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新型血管通路血液透析解决方案提供商Dialybrid完成1500万欧元A轮融资,并宣布新型Silkothane®动静脉移植物成功完成首次人体植入,用于血液透析血管通路

Dialybrid secures €15 million series A round and announces successful first-in-human implant of novel Silkothane® Arteriovenous Graft for vascular access in hemodialysis

GlobeNewswire 等信源发布 2026-09-22 06:30

可切换为仅中文


Silkothane® Arteriovenous Graft is a novel hybrid arteriovenous graft engineered to integrate into patients’ vessels and provide a safe, easy-to-cannulate, durable, vascular access for hemodialysis in patients with end-stage kidney disease

Silkothane® 动静脉移植物是一种新型杂交动静脉移植物,旨在整合到患者的血管中,为终末期肾病患者提供安全、易于穿刺、耐用的血液透析血管通路。

€15 million Series A led by new investor XGEN Venture, with participation from CDP Venture Capital

由新投资者XGEN Venture领投、CDP Venture Capital参投的1500万欧元A轮融资

Successful first-in-human implant of the Silkothane® Arteriovenous Graft in a pilot clinical trial enrolling in Italy

在意大利开展的试点临床试验中,Silkothane® 动静脉移植物成功完成首例人体植入

Dialybrid to present at LSI Europe '26 Emerging Medtech Summit on September 29, 2026

Dialybrid 将于 2026 年 9 月 29 日在 LSI Europe '26 新兴医疗科技峰会上发表演讲

Cantù, Italy, September 22

意大利坎图,9月22日

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, Dialybrid S.r.l. (Dialybrid), a privately held medical device company developing a novel vascular access solution for hemodialysis based on Silkothane®, a patented hybrid material made up of silk fibroin and polyurethane, announced today the closing of a €15 million series A round led by new investor XGEN Venture, with participation of CDP Venture Capital (Rilancio Fund)..

Dialybrid S.r.l.(简称“Dialybrid”)是一家私营医疗器械公司,致力于开发基于Silkothane®的新型血液透析血管通路解决方案。Silkothane®是一种由丝素蛋白和聚氨酯组成的专利混合材料。该公司今日宣布,完成由新投资者XGEN Venture领投、CDP Venture Capital(Rilancio基金)参与的1500万欧元A轮融资。

The financing will fund clinical development of Dialybrid’s Silkothane® Arteriovenous Graft as a hemodialysis vascular access, and preclinical development of the Silkothane® material in other vascular applications. The first-in-human (FIH) clinical trial is enrolling and the first patient has been successfully implanted by coordinating principal investigator Prof.

这笔融资将用于资助Dialybrid公司的Silkothane®动静脉移植物作为血液透析血管通路的临床开发,以及Silkothane®材料在其他血管应用中的临床前开发。首次人体(FIH)临床试验正在招募受试者,且在协调主要研究者Prof.的主持下,已成功为首位患者植入该移植物。

Matteo Tozzi, MD, Director of the Vascular Surgery Department at ASST Sette Laghi and Professor of Vascular Surgery at Insubria University, in Varese, Italy..

马泰奥·托齐(Matteo Tozzi)医学博士,意大利瓦雷泽ASST Sette Laghi医院血管外科主任,因苏布里亚大学血管外科教授。

Francesco Giovanni Greco, Chairman and Chief Executive Officer of Dialybrid

弗朗切斯科·乔瓦尼·格雷科,Dialybrid 董事长兼首席执行官

, commented: “We are delighted to announce the closing of our series A round and the start of the first-in-human trial, a transformative milestone for our company. According to the KDOQI Clinical Practice Guideline for Vascular Access

评论道:“我们很高兴地宣布完成A轮融资,并启动首次人体试验,这对我们公司而言是一个具有变革意义的里程碑。根据KDOQI血管通路临床实践指南

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, the ideal hemodialysis access should provide adequate flow rates to sustain prescribed dialysis and be easy to access/cannulate, cost effective, acceptable to patients, and associated with excellent long-term patency and minimal complications. We are developing Silkothane® Arteriovenous Graft to offer physicians and patients a novel vascular access solution for hemodialysis that delivers all these characteristics, ultimately addressing a strong unmet clinical need.”.

理想的血液透析通路应能提供充足的血流速率以维持处方透析,并易于穿刺/插管,具有成本效益,患者接受度高,且具备优异的长期通畅率和极低的并发症发生率。我们正在开发Silkothane®动静脉移植物,旨在为医生和患者提供一种新型血液透析血管通路解决方案,具备上述所有特性,从而最终满足迫切而未竟的临床需求。

“We are excited about our investment in Dialybrid, which reflects our focus on Italian, innovative life science companies developing novel best-in-class solutions for high unmet medical needs, such as vascular access in hemodialysis. We look forward to supporting the company as it advances Silkothane® Arteriovenous Graft through the clinical stage towards regulatory approval,” said .

