TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears.
The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence.
The company reported today that the predicate system measures the biomarker MMP-9 qualitatively, while TearLab’s test measures MMP-9 quantitatively. The FDA is looking for more data to establish correlation between the predicate and TearLab’s sytem, the company said.
“The FDA’s feedback to our submission for the TearLab Discovery Platform was very helpful in establishing the steps needed to demonstrate substantial equivalence through the 510(k) process,” CEO Seph Jensen said in prepared remarks. “We believe we can address the comments raised in the FDA’s letter and plan to submit our response within the allowed 180 day timeframe. We remain on track to have a clearance decision sometime in the second half of 2018.”
At the end of last year, TearLab announced it would implement a new business model to help the company keep its established customer base and reduce its cash burn rate.
TearLab did not report exactly how many employees it will let go as part of its restructuring effort, but said it plans to “reduce headcount across its commercial, administrative and technical functions.”The company expects to incur a charge of $200,000 – $250,000 related to employee severance costs.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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