The lead investor in the oversubscribed round was the Swiss firm Gisev Family Office, with other contributions from new and existing investors including the US charity, the Wyss Foundation.
The University of Zurich life science spin-off targets large and deep burns that reach the lower layer of skin tissue called the dermis, which is needed for wound healing. These burns often result in painful, disfiguring scars. The current standard of treatment is a skin graft from elsewhere on the patient’s body. However, these aren’t available in large quantities, and can still result in scars because they contain little tissue from the dermis layer.
To address this problem, Cutiss harvests a tiny sample of healthy skin from the patient. Cells are expanded in vitro and then combined with a hydrogel to produce a personalized skin graft that contains both the epidermis and dermis layers.
Cutiss CEO Daniela Marino told me what makes her firm’s personalized skin grafts unique is they permanently cover deep skin defects. “We can produce large quantities of skin grafts starting from a ‘stamp-size biopsy,’” she said. “Because of the biological characteristics of our product, we expect minimal scarring after treatment.”
The firm’s regenerative medicine candidate has completed a phase I clinical trial on pediatric patients and is currently in phase II testing in both adults and children.
Cutiss will use the Series B funds to finance the development of its lead program for burns. This development includes completing ongoing phase II trials and scaling up the manufacture of the therapy. As the treatment has an orphan designation from the EMA, the company is still to decide with the EMA whether the treatment will require phase III trials. The aim is to file for market authorization in Switzerland and the EU in 2022.
“We are working on the full automation of the manufacturing process, so that our product could be produced in different parts of the world, in a quick manner and also affordably,” Marino said.
“So we propose a personalized, permanent solution that can cover large areas, results in no scarring, and can be delivered to patients worldwide. There is no other product with those characteristics.”
Some current alternatives to patient skin grafts are used as temporary wound coverings but aren’t suitable for a permanent graft, such as from cadavers or animals. In contrast, Marino underlined that Cutiss’ candidate is more than temporary.
“What we do is an organ transplantation,” she said. “Skin is our largest organ, and our product remains on the body and regenerates after transplantation.”
Cutiss has some big competition in the regenerative medicine field. One of the most advanced companies developing skin autograft alternatives is the UK pharma company Mallinckrodt. Its phase III-stage lab-grown skin is designed to be off-the-shelf rather than personalized, which could make it quicker to deliver to patients. Mallinckrodt aims to apply for FDA approval this year.
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