Regulatory agencies request more information on Nuvectra's Virtis system
Nuvectra closed the day down over 15% on news that its Virtis sacral neuromodulation device will require more information from both the U.S. and European regulatory agencies.
As part of its review of the Virtis PMA original application and the amendment submitted in April 2018, the FDA recently requested that Nuvectra provide supplemental information related to any modifications or changes to the Virtis device, labeling and manufacturing, as well as clarifications of data related to MRI. Nuvectra has been in active communications with the FDA and intends to promptly file comprehensive responses to address the FDA's requests.
At that point, the FDA will then have up to 180 days to review the responses.
From a European regulatory perspective, TÜV SÜD recently informed Nuvectra that clinical study data will be required before it can recommend approval of CE Mark for the Virtis system. The company is continuing its discussions with TÜV SÜD regarding its application to clarify the breadth of clinical data that may be requested.
Scott Drees, Chief Executive Officer, commented, “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.”
Mr. Drees continued, “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.”
As you can see in the slide below, Nuvectra is projecting an almost $700 million market for the Virtis system. Nuvectra's stock likely had this opportunity baked into the price which is why the stock saw such a big decline on the news.