Positive Data From the TearLab(TM) Osmolarity System 510K Submission Presented Today at the American Academy of Ophthalmology (A
11 Noviembre 2008 - 9:00AM
Marketwired
OccuLogix, Inc. (NASDAQ: OCCXD)(TSX: OC) announced that Dr. Richard
Lindstrom, MD, today presented data demonstrating clinical
performance, usability and safety data for the TearLab Osmolarity
System. The data is derived from the recent 510(k) filing to the US
Food and Drug Administration (the FDA) for clearance to market the
TearLab(TM) Osmolarity System and the TearLab(TM) Osmolarity Test
Card in the United States. Dr. Lindstrom is Adjunct Professor
Emeritus for the University of Minnesota Dept. of Ophthalmology and
is the Founder and Attending Surgeon at Minnesota Eye Consultants.
Dr. Lindstrom serves on the Board of Directors of Occulogix.
Clinical Validation
The objective of the 510(k) submission study was to validate the
performance of the TearLab(TM) Osmolarity System when performed in
physician office laboratories (POL) by health care professionals
using human tear fluid collected from 234 volunteer subjects in
three study sites.
Performance-Precision and Accuracy
The study demonstrated that the TearLab System was able to
measure the osmolarity of tears with the same accuracy as a
laboratory osmometer, with a correlation of 0.95%.
The TearLab which takes only seconds to perform, and is
noninvasive was also found to be precise, exceeding the industry
standards set by other point-of-care tests such as glucose and
cholesterol. These outstanding performance characteristics were
achieved while only using a fraction of the volumes typically
needed to perform diagnostic assays.
Usability
To assess ease of use, TearLab operators were allowed to only
read the operation manual, and with no additional training or
assistance were tasked to collect tears and performed the TearLab
osmolarity test on both eyes of 234 subjects. Operators collected
tears successfully 468 times out of 468 attempts. TearLab received
an average 4.8 of 5.0 agreement rating with statements that the
TearLab was easy to use.
Safety
Tear collection using the TearLab Osmolarity System was found to
be safe, as there were no reports of corneal or conjunctival trauma
over 234 subjects and 468 eyes. No discomfort due to tear
collection was reported 24 hours post-collection.
Following the data presentation Dr. Lindstrom remarked, "Quality
vision requires a healthy tear film. I am excited about the new
TearLab Osmolarity System, as I believe it will enhance my ability
to diagnose and manage ocular surface disease in the surgical
patient, improving their visual outcome , comfort and quality of
life."
Eric Donsky, CEO of OccuLogix also expressed his appreciation to
Gary Foulks, MD, Kelley Nichols, MD, FAAO and David Geffen, OD,
FAAO our clinical sites investigators for doing a tremendous job in
this trial.
The TearLab(TM) Osmolarity System
The TearLab(TM) Osmolarity System uses a novel lab-on-a-chip
approach that requires less than 50 nL (nanoliters) of tear fluid
in order to measure tear osmolarity. By using such a small amount
of tears, the TearLab(TM) Osmolarity System eliminates the
challenges that previously prevented point-of-care osmolarity
testing. The TearLab(TM) system can produce a sample-to-answer
result in less than 30 seconds and is simple enough to be operated
by a technician.
About OccuLogix, Inc.
OccuLogix (www.occulogix.com) is a healthcare company focused on
ophthalmic devices for the diagnosis and treatment of age-related
eye diseases. Its wholly-owned subsidiary, OcuSense, Inc.
(www.ocusense.com), is an in-vitro diagnostics company developing
and commercializing novel, laboratory-on-a chip technologies that
enable eye care practitioners to test for highly sensitive and
specific biomarkers in tears at the point-of-care.
Forward-Looking Statements
This press release may contain forward-looking statements. These
statements relate to future events and are subject to risks,
uncertainties and assumptions about the Company. These statements
are only predictions based on our current expectations and
projections about future events. You should not place undue
reliance on these statements. Actual events or results may differ
materially. Many factors may cause our actual results to differ
materially from any forward-looking statement, including the
factors detailed in our filings with the Securities and Exchange
Commission and Canadian securities regulatory authorities,
including but not limited to our Forms 10-K and 10-Q. We do not
undertake to update any forward-looking statements.
1. Tomlinson A, Khanal S, Ramaesh K, Diaper C, McFadyen A. Tear
film osmolarity: determination of a referent for dry eye diagnosis.
Invest Ophthalmol Vis Sci 47:4309-15, 2006.
Contacts: Investor Relations: Eric Donsky (858) 794-1400 Email:
edonsky@tearlab.com All other inquiries: Tracy Puckett (678)
566-3829 Email: tpuckett@tearlab.com
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