Nuvectra has issued an update on its US Food and Drug Administration (FDA) pre-market approval (PMA) application and its application for CE mark in Europe for Virtis, the company’s Sacral Neuromodulation (SNM) System for the treatment of chronic urinary retention and the symptoms of overactive bladder.
This update caused the share price to fall by 15.34% (US$3.15) to close at US$17.38 Monday, and the price continued to drop in after-hours trading.
As part of its review of the Virtis PMA original application and the amendment submitted in April 2018, the FDA recently requested that the company provide supplemental information related to any modifications or changes to the Virtis device, labelling and manufacturing, as well as clarifications of data related to magnetic resonance imaging. The company has been in communication with the FDA and intends to file comprehensive responses to address the FDA’s requests. The FDA will then have up to 180 days to review the company’s responses.
Also, TÜV SÜD, the European regulatory body, recently informed the company 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, CEO, 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 US. 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 US SNM market as soon as possible following FDA approval.”
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.”