Nuvectra says FDA request for more information will delay Virtis approval

Nuvectra said last night in its earnings release, “We remain committed to the sacral neuromodulation (SNM) opportunity via the eventual FDA approval of Virtis, our SNM system for the treatment of chronic urinary retention and the symptoms of overactive bladder. As an update, the FDA has requested additional information as part of our PMA application. To satisfy their request, we will secure supplementary data on the biocompatibility of our Virtis leads and expect to submit this information around year end 2019. Accordingly, we project potential Virtis approval in the first half of 2020 and therefore no longer expect Virtis-related revenue in 2019.” Shares of Nuvectra are down 12% in premarket trading to $8.25.
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