The technology to conquer glaucoma Chris Pulling CEO cpulling

Transcription

The technology to conquer glaucoma Chris Pulling CEO cpulling
The technology to conquer glaucoma
Chris Pulling
CEO
[email protected]
BG Implant Overview
 Novel nanotechnology implant that shunts aqueous directly to the
tear film without risk of internal infection
 >$1MM already invested by principals; >$3.4MM total
 Just closing $2.2MM series B
 Funding through 10 patient US feasibility trial
 Successful prototype development with foundational bench and
animal data
 Proven, expert and hands-on leadership team
 Clear and achievable regulatory AND reimbursement path
Glaucoma
 Common : 105 million WW, doubling in 20 years
 Devastating : second leading cause of blindness
in the world (cataracts)
 Leading cause of irreversible blindness
 polls show shorter life preferred over
blindness
 Unmet Need : no treatment universally accepted
as safe and effective; WHO has dropped
glaucoma screening
The Brown Glaucoma Implant
 Shunts directly to the tear film



No bleb
Not shunting to enclosed space within eye; scarring/plugging is not a failure mode
No episcleral venous pressure component => resorption, nocturnal supine IOP
increase
 Has a filter providing precise flow control (P=RxF)


Filter is the only source of resistance to AH outflow
Engineered to achieve 8-12mmHg IOP
 Surface biocompatibility good; hydration shell in inner lumen resists
attachments of proteins, cells, and bacteria
 Bulk biocompatibility good. Rigidity match with sclera + surface
biointegration = no micromotion
 Three issued patents; two provisionals filed
Current Technology
BG Implant
Dime
Dime
Collagen Type 1
Structural Polymer
Polyethylene Glycol (low MW)
Polyethylene Glycol (high MW)
(PEG)
AH Outflow
Polyethylene Glycol (high MW)
Polyethylene Glycol (low MW)
Filter
Structural Polymer
Collagen Type 1
P=FxR
Nanofabrication / micromachining
Lumen’s PEG surface:
Very hydrophilic
Selfpriming
(bacterial broth)
Pressure in 2-Week Flow Test
Pressure Drop (mmHg)
50
Flow rate: 2.5 ml/min (physiological)
40
30
20
10
0
0
48
96
144 192
Time (hour)
240
288
336
Complete Bacterial Exclusion after 2-weeks
Bacterial Broth
Outlet
Inlet Flow
No bacteria were found
inside the device
Initial Animal Safety Testing
 Easily implantable
 Tolerated well
 Securely scarred into place
 No infection, with no PMNs or bacteria seen
within or around the device
 Constant AH bathing of cornea not irritant
 OSD, dry eye
MicroOptx Summary
 Shunts AH directly to the tear film: no bleb; no EVP
component to raise nocturnal IOP
 Hits Threshold IOP, and no hypotony
 Inner lumen PEG: resists bacterial, protein, and cell
adherence
 Biointegrates with sclera, so no tunnel infection risk
 In human trials in 9-12 months
Ending the worlds leading cause of blindness

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