SAN DIEGO, Jan. 04, 2018 (GLOBE NEWSWIRE) -- TearLab Corporation (OTCQB:TEAR) (TSX:TLB) (“TearLab” or the “Company”) today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the potential clearance of its TearLab Discovery™ Platform, the Company’s next-generation in-vitro diagnostic testing system. The submission covers the TearLab Discovery™ Platform and a test card measuring the inflammatory biomarker, MMP-9. TearLab Discovery™ will also be capable of performing the Company’s current FDA cleared tear osmolarity test.
TearLab Discovery™ MMP-9 has an FDA-cleared predicate, which the Company believes will have a positive impact on the review period of its application. Additionally, both MMP-9 and the current tear osmolarity test have existing quantitative reimbursement codes in the U.S., which the Company believes will provide immediate reimbursement upon a potential commercial launch.
“The FDA submission for the TearLab Discovery™ Platform is a significant milestone for the Company, and we are pleased to have finished the filing process. We are optimistic about the completeness of the package we submitted, and we look forward to engaging with the agency during the review process,” said Seph Jensen, TearLab’s Chief Executive Officer. “Discovery has garnered significant positive feedback from members of the eye care community since its introduction at the European Society of Cataract and Refractive Surgeons Annual Meeting in October 2017, and we continue to believe in the platform’s potential to address a significant unmet need for effective, objective tools to diagnose ophthalmic conditions.”
The Company previously announced a new business model that will focus its commercialization efforts on supporting existing customers, concentrating resources on completing the development of its TearLab Discovery™ Platform and reducing its cash burn. Consistent with these priorities, the Company plans to file for Waiver categorization with the FDA under the Clinical Laboratory and Improvement Amendments (CLIA) after it receives FDA 510(k) clearance for the TearLab Discovery™ Platform to allow the test to be performed at the point-of-care. Both the MMP-9 predicate device and the current TearLab osmolarity test have existing CLIA Waivers to allow point-of-care testing. In the interim, the Company will continue to build the clinical data package for the commercial launch of the TearLab Discovery™ Platform which it expects after securing both the FDA clearance and the CLIA waiver.
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 OTCQB Market under the symbol 'TEAR' and on the Toronto Stock Exchange under the symbol 'TLB'.
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 timing and ability to gain regulatory clearance of the TearLab Discovery™ Platform by the FDA and the timing an ability to gain a CLIA waiver for point-of-care testing, potential reimbursement rates for the Discovery™ Platform test in the U.S. including the market perception and acceptance of reimbursement levels, as well as the market perception, acceptance and our ability to successfully develop and commercialize the TearLab Discovery™ System and the TearLab Osmolarity System and the ability to reduce our cash burn. 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 Reports on Form 10-Q for the quarter ended September 30, 2017, filed with the SEC on November 13, 2017. We do not undertake to update any forward-looking statements except as required by law.
The Ruth Group