Restoring Skin, Restoring Lives: The Groundbreaking Technology of CUTISS AG’s denovoSkin™

“Be curious, be creative, and don’t be afraid to take risks. If you never try anything crazy, you’ll never make any headway.” Dr. Daniela Marino
By Mohammed Irshad

Swiss-based biotech company CUTISS AG is revolutionizing the world of regenerative medicine with its pioneering product, denovoSkin™. CEO Dr. Daniela Marino, a scientist at heart, is passionate about restoring patients’ skin and improving their quality of life. In this feature story, we take a closer look at Dr. Marino’s journey and the challenges CUTISS faced in its mission to help millions of patients in need.
Dr. Marino’s journey from being a scientist to CEO began when she was a child, as she always wanted to be a scientist. Now, as the CEO of CUTISS, she oversees a team of 40 talented and skilled colleagues. After seeing the positive results of her product during her postdoc, she knew she had to take on the challenge of building a company and bringing it to market. Despite facing obstacles such as lack of experience and family obligations, Dr. Marino’s determination and stubbornness helped her to see it through. Though it is a big responsibility, she finds it exciting and stimulating to work with scientists, medical doctors, and other experts in various fields.
“As a Biotechnology student, I became interested in skin tissue engineering during my PhD when I was introduced to skin research,” Dr. Marino shared with enthusiasm. “After completing my research and discovering CUTISS’ product, denovoSkin, I realized its potential to help millions of patients in need.”
“CUTISS is driven by the mission to provide effective, safe, and accessible treatments for skin injuries. As the body’s largest organ, skin plays a crucial role in protecting us from disease and injury. Millions of people worldwide require surgical interventions to restore skin function, such as severe burns,” she explained. “CUTISS is focused on developing bioengineered skin tissue that has shown proof of concept and safety in clinical studies. By restoring patients’ skin, we can save lives and improve the quality of life for those in need.”
CUTISS prioritizes its commitment to improving healthcare and helping patients over profitability, as shown in its efforts to develop a life-saving and life-changing personalized skin graft, denovoSkin. While scalability presents challenges, they have developed the world’s first machine to automate its production and make it more accessible. Dr. Marino spoke with great passion when she said that “Our goal is to optimize and de-centralize manufacturing, with the vision of having such machines in all major burn centers around the world. I believe that by putting patients first and advancing scientific innovation, profitability will follow.”
CUTISS’ technology is unique in its approach to treating deep skin injuries with personalized, bio-engineered dermo-epidermal skin grafts. There are currently no comparable competitors in the field. DenovoSkin™ promises a superior quality of life for millions of patients, and its manufacturing process can be automated. The product is in late-stage clinical trials and has completed Phase 1 safety trials, with Phase 2 efficacy trial results expected in the first half of this year. DenovoSkin™ is a medicinal product in the European Union and a biologic in the USA.
“To ensure reliability and consistency, in 2022, CUTISS established its own onsite manufacturing facility to produce tissue-engineered products,” explained Dr. Marino. “The facility received certification of compliance for Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from Swissmedic, the Swiss Agency for Therapeutic Products. This state-of-the-art facility, covering a surface area of 150 square meters, includes several laboratories such as a biobank and a histology lab. Additionally, the company has implemented bespoke standards for transportation and logistics to deliver its products to patients. These measures have been demonstrated through ongoing clinical trials across three European sites and compassionate patient use of the denovoSkin in 2022,” she added.
CUTISS is awaiting Phase 2 clinical trial results for denovoSkin, expected to have a significant impact on burn patients. Additionally, the company is set to commercialize the medical device VitiCell®, which treats skin pigmentation disorders such as Vitiligo, affecting a large population worldwide. VitiCell® enables autologous cellular grafting by a medical professional in an outpatient setting, making it easily accessible to patients.
CUTISS plans to collaborate with healthcare providers in the UAE and GCC to bring its technology and services to patients in the region. The company is seeking manufacturing and distribution partners for VitiCell® in the region.
CUTISS AG’s revolutionary technology and commitment to improving healthcare and helping patients offer new hope for millions of people around the world. The company’s personalized skin therapy has the potential to significantly improve the quality of life for patients with severe skin injuries and pigmentation disorders, and Dr. Marino’s inspiring journey is a testament to the power of determination and innovation in transforming regenerative medicine.