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The LacriPen™ – A Handheld
Portable Ophthalmic Osmometer
and Diagnostic Instrument
…a portable laboratory in the palm of your hand
Presented by:
© Copyright 2015, LacriScience, LLP
Dr Chris D. Geddes, Ph.D., FRSC
Professor, University of Maryland for
LacriScience LLC, Paul T. Gavaris MD
Managing
Member
Slide
LacriScience
Tear Osmolarity and Dry Eye
Tomlinson, et. al.2 - 2006
Metadata analysis of peer reviewed
measurements for tear samples
from normal eyes and subtypes of
dry eyes.
Established an osmolarity
threshold of 316 mOsm for dry eye
diagnosis.
Osmolarity
All Studies 1978-2005
1.
Normal Eyes
Mean = 302.2 mOsm
S.D. = 9.7 mOsm
Probability
Farris1 - 1994
Suggested that tear osmolarity
measurement offers a possible
gold standard for the diagnosis of
dry eye disease.
Dry Eyes
Mean = 326.9 mOsm
S.D. = 22.1 mOsm
315.6 mOsm
0.
260. 280. 300. 320. 340. 360. 380. 400.
Osmolarity
1) Farris RL. “Tear osmolarity: a new gold standard?” AEMB. 1994;506: 495–503.
2) Tomlinson A, Khanal S, Ramaesh K, Diaper C, and McFadyen A. “Tear Film Osmolarity: Determination of a Referent for Dry Eye
Diagnosis”, Investigative Ophthalmology & Visual Science, October 2006, Vol. 47, No. 10
© Copyright 2015, LacriScience, LLP
Slide 2
LacriScience
Surface Plasmon Resonance:
How it Works
Gold Film
Sensing
Surface
SPR “Line”
SPR
Prism
SPR Angle
(pixels)
Image Sensor
Typical SPR Image
Light Source
The Surface Plasmon Resonance Technique
for Tear Osmolarity Measurement
and more !
© Copyright 2015, LacriScience, LLP
Relative
Response
Tear
Fluid
Slide3
The location of the central minima of the SPR
curve is proportional to the refractive index of the
tear fluid in contact with the gold sensing surface.
LacriScience
Air Lines at 855 nm and 950 nm
The LacriPen™ allows for multiple Analytes to be detected
© Copyright 2015, LacriScience, LLP
Slide
LacriScience
Chassis Assembly with Cap
© Copyright 2015, LacriScience, LLP
Slide4
LacriScience
Advanced Optics
Extremely High Precision and Accuracy
Optical Chassis
Cylinder lens
Collimating lens
855 & 950 nm LEDs
SPR Cap
Ximea Imager
Optical wedge
Actual Pen with Optics
Our Advanced Data Analysis allows the detection of Tear Osmolarity and other
Ophthalmic Markers with incredible speed, accuracy and precision.
© Copyright 2015, LacriScience, LLP
Slide 6
LacriScience
Disposable Cap
One Cap per Eye
Self Calibrating: LacriPen™ Self Calibrates when Turned On
© Copyright 2015, LacriScience, LLP
Slide 7
LacriScience
Intelligent Sensors on the Tip of your Pen
“Smart Sensor” Selection
•
•
•
•
•
•
•
•
Osmolarity Parameter
Specification
Osmolarity range
260 to 400 mOsm
Tear Osmolarity
MMP-9
Osmolarity resolution
Adenovirus
Herpes Zoster
MMP-9 Range
Herpes Simplex
MMP-9 resolution
Lactoferrin
Tryptase
Sensors
MRSA
< 2.0 mOsm
1 – 100 ng/ml
≈ 5 ng/ml
Single use
disposable
Simply Change the Cap to a different Smart Sensor, The LacriPen™ does the Rest.
© Copyright 2015, LacriScience, LLP
Slide8
LacriScience
LacriScience’s Intellectual Property
A very strong and expanding position
U.S. Patents
• USA 7,395,103 - July 2008
- Surface Plasmon Resonance Based
Nanoliter Tear Osmometer
• USA 8,249,682 - August 2012
- Device for Measuring Concentrations
of Constituents of Tear Sample
• Counterparts of these patents are
pending in the EU, Canada, Australia,
Japan, India, South Korea
• USA – March 2015
- Advanced Pen & Cap Design and Tear
Analytics – World wide.
© Copyright 2015, LacriScience, LLP
Slide9
LacriScience
Business Plan
Potential Markets:
Dry Eye:
Humans:
Veterinary:
Diagnostics:
Ophthalmology
General & Veterinary Medicine
U.S.
30 million
15 million pets have dry eye
3 million
10 million
Product Costs
Product Sales
The LacriPen™
$400
$1400 per pen
Osmolarity
Sensor
$1.00
$6.00 per eye
Diagnostic
Sensor
$1.50
$7.50 per test
© Copyright 2015, LacriScience,
The LLP
LacriPen™
Slidein Ophthalmic Point-of-Care
- A Paradigm Shift
LacriScience
LacriPen™ Timeline
June 2015 - Complete development of updated sensor design (simpler
and less expensive).
August 2015 - Complete laboratory and clinical trials.
November 2015 - Submit for 510K with present market predicate
December 2015 - Complete development of pre-manufacturing
schedule
The most advanced and portable ophthalmic diagnostic in the world today
© Copyright 2015, LacriScience, LLP
Slide 12
LacriScience
Thank you
The Lacripen™
Changing the Way we Think
about and Use Ophthalmic Diagnostics
Today
LacriScience
© Copyright 2015, LacriScience, LLP
Slide