Weltweit leiden Millionen von Menschen an schweren Hautdefekten. Heutige Behandlungsmethoden hinterlassen oft permanente und einschränkende Narben, die die Beweglichkeit und das Wachstum behindern. Also Folge sind Nachfolgeoperationen, eine intensive Betreuung zu Hause und psychosoziale Rehabilitation nötig. Im heutigen Blitzinterview ist Dr. Daniela Marino, CEO und Mitgründerin der Cutiss AG, die für Patienten mit Verbrennungen, chirurgischen und plastischen Eingriffen oder Hautdefekten neue Haut zu produzieren plant.
Fakten
- Jährlich werden weltweit über 11 Mio. Menschen mit Hautverbrennungen registriert.
- Weltweit gibt es über 50 Mio. Patienten mit Folgen von plastischen und rekonstruktiven Eingriffen, Tumorresektionen, ULCERS und Hautdefekten.
- Für die Herstellung von denovoSkin™ wird dem Patienten eine kleine Biopsie gesunder Haut entnommen. Aus dieser Biopsie werden epidermale und dermale Zellen isoliert und in vitro expandiert. Diese Zellen werden mit einem Hydrogel zu einem dermo-epidermalen Hauttransplantat zusammengefügt, danach ist denovoSkin™ bereit für die Transplantation um den Hautdefekt des Patienten zu decken. Klinische Studien zur Sicherheit von denovoSkin™ sind abgeschlossen. Die klinischen Studien zur Wirksamkeit des Produktes werden in Kürze gestartet und von Wyss Zurich unterstützt.
- Cutiss AG ist Preisträger von Venture 2015, A. De Vigier 2017 und ist Top 34 Swiss Start-up.
Das Interview wurde auf Englisch durchgeführt.
Bioengineering large quantities of personalized skin is something unique. How was the idea of Cutiss born?
The solution which we are trying to bring to the market was developed in an academic lab in Zurich, the Tissue Biology Research Unit (TBRU) . The TBRU is a lab of the Department of Surgery of the Children’s Hospital in Zurich. There, it was clear that there was a great clinical unmet need: patients with burns, especially children, are destined to a very poor quality of life due to scarring. Why not searching for a solution? 16 years later, we are here offering denovoSkin™ – a personalized, permanent treatment for skin defects.
Whenever a patient needs skin replacement, e.g. after a burn, a plastic surgery intervention, tumor resection etc. , we can create a tissue which is a patient’s own tissue. There is no rejection and the tissue is taken and will minimally scar due to its dermo-epidermal structure.
Furthermore, in case of large wounds, donor site shortage is a challenge, but with denovoSkin™, we can provide llarge quantities of skin starting off from a small biopsy. The research was done and the team was ready to come with a pre-clinic package in 2011. Then, I joined the lab and got the assignment to write an FP7 grant to raise funds to do a first clinical trial. Our application was successful: we raised CHF 9 million to do first-in-human trials of our product. It took us two years to get to the clinic. Once we saw four patients with promising results, my question was «What are we going to do afterwards?».
How did it happen that you founded the company?
Phase I was funded by the grant but that was it. So I thought: «How about creating a company?». The EU offered a free business training where I could go to learn about business planning.
I attended the course for a full week and I came back completely brainwashed with the idea that we have a product and we should create a start-up and raise funds.
I took the challenge to switch from an academic career into business right at that moment. The company was created in 2015 but officially incorporated in 2017.
Who are the people behind Cutiss?
In addition to me and our Chief Technology Officer, we have an excellent production team. Recently, our Chief Innovation Officer has brought the industry experience into the company. Right now, we are creating robots to produce skin automatically.
If you want to reach out to many patients you cannot produce manually, it is matter of costs and standardization. That is why we raised a seed round to launch this automation project.
Today, we have people collaborating with us on the engineering level, a clinical team and specialists that do clinical trials at the clinical centers in Switzerland, NL and UK. Besides that, we have consultants for regulatory issues.
Daniela, how do you find these people? You just call them and say: «Hey guys, this is the issue we are having now. Come help us.»
It’s a big challenge if you are a scientist. You just do not have the right network to build a business. But I got help from the CTI (Commission for Technology and Innovation). CTI assigns a business coach to you. In most cases, it is a senior entrepreneur who opens his network to you. So you can reach out to people, attend business conferences and courses to develop into an entrepreneur. It takes a year, and you got your own network that can help you out. Communication is also a key point! I love talking and that was easy to me. Be humble and just ask – that is the only way. Writing the business plan is also a challenge for a scientist, it took me almost a year to developa first sound version.
By the way, what did you do before?
I studied Biotechnology. Afterwards, I did a Ph.D. in Pharmaceutical Science. And in my postdoc, I was doing tissue engineering research at TBRU.
Cutiss raised 1 million in a seed round? How did it happen?
It happens when you need money and you start talking to investors who have money. You contact them, answer their questions and share your vision. In the end, you find those who believe in you and your project and are ready to take the risk.
Daniela, what was the most competitive argument you presented in talks with investors?
I think this is a very emotional case. Everybody knows somebody that got burned once. And it is especially important to kids who suffer the most. They can’t go to school, they can’t move properly and they can’t live a normal life. With denovoSkin™, we have the chance to save a life if there is a large burn, but also to go beyond, and significantly improve the quality of life afterwards.
Is there a comparable solution on the market?
No, there is no comparable solution on the market. Today, if you have a wound on your left arm the surgeon takes skin from your right arm to cover the wound (autograft). There are, for instance, acellular dermal templates that can be placed on the wounds and left there for 3 weeks until a surgeon will do an autograft. But it doesn’t solve the problem. If you have large wounds, you still have the challenge of the donor site shortage.
How people who got burned will be treated in the future?
In the future, we envision denovoSkin™ to be a routine treatment. If you are a severely burned patient you will come to the hospital. Then, the surgeons will decide on the therapy depending on the size and the severity of the wound. The patient could be treated exclusively with denovoSkin or in combination with autografts. If we talk about the reconstructive medicine denovoSkin could represent the long-awaited solution. We will automate the production to be in close proximities to hospitals all over the world.
What have you learned from your entrepreneurial journey?
If you do applied research to find a new therapy for patients, think business early ahead. You need to bring the solution to the market because people won’t access it otherwise. Don’t do experiments which only meet your professor’s expectations, plan the experiments in a way regulatory authorities would accept, this will speed up your process. If you publish a paper think business first. If your work could be patented, file a patent before publishing. Think business early on.