News

  • 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.

  • 27 November 2018

    Arsanis, Inc. (Nasdaq: ASNS) and privately-held X4 Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics designed to improve immune cell trafficking to treat rare diseases and cancer, today announced that they have entered into a definitive merger agreement under which X4 Pharmaceuticals is expected to merge with a wholly-owned subsidiary of Arsanis in an all-stock transaction. The merger would result in a combined company operating under the X4 Pharmaceuticals name that will focus on the development and commercialization of X4’s lead product candidate, X4P-001, and the advancement of X4’s pipeline of treatments for rare diseases of the immune system and rare cancers.