TearLab Corp fka TEAR

[CatCat]

"Received feedback from the U.S. Food and Drug Administration (FDA) on the 510(k) submission for Tearlab Discovery™ Platform; plans to submit response in Q3"


https://finance.yahoo.com/news/tearlab-corporation-reports-first-quarter-200100857.html?.tsrc=rss&guccounter=1

"First Quarter and Recent Highlights

First quarter revenue of $6.4 million

Income from operations of $0.2 million, compared to operating loss of $3.4 million in first quarter 2017

Expanded the U.S. active device base to 4,713 TearLab Osmolarity Systems

Received feedback from the U.S. Food and Drug Administration (FDA) on the 510(k) submission for Tearlab Discovery™ Platform; plans to submit response in Q3

Launched the TearLab Osmolarity System at the 2018 Simpósio Internacional Moacyr Álvaro (SIMASP) Annual Meeting in Brazil in collaboration with Brazilian commercial partner, Adapt Produtos Oftalmológicos

Amended loan agreement with CRG to defer the cash interest payments for each quarter in fiscal year 2018 and reduce the minimum liquidity requirement from $5.0 million to $3.0 million.

Entered into Restated License Agreement with UCSD to reduce royalty from 5.5% to 3%, retroactive to July 1, 2017

Cash position of $7.4 million as of March 31, 2018"

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"2018 is an important year for TearLab, as we work to achieve FDA clearance for the TearLab Discovery™ System in the U.S. and execute against our new business model,” said Seph Jensen, TearLab’s Chief Executive Officer. “In the first quarter of 2018, we grew our customer base while significantly reducing operating expenses, which demonstrates the health of our core business. In addition, we launched our Osmolarity System in Brazil, Latin America’s largest dry eye market, at the 2018 SIMASP Annual Meeting with the support of our commercial partner in Brazil, Adapt. Overall it was a very positive quarter and we believe our results demonstrate the growing awareness and importance of advanced diagnostics for ocular surface disease.”