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© Copyright 2016, LacriScience, LLC Slide
LacriScience
The LacriPen™ – A Handheld Portable Ophthalmic
Osmometer and Diagnostic Instrument
…a portable laboratory in the palm of your hand
Presented by:
Dr Chris D. Geddes, Ph.D., FRSC
Professor, University of Maryland (UMBC) for
LacriScience LLC, Paul T. Gavaris MD
Managing Member
© Copyright 2016, LacriScience, LLC Slide
LacriScience2
LacriPen™ - Point of Care Diagnostics: A Reality
Osmolality – Previously debuted Goal ± 2 mOsms/L – 1 sec
MMP-9 – Analytical readout 1 – 200 ng/ ml; ± 5 ng/ml
Developed Universal Platform MMP-9; Adenovirus; MRSA
Started Clinical Testing 2 Locations – IRB
Continued Bench Testing New data handling
Talk Overview and Update since OIS Chicago
© Copyright 2016, LacriScience, LLC Slide
LacriScience
Surface Plasmon Resonance
“Precision Engineering”
LacriPen™
From bench top…………… to the eye
Rapid Measurements < 1 sec
Disposable – one time use Sensor
3
© Copyright 2016, LacriScience, LLC Slide
LacriScience4
5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
6
280 300 320 340
950-855sol/950–
855air
Osmolarity, mOsms/L
Two Wavelength Ratiometric Measurements
Good Sensor Prism to Prism Reproducibility Improved Manufacturing Processes
Excellent Linear Pen Responses Salt Solutions, Contrived Tears
Pen to Pen Reproducibility Developing correction factors
We use a Wavelength Ratiometric approach
• Divide dual channel signals
• Corrects for Prism-to-Prism variations
• Corrects for LED intensity differences
• Corrects for manufacturing differences
© Copyright 2016, LacriScience, LLC Slide
LacriScience
MMP-9
Specifically detect MMP-9 from 1 – 200 ng/ml
Quantitation of MMP-9 – Monitor Treatment
Precision  5 ng/ml – No other device today
No Anesthesia; No Scraping of the Eyelid
5
Point of CareLacriPen™
5
0
20
40
60
80
100
120
0 200 400 600
SPRDeltaPixel
Shift
MMP-9 ng / ml
Representative Data from Testing
(855 channel)
0
5
10
15
20
25
0 5 10 15 20 25 30
SPRDeltaPixel
Shift
MMP-9 ng / ml
Enlarged Region
© Copyright 2016, LacriScience, LLC Slide
LacriScience
Unique Proprietary Scaffold –
Universal for other Affinity Interactions
Antibody (DNA or RNA)
Antigen of Interest
Unique Universal Scaffold – Reduced Cost / Development Time
Tunable Dynamic Sensing Range – Binding Site / Surface Capacity
Disposable Sensor Prism
Disposable Sensor Prism
Gold Film
CM-Dextran Coating
Antibody for analyte, MMP-9, MRSA etc
Surface Blocking,
NHS-ester coupling
6
© Copyright 2016, LacriScience, LLC Slide
LacriScience
LacriPen™ Diagnostics
Select Diagnostic Results
#1
#2
#3
#4
#5
For Future Diagnostics – Bluetooth input
MMP-9
Adenovirus
Tryptase
Gm-Neg Bact
MRSA
ng/ml
ng/ml
Pos/Neg
Pos/Neg
Pos/Neg
© Copyright 2016, LacriScience, LLC Slide
LacriScience8
Update on Clinical Testing
Dual Path – Osmolarity and Smart Diagnostics
IRB Approved in February 2017 for 15 patient study
Testing on April 19th 2017 Completed
Clinical Testing at Virginia Eye Consultants
© Copyright 2016, LacriScience, LLC Slide
LacriScience
The LacriPen™ is easy to Use and Rapid
Low Cost of Pen  $1500
Diagnostic Intelligent Sensors  $7  $9
Instantaneous 1 second Readout
9
© Copyright 2016, LacriScience, LLC Slide
LacriScience
Thank You
10
Changing the Way we Think
about and Use Ophthalmic Diagnostics Today
The Lacripen™

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Ophthalmology Innovation Showcase 1 - LacriScience

