Nuvectra, which spun out of Greatbatch in 2016, saw shares fall nearly 25% after it updated on its applications for FDA and CE Mark clearance in the European Union for its Virtis sacral neuromod device, saying it has been asked to submit additional information and clinical study data to the regulatory bodies.
The Plano, Texas-based company said that the FDA requested additional information as part of a review of its premarket approval application submitted in April. The federal watchdog is requesting supplemental info related to modifications or changes to the device, labeling and manufacturing data and clarifications of data related to MRI.
After receiving the data, the FDA will have 180 days to review it, pushing possible time to clearance back in the US. Nuvectra said it is in active communications with the FDA, and that it plans to work proactively to complete the review process “as soon as possible.”
Nuvectra said that a European regulatory body responsible for CE Mark approval also requested clinical study data before it can approve the Virtis system. The company said it is continuing discussions with the body regarding the application to “clarify the breadth of clinical data that may be requested.”
“Our primary focus is gaining FDA approval of the Virtis system in order to both provide therapy to patients and to address the significant market opportunity for SNM in the U.S. We remain encouraged by our recent interactions with the FDA and believe that our responses will adequately address the FDA’s requests. We are pleased that our facility and pre-PMA audit have been completed without findings. We will continue to work cooperatively with the FDA to conclude the review of our application expeditiously and look forward to entering the U.S. SNM market as soon as possible following FDA approval. We will revisit our corporate strategy to enter the SNM market in Europe and will engage with TÜV SÜD to determine a reasonable clinical pathway to CE Mark approval,” CEO Scott Drees said in a press release.
Shares in Nuvectra have fallen 24.1% so far today, at $15.58 as of 10:51 a.m. EDT.