Daniela Marino and the start-up Cutiss, which grows human skin in the laboratory

Daniela Marino scaled 1

At the age of seven, Daniela Marino already had clear ideas: when she grew up, she would be a researcher. Today, that curious little girl has every reason to be proud of herself.

We met her in Milan, at La Ripartenza, the event organized by Nicola Porro, and asked her a few questions.

Her career is a journey that combines study, determination, and vision. After graduating in Biotechnology from the University of Milan and obtaining a PhD from the Swiss Federal Institute of Technology in Zurich, Daniela Marino now heads one of the most innovative companies in European regenerative medicine. Her start-up, based in Schlieren, near Zurich, continues to win awards and recognition in the biotech sector.

The company is called Cutiss and is working on an ambitious yet concrete goal: to produce human skin in the laboratory. The process starts with a tiny sample of healthy skin, about the size of a postage stamp. From that fragment, it is possible to isolate enough cells to grow new skin tissue in the laboratory that is perfectly compatible with the patient.

The potential of this technology is extraordinary, especially for those suffering from severe burns or extensive skin diseases. A particularly significant result came last year, when the technology developed by Cutiss helped save the life of a 20-day-old newborn with extensive burns.

Founded in 2017, CUTISS is an advanced clinical TechBio company focused on skin tissue therapy, regenerative medicine, tissue engineering, and skin pigmentation.

The skin is the largest organ in the body. Every day around the world, patients need or request surgery to restore skin function in acute cases (burns and trauma) or elective cases (scar revision, giant nevi or tumor resection, reconstructive and plastic surgery, etc.).

The current standard of care in plastic, reconstructive, and burn surgery—autografting—is limited by a shortage of donor sites and results in permanent, debilitating, and disfiguring scars. Many patients require multiple corrective surgeries, psychosocial rehabilitation, and intensive home care.

CUTISS is redefining skin surgery by replacing autografts with denovoSkin™, our first personalized skin tissue therapy, which can be produced in large quantities and regenerates without leaving scars.

Despite the inevitable challenges of such an advanced field, Daniela Marino does not seem easily discouraged. Talking to her, you sense her energy, confidence, and contagious dynamism. This attitude has allowed her to transform herself, almost without realizing it, from a pure researcher into a successful entrepreneur.

“I found out what a business plan is on Google,” she says with a laugh.

What motivates her, however, remains the same thing that fascinated her as a child: the real possibility of helping people. Offering new hope to those suffering from serious skin problems or children with potentially life-threatening burns is what gives meaning to all her work.

Daniela Marino lives in Switzerland and is the mother of two children. Researcher, entrepreneur, mother: three roles that require energy and dedication.

Her secret?

“You just have to really want it. Life itself, step by step, finds a way to offer us solutions.”

You say that coming from a humble family, you couldn’t afford to stay in Italy for your PhD. How much does the economic and structural context really affect the fate of a young researcher?

The economic and structural context has a huge impact. In Milan, there was no support for us students, and the high cost of living was a major factor. But I believe that, in the end, studying in difficult conditions provides a motivational boost: you have to graduate quickly and look ahead. I would do it all again.

Was there a specific moment when you realized that your research could not remain confined to the laboratory but had to become a therapy for patients?

In Zurich, after my PhD, I started working as a researcher in a laboratory at the University of Zurich (2009), where there was very close collaboration with the pediatric hospital. The laboratory’s ultimate goal was to study the possibility of creating human skin on demand. When, thanks to my contribution, this vision became a reality for the first 10 patients (2014) in the first pilot study, it became clear to me. It was no longer just a project but an advanced medical product.

If you had to explain denovoSkin to the parent of a child with burns, without using technical terms, what would you say?

Today, the standard treatment for burn wounds (but also in many other cases, e.g., scar reconstruction) is to take thin strips of skin (using a machine similar to that used to slice cheese) from healthy parts of the child’s body (thus creating new wounds) and apply them to the wounds to be treated. Large quantities of flaps are taken if the wounds to be treated are extensive, and the flaps are very thin (to avoid creating new, very deep wounds in healthy areas). Unfortunately, however, the wounds to be treated are very deep, and this ‘difference’ in thickness causes scarring. At CUTISS, we offer quantity and quality. We can produce large quantities of skin tissue from a biopsy of the patient’s healthy skin the size of a postage stamp, and we produce our own tissue, which is not thin but thick: therefore, no scarring is created.

What is the most concrete difference between Cutiss bioengineered skin and a traditional autograft in terms of quality of life for the patient?

Healthy skin is not removed (except for a small biopsy the size of a postage stamp) and therefore remains “unharmed,” and the tissue we generate, once transplanted, integrates and remains with the patient for life without creating a scar. This means that patients can grow better, move better, look better, and have lower costs and less need to ‘treat and maintain’ their scars (think of creams, bandages, therapies, further surgery, etc.).

Among the first patients treated, was there a clinical result that made you think, “This technology can really change the lives of these children”?

The quality of the tissue a few months after the triple transplant: soft, elastic, supple, incredible.

Today, the “moment of truth” is phase 3: what is the biggest obstacle—scientific, human, or regulatory—that could slow down the arrival of this therapy to patients?

Our product is an advanced therapy and requires a long time for approval. We are doing our best to complete clinical development in record time, as well as the validation of the production process. We hope that regulatory bodies will be attentive to the needs of patients and can also speed up the process.

You are working to automate the production of bioengineered skin: what would change, in practical terms, if this technology became available on a large scale in hospitals?

The future of tissue bioengineering lies in automation. There are many patients around the world, and with automation we can produce more efficiently and in a decentralized manner. It is a new, small, and quiet revolution in regenerative medicine. CUTISS believed in it from the beginning and today has a globally competitive offering: a product in phase 3 and an automated platform that is almost ready for use.

After building all this abroad, do you think a project like Cutiss could have been born in Italy?

Of course, I look at Italy with a melancholic gaze and would very much like to do something here. We are already active with our centers of excellence in Naples and Padua, and I hope to be able to do more soon. In my mind, Italy represents a strategic hub for access to southern Europe, North Africa, and beyond.

After years of research, investment, and challenges, when do you really feel that all this work makes sense?

Every morning when I wake up, tired but happy. I love my job and the challenges are ENDLESS, but what we do is really something that is needed, that helps, that gives hope and smiles. It has to make sense.

If everything goes according to plan, how do you imagine Cutiss in five years: an elite therapy or a new standard in reconstructive medicine?

A new standard. Proof that there is no need to differentiate between “business” and “impact,” that it is possible to create lucrative yet healthy and ethical businesses, with grand global plans that are nonetheless empathetic towards humanity. I hope that CUTISS can set a good example and that many more therapies will follow in our footsteps.

In a world where science moves fast, Daniela Marino’s story reminds us that behind every discovery there is intuition, courage, and quiet determination. And sometimes it takes very little—a piece of skin the size of a postage stamp—to rewrite the destiny of a life.

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