  • 1. © Copyright 2016, LacriScience, LLC Slide LacriScience The LacriPen™ – A Handheld Portable Ophthalmic Osmometer and Diagnostic Instrument …a portable laboratory in the palm of your hand Presented by: Dr Chris D. Geddes, Ph.D., FRSC Professor, University of Maryland (UMBC) for LacriScience LLC, Paul T. Gavaris MD Managing Member
  • 2. © Copyright 2016, LacriScience, LLC Slide LacriScience2 LacriPen™ - Point of Care Diagnostics: A Reality Osmolality – Previously debuted Goal ± 2 mOsms/L – 1 sec MMP-9 – Analytical readout 1 – 200 ng/ ml; ± 5 ng/ml Developed Universal Platform MMP-9; Adenovirus; MRSA Started Clinical Testing 2 Locations – IRB Continued Bench Testing New data handling Talk Overview and Update since OIS Chicago
  • 3. © Copyright 2016, LacriScience, LLC Slide LacriScience Surface Plasmon Resonance “Precision Engineering” LacriPen™ From bench top…………… to the eye Rapid Measurements < 1 sec Disposable – one time use Sensor 3
  • 4. © Copyright 2016, LacriScience, LLC Slide LacriScience4 5 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6 280 300 320 340 950-855sol/950– 855air Osmolarity, mOsms/L Two Wavelength Ratiometric Measurements Good Sensor Prism to Prism Reproducibility Improved Manufacturing Processes Excellent Linear Pen Responses Salt Solutions, Contrived Tears Pen to Pen Reproducibility Developing correction factors We use a Wavelength Ratiometric approach • Divide dual channel signals • Corrects for Prism-to-Prism variations • Corrects for LED intensity differences • Corrects for manufacturing differences
  • 5. © Copyright 2016, LacriScience, LLC Slide LacriScience MMP-9 Specifically detect MMP-9 from 1 – 200 ng/ml Quantitation of MMP-9 – Monitor Treatment Precision  5 ng/ml – No other device today No Anesthesia; No Scraping of the Eyelid 5 Point of CareLacriPen™ 5 0 20 40 60 80 100 120 0 200 400 600 SPRDeltaPixel Shift MMP-9 ng / ml Representative Data from Testing (855 channel) 0 5 10 15 20 25 0 5 10 15 20 25 30 SPRDeltaPixel Shift MMP-9 ng / ml Enlarged Region
  • 6. © Copyright 2016, LacriScience, LLC Slide LacriScience Unique Proprietary Scaffold – Universal for other Affinity Interactions Antibody (DNA or RNA) Antigen of Interest Unique Universal Scaffold – Reduced Cost / Development Time Tunable Dynamic Sensing Range – Binding Site / Surface Capacity Disposable Sensor Prism Disposable Sensor Prism Gold Film CM-Dextran Coating Antibody for analyte, MMP-9, MRSA etc Surface Blocking, NHS-ester coupling 6
  • 7. © Copyright 2016, LacriScience, LLC Slide LacriScience LacriPen™ Diagnostics Select Diagnostic Results #1 #2 #3 #4 #5 For Future Diagnostics – Bluetooth input MMP-9 Adenovirus Tryptase Gm-Neg Bact MRSA ng/ml ng/ml Pos/Neg Pos/Neg Pos/Neg
  • 8. © Copyright 2016, LacriScience, LLC Slide LacriScience8 Update on Clinical Testing Dual Path – Osmolarity and Smart Diagnostics IRB Approved in February 2017 for 15 patient study Testing on April 19th 2017 Completed Clinical Testing at Virginia Eye Consultants
  • 9. © Copyright 2016, LacriScience, LLC Slide LacriScience The LacriPen™ is easy to Use and Rapid Low Cost of Pen  $1500 Diagnostic Intelligent Sensors  $7  $9 Instantaneous 1 second Readout 9
  • 10. © Copyright 2016, LacriScience, LLC Slide LacriScience Thank You 10 Changing the Way we Think about and Use Ophthalmic Diagnostics Today The Lacripen™