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

Lehman Brothers Treasury Considers Sale and Final Wind-Down3.8.2026 15:30:00 CEST | Press release

Lehman Brothers Treasury Co. B.V. in liquidation (“LBT”) today, through its U.S. counsel Herbert Smith Freehills Kramer (USA) LLP, announced that LBT is considering a final wind-down of its estate. In connection therewith, LBT has retained Seaport Loan Products LLC as its exclusive placement agent in connection with the potential sale of LBT’s principal remaining asset – a $19.6 billion Class 4A allowed claim against Lehman Brothers Holdings Inc. (the “LBHI Claim”). LBT expects the sale to occur, if at all, in August 2026. To the extent the LBHI Claim is sold, LBT expects to make a final distribution to the holders of its existing notes and thereafter facilitate the cancellation of those notes and the final wind down of its estate in September 2026. The foregoing is subject to further consents and authorizations and LBT retains sole discretion to abandon or otherwise discontinue any sale process at any time. Accordingly, there can be no assurances that the sale process will be conducte

ClickHouse Launches ClickHouse Labs With Andy Pavlo as VP of Database Research3.8.2026 15:30:00 CEST | Press release

Renowned database researcher will lead a new group dedicated to advancing foundational database technology and sharing its work openly with the broader community ClickHouse today announced the launch of ClickHouse Labs, a new research group led by Andy Pavlo, one of the database industry’s most prominent researchers. Dr. Pavlo joins ClickHouse as Vice President of Database Research and will build a team dedicated to advancing the state of the art in database systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260803890510/en/ Andy Pavlo, VP of Database Research, ClickHouse Pavlo is an award-winning database researcher and professor at Carnegie Mellon University’s Computer Science Department. He is known throughout the database community for his work on autonomous databases, transaction processing, and large-scale data analytics. At ClickHouse, he will bring that expertise to some of the most ambitious and consequential c

EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership3.8.2026 15:00:00 CEST | Press release

EuroTeleSites, one of Central and Eastern Europe's leading independent tower companies, today announced the results of its first year in partnership with Sitetracker, the leading global Asset Lifecycle Management platform. One year into the deployment, EuroTeleSites reports meaningful progress in its digital transformation, with measurable improvements in operational efficiency, cross-market transparency, and project coordination across its six-country footprint. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727009809/en/ EuroTeleSites Strengthens Operations One Year into Sitetracker Partnership Driving Efficiency in a Complex, High-Investment Environment EuroTeleSites invests approximately 25% of its revenue into capital expenditures in 2026, funding the construction and upgrade of tower infrastructure across Central and Eastern European markets. Managing this level of scale and complexity demands robust digital support

Visa to Acquire BioCatch3.8.2026 14:30:00 CEST | Press release

BioCatch’s behavioral and device intelligence expertise expected to help detect scams, account takeovers and digital fraud before they happen Visa (NYSE: V) today announced it has signed a definitive agreement to acquire BioCatch, a leading provider of behavioral-first, multi-signal fraud intelligence, from funds advised by Permira and other shareholders for $2.4 billion in cash. The acquisition of BioCatch complements Visa’s existing cyber, fraud, risk and security solutions and is expected to help clients better protect themselves and their customers from the growing threat of account takeovers, scams, money mules and application fraud. Since its inception, BioCatch has developed innovative AI and machine learning-based solutions that analyze thousands of application, behavioral, device, and network signals—such as keystrokes, touch gestures, and device handling—to detect fraud and distinguish legitimate users from fraudsters in real time. BioCatch protects 1.8 billion devices and 76

U.S. Bank Investment Services enhances investor and client onboarding experience for alternative investments3.8.2026 14:16:00 CEST | Press release

U.S. Bank Investment Services today announced it has gone live with a new client lifecycle management (CLM) platform, providing a comprehensive onboarding solution for alternative investment clients and the investors in their funds. The implementation is a key milestone in Investment Services’ multi-phased technology transformation strategy, aimed at modernizing processes, workflows and reporting across the private funds space. U.S. Bank leverages CLM provider Fenergo and its Fen-X platform. Fen-X automates many of the manual processes traditionally associated with underlying investors and direct client relationships and accelerates account setup while maintaining regulatory requirements. The enhanced onboarding experience provides investors and clients with more transparency throughout the process and enables integration with other solutions providers involved in the investor journey, such as screening and tax reporting. The investor experience has been further enhanced with an invest

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