Presented at 2018 VEITH Symposium (www.veithsymposium.org) 11/17/2018 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels New AV Graft Remains Patent & Resists Infection Disclosures: AORTICA Corporation; Co-Founder Benjamin W. Starnes, MD The Alexander Whitehill Clowes Endowed Chair in Vascular Surgery Professor and Chief of Vascular and Endovascular Surgery University of Washington and Harborview Medical Center 2 10.22.18 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels Background • The use of central venous catheters for hemodialysis remains high, and the greatest threat to the safety of patients dialyzed through catheters is catheter-related bloodstream infection (CRBSI). Improved Patency • In the US alone, over 50,000 new cases of CRBSI occur each year in this population. • Studies have shown these patients require hospitalization for up to 13 days at an average cost of $24,000 per infection, with mortality rates up to 25%. 3 4 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels Why conventional AV grafts occlude STARgraft solves occlusion problem Solving this problem would have high impact Biointegrating outer surface Scar tissue forms No Scar outside Tissue AV graft STARgraft Vein Vein Flow blocked Stays open Neointimal to flow hyperplasia 5 6 1 STARgraft is an investigational device not available for commercial sale.
Presented at 2018 VEITH Symposium (www.veithsymposium.org) 11/17/2018 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels Close-up view of STAR biomaterial STARgraft maintains wall flexibility & motion • Made of medical-grade silicone (used in many commercial implants) Control STARgraft • Unique geometric structure prevents both scarring & infection o Open-pore 3D scaffold with tightly-controlled dimensions Graft wall porous silicone granules STAR biointerface STAR biomaterial Ultrasound catheter ePTFE (sheep 3 months post-implant) ePTFE 5 mm STAR -coated wall moves with flow 300 µm lumen 50 µm mm like a natural blood vessel 7 8 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels STARgraft shows excellent results in animal studies Consistently superior patency in multiple sheep studies 6-month angiograms (sheep) Pooled results show 80% reduction in occlusion conventional ePTFE graft STARgraft % of diameter occluded Intravascular ultrasound Narrowing Control STARgraft (Conventional Graft) (coated with STAR ) Narrowing Wide Open Nearly Occluded Narrowing Narrowing Wide Open 10 mm at 6 months 9 9 10 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels STARgraft prevents biofilm in sheep model conventional ePTFE graft STARgraft Bacteria Example of a leading AV graft that is heavily concentration colonized with bacteria near suture line Only isolated bacteria, blue clusters = Staph aureus no biofilm clusters LOG scale ( 𝜈 m 2 /mm 2 ) 100 µm minimal fibrotic 1000x capsule reduction Infection Resistance wrinkles in dense fibrotic capsule ePTFE STAR Sheep at 2 months post-implant STARgraft Bacteria preferentially colonize ePTFE devices, but STARgraft remains virtually biofilm-free 11 12 2 STARgraft is an investigational device not available for commercial sale.
Presented at 2018 VEITH Symposium (www.veithsymposium.org) 11/17/2018 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels STAR biomaterial resists infection even in STAR biomaterial resists infection even in far more demanding conditions far more demanding conditions Percutaneous port being developed for dialysis access Percutaneous port being developed for dialysis access STAR -coated port (day 21) Control port (day 15) STAR -coated port N = 48 % Survival Uncoated control N = 16 STAR -coated ports were infection-free Untreated controls became Days post-implant after 30 days in nearly all cases. infected in nearly all cases. (pigs) Representative photos (pig) 13 14 Synthetic Grafts that Perform Like Natural Vessels Synthetic Grafts that Perform Like Natural Vessels STAR biomaterial resists infection even in Value of STARgraft AV graft far more demanding conditions Expected to reduce cost, illness & death among dialysis patients At 6 weeks, all STAR -coated ports were infection-free & cleanly healed • As replacement for conventional graft: Less frequent interventions Less frequent infections All 4 controls were infected & removed within 3 weeks • As alternative to fistula: Avoids extended use of infection-prone catheter STATUS: first human trial begins Q1 ’19 STAR -coated ports Healionics contact : Mike Connolly, CEO mike@healionics.com 425-765-3199 15 Representative of all 4 pigs in the study 16 3 STARgraft is an investigational device not available for commercial sale.
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