The second tranche of the Series C round brings total funds raised to more than CHF 125 million. The proceeds will be used to progress with the Phase 3 trial of the lead product denovoSkin and to prepare for its commercialization. The funds will also advance the industrialization and clinical readiness of the world’s first automated manufacturing platform for personalized tissue therapy..

C轮融资的第二笔资金使总融资额超过1.25亿瑞士法郎。这笔资金将用于推进主导产品denovoSkin的第三阶段试验，并为其商业化做好准备。资金还将推动全球首个个性化组织治疗自动化制造平台的工业化和临床准备工作。

CUTISS

CUTISS

’ personalized, bioengineered skin graft denovoSkin is designed for patients undergoing skin surgery for burns, reconstructive and plastic procedures. 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.

个性化、生物工程皮肤移植denovoSkin专为接受烧伤、重建和整形手术的患者设计。迄今为止，长期随访显示，它大幅减少了供体部位的损伤，迅速成熟，安全恢复皮肤功能，以近乎无疤痕的方式再生，并与患者一同生长。

The Phase 3 confirmatory study in adolescent and adult severe burn patients started enrolling patients this year; it has a total of 2-year follow up period. The first data set is expected by end of 2026..

青少年和成人重度烧伤患者的III期确证性研究今年开始招募患者；该研究总共有2年的随访期。预计第一组数据将在2026年底出炉。

The funds from the Series C round will be used for the clinical trial and the industrialization of CUTISS’ manufacturing platform. In April 2025, CUTISS announced a strategic

C轮资金将用于CUTISS的临床试验及其制造平台的产业化。2025年4月，CUTISS宣布了一项战略。

partnership with Tecan

与Tecan的合作关系

to enable the transition of CUTISS’ automated manufacturing solution from engineering development to industrial-grade production. The Series C co-lead investors – the family office of Giammaria Giuliani, a longstanding lead investor, and a US family represented by

为了实现CUTISS自动化制造解决方案从工程开发到工业级生产的转型。C轮融资的共同领投者——长期主要投资者Giammaria Giuliani的家族办公室，以及一个由

Shiloh Advisors AG

士师顾问公司

– were joined in 2025 by new investors ranging from family offices to industry players, as well as an investor collective at

——2025年，新的投资者加入，包括从家族办公室到行业参与者，以及一个投资者集体在

Swisspreneur

瑞士企业家

.

。

Agreement for first production center

第一个生产中心协议

Among the equity investors is

其中的股权投资者是

Rode Kruis Ziekenhuis / Burn Center Beverwijk

红十字医院/贝弗韦克烧伤中心

(RKZ). In addition to the investment CUTISS and RKZ have signed a collaboration agreement, which could see the creation of CUTISS’ first international commercial production facility in the Netherlands, once denovoSkin is commercially approved. The agreement is set on the possibility for CUTISS to open a center of excellence for denovoskin production in Beverwijk..

（RKZ）。除了投资外，CUTISS和RKZ还签署了一项合作协议，一旦denovoSkin获得商业批准，这可能会促成CUTISS在荷兰建立首个国际商业生产设施。该协议基于CUTISS在贝弗韦克开设denovoskin生产卓越中心的可能性。

Dr. Daniela Marino, CEO and co-founder of CUTISS, stated: “The successful closing and partnerships demonstrates confidence in our vision and ability to bring transformative skin therapies to patients. We’re grateful for the continued trust of existing investors and warmly welcome new investors on board, including key strategic ones.

CUTISS首席执行官兼联合创始人丹妮拉·马里诺博士表示：“成功完成交易并达成合作伙伴关系，证明了我们的愿景和为患者带来变革性皮肤治疗的能力得到了认可。我们感谢现有投资者的持续信任，并热烈欢迎新投资者的加入，其中包括关键的战略投资者。”

The agreement with RKZ sets the stage for our future expansion with the potential to revolutionize the skin surgery market in Europe and globally.”.

与RKZ的协议为我们的未来扩展奠定了基础，有望彻底改变欧洲乃至全球的皮肤手术市场。

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.”.

纳丁·维勒尔斯，罗斯十字医院/贝弗韦克烧伤中心首席执行官评论道：“作为一家致力于推进烧伤护理的临床机构，我们承诺支持CUTISS和denovoSkin的开发。我们很高兴继续深化合作，所签署的协议阐明了我们将他们革命性的皮肤组织疗法优先带给患者的愿景。”

Second product in the pipeline

管道中的第二个产品

The proceeds from the funding round will be also used to enable the market launch of VitiCell. CUTISS has exclusive rights to globally commercialize VitiCell, an MDD CE-marked medical device developed by IBSA Pharma. The device enables autologous cell grafting for skin re-pigmentation, offering a personalized treatment option for patients with vitiligo.

本轮融资的收益还将用于推动VitiCell的市场推出。CUTISS拥有全球商业化VitiCell的独家权利，这是一种由IBSA Pharma开发的MDD CE认证医疗器械。该设备可实现自体细胞移植以进行皮肤再着色，为白癜风患者提供个性化的治疗选择。

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..

未来，接受denovoSkin治疗的患者也可能从该疗法中受益。一旦获得欧盟MDR CE标志，CUTISS将推出VitiCell。

(Press release / SK)

（新闻稿 / SK）

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