FDA rejects BTG's Elevair endobronchial coil system 

BTG announced on Thursday that the FDA issued a not-approvable letter regarding its marketing application for the Elevair endobronchial coil system to treat patients with severe emphysema. BTG said it is "reviewing options and will provide an update in due course."

The company noted that its PneumRx subsidiary, which it acquired in 2014, received confirmation from the agency that it will not be granted pre-market approval for the device. In June, BTG said an FDA advisory panel voted against approval of Elevair, causing the device maker's shares to fall as much as 10 percent.

Commenting on the latest news, analysts at Peel Hunt suggested that investors had likely already written off Elevair for the US market on account of the FDA advisory panel vote. "As such, this news will have little impact on estimates or valuation, but might be a small incremental negative for sentiment as it reinforces the difficulty BTG is experiencing in its attempt to pivot the group to interventional medicine amid the decline of its other two more legacy divisions," the analysts said.

In April, BTG stated that it was taking an impairment charge of 150 million pounds ($199 million) on the fair value of its PneumRx coils, adding that it "[did] not expect material revenues from this product over the next two years."

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