“我们对投资Dialybrid感到兴奋,这体现了我们专注于意大利创新型生命科学公司,这些公司正在开发 novel 同类最佳解决方案,以满足尚未被充分满足的重大医疗需求,例如血液透析中的血管通路。我们期待在公司推动Silkothane®动静脉移植物通过临床阶段直至获得监管批准的过程中提供支持。”

Daniele Scarinci, Co-Founder and Managing Partner at XGEN Venture

Daniele Scarinci,XGEN Venture 联合创始人兼管理合伙人

.

“I am proud to lead the first-in-human trial investigating the use of Silkothane® Arteriovenous Graft in vascular access for hemodialysis and extremely satisfied by the ease-of-implant in the first patient ever. If it works as intended, this new graft may provide vascular surgeons a new tool with shorter cannulation time than native fistulas and longer durability than commercially available grafts,” said .

“我很自豪能够领导这项首次人体试验,研究Silkothane®动静脉移植物在血液透析血管通路中的应用,并对首位患者植入过程的简便性感到极为满意。如果该移植物能达到预期效果,它将为血管外科医生提供一种新工具,其穿刺准备时间短于自体动静脉内瘘,且耐用性优于市面上现有的移植物。”

Prof. Matteo Tozzi, MD, coordinating principal investigator of the FIH study

马泰奥·托齐教授,医学博士,首次人体试验研究的协调主要研究者

.

“We are proud to support Dialybrid at this important stage in its development. Silkothane® is a technologically innovative and clinically relevant product in the strategic vascular access for hemodialysis market, with the potential to improve patient outcomes and redefine standards of care,” said

“我们很自豪能在Dialybrid发展的这一重要阶段为其提供支持。Silkothane®是血液透析战略血管通路市场中一项具有技术创新性和临床相关性的产品,有望改善患者预后并重新定义护理标准,”

Caterina Siclari, Head of Rilancio Fund of CDP Venture Capital

卡特琳娜·西克拉里,CDP风险投资公司Rilancio基金负责人

.

Over half a million vascular access procedures for hemodialysis are performed each year in the European Union and United States by either implanting a synthetic arteriovenous graft (AVG) or surgically creating a native arteriovenous fistula (AVF). AVGs provide faster access to hemodialysis but have low long-term durability and increased risk of infection.

在欧盟和美国,每年通过植入合成人工动静脉移植物(AVG)或手术建立自体动静脉内瘘(AVF)进行的血液透析血管通路手术超过50万例。AVG能够更快地实现血液透析通路,但其长期耐久性较差,且感染风险较高。

AVFs are more durable, but require a longer maturation time before they can be used in hemodialysis. About 60% of AVGs and 40% of AVFs fail in the first year, leaving a substantial unmet need for safe and durable vascular access.

动静脉内瘘(AVF)更耐用,但在用于血液透析之前需要更长的成熟时间。约60%的动静脉移植物内瘘(AVG)和40%的动静脉内瘘(AVF)在第一年内失效,这表明对安全且耐用的血管通路存在巨大的未满足需求。

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Silkothane® Arteriovenous Graft

Silkothane® 动静脉移植物

is a novel, partially resorbable vascular access solution based on a patented hybrid material that delivers the advantages of both native and synthetic materials. Silkothane® consists of silk fibroin, a biocompatible and bioresorbable material that supports endogenous tissue remodeling, combined with polyurethane, an elastic synthetic biocompatible material that does not resorb and endows the graft with increased durability and long-term stability.

是一种新颖的、部分可吸收的血管通路解决方案,基于一种专利混合材料,兼具天然材料和合成材料的优势。Silkothane® 由丝素蛋白和聚氨酯组成:丝素蛋白是一种具有生物相容性和生物可吸收性的材料,能够支持内源性组织重塑;聚氨酯是一种具有弹性的合成生物相容性材料,不可吸收,赋予移植物更高的耐久性和长期稳定性。

The proprietary Silkothane® manufacturing process, based on electrospinning, enables precise tuning of mechanical properties optimized for rapid graft use, long-term patency, and low rates of infection, overcoming the limitations of commercially available vascular access options..

基于静电纺丝技术的专有Silkothane®制造工艺,能够精确调控机械性能,以优化快速移植使用、长期通畅性及低感染率,从而克服市售血管通路选择的局限性。

The

first-in-human study

首次人体研究

is planned to enroll 18 adult patients across four Italian centers. The open-label single-arm study will measure safety and performance of Silkothane® Arteriovenous Graft for hemodialysis access. The trial will follow patients for up to 60 months with interim analyses at 6, 12 and 24 months.

