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SAN DIEGO, Jan. 25, 2017 -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) announced today that it has received approval for the TearLab Osmolarity System from the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) in Mexico. This approval allows TearLab to begin selling the product to aid in the diagnosis of Dry Eye Disease (DED) in Mexico.
The TearLab Osmolarity System, which provides an objective assessment to diagnose and manage patients with DED by measuring the osmolarity of human tears, is expected to launch in the Mexican market in the first half of 2017. The Company has signed an exclusive distribution agreement with Cyan Medica, a prominent sales, marketing and distribution organization offering extensive knowledge, experience, relationships and proven success across the ophthalmic market in Mexico.
Seph Jensen, CEO for TearLab Corporation said, "The COFEPRIS approval is a significant regulatory milestone for our Company as it further expands our global footprint, and gives us entry into one of the largest markets in which TearLab did not yet have a presence. We believe that there is a significant unmet need in the Mexican market for a reliable, objective tool to aid in the diagnosis of DED, which is supported by the interest in the approval of the TearLab Osmolarity System among the country’s eye care professionals.”
DED is a highly prevalent condition in Latin America with an estimated 26 million people suffering from the disease. As the second largest country in Latin America, Mexico represents a significant global market for DED diagnostics and treatments.
To date, TearLab has placed over 5,000 devices worldwide, with more than 6 million tests performed globally since the commercial launch of the TearLab Osmolarity System in 2012.
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. 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 contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others, statements concerning the market for dry eye patients, the potential success in commercializing the TearLab Osmolarity System in Mexico by our commercial partner, the future relationships with commercial partners in Mexico and the potential interest in the TearLab Osmolarity System in Mexico by eye care professionals. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are based on management’s current, preliminary expectations and are subject to various risks and uncertainties. Many factors, risks and uncertainties may cause our actual results to differ materially from forward-looking statements, including the factors, risks, and uncertainties detailed in our filings with the Securities and Exchange Commission and Canadian securities regulatory authorities, including but not limited to our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the SEC on March 9, 2016, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed with the SEC on November 9, 2016. We do not undertake to update any forward-looking statements except as required by law.
Investor Contact: The Ruth Group Lee Roth Tel: 646-536-7012 [email protected]
