Disclosures: AORTICA Corporation; Co-Founder Benjamin W. Starnes, - - PDF document

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Disclosures: AORTICA Corporation; Co-Founder Benjamin W. Starnes, - - PDF document

Aug 03, 2023 154 likes •192 views

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:

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11/17/2018 1

Synthetic Grafts that Perform Like Natural Vessels

10.22.18

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

New AV Graft Remains Patent & Resists Infection

Synthetic Grafts that Perform Like Natural Vessels

Disclosures: AORTICA Corporation; Co-Founder

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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).

  • In the US alone, over 50,000 new cases of CRBSI
  • ccur 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%.

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Synthetic Grafts that Perform Like Natural Vessels

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Improved Patency

Synthetic Grafts that Perform Like Natural Vessels

AV graft

Scar tissue forms

  • utside

Neointimal hyperplasia

Vein

Flow blocked

Why conventional AV grafts occlude Solving this problem would have high impact

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Synthetic Grafts that Perform Like Natural Vessels

Vein STARgraft

Stays open to flow No Scar Tissue Biointegrating

  • uter surface

STARgraft solves occlusion problem

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STARgraft is an investigational device not available for commercial sale. Presented at 2018 VEITH Symposium (www.veithsymposium.org)

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11/17/2018 2

Synthetic Grafts that Perform Like Natural Vessels

Close-up view of STAR biomaterial

  • Made of medical-grade silicone (used in many commercial implants)
  • Unique geometric structure prevents both scarring & infection
  • Open-pore 3D scaffold with tightly-controlled dimensions

mm

5 mm

STAR biointerface ePTFE

lumen

50 µm

ePTFE

300 µm porous silicone granules

STAR biomaterial

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Synthetic Grafts that Perform Like Natural Vessels

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STAR-coated wall moves with flow like a natural blood vessel

STARgraft maintains wall flexibility & motion

Control STARgraft

Ultrasound catheter Graft wall

(sheep 3 months post-implant)

Synthetic Grafts that Perform Like Natural Vessels

Narrowing

10 mm

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STARgraft shows excellent results in animal studies

Narrowing Narrowing Narrowing

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STARgraft conventional ePTFE graft

6-month angiograms (sheep)

Synthetic Grafts that Perform Like Natural Vessels

Consistently superior patency in multiple sheep studies

% of diameter occluded

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Pooled results show 80% reduction in occlusion

Control

(Conventional Graft)

STARgraft

(coated with STAR)

Nearly Occluded Wide Open Wide Open

Intravascular ultrasound

at 6 months

Synthetic Grafts that Perform Like Natural Vessels

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Infection Resistance

Synthetic Grafts that Perform Like Natural Vessels

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100 µm wrinkles in dense fibrotic capsule

Example of a leading AV graft that is heavily colonized with bacteria near suture line blue clusters = Staph aureus

Bacteria preferentially colonize ePTFE devices, but STARgraft remains virtually biofilm-free Bacteria concentration

LOG scale (𝜈m2/mm2)

STARgraft prevents biofilm in sheep model

Sheep at 2 months post-implant

ePTFE

minimal fibrotic capsule Only isolated bacteria, no biofilm clusters

STARgraft

conventional ePTFE graft STARgraft STAR

1000x reduction

STARgraft is an investigational device not available for commercial sale. Presented at 2018 VEITH Symposium (www.veithsymposium.org)

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11/17/2018 3

Synthetic Grafts that Perform Like Natural Vessels

STAR-coated port (day 21) Control port (day 15)

Untreated controls became infected in nearly all cases. STAR-coated ports were infection-free after 30 days in nearly all cases.

STAR biomaterial resists infection even in far more demanding conditions

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Representative photos (pig)

Percutaneous port being developed for dialysis access

Synthetic Grafts that Perform Like Natural Vessels

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Days post-implant

(pigs)

% Survival STAR-coated port Uncoated control STAR biomaterial resists infection even in far more demanding conditions

Percutaneous port being developed for dialysis access N = 48 N = 16

Synthetic Grafts that Perform Like Natural Vessels All 4 controls were infected & removed within 3 weeks

STAR-coated ports At 6 weeks, all STAR-coated ports were infection-free & cleanly healed

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Representative of all 4 pigs in the study

STAR biomaterial resists infection even in far more demanding conditions

Synthetic Grafts that Perform Like Natural Vessels

Value of STARgraft AV graft

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Expected to reduce cost, illness & death among dialysis patients

  • As replacement for conventional graft:
  • Less frequent interventions
  • Less frequent infections
  • As alternative to fistula:
  • Avoids extended use of infection-prone catheter

STATUS: first human trial begins Q1 ’19

Healionics contact: Mike Connolly, CEO mike@healionics.com 425-765-3199

STARgraft is an investigational device not available for commercial sale. Presented at 2018 VEITH Symposium (www.veithsymposium.org)