SAN DIEGO, May 12, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) announced today that it has received approval for the TearLab Osmolarity System from the Agência Nacional de Vigilância Sanitária (ANVISA) in the Federative Republic of Brazil. This approval allows TearLab to begin selling the product to aid in the diagnosis of Dry Eye Disease (DED) in the Brazilian market, the largest in Latin America.
The TearLab Osmolarity System, which provides an objective assessment to aid in the diagnosis and management of patients with DED by measuring the osmolarity of human tears, is expected to launch in the Brazilian market in the third quarter of 2017. The Company is currently working to finalize its distribution and launch plans in Brazil.
Seph Jensen, CEO for TearLab Corporation said, "The ANVISA approval is a significant regulatory milestone for our Company as it further expands our global footprint, and gives us entry into Latin America’s largest market and one of the largest markets in which we did not have a presence. We are pleased that this approval was received well ahead of the anticipated fourth quarter 2017 timeframe and believe there is unmet need in the Brazilian market for a reliable, objective tool to aid in the diagnosis of DED among the country’s eye care professionals. We look forward to now accelerating our plans for a robust launch.”
DED is a highly prevalent condition in Latin America with an estimated 26 million people suffering from the disease. As the largest country in Latin America, Brazil represents a significant global market for DED diagnostics and treatments.
To date, TearLab has placed over 5,500 devices worldwide, with more than 8 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 in Brazil, the potential success in developing and commercializing the next generation testing system and the TearLab Osmolarity System in Brazil, the acceptance of the TearLab Osmolarity system by eye care professionals in Brazil and the ability to secure an appropriate distribution partner in Brazil. 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, 2016, filed with the SEC on March 10, 2017, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which TearLab expects to file with the SEC on May 15, 2017. We do not undertake to update any forward-looking statements except as required by law.