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

GenBio AI Builds First World Model of the Human Cell18.8.2026 15:00:00 CEST | Press release

First-of-its-kind system simulates human cell behavior across the full biological hierarchy, from DNA and RNA through protein to the whole-cell level GenBio AI ('GenBio') is an AI for Science company co-founded by Nobel Laureate David Baker, leading AI scientist Eric Xing, and other prominent life science and artificial intelligence researchers from Stanford, Carnegie Mellon University, Mohamed Bin Zayed University of Artificial Intelligence, Harvard, Weizmann Institute, and other research institutions. Today, the company introduced AIDO Cell, its virtual cell world model — the first system capable of simulating a human cell, both in its natural state and in response to drugs and other interventions, across its full biological hierarchy, from DNA and RNA through protein to the whole-cell level. A Key First in Biological and Medical Sciences: Full-hierarchy virtual cell simulation has been widely identified as a key milestone in computational biology. Compared to the previous efforts by

Xsolla Partner Network Expands Verified Creator Partnerships and Unifies Campaign Management Ahead of gamescom 202618.8.2026 15:00:00 CEST | Press release

Developers Gain Vetted Creator Partnerships And A Single Campaign Workflow, Managed From The Publisher Account They Already Use Xsolla, a global video game commerce company, today announced an expansion of the Xsolla Partner Network ahead of gamescom 2026 in Cologne, giving game developers a simpler, more reliable way to grow their games through creators. The creator platform now lives within Xsolla Publisher Account, where developers already run their business, with verified creator onboarding and a redesigned and unified campaign workflow. Flat-fee campaigns, a new guaranteed payment option alongside revenue share, and data-driven creator recommendations are coming soon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818140062/en/ Graphic: Xsolla Xsolla Partner Network gives developers one place to launch, manage, track, and report on creator campaigns while Xsolla handles payments, payouts, taxes, and compliance.Verifi

KOCCA to Showcase 13 Korean Game Companies at ‘Gamescom 2026’ with PC, Mobile, and VR Lineups18.8.2026 14:48:00 CEST | Press release

- Featuring a diverse lineup of roguelike deckbuilders, AI-powered rhythm education, and cooperative horror games - Ranging from new titles based on the popular animated IP ‘LARVA’ to real-time K-POP dance coaching content - Hands-on experience available August 26–28 at the Korea Joint Pavilion B2B Hall, Koelnmesse, Booth Hall 3.2 C-050g–D051g The Korea Creative Content Agency (KOCCA) announced that 13 Korean game companies will gather under one roof at Gamescom 2026, Europe’s largest game show, held in Cologne, Germany, from August 26 to 28 (B2B, 09:00~20:00). Located in Booth Hall 3.2 C-050g–D051g, the Korea Joint Pavilion offers visitors hands-on experiences with an expansive lineup of titles, ranging from PC and mobile games to VR-powered titles across diverse genres. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260818271881/en/ KOCCA will bring 13 Korean game companies to Gamescom 2026 in Cologne, Germany (Image: KOCC

SLB to Support Offshore Production Restoration for Brunei Shell Petroleum18.8.2026 14:06:00 CEST | Press release

Integrated execution model combines multiple disciplines to improve recovery from mature offshore assets Global energy technology company SLB (NYSE: SLB) today announced it has been awarded a contract by Brunei Shell Petroleum (BSP) to support production restoration from shut-in wells across multiple offshore fields. The contract scope spans subsurface evaluation, well candidate selection, engineering and offshore execution. Project management, intervention services, monitoring, metering and marine logistics are integrated within a single coordinated execution model designed to support efficient production restoration. “Building on our long collaboration in the region, this contract reflects a shared commitment to maximizing value from existing offshore resources,” said Gokhan Yarim, senior vice president of Integration, SLB. “Together with BSP, we are combining SLB’s production expertise and integrated execution capabilities to help restore production from shut-in wells, increase reco

BeOne Medicines, BeOne Care Foundation, and The Max Foundation Renew Partnership to Expand Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries18.8.2026 12:00:00 CEST | Press release

Renewed collaboration builds on access provided to more than 300 patients with CLL to date and plans to support approximately 1,000 patients through 2028 BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, together with the BeOne Care Foundation, a nonprofit charitable foundation, and The Max Foundation, a leading global health nonprofit organization, today announced the renewal of their partnership through 2028 to expand access to BRUKINSA® (zanubrutinib) for the treatment of chronic lymphocytic leukemia (CLL) in low- and middle-income countries, with the program projected to support approximately 1,000 patients cumulatively. Building on a collaboration launched in 2023, the renewed partnership reflects the organizations’ shared commitment to improving access to innovative cancer treatments in underserved communities. To date, the partnership has enabled access to BRUKINSA for more than 300 patients with CLL across Armenia, Ethiopia, and

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