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

Garvan Institute of Medical Research Joins Parse Biosciences’ Certified Service Provider Network15.7.2026 22:00:00 CEST | Press release

Researchers across Asia-Pacific gain a new option for high-quality single cell sequencing through Garvan's Evercode WT services Parse Biosciences, a QIAGEN company, and the leader in scalable and accessible single cell sequencing, today announced that the Genomics Platform Core Facility within the Garvan Institute of Medical Research has joined its Certified Service Provider (CSP) Program. The partnership broadens access to high-quality, scalable single cell sequencing across Australia, the wider Asia-Pacific region, and beyond. Garvan is one of Australia's preeminent medical research institutions, with the Genomics Platform having deep experience in cell sorting, capture, and sequencing. As a Certified Service Provider, Garvan will offer Parse's Evercode WT kits to researchers across the region. "We see a growing number of requests for Parse projects and find the technology easy to implement and run, generating great data," said Chris O'Keeffe, Cellular Genomics Lead at the Garvan Ins

Grafana Labs Named a Leader in 2026 Gartner® Magic Quadrant™ for Observability Platforms and Positioned Furthest in Completeness of Vision15.7.2026 20:21:00 CEST | Press release

Named a Leader for the third consecutive year and placed furthest in vision for the second year in a row, the company has had a landmark year of innovation as observability becomes essential infrastructure for teams building and running AI at scale. Grafana Labs, the company behind the open observability cloud, today announced it has been named a Leader in the Gartner® Magic Quadrant™ for Observability Platforms for the third consecutive year, and positioned furthest on the Completeness of Vision axis for the second year running. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715814984/en/ 2026 Gartner® Magic Quadrant™ for Observability Platforms We believe this placement reflects where the market is headed: toward open, composable observability that helps teams in the AI era understand systems that are increasingly complex and agentic, and rapidly scaling thanks to AI-assisted engineering. A Platform Built for the AI Era

Spectro Cloud Raises $100 Million Series D to Help Customers Move AI Infrastructure Into Production Across Enterprise, Public Sector, Neocloud and Sovereign Cloud Environments15.7.2026 18:20:00 CEST | Press release

Growth Equity at Goldman Sachs Alternatives leads oversubscribed round with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus as organizations look to turn AI silicon into business outcomes Spectro Cloud, a leading provider of AI infrastructure management software, today announced it has raised more than $100 million in an oversubscribed Series D funding round led by Growth Equity at Goldman Sachs Alternatives, with strategic participation from AMD Ventures, Ericsson, LG Technology Ventures, and Maximus. The new funding brings Spectro Cloud’s total capital raised to $260 million and will accelerate the company’s mission to help enterprises, public sector organizations, neoclouds and sovereign clouds build and operate production AI infrastructure with greater control over cost, security and governance. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715551858/en/ Spectro Cloud raises $

K-Beauty Goes Global: Sales Surge 53% as Korean Innovation Reshapes Beauty Growth15.7.2026 16:00:00 CEST | Press release

New NIQ data shows K-Beauty value sales rose 53% year-over-year and 131% over two years, underscoring how regional beauty trends, social commerce and ingredient-led innovation are reshaping global beauty growth. NIQ (NYSE: NIQ), a global leader in consumer intelligence, today released new findings showing K-Beauty has become a rapidly growing global beauty segment, with value sales up 53% year-over-year and 131% over the past two years. The data points to a broader shift in beauty growth, as regional innovation, social commerce and digitally driven consumer demand increasingly shape what scales globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260715867578/en/ K-Beauty accelerates across global markets In its latest report, K-Beauty Goes Global, NIQ shows how Korean beauty is reshaping consumer expectations, accelerating innovation cycles and redefining competitive dynamics across the global beauty market. What began

Viz.ai to Support the MINUTE Trial, a Landmark Multicenter Study Evaluating the SCUBA Technique for the Treatment of Intracerebral Hemorrhage15.7.2026 15:00:00 CEST | Press release

Viz Neuro™ Suite, including Viz ICH™ and Viz ICH Plus™, to facilitate rapid detection and care coordination for patients with basal ganglia hemorrhage across trial sites nationwide. Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced its support for the Minimally Invasive Neurosurgery Trial for Ultra-early Treatment (MINUTE) Trial, a prospective, multicenter, randomized study evaluating whether the SCUBA technique, an endoscopic, catheter-based approach for ultra-early evacuation of basal ganglia intracerebral hemorrhage (BGH), is a promising alternative to standard medical management to potentially improve functional patient outcomes. The study aims to initiate both randomization and surgical intervention within 120 minutes of key clinical time points, reflecting the urgent nature of intracerebral hemorrhage care. Participating sites will have the ability to leverage the Viz Neuro Suite platform, including Viz ICH and Viz ICH Plus, to

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