Cutiss AG

18/03/2026

This month we celebrated the 9th birthday of CUTISS!

Our amazing team was able to mark this milestone in a particularly meaningful way, together with our medical trainers and many of the clinical investigators and their teams involved in our ongoing Phase 3 trial who travelled to Zurich from 7 different EU countries for 2 days of workshops, networking and discussions.

Our progress is the result of a shared effort between CUTISS’ team, surgeons, clinical teams, researchers, partners (including Tecan and Rode Kruis Ziekenhuis) and patients. Their trust and dedication honor us and give us an amazing motivation to keep pushing the boundaries in skin surgery.

As our Phase 3 study of denovoSkin™ and our automation program continue, we remain focused on developing a personalized, scalable and accessible skin tissue therapy that can significantly improve outcomes for patients with severe skin injuries and reduce the burden of today’s standard treatments.

We have our goals in sight, and we remain committed to make our therapy available to as many patients, as soon as possible

04/12/2025

A major step forward in personalized skin tissue therapy: we’re excited to share that the 1-year results from our Phase 2 clinical trial of denovoSkin™ have now been published in eClinicalMedicine (The Lancet Discovery Science).

The results demonstrate safety and – in sharp contrast to the intra-patient autografting control – a significantly reduced need for donor-site harvesting together with minimal scarring.

These outcomes reinforce the potential of denovoSkin™ to safely spare donor sites, improve long-term healing, and offer a new therapeutic path for patients with severe burns.

While the paper reports the 1-year results, the clinical follow-up for this study has now been completed through 3 years, further enriching our long-term data.

In parallel, our Phase 2 pediatric burn study is ongoing and will soon reach its 1-year readout, the reconstructive Phase 2 trial is nearing its 2-year readout, and our Phase 3 trial continues to progress in the EU and Switzerland.

24/11/2025

🎥 Our mission: revolutionizing skin surgery through personalized regenerative medicine.

This video was created following our 2nd place at The Spark – Der Deutsche Digitalpreis 2025 — the first time a Swiss company has received this recognition.

At CUTISS, we’re developing denovoSkin™, a personalized, bio-engineered human skin graft for patients with severe skin injuries. By combining bioengineering with automation, we’re scaling the future of skin tissue therapy.

10/11/2025

🏆 CUTISS takes 2nd place at The Spark Award 2025 – and makes Swiss history!

We’re proud that CUTISS has been awarded 2nd place at this year’s The Spark – Der Deutsche Digitalpreis, recognizing breakthrough deep-tech innovation across Germany, Austria, and Switzerland. What an incredible evening in Munich last week!

This also marks the first time a Swiss company has received an award at The Spark. It has been an honor to represent Swiss tech and regenerative medicine innovation amongst the inspiring group of finalists.

A big thank you to Handelsblattt and McKinsey & Company for continuing to organize this award over 10 years, and of course to everyone who supported and voted for us along the way.

Shout out and congratulations to Black Semiconductor for winning their well-deserved first place!

Photos credit © Marc-Steffen Unger for Handelsblatt.

29/09/2025

CUTISS has been nominated for the 2025 Prix Galien USA in the Best Startup category!

The Prix Galien Awards are among the most prestigious recognitions in life sciences, celebrating biomedical innovation that improves the human condition.

This year’s ceremony will take place in New York City on October 30. Following our recent Series C financing round close and ongoing Phase 3 clinical trials for denovoSkin™, we’re excited to attend.

Reach out to our CEO Daniela Marino who will be in NYC at the end of October.

10/09/2025

🚨 Big update from CUTISS!

We’ve signed a strategic agreement with Rode Kruis Ziekenhuis / Brandwondencentrum Beverwijk in the Netherlands 🇳🇱 - home to the leading Burn Center Beverwijk. This lays the foundation for a future CUTISS production center and deeper collaboration in burn care.

