{"id":53448,"date":"2023-01-31T12:02:06","date_gmt":"2023-01-31T11:02:06","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/axonics-receives-fda-approval-for-fourth-generation-rechargeable-sacral-neuromodulation-system\/"},"modified":"2023-01-31T12:02:06","modified_gmt":"2023-01-31T11:02:06","slug":"axonics-receives-fda-approval-for-fourth-generation-rechargeable-sacral-neuromodulation-system","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/axonics-receives-fda-approval-for-fourth-generation-rechargeable-sacral-neuromodulation-system\/","title":{"rendered":"Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System"},"content":{"rendered":"
\n

IRVINE, Calif.–(BUSINESS WIRE)–Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company\u2019s fourth-generation rechargeable sacral neuromodulation system.\n<\/p>\n

<\/a><\/p>\n

\nThe newly approved Axonics R20\u2122<\/sup> neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. This compares to the third-generation\u2019s recharge interval of once a month for one hour. The Axonics R20 neurostimulator utilizes the same small 5cc form factor as the Axonics R15\u2122 and is paired with the same tined lead and intuitive patient remote control. Axonics plans to commercially launch the product in the United States in March.\n<\/p>\n

\n\u201cDelivering a superior patient experience has been at the forefront of our sacral neuromodulation development efforts,\u201d said John Woock, Ph.D., executive vice president, chief marketing and strategy officer of Axonics. \u201cPatients with overactive bladder tell us that first and foremost, they value efficacy and a long-lived solution to address their chronic condition. The Axonics R20, which requires recharging just twice per year, represents another significant breakthrough for rechargeable neuromodulation devices and underscores our commitment to continuous innovation. We are confident that Axonics\u2019 keen focus on the incontinence patient population and increasing public awareness<\/a> of sacral neuromodulation has the potential to drive significant market expansion in the years ahead.\u201d\n<\/p>\n

\nAbout Axonics\u00ae<\/sup><\/b>\n<\/p>\n

\nAxonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 1 on the 2022 Financial Times<\/a> ranking of the 500 fastest growing companies in the Americas and No. 4 on the 2022 Deloitte<\/a> Technology Fast 500\u2122 following its No. 1 ranking in 2021.\n<\/p>\n

\nAxonics sacral neuromodulation (SNM) systems provide patients suffering from overactive bladder and\/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company\u2019s best-in-class urethral bulking hydrogel, Bulkamid\u00ae<\/sup>, provides safe and durable symptom relief to women with stress urinary incontinence (SUI). Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 29 million women in the U.S. alone. Axonics\u2019 clinically proven products are offered at hundreds of medical centers across the U.S. and abroad. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. For more information, visit www.axonics.com<\/a>.\n<\/p>\n

\nForward-Looking Statements<\/b>\n<\/p>\n

\nStatements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as \u201cplans,\u201d \u201cexpects,\u201d \u201cbelieves,\u201d \u201canticipates,\u201d \u201cdesigned,\u201d and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov<\/a>. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nAxonics contact<\/b>:
\n
Neil Bhalodkar
\n
949-336-5293
\n
ir@axonics.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

IRVINE, Calif.–(BUSINESS WIRE)–Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company\u2019s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20\u2122 neurostimulator is labeled for a functional … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53448","6":"format-standard","7":"category-industry"},"yoast_head":"\nAxonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/axonics-receives-fda-approval-for-fourth-generation-rechargeable-sacral-neuromodulation-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"IRVINE, Calif.–(BUSINESS WIRE)–Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company\u2019s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20\u2122 neurostimulator is labeled for a functional ... 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