CA-AXONICS-MODULATION
4.2.2020 12:02:06 CET | Business Wire | Press release
Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable Sacral Neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced that the German Institute for the Hospital Remuneration System (“InEK”) granted Status 1 reimbursement approval to the Axonics r-SNM® System under a New Examination and Treatment Method (“NUB”).
The NUB program allows hospitals to apply to the German government for additional funding for innovative medical devices when existing reimbursement is limited. Extra funding was requested by 36 hospitals in Germany who wish to start using the Axonics r-SNM System in 2020. These hospitals will now be allowed to benefit from specific reimbursement that yields a higher payment for the Axonics System as compared to the non-rechargeable SNM system currently marketed by the legacy provider.
Raymond W. Cohen, CEO of Axonics, commented, “The large number of hospitals who have applied for NUB demonstrates the appetite of German physicians for the Axonics System. This NUB approval for additional reimbursement is based in part on the economic advantages of our long-lived rechargeable SNM system as compared to the competitor’s non-rechargeable device that requires replacement every 3-5 years due to battery depletion. The launch of the Axonics System is not only important for patient care, but it is also instrumental in helping healthcare systems around the world be more cost effective. Approval of higher reimbursement for our rechargeable SNM system clearly indicates that the InEK understands the long-term savings opportunity that we are able to offer.”
The Axonics System obtained European CE Mark approval in June 2016 for the treatment of overactive bladder, urinary retention and fecal incontinence. Following a post-approval clinical study in Europe, the Axonics System was launched internationally in England, the Netherlands and Canada at the end of 2018. Axonics launched commercially in the United States following a pivotal clinical study in the United States and FDA approval in late 2019.
About Axonics Modulation Technologies, Inc. and Sacral Neuromodulation
Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. Simply stated, these conditions are caused by a miscommunication between the pelvic floor nerves and the brain and significantly impact quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, representing a potential $6 billion market opportunity. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first rechargeable SNM system approved for sale in the U.S. and the first to gain full-body MRI labeling. For more information, please visit the Company’s website at www.axonics.com .
Forward-Looking Statements
Statements 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 “planned,” “expects,” “believes,” “anticipates,” “designed,” 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. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200204005324/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Alpaca Completes EEA Passporting to 29 Countries, Expanding Access to Regulated Investment Services Across Europe7.7.2026 09:00:00 CEST | Press release
Alpaca now provides regulated, localized investment services across the European Economic Area Alpaca, a global leader in brokerage infrastructure APIs, today announced that it has completed the process to passport its regulated and localized investment services across 29 countries in the EEA (European Economic Area) through its Spain-based EEA hub. The completion of EEA passporting enables Alpaca to extend the regulatory foundation established through its European entity, which is authorized and registered with Spain’s Comisión Nacional del Mercado de Valores (CNMV), across the EEA under the MiFID II framework. Together with Alpaca’s regulated UK entity, this milestone strengthens Alpaca’s ability to support fintechs, financial institutions, and enterprise partners building regulated investment products across Europe, reaching a market of nearly 500 million people. The passported countries include Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finla
Capvidia Announces 2026 R1 Software Release to Strengthen MBD Readiness, QIF Workflows, and Digital Thread Automation7.7.2026 09:00:00 CEST | Press release
Latest release brings MBDReady Check into Creo, expands QIF-based Weld Analysis for NX, improves inspection workflows, and adds STEP AP242 Edition 3 compatibility. Capvidia, a provider of Model-Based Definition (MBD), Model-Based Enterprise (MBE), and CAD interoperability software, today announced Capvidia 2026 R1, the latest version of its software portfolio for manufacturers, OEMs, suppliers, and quality organizations. Built with more than 5,600 development hours, Capvidia 2026 R1 includes a combination of over 400 new features, improvements, customer-requested enhancements, and bug fixes across the Capvidia product portfolio. The release helps manufacturers make model-based workflows more practical, validated, and automation-ready. Capvidia 2026 R1 introduces MBDReady Check inside MBDConnect for Creo, expands QIF-based Weld Analysis for Siemens NX, improves Bill of Characteristics and 2D ballooning workflows in MBDVidia, strengthens semantic recognition for machine-readable inspecti
Landmark Global Galderma Survey Shows 9 out of 10 People Are Affected by Skin Quality Concerns7.7.2026 07:00:00 CEST | Press release
World’s most extensive skin quality profiling survey of more than 11,000 people across Europe, Asia, and the Americas finds that nine out of ten people are affected by skin quality concerns, with the most important attributes of good skin quality identified as smooth, hydrated and glowing skin1 Results show that skin quality has an impact on quality of life for 85% of people, with more than a third feeling self-conscious, insecure or anxious due to poor skin quality1 In response to clinicians’ calls for a universal assessment tool to help address these concerns, Galderma supported leading experts in the development of the Skin Quality Assessment Scale; a holistic, science-based tool to evaluate skin quality comprehensively and guide personalized, long-term treatment planning2 At Galderma, we champion skin quality by providing insights, tools, and solutions to better understand and address a wide spectrum of concerns, helping people take pride and feel comfortable in their own skin at e
Morinaga Milk Achieves Self-Affirmed GRAS Status for LAC-Living+™, Expanding U.S. Opportunities for Its Postbiotic Ingredient7.7.2026 04:00:00 CEST | Press release
Clinical evidence–backed postbiotic supports mood and well-being with formulation flexibility for diverse applications Morinaga Milk Industry Co., Ltd. (TOKYO:2264), a leading Japanese dairy and functional ingredient company, today announced that it has achieved self-affirmed GRAS (Generally Recognized As Safe) status in the United States for LAC-Living+™ (L. helveticus MCC1848), its proprietary postbiotic ingredient. This milestone expands the commercial availability of LAC-Living+ in the U.S. market and enables its use in dietary supplements, functional foods, and beverages, supporting the development of products designed to address growing consumer demand for health and well-being solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706806943/en/ Growing Interest in Postbiotics and Mental Well-Being Consumer interest in proactive health management has expanded significantly in recent years, alongside increasing aw
Access Advance Welcomes New Licensors to the Video Distribution Patent Pool7.7.2026 02:00:00 CEST | Press release
Access Advance LLC today announced that Sharp, M&K Holdings, Tagivan and 9 other patent owners who own substantial video codec patent portfolios that cover the core technologies behind video decoding, processing, and streaming media delivery, have joined the Video Distribution Patent Pool (VDP Pool) in the first half of 2026. "The addition of all of these new Licensors’ patent portfolios is a real win for both the VDP Pool and our many existing and future Licensees,” said Peter Moller, CEO of Access Advance. “These companies have broad and deep patent portfolios and further enhance the program’s market leading position in resolving the licensing issues around the use of modern video codecs across all the diverse business models of internet video streaming.” The following patent holders have joined the VDP Pool as Licensors in the first half of 2026: Digital Insights Inc. Hanbat National University Industry-Academic Cooperation Foundation Hanwha Vision Co., Ltd. Industry-Academy Coopera
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
