Business Wire

CA-AXONICS-MODULATION

4.2.2020 12:02:06 CET | Business Wire | Press release

Share
Axonics® Sacral Neuromodulation System Receives Reimbursement Approval in Germany

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.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

David Hagan, Dean and Pegasus Professor at CREOL, The College of Optics and Photonics, Will Serve as Vice President of SPIE26.8.2026 05:00:00 CEST | Press release

Newly elected SPIE board members bring distinct backgrounds to optics and photonics community David Hagan has been elected to serve as the 2027 Vice President of SPIE, the international society for optics and photonics. He will serve as President-Elect in 2028, and as the Society’s President in 2029. The SPIE Board of Directors is influential in the scientific community, establishing policy and strategy and conducting activities of interest to SPIE Members. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260825934622/en/ Top row, from left to right: David Hagan, Jim McNally, Mark Clampin. Bottom row, from left to right: Marla Dowell, Jana Kainerstorfer, Katie Schwertz The 2026 SPIE President, Julie Bentley, professor of optics at the University of Rochester, made the new electees announcement at the Annual General Meeting of the Society on 25 August during SPIE Optics + Photonics. Terms begin on 1 January 2027. In addition to

FORTÉ Acquires Vega Global, APAC's Largest Systems Integrator, Expanding Global Reach26.8.2026 03:00:00 CEST | Press release

With new presence in Asia, FORTÉ serves customers in more than 70 cities worldwide – the largest global footprint in the industry FORTÉ, the leader in communication and collaboration solutions designed for the modern workplace, today announced its acquisition of Vega Global, APAC’s largest systems integrator and a leading provider of workplace technology and audiovisual solutions serving corporate, education, government and other market segments. With this acquisition, FORTÉ adds to its international presence, including established office locations in Hong Kong, Mainland China, India, Japan, Taiwan, Thailand, Singapore, Korea, Vietnam, Australia, Philippines, Malaysia, Macau, New Zealand, Indonesia, and United Arab Emirates. With its headquarters in Minneapolis, Minn., FORTÉ also has operations in the U.S., Ireland, Germany, Sweden, the United Kingdom, and Mexico. “Multinational organizations need strategic partners who can deliver consistent communication and collaboration experiences

Access Advance Launches Exploration Phase for an AV1/AV2 Device and Software Patent Pool, Invites Participation of Potential Licensors26.8.2026 02:00:00 CEST | Press release

Access Advance LLC announced today that in conjunction with the recent release of the AV2 video codec specification, it has launched the exploratory phase for a new patent pool covering devices and software implementing the AV2 video codec, as well as its predecessor AV1. During this exploratory phase, Access Advance will engage with market participants to seek their input, including holding pool formation discussions with potential licensors to gather their feedback on the scope, structure, and terms of a prospective program. All patent owners with a good-faith belief that they own or control AV1 and/or AV2 essential patents are invited to participate in the pool formation discussions. AV1 adoption is being driven largely by members of the Alliance for Open Media (“AOM”). AOM members such as Google, Meta, and Netflix increasingly utilize AV1 to deliver video, and adoption now spans smart TVs, streaming media players, mobile devices, web browsers, and chipsets. AV2, AOM’s successor to

Lattice to Showcase Industrial FPGA Innovations at FPGAWorld Conference 202625.8.2026 22:00:00 CEST | Press release

Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced its exhibition plan for the upcoming FPGAWorld Conference 2026, taking place on Sept. 8, 2026, in Stockholm, Sweden. As part of the event, Lattice will deliver technical presentations and host a demo showcase focused on how its low power FPGA solutions are advancing Industrial IoT and sensor bridging applications. Who: Lattice Semiconductor What / When (GMT+2): Tuesday, Sept. 8, 2026 Lattice Demo Showcase Presentations (Track: 12:20 – 13:35, Room Brave 05) “Solving Your Power Puzzle: Lattice FPGAs’ Path to Uncompromised Low Power” “Practical Security Fundamentals for FPGA Engineers” Where: AFRY, Frösundaleden 2A, 169 70 Solna, Sweden The FPGAWorld Conference is an international forum for researchers, engineers, teachers, students, and hackers. It covers topics such as complex analog/digital/software FPGA SoC systems, FPGA/ASIC-based products, educational and industrial cases,

France Becomes First Official Participant at Expo 2030 Riyadh25.8.2026 19:40:00 CEST | Press release

France is the first country to officially sign its Participation Contract for Expo 2030 Riyadh, a major milestone in its preparations and growing international momentum. The signing took place on the sidelines of the visit to France by His Royal Highness Prince Mohammed bin Salman bin Abdulaziz Al Saud, Crown Prince and Prime Minister. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260825634516/en/ The ceremony in Paris was attended by H.H. Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and Dimitri S. Kerkentzes, Secretary General of the BIE. The Participation Contract was signed by Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, and Jacques Maire, Chairman of the Compagnie Française des Expositions (COFREX). The agreement formally establishes France’s participation in Expo 2030 Riyadh, providing the framework for its presence throughout the six-month event. It spec

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye