Today CUTISS, a late-stage clinical TechBio at the forefront of tissue therapeutics and regenerative medicine, has announced the closing of its Series C round for €57.9 million (CHF 56M) with existing and new investors, bringing total funds raised to more than €129.3 million (CHF 125M).
Established in 2017 as a spin-off of the Tissue Biology Research Unit of the University of Zurich, CUTISS is at the forefront of tissue engineering therapy and regenerative medicine.
Its lead product, denovoSkin, is a bio-engineered, personalised skin graft that promises to transform skin surgery, especially for burn victims.
I spoke to CEO and co-founder Dr Daniela Marino in May last year, so I was excited to talk again.
A bioengineered graft that grows with the patient
The personalised (autologous), bioengineered skin graft denovoSkin™ is designed for patients undergoing skin surgery for burns, reconstructive and plastic procedures. denovoSkin™ is bilayer, composed of both dermis and epidermis.
Long-term follow-ups to date have shown that it drastically spares donor sites, matures quickly, safely restores skin function, regenerating in a near-scarless manner, and growing with the patient.
As a result, it has the potential to significantly reduce healthy skin harvesting and scar care (including follow-up corrective surgeries), and improve quality of life.
From investor hesitation to FOMO: How a Dutch burn centre unlocked the funding
Late-stage funding is never easy. Marino acknowledged that the fundraising process was unusually drawn out. “It took a long time—definitely harder than usual,” she said.
“Even the last round wasn’t done in a week, but this time you could really feel that although there was strong interest in the story — the data speaks for itself — investors just took much longer to make decisions.
It stretched on and on. At times, I wasn’t sure if they were waiting for an apocalypse or a miracle in the markets. In the end, I spent almost two years pitching nonstop, which was painful.”
To manage the process, CUTISS staged the raise in multiple closings. “That turned out to be the smartest move,” Marino explained.
“With the first closing, we were able to demonstrate real milestones—launching Phase 3, starting recruitment. People thought that with the new European system this would be too complex, but we showed we could succeed.”
Momentum built after a key strategic backer came on board, as CUTISS has also signed a collaboration agreement with its new investor Rode Kruis Ziekenhuis (RKZ), which could see the creation of CUTISS’ first international commercial production facility in the Netherlands, once denovoSkin is commercially approved.
RKZ is a leading EU clinical trials centre, participating in the Phase 2 and Phase 3 trials for denovoSkin.
“Once the burn unit hospital in the Netherlands invested, it sent a strong signal,” she said.
“They saw that Phase 3 was happening, the timing was clear, and the product was truly on track. That investment unlocked the rest — suddenly, the other investors who had been hesitating for so long felt the FOMO. Within three or four weeks, after two years of effort, the round came together.”
Nadine Vieleers, CEO Rode Kruis Ziekenhuis / Burn Center Beverwijk, commented:
“As a clinical institution dedicated to advancing burn care, we’re committed to support CUTISS and the development of denovoSkin.
We’re excited to continue our closer collaboration, and the agreement we’ve signed sets out our vision for bringing their revolutionary skin tissue therapy to our patients as a priority.”
The Series C co-lead investors – the family office of Giammaria Giuliani, a longstanding lead investor, and a US family represented by Shiloh Advisors AG – were joined in 2025 by new investors ranging from family offices to industry players, as well as an investor collective at Swisspreneur.
Silvan Krähenbühl, speaking on behalf of Swisspreneur, commented:
"We’re proud that Swisspreneur participated in the latest funding round of CUTISS, a pioneering Swiss biotech company. Their mission to revolutionise skin regeneration is exactly the kind of bold innovation we love to support, and we're excited for the next phase in the journey ahead."
For Marino, the validation goes beyond capital.
“It’s not just a family office or a private investor—it’s one of Europe’s leading burn hospitals betting on our technology. That makes it a strategic investment and sends a powerful message.”
CUTISS is working to scale up the production of denovoSkin™ through automation.
The company has already developed a first-in-class automation platform for the scalable production of personalised tissue therapy. This patented, fully-closed, end-to-end system enables de-centralised production, cost-effective scale-up, and high return on investment. Platform industrialisation is now ongoing.
Orphan drug status and broad applications put CUTISS at the forefront of regenerative medicine
The funding proceeds will be used to progress with the Phase 3 trial of the lead product denovoSkin.
Currently in Phase 3 clinical trials in Europe, denovoSkin has received Orphan Drug Designation from Swissmedic, the European Medicines Agency (EMA), and the US FDA for the treatment of burns.
Marino explained the trial process:
“We started recruiting this year in Europe and Switzerland, really at full speed from the second quarter,” she explained.
“We have almost 20 sites in the trial. It took some time to bring them all online, but now we expect to have our first dataset by the end of next year. This summer we already saw a lot of patients coming through.
We’re at the very last step.
If Phase 3 confirms what we saw in Phase 2, the future looks bright. Now that the fundraising round is closed, all of our energy is going into that.”
Asked about the types of patients taking part in the trials, Marino pointed to the broad scope of applications.
“In Phase 1, we treated both patients with active burns and those undergoing removal of a scar or giant nevus, and we followed them for five years with good results.
In Phase 2, we expanded—one full trial just with burn patients, and another across reconstructive cases, from scar revisions to tumor resections to gender reassignment surgery. The outcomes have been very consistent. The product seems highly versatile.”
She attributed that versatility to the underlying biology.
“Each time, the product is freshly prepared for the individual patient. If the wound bed is well prepared, it doesn’t really matter why the wound is there—whether from burns or reconstruction.
Of course, actively burned patients are very fragile, so we see dropouts, sepsis, even deaths. It’s a very complex trial to run. But physiologically and biologically, when the wound is ready, our product appears to work across indications.”
Further, there is a huge potential beyond burns."
Over a million skin surgeries are performed per year in Europe. According to Marino:
“We are really trying to approach the market in a very clever way: by getting there as fast as possible with the highest demand in burns, but really trying to serve the market correctly and support patients who had a trauma or an accident or a cancer to be able to use the technology correctly as well.”
Paramount to this evolution and acceleration is a partnership Tecan, a Swiss-American company that produces machines for life science, announced earlier this year.
Marino admits:
“Tecan was a real jackpot for us in the first quarter,” she said. “Up to now, our machines were developed as prototypes with engineers. But what we need are real, deployable devices — and with Tecan, we’re moving very quickly toward that finish line.”
CUTISS to launch VitiCell for personalised vitiligo treatment
CUTISS also has exclusive rights to globally commercialise VitiCell, an MDD CE-marked medical device developed by IBSA Pharma.
The device enables autologous cell grafting for skin re-pigmentation, offering a personalised treatment option for patients with vitiligo. This chronic autoimmune disorder causes patches of skin to lose pigment or colour.
According to Marino, vitiligo, a condition that remains poorly understood.
“It’s very prevalent and actually increasing, but nobody really knows why.
That lack of understanding comes from years of neglect—vitiligo was long dismissed as a cosmetic issue rather than a medical one, so little research was done.
Yet now we know these patients face higher cancer risks, immune response issues, and other comorbidities. Socially, the stigma can be devastating—in some cultures it can prevent people from having any kind of normal life.”
Using VitiCell, “within an hour, clinicians can take a thin piece of pigmented skin from the patient, isolate the melanocytes, and apply them to the depigmented lesion so the cells repopulate the area,” Marino explained.
“It’s still personalised, still cell therapy, and a perfect addition to our approach. We’re now in the regulatory transition from MDD to MDR, and once that’s complete, we’ll launch. The demand is already incredible.”
In the future, patients treated with denovoSkin may also benefit from this therapy. CUTISS will launch VitiCell once the EU MDR CE marking is granted.
“The vision is that by the time Phase 3 data is positive, the machines are ready, and we already have revenues from this device,” Marino explained.
“At that point, the company will truly be positioned as a commercial entity.”
CUTISS is at the forefront of a growing tissue engineering wave
Looking ahead, Marino sees CUTISS riding the broader wave of tissue engineering.
“It’s a field that’s really taking off. Just yesterday I saw news of a new printer for tissues— it’s becoming the next big thing,” she said. “We see CUTISS as one of the leaders.
To the best of our knowledge, we’re the only company with a product already in Phase 3 and machines close to being market-ready. It’s an exciting point of development in such a fast-growing sector.”
The next step, she noted, is not just regulatory approval but ensuring adoption.
“That could mean an acquisition by a company already taking the lead in tissue and organ regeneration or others in the TechBio space.
It could mean an IPO, so we grow internally and expand into other applications beyond skin. Or it could mean a large private equity round in a few years, depending on how the market evolves.”
Marino is keeping an open mind.
“Five years ago, the idea of an acquisition felt remote—I couldn’t see who would be able to sell this product effectively. But now, there are strong candidates emerging.
By the time we’re ready, the landscape will look very different. Tissue and organ therapy is moving to the forefront, and CUTISS is well positioned to be part of that story.”
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