Nuvectra Corporation (NASDAQ:NVTR) Files An 8-K Other EventsItem 8.01. Other Events.
On July 2, 2018, Nuvectra Corporation (the “Company”) announced via press release that on June 18, 2018, it received notice from the Food & Drug Administration (the “FDA”) regarding its original pre-market approval application and its subsequent amendment to such application for its VirtisTM Sacral Neuromodulation Device (“Virtis”). The FDA requested that the Company provide supplemental information related to modifications to the Virtis device, labeling and manufacturing. Specifically, the FDA asked the Company to provide a more descriptive explanation of the changes in its most recent amendment relative to what was provided in the Company’s original PMA submission, as well as clarifications of data related to MRI compatibility. The Company clarified the FDA’s requests on June 27, 2018 and is in the process of preparing comprehensive responses to address each request, thereby initiating a 180-day review process by the FDA.
On June 22, 2018, the Company also received notice from TÜV SÜD, the Company’s notified body in Europe, regarding its Virtis application for CE Mark. TÜV SÜD notified the Company that it was unable to approve the Company’s CE Mark for Virtis without additional clinical study data regarding the safety and efficacy of the device for the requested indication. On June 28, 2018, the Company confirmed TÜV SÜD’s decision and initiated discussions with TÜV SÜD regarding its CE Mark application and the scope of future clinical data that may be requested. As the Company completes its assessment of TÜV’s clinical requirements, it is currently evaluating the best path to pursue its application for CE Mark.
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Item 8.01 |
Financial Statements and Exhibits. |
(d)Exhibits.
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99.1 |
Press Release issued by Nuvectra Corporation, dated July 2, 2018 |
Nuvectra Corp ExhibitEX-99.1 2 ex_117192.htm EXHIBIT 99.1 ex_117192.htm Exhibit 99.1 Company Contacts: Investor Contacts: Nuvectra Corporation The Ruth Group Walter Berger,…To view the full exhibit click here
About Nuvectra Corporation (NASDAQ:NVTR)
Nuvectra Corporation is a neurostimulation company that focuses on helping physicians to improve the lives of people with chronic neurological conditions. The Company’s Algovita Spinal Cord Stimulation (SCS) System (Algovita) is the Company’s commercial offering and is Conformite Europeene (CE) marked and the United States Food and Drug Administration (FDA) approved for the treatment of chronic pain of the trunk and/or limbs. Its technology platform also has capabilities under development to support other neurological indications, such as sacral nerve stimulation (SNS) and deep brain stimulation (DBS). In addition, its NeuroNexus Technologies, Inc. (NeuroNexus) subsidiary designs, manufactures and markets neural-interface technologies for the neuroscience clinical research market. Its Virtis is an application of the Company’s neurostimulation technology platform and its first product for the SNS market. Its subsidiaries include Algostim, LLC (Algostim) and PelviStim LLC (PelviStim).
