A company that spun out of Greatbatch in 2016 experienced a painful drop in its stock price Monday after updating investors on its regulatory progress for a sacral neuromodulation (SNM) system designed to treat chronic urinary retention and the symptoms of overactive bladder.
Plano, TX-based Nuvectra said FDA has asked for additional information related to any modifications or changes to its Virtis device, labeling, and manufacturing as well as clarifications of data related to MRI. The company also has been asked to submit clinical study data to the European Union regulatory before it can recommend CE mark approval for the same device.
Nuvectra shares fell 15.34% ($3.15) to close at $17.38 Monday, and the price continued to drop in after-hours trading.
The company said it submitted an amendment to its original pre-market approval (PMA) application in April and that it intends to "promptly file comprehensive responses" to address FDA's requests for more information. The agency will then have up to 180 days to review Nuvectra's responses. The company also said it will continue its discussions with the regulatory body in Europe to clarify the breadth of clinical data that may be requested for CE mark approval.
"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.," said Scott Drees, CEO of Nuvectra.
Drees said the company has been encouraged by its recent interactions with FDA and that he believes Nuvectra's responses will adequately address the agency's requests. He also noted that the company's 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," Drees said.
As for the SNM market in Europe, Drees said the company will revisit its corporate strategy and will engage with the European regulatory body, TÜV SÜD, to "determine a reasonable clinical pathway to CE mark approval."