CA-AXONICS-MODULATION
4.2.2020 12:02:06 CET | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200204005324/en/
Link:
About Business Wire
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
Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 20266.7.2026 15:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™ and the leading third-party support provider for Oracle, SAP and VMware software, today announced it will report earnings after market close on July 30, 2026. The company will host a conference call and webcast on that date to discuss the second quarter 2026 results and the second half 2026 outlook at 5:00 p.m. Eastern / 2:00 p.m. Pacific time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260706560476/en/ Rimini Street to Report Second Quarter 2026 Financial Results on July 30, 2026 A live webcast of the event will be available on Rimini Street’s Investor Relations site via the Rimini Street IR events link and directly via the webcast link. Dial-in participants can access the conference by dialing 1-800-836-8184. A replay of the webcast will be available for one year following the event. About Rimini Street, Inc. Rimini Street, Inc. (Nasda
Orion and Shilpa Medicare Expand Partnership to Develop and Supply Nivolumab Biosimilar for Europe6.7.2026 15:00:00 CEST | Press release
Shilpa Medicare Limited announced that its wholly owned subsidiary, Shilpa Biologicals Private Limited, has entered into a co-development and supply agreement with Orion Corporation for intravenous (IV) nivolumab biosimilar referencing one of the world’s most widely used cancer immunotherapies to widen patient access across Europe. Nivolumab helped usher in the era of immuno-oncology, transforming the outlook for patients with cancers such as melanoma and lung cancer. As the originator approaches loss of exclusivity in Europe, this partnership aims to put a high-quality, EU-GMP-manufactured nivolumab biosimilar within reach of more patients, reducing healthcare burden. In 2025, Nivolumab recorded sales of approximately USD4.1 billion (Source: IQVIA/IMS) Europe — underscoring the scale of the opportunity. Under the agreement, Orion will hold the exclusive rights to register, market, distribute and sell the nivolumab biosimilar across Europe. Shilpa Biologicals will lead product developm
No-Loss Trading Platform UpsideOnly Surpasses 100,000 Users Within Weeks of Launch6.7.2026 14:48:00 CEST | Press release
Rapid growth shows strong demand for a new trading model where users can make market predictions without risking their own capital Perpetuals.com Ltd (Nasdaq: PDC), today announced that UpsideOnly, its risk-free trading and market prediction platform, has seen a surge in new user sign-ups, surpassing the important milestone of 100,000 traders within weeks of its launch on May 19. UpsideOnly lets users make predictions about where global equity, commodity, forex, and crypto markets are heading without ever placing a real trade themselves. Perpetuals uses its own capital to trade on the strongest signals identified by its proprietary AI. If those trades win, Perpetuals shares the profits with the users who helped generate the signal. If the trade doesn’t make money, users lose nothing. Reaching 100,000 users so quickly after launching is a reflection of the enormous demand for a platform that flips the traditional retail trading model on its head, with early platform data showing strong
Klarna Submits Application for U.S. Banking License6.7.2026 14:30:00 CEST | Press release
Klarna (NYSE: KLAR), the global digital bank and flexible payments provider, today announced it has submitted applications to the Utah Department of Financial Institutions and the Federal Deposit Insurance Corporation (FDIC) to establish Klarna Bank USA, a proposed Utah-chartered industrial bank. Klarna has operated as a licensed bank in Europe since 2017 and serves U.S. customers through valued partner banks. Since 2019, Klarna has provided Americans with access to over $91.3 billion in responsible credit, saving them more than $5.1 billion in interest compared to revolving credit card debt. Today, 30 million Americans use Klarna each year, and hundreds of thousands of merchants rely on Klarna to grow their businesses. "Banking is built on trust," said Sebastian Siemiatkowski, co-founder and CEO of Klarna. "We've seen firsthand the appetite for a fairer, more transparent approach in the U.S., and our own banking license is the natural next step, giving customers tools to borrow respon
IQM Quantum Computers Acquires Assets of Quantistry GmbH to Bridge the Gap Between Quantum Algorithms and Solutions for Industrial Enterprises6.7.2026 14:00:00 CEST | Press release
This is a strategic asset acquisition comprising proprietary software and intellectual property of Quantistry GmbH, a pioneer in cloud-native, AI-powered chemical and materials simulation By integrating Quantistry’s advanced simulation platform with IQM’s leading quantum computing hardware, IQM will deliver an end-to-end quantum-classical applications development platform and algorithm libraries powered by a user-friendly native-AI computing environment The transaction secures a critical enterprise software layer that accelerates IQM’s application roadmap, enabling industrial enterprises to develop quantum application proof-of-concepts and scale them over time, backed by a reliable, long-term quantum roadmap It also enhances IQM’s ability to deepen domain expertise across specific industry verticals Quantistry’s core quantum chemistry and machine learning engineering team will join IQM, strengthening the company’s ability to deepen relationships with tier-one industrial enterprises acr
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
