If you rode the tram with Daniela Marino after work one day in early April, you probably would’ve heard her elated screams. She was screaming in her office, too, and later that day when she got home.
Marino’s excitement was warranted. Her Swiss biotech, Cutiss, had not only recently announced positive results from the phase 2 clinical trial of its lead product, denovoSkin, but Nasdaq had also splashed a huge congratulations message about the results across its iconic screen in Times Square.
“When Nasdaq picked up the news about the phase 2, you can imagine … I was pretty loud,” she said with a laugh.
Marino’s enthusiasm for her company, science and life is infectious. She punctuates her speech — and her social media posts — with figurative and literal exclamation points. And as a “loud” Sicilian working in the Swiss biotech world, she doesn’t plan to tamp down her exuberant personality anytime soon.
“We are, by definition, hot-blooded people. We scream, we are loud, we laugh, make jokes, and that’s me,” she said. “I’m very, very emotional and passionate about what I do, and I don’t feel like masking it.”
A new quality of care
Marino is the CEO and co-founder of Cutiss, a Swiss clinical-stage life sciences company focused on regenerative medicine, tissue engineering and skin pigmentation. Its lead product, denovoSkin, is a personalized bioengineered human skin graft that showed efficacy as a dermo-epidermal skin substitute in adult and adolescent burn patients in the phase 2 trial.
Unlike traditional skin grafting, which transfers a thin layer of skin from a donor site and which Marino describes as “a technique,” rather than a product, denovoSkin creates multiple layers, or a full thickness, of skin tissue. And it can be bioengineered in large quantities from a sample of healthy skin the size of a postage stamp.
“I can use a stamp and give you back a carpet of skin,” Marino said.
DenovoSkin also has the potential to outperform the current standard of care because it can grow with the patient, limit scarring and drastically reduce the number of follow-up corrective surgeries required, particularly in children, the company said. Marino added that the product can develop into near-normal skin, improving a patient’s quality of life in terms of functionality, elasticity, smoothness, pain, itching, contraction and aesthetics.
“It will look better and it will feel better, and that’s why we really believe that this product has a unique opportunity to address a huge problem,” she said.
In addition to burns, the tech could also be used in skin traumas, reconstructive or plastic procedures, skin cancer, and cutaneous congenital malformations.
Cutiss plans to target markets in Europe, Switzerland and eventually the U.S., and denovoSkin has received Orphan Drug Designation for the treatment of burns by Swissmedic, EMA and FDA. In early 2022, the company also received exclusive rights to globally commercialize VitiCell, a product developed and patented by IBSA Pharma for skin re-pigmentation.
From the bench to the C-suite
Founded in 2017, Cutiss is a spin-off from the University Children’s Hospital in Zurich. After studying biotechnology and biology in Milan, Marino went to Switzerland for her Ph.D. and landed at the University of Zurich where she was tasked with managing a translational medicine skin grafting project that would eventually become Cutiss.
“Once I saw the results of the phase 1, which was conducted in Zurich on 10 children, I thought this was too good to be just left in the academic hands and publication storyline,” Marino said.
“I saw something that could make a lot of difference in patients’ lives, and I thought, somebody has to move it forward."
In North America and Europe, there are about 60,000 severe burn patients each year and more than 1.5 million reconstructive surgery patients. Because of the promising science and unmet need, Marino started looking around for someone to take that academic work and turn it into a company. When no one stepped up, she decided it was up to her.
“I took the challenge myself,” she said.
Although she planned to be “behind the bench” her whole life, Marino found that in co-founding Cutiss, she was “somehow driven by the same motivation that brought me to be a scientist.”
“I saw something that could make a lot of difference in patients’ lives, and I thought, somebody has to move it forward, and if there’s nobody better than me, maybe I’ll just take the chance,” she said.
A bold approach
Despite leaving academia behind, Marino says she never has time to be bored. There’s always something to do, something to learn or some issue to resolve.
“Building a startup from scratch is like being on a rollercoaster every day,” she said.
The company expects that its phase 2 full data analysis with a three-year follow-up be available in 2025, and also just sent a piece of skin to space as part of an advanced research and development mission on board the International Space Station. By observing the biological processes and cell behavior of skin tissue in the space environment, Cutiss hopes to develop wound healing strategies for astronauts during spaceflight, gain greater understanding of the space environment on human health, and advance new medical treatments and technologies for people on Earth.
Meanwhile, Marino has also learned how to create and lead a company without losing herself. Just two months after incorporating Cutiss, Marino’s second child was born. But her experience with new motherhood didn’t slow her down — instead, Marino incorporated it into how she ran the company, taking her mother and newborn baby to those early investor meetings.
At first, she said the investors were shocked to have a baby around, but they eventually embraced it. One potential investor even offered to hold the child and eventually got the fussy little boy to fall asleep in his arms. Marino asked if she could hire him as a helper, and although she was kidding, he ended up investing in Cutiss.
“It felt so good because actually you can change things by being extremely bold and just saying look, this is how I want to do it,” she said. “My business is my business, my family is my family, but I don’t want to take one or the other. So you’re going to have to listen to me make stupid jokes about motherhood and now you’ll get used to it. And somehow it worked.”
It’s just one of the ways that Marino is unabashedly herself, and her communication style conveys her commitment to the company and its work.
“Part of who I am is in my company now, so I also don’t want to mask that,” she said. “Part of the reason why we also manage to continue fundraising and everything is because people can feel the kind of passion in the story.”
And if they also hear her occasionally screaming with excitement, so be it.
“That’s who I am,” Marino said.