计划在意大利的四个中心招募18名成年患者。这项开放标签、单臂研究将评估Silkothane®动静脉移植物在血液透析通路中的安全性和性能。该试验将对患者进行长达60个月的随访,并在第6、12和24个月时进行中期分析。

Dialybrid Chief Technology Officer Stefania A. Riboldi will be attending the

Dialybrid 首席技术官 Stefania A. Riboldi 将出席

LSI Europe '26 Emerging Medtech Summit

2026年欧洲LSI新兴医疗科技峰会

at the Grand Hyatt Barcelona, Spain, and will present the company on September 29

在西班牙巴塞罗那的君悦酒店,并将于9月29日展示该公司

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at 11:25 a.m. CEST (UTC+2) in Library B. In addition, she will be speaking during a panel discussion together with XGEN Venture MedTech Specialist & Dialybrid Board Member Luca Porro on September 30

于中欧夏令时(UTC+2)上午11:25在B图书馆。此外,她将于9月30日与XGEN Venture医疗科技专家兼Dialybrid董事会成员Luca Porro共同参加小组讨论并发言。

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at 10:30 a.m. CEST (UTC+2) in Track 5 - Loft Ballroom.

中欧夏令时(UTC+2)上午10:30,第5分会场 - Loft宴会厅。

Dialybrid S.r.l.

迪亚利布里德有限责任公司

(www.dialybrid.com)

(www.dialybrid.com)

is a clinical-stage medical device company developing novel arteriovenous vascular grafts for hemodialysis and other vascular applications based on Silkothane®, a patented innovative hybrid material consisting of silk fibroin and polyurethane. The lead clinical-stage product, Silkothane® Arteriovenous Graft, is an arteriovenous graft engineered to enable fast access to hemodialysis and high durability, overcoming the limitations of commercially available vascular access options..

是一家处于临床阶段的医疗器械公司,致力于开发基于Silkothane®的新型动静脉血管移植物,用于血液透析及其他血管应用。Silkothane®是一种获得专利的创新型混合材料,由丝素蛋白和聚氨酯组成。其主要的临床阶段产品Silkothane®动静脉移植物是一种经工程化设计的动静脉移植物,能够实现快速建立血液透析通路并具有高耐久性,从而克服现有市售血管通路方案的局限性。

XGEN Venture (www.xgenventure.com)

XGEN 创投(www.xgenventure.com)

is an Italian alternative investment fund manager (Società di Gestione del Risparmio, or SGR) established in 2021 by the former Genextra team, with over 15 years of activity and significant experience in the startup process, the discovery and the development of novel solutions for high unmet medical needs.

是一家意大利另类投资基金管理公司(Società di Gestione del Risparmio,简称SGR),由前Genextra团队于2021年创立,拥有超过15年的行业经验,在初创企业孵化、发现以及开发针对高度未满足医疗需求的创新解决方案方面具备丰富经验。

The XGEN team is currently investing out of its first fund, XGEN Venture Life Science Fund, launched at the end of 2022..

XGEN团队目前正从其首只基金——于2022年底推出的XGEN风险投资生命科学基金——进行投资。

CDP Venture Capital (www.cdpventurecapital.it)

CDP 风险投资(www.cdpventurecapital.it)

is the largest venture capital management company in Italy and one of the largest in Europe. It operates in strategic fields for the future, investing directly or indirectly in startups, innovative SMEs and in venture capital funds to create an infrastructure that could support the entire life cycle of the new enterprises..

是意大利最大的风险投资管理公司,也是欧洲最大的风险投资管理公司之一。它面向未来的战略领域开展业务,通过直接或间接投资于初创企业、创新型中小企业以及风险投资基金,构建能够支持新企业全生命周期的基础设施。

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National Kidney Foundation (2020), KDOQI (Kidney Disease Outcome Qualitative Initiatives) Clinical Practice Guideline for Vascular Access: 2019 Update. American Journal of Kidney Diseases, 75(4), S1-S164. https://doi.org/10.1053/j.ajkd.2019.12.001

美国国家肾脏基金会(2020),KDOQI(肾脏病预后质量倡议)血管通路临床实践指南:2019年更新。《美国肾脏病杂志》,75(4),S1-S164。https://doi.org/10.1053/j.ajkd.2019.12.001

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Niklason et al., Kidney360. 2020 Oct 15;1(12):1437-1446. https://doi.org/10.34067/kid.0003502020

Niklason 等,《Kidney360》。2020年10月15日;1(12):1437-1446。https://doi.org/10.34067/kid.0003502020

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Bylsma et al., Eur J Vasc Endovasc Surg. 2017 Oct;54(4):513-522. https://doi.org/10.1016/j.ejvs.2017.06.024

Bylsma 等人,《欧洲血管与血管内外科杂志》,2017年10月;54(4):513-522。https://doi.org/10.1016/j.ejvs.2017.06.024

For more information, please contact:

如需更多信息,请联系:

Media & Investor Contact

媒体与投资者联系

Giovanni Ca’ Zorzi

乔瓦尼·卡·佐尔齐

Cohesion Bureau

凝聚力局

giovanni.cazorzi@cohesionbureau.com

giovanni.cazorzi@cohesionbureau.com

+33 7 84 67 07 27

+33 7 84 67 07 27

Attachments

附件

20260922 Dialybrid PR Series A + FIH_Final

20260922 Dialybrid PR系列A + FIH_最终版

Dialybrid's team

Dialybrid 的团队