SAN DIEGO, Feb. 14, 2018 (GLOBE NEWSWIRE) — TearLab Corporation (OTCQB:TEAR) (TSX:TLB) (“TearLab” or the “Company”) today announced its plans to appeal a recent ruling from the Federal Court of Canada related to its single Canadian patent. TearLab initiated the lawsuit against I-Med Pharma and its i-Pen Osmolarity System in the Federal Court of Canada during February 2016. In the ruling published yesterday, the court found that the i-Pen did indeed infringe the TearLab patent; however, specific claims in the patent were deemed by the trial judge to be invalid. TearLab will appeal the finding of invalidity.
TearLab also reported that it has successfully passed the acceptance review phase with the U.S. Food and Drug Administration (FDA) for the clearance of its TearLab Discovery™ Platform, the Company’s next-generation in-vitro diagnostic testing system. The FDA will now progress to the substantive review of the filing. After securing FDA clearance, TearLab intends to pursue a CLIA waiver in an effort to prepare for commercialization in the US market. The Company has multiple additional patents beyond the single Canadian patent in the U.S. protecting the intellectual property around both osmolarity testing and the TearLab Discovery™ Platform. TearLab continues to prepare for the market introduction of the Discovery Platform, which the Company expects in the second half of 2018.
“Passing of the FDA acceptance review is an important milestone in the clearance process for the TearLab Discovery™ Platform. We are pleased to have progressed to the substantive review phase and look forward to advancing our development program,” said Seph Jensen, TearLab’s Chief Executive Officer.
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 appeal of the court ruling in Canada and the likelihood of success, the timing and ability to gain regulatory clearance of the TearLab Discovery™ Platform by the FDA, the timing and ability to gain a CLIA waiver for point-of-care testing, the timing of the market introduction of the TearLab Discovery™ System in the United States and our ability to successfully develop and commercialize the TearLab Discovery™ System. 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.
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