OccuLogix Submits 510(k) Premarket Notification for the Tearlab(TM) Osmolarity System
29 10월 2008 - 9:00PM
Marketwired
OccuLogix, Inc. (NASDAQ: OCCXD)(TSX: OC) announced today that its
subsidiary, OcuSense, Inc., has submitted its 510(k) premarket
notification 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.
As previously disclosed, the TearLab(TM) system recently
obtained CE Marking and is currently being sold and marketed in
five European countries through exclusive distributor agreements.
In the United States, prior to 510(k) clearance from the FDA, the
system is available for research use only.
Clinical Validation
The regulatory application included a study that validated 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 volunteer subjects. The study
looked at:
- Usability
- Safety
- Clinical performance
The study involved three sites and enrolled 234 patients. The
Company expects to release top-line data from the study at the
American Academy of Ophthalmology (AAO) and European Society of
Ophthalmology (SOE) 2008 Joint Meeting in November.
"We are pleased to reach this significant milestone," commented
Eric Donsky, CEO of OccuLogix. He further remarked, "We are looking
forward to the FDA review of our submission and the opportunity to
provide eye care practitioners with the ability to use quantitative
physiological data at the point of care with the TearLab(TM)
Osmolarity System".
Benjamin Sullivan Ph.D., Chief Scientific Officer of OccuLogix,
commented, "The TearLab(TM) system has been shown to eliminate the
effects of evaporation and sample transfers on nanoliter osmolarity
measurements. The TearLab(TM) system allows lab technicians to
obtain the quantitative measurement of tear osmolarity, and the
speed of the test lets it integrate seamlessly into the clinical
workflow."
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: OccuLogix, Inc. Eric Donsky Investor Relations (858)
794-1400 Email: edonsky@tearlab.com Website: www.occulogix.com All
other inquiries: Tracy Puckett (678) 566-3829 Email:
tpuckett@tearlab.com
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