8.12.19 Mike Connolly, CEO [email protected] Improved Devices for Dialysis Access STARgraft STARport
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8.12.19
Key developments since 2018 IDEAS conference
• STARgraft Occlusion-Resistant AV graft – Has begun first human trial
• STARport Needle-free Dialysis port – Awarded $3M NIH grant to support development
2
3
AV graft
After implant, a conventional graft stiffens due to scar tissue that forms
around its outer wall
This produces unfavorable flow shear stresses at lumen wall, which stimulate Neointimal Hyperplasia (NIH)
Vein
4
Vein
STARgraft
More favorable flow shear stresses at lumen wall minimize NIH, keeping graft open to blood flow
Biointegrating outer surface reduces scar tissue, keeping graft wall flexible
External STAR coating prevents internal stenosis
5
Cross-sectional view of STARgraft structure • Unique geometric structure prevents both scarring & infection
o Open-pore 3D scaffold with tightly-controlled dimensions o Made of medical-grade silicone (used in many commercial implants)
mm
7
STAR-coated wall moves with pulsating flow like a natural blood vessel
STARgraft maintains wall flexibility & motion
Control STARgraft
Ultrasound catheter
Graft wall
Narrowing
Narrowing
Narrowing
Narrowing
8
Synthetic Grafts that Perform Like Natural Vessels
In pooled results of multiple sheep studies STARgraft shows 80% reduction in stenosis
% of diameter occluded
10
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 concentration LOG scale (m2/mm2)
STARgraft resists infection
ePTFE
STARgraft
Value of STARgraft AV graft
11
Reduced cost, illness & death among dialysis patients:
• As replacement for conventional graft: o Resists primary cause of failure (venous-end stenosis),
resulting in less frequent interventions o Reduced infections
• As alternative to fistula: o Allows patient to avoid infection risk associated with
extended use of catheter during fistula maturation
Synthetic Grafts that Perform Like Natural Vessels
Status of STARgraft
First human study began April 2019 ClinicalTrials.gov NCT03916731
• Randomized controlled trial of 50 patients: – 25 STARgraft, 25 control – Control is a market-leading ePTFE graft
• Primary endpoint: – Primary unassisted patency at 6 months
• Trial Status: – Enrollment 66% complete – Periodic follow-ups to track performance trends
• 12 months total study period 12
Synthetic Grafts that Perform Like Natural Vessels
13
Synthetic Grafts that Perform Like Natural Vessels
STARport functional prototypes tested in vivo
14
Synthetic Grafts that Perform Like Natural Vessels
STARport solves problems suffered by earlier ports
• Two dialysis ports marketed in 1980s were popular, but discontinued due to problems with infection & occlusion
• STARport solves both problems: o Port is coated with infection-resistant STAR material o Connects to blood vessels via occlusion-resistant STARgraft
15
Angiogram of STARport at 90 days in sheep
16
17
Days post-implant (pigs)
18
All 4 controls were infected & removed within 3 weeks
STAR-coated ports
Representative of the 4 pigs studied
Synthetic Grafts that Perform Like Natural Vessels
Value of STARport dialysis port
Eliminating the use of needles would:
• Reduce: o Pain o Morbidity (hematoma, infection, etc.) o Staff time (needle insertion, post-removal hemostasis) o Cost (morbidity + staff time & training)
• Facilitate home-based dialysis
• Provide an optimal means of continuous access for a future wearable artificial kidney (WAK)
Recently awarded $3M NIH grant to fund design refinement, additional preclinical testing, and regulatory preparation
19
Slide Number 14
Slide Number 15
Slide Number 16
Slide Number 17
Slide Number 18
Slide Number 19
Key developments since 2018 IDEAS conference
• STARgraft Occlusion-Resistant AV graft – Has begun first human trial
• STARport Needle-free Dialysis port – Awarded $3M NIH grant to support development
2
3
AV graft
After implant, a conventional graft stiffens due to scar tissue that forms
around its outer wall
This produces unfavorable flow shear stresses at lumen wall, which stimulate Neointimal Hyperplasia (NIH)
Vein
4
Vein
STARgraft
More favorable flow shear stresses at lumen wall minimize NIH, keeping graft open to blood flow
Biointegrating outer surface reduces scar tissue, keeping graft wall flexible
External STAR coating prevents internal stenosis
5
Cross-sectional view of STARgraft structure • Unique geometric structure prevents both scarring & infection
o Open-pore 3D scaffold with tightly-controlled dimensions o Made of medical-grade silicone (used in many commercial implants)
mm
7
STAR-coated wall moves with pulsating flow like a natural blood vessel
STARgraft maintains wall flexibility & motion
Control STARgraft
Ultrasound catheter
Graft wall
Narrowing
Narrowing
Narrowing
Narrowing
8
Synthetic Grafts that Perform Like Natural Vessels
In pooled results of multiple sheep studies STARgraft shows 80% reduction in stenosis
% of diameter occluded
10
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 concentration LOG scale (m2/mm2)
STARgraft resists infection
ePTFE
STARgraft
Value of STARgraft AV graft
11
Reduced cost, illness & death among dialysis patients:
• As replacement for conventional graft: o Resists primary cause of failure (venous-end stenosis),
resulting in less frequent interventions o Reduced infections
• As alternative to fistula: o Allows patient to avoid infection risk associated with
extended use of catheter during fistula maturation
Synthetic Grafts that Perform Like Natural Vessels
Status of STARgraft
First human study began April 2019 ClinicalTrials.gov NCT03916731
• Randomized controlled trial of 50 patients: – 25 STARgraft, 25 control – Control is a market-leading ePTFE graft
• Primary endpoint: – Primary unassisted patency at 6 months
• Trial Status: – Enrollment 66% complete – Periodic follow-ups to track performance trends
• 12 months total study period 12
Synthetic Grafts that Perform Like Natural Vessels
13
Synthetic Grafts that Perform Like Natural Vessels
STARport functional prototypes tested in vivo
14
Synthetic Grafts that Perform Like Natural Vessels
STARport solves problems suffered by earlier ports
• Two dialysis ports marketed in 1980s were popular, but discontinued due to problems with infection & occlusion
• STARport solves both problems: o Port is coated with infection-resistant STAR material o Connects to blood vessels via occlusion-resistant STARgraft
15
Angiogram of STARport at 90 days in sheep
16
17
Days post-implant (pigs)
18
All 4 controls were infected & removed within 3 weeks
STAR-coated ports
Representative of the 4 pigs studied
Synthetic Grafts that Perform Like Natural Vessels
Value of STARport dialysis port
Eliminating the use of needles would:
• Reduce: o Pain o Morbidity (hematoma, infection, etc.) o Staff time (needle insertion, post-removal hemostasis) o Cost (morbidity + staff time & training)
• Facilitate home-based dialysis
• Provide an optimal means of continuous access for a future wearable artificial kidney (WAK)
Recently awarded $3M NIH grant to fund design refinement, additional preclinical testing, and regulatory preparation
19
Slide Number 14
Slide Number 15
Slide Number 16
Slide Number 17
Slide Number 18
Slide Number 19
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