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

Tide Crosses 2 Million Members Worldwide - Big Step Forward in Mission to Support and Grow Small Businesses27.5.2026 08:00:00 CEST | Press release

Continuing to grow in the UK and internationally, with India seeing especially strong member growth in the last 12 months In the UK, Tide has 15% market share and has helped small businesses access over £1.75bn in credit Rapid roll out of products; from admin, accounting and tax tools; subscription options; payment solutions; government registrations; bill payments and credit Tide, the UK’s leading business management platform, today announces it has crossed 2 million members globally, with India in particular seeing strong growth. More than 1.1 million small businesses joined Tide in India since the company launched there in December 2022. This makes India Tide’s fastest-growing market by member acquisition. The UK is Tide’s home market, with 900,000 SMEs, 15% market share, and the majority of the company’s revenue. Tide’s steadily expanding its presence in Europe, with Germany and France, where the platform is gaining strong traction, thanks to millions of small businesses turning to

Alfasigma presents first data on filgotinib from the Phase 3 OLINGUITO trial in axial spondyloarthritis at EULAR 202627.5.2026 08:00:00 CEST | Press release

The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific and investor media only.In the OLINGUITO Phase 3 study in radiographic (r) and non-radiographic (nr) axial spondyloarthritis (axSpA) a significantly greater proportion of patients achieved the prespecified primary endpoint of ASAS40 with filgotinib compared with placebo at week 16.The improvements in signs and symptoms of axSpA with filgotinib, an oral, once-daily JAK1 preferential inhibitor, were observed as early as week 1 and maintained over 52 weeks of treatment.In the r-axSpA and nr-axSpA filgotinib groups, of those achieving a response in the prespecified primary endpoint of ASAS40 at week 16, 84.6% and 78.0% maintained their responses to week 52, respectively.In OLINGUITO no new safety signals were observedfor filgotinib over 52 weeks, and the safety profile was consistent with the known overall safety profile.Primary results from the Phase 3 OLINGUITO tria

Royal London Asset Management Expands Relationship with SS&C to Service New Australian Funds27.5.2026 00:00:00 CEST | Press release

SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today announced that Royal London Asset Management, a leading U.K. fund management company, has extended its relationship with SS&C. SS&C Global Investor & Distribution Solutions will provide fund administration and unit registry services for its new range of Australian active funds, including: Royal London Global Equity Diversified Fund Royal London Global Equity Enhanced Fund Royal London Global Equity Select Fund Royal London Short Duration Global High Yield Bond Fund RLAM is part of Royal London, the U.K.’s largest mutual life, pensions and investment company. SS&C services approximately £72bn in assets under management across its U.K. fund range. Equity Trustees will serve as the Responsible Entity for RLAM’s new funds, which have launched with around AUD $1 billion in AUM. The unit trusts are structured as feeder funds, providing investors with indirect exposure to RLAM’s range of Dublin-domiciled Undertakings for Collective Investm

SLB Announces Date for Second-Quarter 2026 Results Conference Call26.5.2026 19:00:00 CEST | Press release

SLB (NYSE: SLB) will hold a conference call on July 24, 2026, to discuss the results for the second quarter ending June 30, 2026. The conference call is scheduled to begin at 9:30 a.m. U.S. Eastern time and a press release regarding the results will be issued at 7:00 a.m. U.S. Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 715-9871 within North America or +1 (646) 307-1963 outside of North America approximately 10 minutes prior to the start of the call and the access code is 3440360. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/157027565 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until July 31, 2026, and can be accessed by dialing +1 (800) 770-2030 within North America or +1

Alipay Launches Next-Generation AI Payment Infrastructure, Debuts AI Wallet and Token Pay to Power Agentic Economy26.5.2026 17:20:00 CEST | Press release

Alipay today introduced its full-stack AI payment solution to partners across industries, ranging from AI companies to traditional retailers, and debuted two new services — the world’s first AI Wallet and Token Pay — to support the agentic economy’s rapid growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260526337824/en/ Alipay Unveils Next-generation AI Payment Infrastructure This launch extends Alipay's next-generation AI payment infrastructure, building on its consumer-facing product Alipay AI Pay and its business-facing AI payment processing product. “While the essence of commerce remains unchanged in the age of AI, the emergence of AI agents is reshaping everything. Drawing on 22 years of technological expertise and commercial know-how, Alipay is building a new generation of AI payment services to accelerate the growth of the agentic commerce ecosystem,” said Cyril Han, CEO of Ant Group. AI Wallet: Giving Users Vis

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