At the same time, we’ve successfully closed our Series C financing round at CHF 56 million, bringing total funds raised to over CHF 125 million! 🙌

This funding will support:
🔹 The ongoing Phase 3 clinical trial of denovoSkin™
🔹 Preparation for commercialization
🔹 The industrialization of our automation platform for tissue therapy production at scale

🗣️ “We’re proud to have come this far, with commercialization now visible on the not-so-distant horizon,” says our CEO, Daniela Marino.
🚀

27/08/2025

🇮🇹 Featured in Fortune Italia!

This week we're featured in Fortune Italia, highlighting our journey from a university lab in Zurich to pioneering personalized skin regeneration through bioengineering and automation.

From treating pediatric burns to advancing Phase 3 trials, it’s been a path of science, setbacks, and breakthroughs - with more to come, of course!

🧬 Read the article (in Italian):
fortuneita.com/pelle-cutiss-la-startup-che-bioingegnerizza-gli-innesti-cutanei/

Cutiss, la startup svizzera che vuole rivoluzionare la velocità con cui si riesce a fornire pelle bioingegnerizzata.

25/07/2025

⚙️Why is scalability the hardest part of advanced therapies?

We’ve seen firsthand that scientific breakthroughs aren’t enough. For personalized, regenerative therapies like denovoSkin™ to reach patients they must be manufactured safely, reproducibly, and at scale.

You can read more in our blog post: https://cutiss.swiss/newsroom2021/advanced-therapy-accessibility-why-scalability-is-the-hard-part/

28/05/2025

Positive interim safety and efficacy results in pediatric burns: clinical trial update

We’ve announced a positive interim analysis in our Phase 2 clinical trial evaluating denovoSkin™’s safety and efficacy in children with severe burns.

The trial compares denovoSkin™ to the standard of care (autografting) using an intra-patient control design. The interim data confirm a favorable safety profile and show positive signals of efficacy, reinforcing the potential of denovoSkin™ in pediatric burn care.

“A clinical trial involving pediatric patients is one of the toughest to conduct and complete. Children with extensive burns face donor site shortage and the current standard of care doesn’t offer satisfactory long-term functional and cosmetic outcomes. We’re looking to revolutionize the treatment for these young and fast-growing patients. We’re grateful to the patients, families, surgeons, clinical teams, stakeholders, investors and the team at CUTISS who are making this trial possible.” - Daniela Marino, CEO of CUTISS

More details available in our newsroom on our site.

21/05/2025

Journal of Burn Care and Research: denovoSkin™ used in pediatric reconstructive burn surgery under compassionate use

A surgical team at Massachusetts General Hospital (Boston) has detailed the use of denovoSkin™ to treat a three-year-old child with 90% TBSA burns, under U.S. FDA compassionate use in an abstract submitted to the , 57th annual meeting, 2025.

This case, the first U.S. application of denovoSkin™, and the first reconstructive surgery under compassionate use, was in the press in October last year, notably in the Boston Globe Media.

The procedure involved reconstructive surgery, including contracture release and treatment of non-healing wounds. The authors report:
✔️ Easy to handle, apply, and care for product
✔️ Engraftment rate >95%
✔️ Durable healed skin

“The development of an autologous, full-thickness skin replacement remains the holy grail for the treatment of full thickness skin loss from burns, wounds, and trauma.” - Journal of Burn Care & Research, 2025

A big thank you to the clinical team at Mass General Hospital for their trust in denovoSkin™ and for their continued commitment to advancing care for complex burn patients!

More details available on our site

09/05/2025

👑 Royal visit shines a light on innovation in burn care – and denovoSkin™

Recently, King Willem-Alexander of the Netherlands visited the Brandwondencentrum Beverwijk where he met with patients and healthcare professionals. He was also introduced to denovoSkin™, our personalized, bio-engineered human skin graft for skin surgery and the treatment of severe burns.

During the visit, he was shown how denovoSkin™ can be applied in surgery and also how it looks and feels on patients who received it – “feels the same as real skin”

We’re proud to see denovoSkin™ integrated into patient care at Beverwijk, one of Europe’s leading centers for complex wound treatment, and we’re grateful for the long-standing collaboration and the Burn Center’s participation in our ongoing Phase 3 clinical trial