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THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

Series A

Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient

MedDevice Startups Staff · 1 day ago · 2 min read · Via GlobeNewswire

Dialybrid closed a 15 million euro Series A on September 22. XGEN Venture led as a new investor, and CDP Venture Capital invested through its Rilancio Fund.

The round landed alongside the first human implant of the Silkothane arteriovenous graft. The material is electrospun silk fibroin combined with polyurethane, meant to keep the handling of a synthetic graft while the silk resorbs. Four Italian centers will enroll 18 adult patients in an open label, single arm study. Prof. Matteo Tozzi, of the vascular surgery department at ASST Sette Laghi in Varese, is principal investigator.

Follow-up runs to 60 months, with interim analyses at 6, 12 and 24 months. That is a long clinical road for a company formed in August 2020 out of LIFTT and Bioengineering Laboratories. Vascular access is also a market where the incumbent ePTFE graft is cheap and familiar, so the numbers that matter here are cannulation time and patency.

Questions & Answers

How much did Dialybrid raise in its Series A?

Dialybrid raised 15 million euros in a Series A announced on September 22, 2026. XGEN Venture led the round as a new investor and CDP Venture Capital invested through its Rilancio Fund.

What is the Dialybrid Silkothane arteriovenous graft?

Silkothane is an electrospun hybrid material that combines silk fibroin with polyurethane. Dialybrid uses it to build an arteriovenous graft for hemodialysis vascular access.

How many patients are in the Dialybrid first-in-human study?

The open label, single arm study will enroll 18 adult patients across four Italian centers. Follow-up runs up to 60 months, with interim analyses at 6, 12 and 24 months.

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