Dialybrid Commences FIH Trial for Silkothane AV Graft for Vascular Access in Hemodialysis

September 22, 2026—Italy-based Dialybrid S.r.l. announced commencement of the first-in-human (FIH) trial of the company’s arteriovenous (AV) graft for vascular access in hemodialysis. The company also announced the closing of a €15 million series A funding round.

According to Dialybrid, its AV graft is based on Silkothane, the company’s hybrid material made up of silk fibroin and polyurethane.

The company stated that the FIH clinical trial is planned to enroll 18 adult patients across four Italian centers. The open-label single-arm study will measure safety and performance of the Silkothane AV graft for hemodialysis access. The trial will follow patients for up to 60 months with interim analyses at 6, 12, and 24 months.

The initial procedure in the trial was conducted by Coordinating Principal Investigator Professor Matteo Tozzi, MD. Prof. Tozzi is Director of the Vascular Surgery Department at ASST Sette Laghi and Professor of Vascular Surgery at Insubria University in Varese, Italy.

The Italy-based company also announced the closing of a €15 million series A round led by new investor XGEN Venture with participation of CDP Venture Capital (Rilancio Fund).

According to the company, the financing will fund clinical development of the AV graft as a hemodialysis vascular access and preclinical development of the Silkothane material in other vascular applications.

“I am proud to lead the FIH trial investigating the use of Silkothane AV graft in vascular access for hemodialysis and extremely satisfied by the ease of implant in the first patient ever,” commented Prof. Tozzi in Dialybrid’s press release. “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.”