Today, I'm writing about a piece of tech that hits close to home. Back in Australia, when my mother was a child, she was severely burned in a kitchen accident from the knee down, resulting in not only severe pain but a lifetime of operations, dealing with severe ulcers, and wearing pressure garments.
Swiss biotech company CUTISS is changing the lives of burn victims and those patients requiring reconstructive skin surgery.
The company has developed denovoSkin, a personalised, bioengineered skin graft.
Classified as an advanced therapy medicinal product, it can be bioengineered in large quantities, starting from a small, stamp-sized piece of the patient's healthy skin. denovoSkin™ is composed of an epidermis (the top protective layer = life) and a dermis (the structural layer below = quality of life) for permanently treating skin defects and injuries.
The biopsy is processed to isolate epidermal and dermal cells. The cells are expanded in vitro (and can be bio-banked for further use) and thereafter used in combination with a hydrogel to form tissue.
I spoke to Dr Daniela Marino, CEO and co-founder, to learn more.
The need for something better
Traditional skin grafts involve taking healthy skin from one area of the body (donor site) and transplanting it to cover a wound or area of damaged/missing skin (recipient site).
This can result in scarring, discolouration, or uneven skin surface at the graft or donor site, as well as a loss of flexibility and tightness as the recipient grows, resulting in reduced mobility and the need for new surgeries.
Marino is a biotechnologist from Italy who originally came to Switzerland for her PhD and wanted to go to the US or Japan.
Postdoc work in skin grafts at the Tissue Biology Research Unit, Department of Surgery, University Children's Hospital Zurich, including first-of-its-kind research in skin grafts. She recalled:
"I was doing my research at the bench, which spun into a translational organisation with the first-in-human tests starting. This did not work on healthy volunteers. These were kids with burns and scars. The data was too good for me to do anything else."
Marino explained:
"Our patients treated in phase one were all kids. And this was years ago. So you can imagine how much they grew in the meantime.
And the skin, which we have transplanted, has grown with them. And in the most drastic cases, like neonatal, we have transplanted skin on a baby injured at four days old. And today, he's a running toddler, and his skin has grown with him without complications."
The benefits of denovoSkin
Significantly, once applied, the skin minimally scars and grows with the patient, drastically reducing the number of follow-up corrective surgeries required, particularly in children. The outcome is potentially life-saving and life-changing.
Marino describes the growing skin as very expandable and elastic:
"It's very soft and pliable, so it has no rough surface. It's easy to apply lotion and even massage. It's not perfect skin, but it's another world compared to conventional skin grafts."
The skin can also be used in reconstructive skin surgery, for example, scar revisions, giant nevi or tumour resections, plastic surgery, and tattoo removal.
As a company, CUTISS's main priority is producing high-quality skin tissue. Marino stressed:
"We are doing tissue engineering; we are not 3D printing skin or mixing skin cells with a matrix. And it has a biological time we can't change, plus we need to adapt to the patient schedule, and production speed is not necessarily what is needed."
However, the company has reduced skin development time from 7 to 8 weeks when this project first started at university, to 3 to 4 today.
Simultaneously, CUTISS is working to scale up the production of denovoSkin™ through automation. The company has developed its own unique approach to bioengineering human skin tissue, composed of three automated modules: cell isolation, cell expansion, and skin tissue formation.
The denovoCast™ is the world's first machine to bioengineer large, personalised skin tissue grafts in a fully closed loop.
The machine has undergone R&D testing at CUTISS, and the company is ready to start industrialisation. In May 2023, it was awarded a CHF 2.5 million grant to advance the pioneering automation program and support the industrialisation of the denovoCast™ (the tissue formation device).
According to Marino:
"In the future, we want these machines to produce the skin autonomously so that if I want to make skin in Melbourne, San Paulo, or Hong Kong, it's the same quality as in the same standards.
This will make the product scalable for real. It will also make the product cheaper — not cheap, but cheaper. It will also make the product much more robust and reproducible."
Skintech in space
Last year saw a SpacePharma micro-lab, containing an experiment by Cutiss, travel to the ISS on SpaceX's 27th commercial resupply mission (CRS-27) for NASA to observe space travel's effects on skin cells and tissue culture.
While data analysis is ongoing, Marino explained:
"The reason we did this is because we are scientists. And we don't want just to provide a product which looks like skin. We would like to have a product which functions like skin. Skin is the largest organ in our body, and it's very complex.
Despite the best of our knowledge, we still don't know everything about it, especially regarding ageing, collagen production, and fibrotic tissue formation. We have not much of an idea how to fully regenerate hair or glands.
It's been shown that microgravity affects skin cell regeneration and production capabilities, such as collagen.
It could be an interesting branch in our research to understand some mechanism of ageing or regeneration, which this microgravity testing could unleash."
Earlier scientific attempts have produced much, so the company thought that surfing the wave of space research could open up new opportunities in molecular biology for skin.
"We have no idea whether this will lead to something. But as scientists, we knew it was worth exploring."
The challenge of funding emerging tech
Like any startup, CUTISS is no stranger to funding challenges. The company is a long-term investment.
As Marino noted:
"We are not selling drones or medical devices with a quick return on investment. We are pioneers here, so our investors can't compare us to almost anything they know about. So you need to be an investor with purpose and a long-term shot.
We are not doing yet another me-too drug.
If we make it work with skin, we could replicate it for many other tissues. So, this will be the beginning of something really big. And to do big things, you need time and money.
We don't have enough old timers in cell biology to say, this will work for sure. It’s a recent field. People are like, 'How do you know? How will you prove it?'"
As such, Marino admits that CUTISS has no VC on board yet, maybe because "sometimes they simply don't know how to investigate our technology.
So, they have been financed by family offices and foundations and banks which have individuals inside who have either done business in cell therapy or have done studies in cell therapies or simply because they believe it's going to be the future.
By comparison, VCs are more structured. The first question is always, 'Are you a biotech or a medtech company?' And I'm like, ' We're a bit of both. We're developing machines to develop skin for therapy.'
The company is sometimes asked about potentially more lucrative areas of skin therapy, such as longevity and tattoo removal.
"I've been asked, 'Why don't you drop burns and go into the tattoo removals? That would be easier.'
But we do clinical trials because if we show the safety and efficacy of massive burns, we can do everything. Expanding to tattoo removals may finally be easier.
We're a mission-driven company. And this is why we do what we do.”
We are at the right time in history with a product that will try to change the status quo in skin surgery.
I mean, look at the geopolitical situation, global warming, and the increase of burns due to hot surfaces and, explosions and wildfires. And on top of that, wars generate a population needing significant care."
Cutiss is currently submitting for phase three trials, which is the last clinical trial, which hopefully will give the company the authorisation for the product's commercial launch.
Update: On May 17, 2024 Cutiss announced the first closing of CHF 25 million in its Series C funding round.
Lead image: CUTISS denovoSkin. Photo: CSEM.
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