SAN DIEGO, Feb. 13, 2017 (GLOBE NEWSWIRE) -- TearLab Corporation (NASDAQ:TEAR) (TSX:TLB) (the “Company”) announced today the achievement of several recent milestones in the global commercialization of the TearLab Osmolarity System, which provides an objective assessment to aid in the diagnosis and management of patients with dry eye disease.
Key Milestones
- Approval in the Republic of Korea by the Ministry of Health and Welfare
- Regulatory filing for approval in the Federative Republic of Brazil
- Commercial launch in the Republic of India
The TearLab Osmolarity System was approved by the Ministry of Health and Welfare in the Republic of Korea as part of its New Medical Technology evaluation process. This approval allows Korean eye care professionals to begin offering this innovative test to their patients and enables TearLab to apply for public reimbursement of the osmolarity test. With a population of over 50 million, Korea represents a new and significant developed market opportunity for the TearLab Osmolarity System. The Company plans to begin commercialization with the new approval in the first quarter of 2017 with its commercial partner, Wooree Technologies, who has an established presence in the Korean eye care market.
The Company also submitted its application to the Agência Nacional de Vigilância Sanitária (ANVISA) for regulatory approval for the TearLab Osmolarity System in the Federative Republic of Brazil. If approved by Brazilian regulatory authorities, the TearLab Osmolarity System can be commercialized in the largest market in Latin America with a population of over 200 million. Based on average review times for similar classes of medical devices in Brazil, an approval is anticipated in the fourth quarter of 2017.
Finally, the Company announced the commercial launch of the TearLab Osmolarity System in India with its commercial partner, My HealthSkape PVT Ltd. Established in 1996, My HealthSkape is one of the largest distributors of ophthalmic equipment in India, supplying products to a broad range of hospitals and government organizations, with a particularly strong presence in the refractive surgery market. The Company and My HealthSkape plan to exhibit to eye care professionals at the All India Ophthalmological Society meeting in mid-February 2017.
Seph Jensen, CEO of TearLab Corporation said, "We are pleased to complete these major milestones for TearLab’s international business as we continue to increase our global footprint in key strategic markets. Due to their size and growing dry eye populations, these three markets represent significant opportunity for us to expand our business and continue toward our goal of making osmolarity testing a global standard of care in diagnosing dry eye disease.”
The TearLab Osmolarity System is approved in more than 40 countries globally. To date, TearLab has placed over 5,000 osmolarity testing devices worldwide, with more than 7 million tests performed globally since the first 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 whether we will receive reimbursement approval in Korea, whether we will receive approval of the TearLab Osmolarity System in Brazil as well as the timing of receiving such approval, the market for dry eye patients in Korea, Brazil and India, the potential success in commercializing the TearLab Osmolarity System in these markets, the future relationships with our commercial partners and the potential interest in the TearLab Osmolarity System in these three markets by eye care professionals and patients. 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.