Dialybrid, a medical device company developing a novel vascular access solution for haemodialysis based on Silkothane, a patented hybrid material made up of silk fibroin and polyurethane, has announced the closing of a €15 million series A round.
Led by new investor XGEN Venture, with participation of CDP Venture Capital, the financing will fund clinical development of Dialybrid’s Silkothane arteriovenous graft as a haemodialysis vascular access, and preclinical development of the Silkothane material in other vascular applications.
A first-in-human (FIH) clinical trial is enrolling and the first patient has been successfully implanted by coordinating principal investigator Matteo Tozzi, director of the Vascular Surgery Department at ASST Sette Laghi and professor of vascular surgery at Insubria University (Varese, Italy).
Francesco Giovanni Greco, chairman and CEO of Dialybrid, 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 [Kidney Disease Outcomes Quality Initiative Clinical] practice guideline for vascular access, the ideal haemodialysis 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 haemodialysis that delivers all these characteristics, ultimately addressing a strong unmet clinical need.”
“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 haemodialysis. We look forward to supporting the company as it advances Silkothane arteriovenous graft through the clinical stage towards regulatory approval,” said Daniele Scarinci, co-founder and managing partner at XGEN Venture.
“I am proud to lead the first-in-human trial investigating the use of Silkothane arteriovenous graft in vascular access for haemodialysis 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 Tozzi, coordinating principal investigator of the FIH study.
“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 haemodialysis market, with the potential to improve patient outcomes and redefine standards of care,” said Caterina Siclari, head of Rilancio Fund of CDP Venture Capital.
Silkothane arteriovenous graft is a novel, partially resorbable vascular access solution based on a patented hybrid material that delivers the advantages of both native and synthetic materials, the company says in a press release. The device consists of silk fibroin, a biocompatible and bioresorbable material that supports endogenous tissue remodelling, combined with polyurethane, an elastic synthetic biocompatible material that does not resorb and endows the graft with increased durability and long-term stability.
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.
The first-in-human study is planned to enrol 18 adult patients across four Italian centres. The open-label single-arm study will measure safety and performance of Silkothane arteriovenous graft for haemodialysis access. The trial will follow patients for up to 60 months with interim analyses at six, 12 and 24 months.
