TearLab Corporation Osmolarity System CLIA Waiver Issued by FDA
Elias Vamvakas, TearLab's Chief Executive Officer, commented, "We believe that, with CLIA Waiver and Medicare reimbursement in place, and with the updated American Academy of Ophthalmology's Preferred Practice Pattern guidelines listing tear osmolarity as a more sensitive method to diagnose Dry Eye Disease, the TearLab Osmolarity test is now well on its way toward being established as a standard of care."
About The TearLab Osmolarity System
The TearLab 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. The TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing and can produce a sample-to-answer result in less than 30 seconds.
About Dry Eye Disease (DED)
DED is a common condition in which the eye does not produce enough tears to keep the surface of the eye sufficiently lubricated. It affects approximately 40 million people in the U.S. and 100 million people worldwide.
About TearLab Corporation
TearLab Corporation (www.tearlab.com) develops and markets lab-on-a-chip technologies that enable eye care practitioners to improve standard of care by objectively and quantitatively testing for disease markers in tears at the point-of-care. The TearLab Osmolarity Test, for diagnosing Dry Eye Disease, is the first assay developed for the award-winning TearLab Osmolarity System. Headquartered in San Diego, CA, TearLab Corporation's common shares trade on the NASDAQ Capital Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB'.
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. For example, any statement regarding changes in the standard of care for the treatment of Dry Eye Disease is a forward-looking statement. 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.
Contact:
InvestorsStephen Kilmer905.906.6908skilmer@tearlab.com MediaLeonard Zehr, Managing DirectorKilmer Lucas Inc.(905) 690-2400 Ext. 41len@kilmerlucas.com