News

  • 2 January 2019

    Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of interim clinical data from the ARTISAN-SNM pivotal clinical study to the U.S. Food & Drug Administration (“FDA”).

  • 10 December 2018

    Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, announced today the publication of a Medtech Innovation Briefing by The National Institute for Health and Care Excellence (“NICE”) following a careful review of the innovations offered by the Axonics System.

  • 4 December 2018

    Axonics Modulation Technologies, Inc.(NASDAQ:AXNX), a medical technology company focused on the design, development and commercialization of rechargeable implantable Sacral Neuromodulation (“SNM”) solutions for the treatment of urinary and bowel dysfunction, today announced that on December 3, 2018, the Company submitted a premarket approval application (“PMA”) to the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System, an investigational medical device.

  • 3 December 2018

    JenaValve Technology, Inc., a developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced U.S. Food and Drug Administration (FDA) approval of expansion of its Investigational Device Exemption (IDE) feasibility studies for the JenaValve Pericardial TAVR System with the Everdur™ transcatheter heart valve (THV) and CoronatixTM Transfemoral Delivery Catheter. The approval expands eligible patient enrollment from 20 patients at extreme or high surgical risk (10 aortic stenosis [AS], 10 aortic regurgitation [AR]) to 80 patients at extreme or high surgical risk (40 AS, 40 AR) at up to 10 U.S. sites. 

  • 29 November 2018

    Axonics Modulation Technologies, Inc.(NASDAQ:AXNX), a medical technology company focused on the design, development and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions for the treatment of urinary and bowel dysfunction, announced today that the Axonics r-SNM™ System has been listed on the U.K.’s National Health Service Supply Chain (“NHS SC”) online catalogue, thereby allowing wide commercial distribution to NHS hospitals in England.