Shire plc / Pervasis Therapeutics, Inc.

Hemodialysis Vascular Access Failure (End-Stage Renal Disease)

Disease Overview

Patients with end-stage renal disease (ESRD) on hemodialysis require durable vascular access — typically an arteriovenous fistula (AVF) or graft (AVG) — to receive treatment. Access failure from intimal hyperplasia, thrombosis, and stenosis is common, driving repeat interventions and hospitalizations; no approved pharmacologic therapy directly addresses access maturation/maintenance.

Competitive Landscape

In 2012 there were no FDA-approved drug or biologic therapies specifically indicated to prevent AV access failure. Standard of care relied on surgical technique optimization, endovascular interventions (PTA, stent grafts such as Bard's Covera/Flair), and antiplatelet/anticoagulation regimens. Competing biologic/device approaches in development included Proteon Therapeutics' vonapanitase (PRT-201, recombinant human elastase) for AVF maturation, and various drug-eluting balloon strategies (e.g., Lutonix DCB) trialed for access salvage. Shire's Vascugel (SRM003) — an allogeneic endothelial cell-seeded gelatin matrix implant developed in Elazer Edelman's Harvard-MIT lab — was distinguished as a regenerative cell therapy aiming to recreate physiologic endothelial signaling at the surgical anastomosis. The Pervasis acquisition slotted Vascugel into Shire's regenerative medicine unit alongside Dermagraft (acquired via Advanced BioHealing in 2011), giving Shire a complementary cell-therapy portfolio addressing diabetic foot ulcers and dialysis access — a logical pairing given ~40% diabetes overlap in ESRD. Vascugel ultimately did not reach approval; Shire divested its regenerative medicine unit in 2014.