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

Focused Support Launches Cavok STRIKE to Expand Link-16 Participation Across the Joint Force14.9.2026 07:00:00 CEST | Press release

Extending Link-16 interoperability without platform-level hardware integration Focused Support LLC today announced the launch of Cavok STRIKE, an integrated software capability that expands the Link-16 tactical battlespace picture by enabling additional operational platforms to participate in the Link-16 network. Modern battlefields have increasing numbers of unmanned systems, sensors, and supporting platforms operating throughout the joint battlespace. The rapid proliferation of Group 1, 2, and 3 UAS, including both expendable and recoverable systems, has created a growing need to integrate these assets into the broader tactical network. Many of these platforms provide operationally relevant information but have historically remained outside the Link-16 network due to limitations in size, weight, power, platform integration complexity, or acquisition cost. Cavok STRIKE addresses this gap by enabling platforms to participate in the Link-16 network as non-command-and-control participant

Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma14.9.2026 07:00:00 CEST | Press release

H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil. “ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.” The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two

MEX Exchange, Part of MultiBank Group, Expands Executive Team as International Growth Accelerates14.9.2026 07:00:00 CEST | Press release

• Brian Liedberg joins MEX Exchange, bringing more than 30 years of experience across global capital markets, electronic trading and FinTech MEX Exchange, the institutional electronic trading platform of MultiBank Group, has announced the appointment of Brian Liedberg as Chief Revenue Officer and Global Head of Sales, strengthening its commercial leadership as the company continues to develop its institutional trading business and expand its presence across international markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260913319267/en/ Brian Liedberg joins MEX Exchange, bringing more than 30 years of experience across global capital markets, electronic trading and FinTech Liedberg brings more than 30 years of experience across global capital markets, electronic trading and financial technology, with a career spanning institutional sales, business development, commercial strategy and revenue growth. Prior to joining ME

Signaloid Announces Appointment of Quantitative Finance and Cloud Veterans to Advisory Board and Senior Commercialization Roles14.9.2026 05:00:00 CEST | Press release

Signaloid strengthens commercialization momentum with the appointment of two senior advisors in quantitative finance and cloud infrastructure.Dr. Han Lee, former Global Head of Quantitative Strategies and Automated Trading at Morgan Stanley, joins to chair Signaloid’s advisory board.Dr. Nachiketh Potlapally, Distinguished Engineer at Nscale, and previously Security Architect at Oracle Cloud Infrastructure and AWS, joins as Signaloid expands deployment of its UxHw technology across cloud and edge environments.Christian Roth, former Senior Director Enterprise Sales / formerly Director Product Marketing EMEA (Data Center, Business Clients, Storage and Networking), Intel. British technology company Signaloid today announced the appointment of three distinguished industry veterans to its advisory board and senior leadership roles, to strengthen the commercialization momentum behind its technology: Dr. Han Lee, former Global Head of Quantitative Strategies and Automated Trading for the Fixed

SES’s Final Three O3b mPOWER Satellites Successfully Launched13.9.2026 22:22:00 CEST | Press release

Additional O3b mPOWER satellites complete constellation and strengthen performance, resiliency and reach of SES's MEO network SES today announced the successful launch of its eleventh, twelfth and thirteenth O3b mPOWER satellites, further expanding its second-generation medium Earth orbit (MEO) system designed to offer high-performance connectivity services around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260913914517/en/ SES’s Final Three O3b mPOWER Satellites Successfully Launched The three satellites launched at 2:49 pm local time aboard a SpaceX Falcon 9 rocket from Space Launch Complex 40 (SLC-40) at Cape Canaveral Space Force Station. “This launch marks a defining milestone for SES as we complete the O3b mPOWER constellation and further strengthen our MEO capabilities,” said Adel Al-Saleh, CEO of SES. “More importantly, it reinforces our ability to deliver resilient, secure and scalable connectivity for

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