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

Philips and Imricor Launch Cardiac Interventional MR Lab Solution, Expanding Longstanding Collaboration27.8.2026 21:27:00 CEST | Press release

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and Imricor Medical Systems (ASX: IMR), a pioneer and world-leading developer of MR-compatible products for interventional MR procedures, today announced a new Interventional MR (iMR) lab solution for Philips 1.5T MR. The first commercially available configuration* combines Philips’ 1.5T MRI platform and Imricor's portfolio of iMR systems and consumables, enabling an MR-guided workflow for cardiac intervention, without compromising on MR field strength. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827693715/en/ Meeting the need for greater tissue insight during cardiac intervention Cardiac arrhythmias affect millions of people worldwide, and catheter ablation is an established and increasingly utilized treatment for many complex cardiac arrhythmias. Yet today, these procedures continue to rely primarily on X-ray fluoroscopy, which provides only

Xsolla Launches Game Biz Institute, an Editorial Platform Where Industry Practitioners Explain the Business of Games27.8.2026 17:32:00 CEST | Press release

New Platform Pairs Independent Researchers and Industry Veterans with Xsolla Experts to Unpack Direct-to-Player Commerce, Monetization, Payments, and Player Retention Xsolla, a global commerce company, today announced the launch of Game Biz Institute (GBI), an editorial platform where named industry practitioners and researchers examine the commercial layer of games: direct-to-player distribution, payments, monetization, user acquisition, and retention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827362663/en/ Graphic: Xsolla Game design has a curriculum. The business of games does not. Engines, pipelines, production, and narrative are taught at hundreds of universities, while the commercial machinery that determines whether good work becomes a durable company is still learned through expensive trial and error, usually after the decisions that mattered have already been made. GBI was built to close that gap by publishi

Star Wars Zero Company™ Now Available On PC, PlayStation 5 and XBOX Series Consoles27.8.2026 17:00:00 CEST | Press release

Bit Reactor’s Debut Title Combines Tactical Depth and Cinematic Elegance for a New Star Wars StoryWatch the Final Trailer to Witness What’s at Stake in the Galaxy Electronic Arts Inc. and Bit Reactor, in collaboration with Lucasfilm Games, announced today that Star Wars Zero Company™, a single-player turn-based tactics game set in the twilight of the Clone Wars™, is now available for PC via the EA app, Steam, and Epic Games Store, and PlayStation®5 and XBOX Series consoles. In Star Wars Zero Company, former Republic officer Hawks and Zero Company, an elite squad of unconventional professionals for hire, are recruited for an operation by Republic Intelligence. From ex-nobles to ex-cons, they now share one mission: Stop the Infinite Coil, a Separatist-aligned cult, and their leader Kundri Fathom before the deadly Shadow Plague consumes the galaxy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827012810/en/ https://www.yout

Rehlko Joins Wisconsin Data Center Coalition as Newest Energy Resilience Member, Reinforcing Its Role at the Center of AI and Digital Infrastructure Growth27.8.2026 15:15:00 CEST | Press release

Global Energy Resilience Leader Reinforces Its Role at the Center of AI and Digital Infrastructure Growth Through Mission-Critical Power Expertise Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced it has joined the Wisconsin Data Center Coalition (WIDCC) as the organization's newest energy resilience member. The membership reflects Rehlko's commitment to advancing Wisconsin's role as a leader in responsible AI infrastructure development, built on reliable and scalable power. Rapid growth in hyperscale and enterprise data center investment is reshaping markets across the world, and Rehlko is building the power infrastructure that makes it possible. Sitting at the intersection of the structural forces driving AI infrastructure expansion, grid reliability, and accelerating electrification, Rehlko brings more than a century of engineering depth and lifecycle capabilit

GenNx360 Capital Partners Closes Fourth Flagship Fund at $865 Million27.8.2026 14:30:00 CEST | Press release

Fund IV success is the result of two decades of proven performance backing lower middle market industrial services and business services companies GenNx360 Capital Partners (“GenNx360” or “the Firm”), a New York City-based private equity firm investing in U.S. lower middle market industrial services and business services companies, today announced the successful closing of GenNx360 Capital Partners IV, L.P. (“Fund IV” or “the Fund”), with $865 million in commitments, exceeding its target. Fund IV is the largest fund raised in GenNx360’s history. Fund IV was supported by a diverse group of existing and new investors including leading pensions, asset managers, insurance companies, foundations, and family offices, reflecting conviction in the firm’s disciplined investment approach, operational value creation model, and tenured, diverse team. Fund IV will continue GenNx360’s differentiated strategy of partnering with lower middle market founders and management teams to scale essential serv

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