Italian medical device company Dialybrid has closed a €15m ($17m) Series A financing round to support the clinical development of its Silkothane arteriovenous graft for haemodialysis access.
XGEN Venture led the financing, with additional participation from CDP Venture Capital (Rilancio Fund).
Dialybrid’s Silkothane arteriovenous graft is designed to serve as a vascular access for patients undergoing haemodialysis with end-stage kidney disease.
The funding will also enable preclinical investigations of the Silkothane material in other vascular uses.
Simultaneously, Dialybrid reported that the first patient has been implanted with the device in a first-in-human clinical trial currently enrolling in Italy.
The procedure was performed by ASST Sette Laghi vascular surgery department director and Insubria University vascular surgery professor Matteo Tozzi.
The open-label, single-arm pilot clinical trial will enrol 18 adult participants across four Italian centres.
It aims to assess the safety and performance of the Silkothane Arteriovenous Graft over a follow-up period of up to 60 months, with interim analyses scheduled at six, 12, and 24 months.
Dialybrid chairman and CEO Francesco Giovanni Greco said: “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, 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.”
Dialybrid stated that more than half a million procedures to create vascular access for haemodialysis are performed each year in the EU and the US.
Existing approaches such as synthetic grafts and native fistulas have various limitations regarding durability and time to use, which Silkothane seeks to overcome through its hybrid material of silk fibroin and polyurethane.
