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
Andersen Consulting styrker sit udbud inden for digital transformation med Aesys2.3.2026 04:19:00 CET | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med den italienske virksomhed Aesys og udbygger dermed sine kompetencer inden for teknologi og systemintegration. Aesys blev stiftet i 2013 og er en virksomhed inden for digital teknologi og systemintegration, der leverer komplette it-løsninger. De kombinerer ekspertise inden for softwareudvikling, cloud computing, machine learning og cybersikkerhed med en stærk historik inden for systemintegration til bank- og bilindustrien og hjælper organisationer med at accelerere deres digitale transformation og forstærke deres teknologiske infrastruktur. "Med dette samarbejde kan vi skabe endnu større værdi for kunderne ved at kombinere vores dybe ekspertise inden for systemintegration med Andersen Consultings globale platform," udtaler Samuel Roberto, international business manager hos Aesys. "Sammen vil vi hjælpe organisationer med at styrke deres teknologiske fundament, implementere innovative løsninger inden for områder som machine learning o
GIGABYTE Powers Telecom AI Transformation with End-to-End Infrastructure at MWC 20262.3.2026 02:00:00 CET | Press release
From AI factories and supercomputing to digital twins, cloud hosting, and edge AI, GIGABYTE enables telecommunications operators to turn network data into intelligence, automation, and new revenue streams. GIGABYTE Technology, a global leader known for its engineering excellence in high-performance computing and AI servers, extends its comprehensive end-to-end AI infrastructure portfolio designed specifically for the telecommunications industry at MWC 2026. GIGABYTE’s end-to-end product solutions enable operators to convert massive volumes of network data into intelligence, automation, and new revenue streams, as telecommunications networks evolve from data carriers into AI-powered digital platforms. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260223386188/en/ GIGABYTE Powers Telecom AI Transformation with End-to-End Infrastructure at MWC 2026 From Network Data to AI Value: Building Telco’s AI Factory At the core of the t
Lenovo Unveils Adaptive AI PCs, Modular Concepts, and Lenovo Qira Rollout at MWC 20262.3.2026 00:01:00 CET | Press release
From modular business computing and glasses-free 3D to foldable gaming and system-level AI, Lenovo advances Smarter AI for All At MWC® 2026, Lenovo™ introduces a new generation of adaptive AI devices and forward-looking concepts designed for business professionals, creators, students, and gamers. Headlined by new modular PC architecture, a glasses-free 3D laptop concept, a foldable gaming handheld device, and the initial rollout of Lenovo Qira, Lenovo’s showcase reflects a broader shift in personal computing toward systems that adapt intelligently to people and their environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260301217460/en/ Across its portfolio, Lenovo continues to focus on delivering technology that is more personalized, proactive, and protected, while building a unified AI ecosystem that works naturally across devices. “The AI era will not be defined by a single device or application, but by intelligent
TVCMALL at MWC 2026: Leading Mobile Accessories Wholesale and Smarter Sourcing1.3.2026 07:00:00 CET | Press release
As MWC Barcelona 2026 highlights the growing role of AI, connectivity, and smarter technology systems, the mobile accessories market is entering a new phase defined by speed and complexity. Product categories continue to expand, designs and styles update faster, and retailers are expected to respond to market changes in shorter cycles. Keeping product lines up to date while managing sourcing efficiently has become a real challenge for retailers and distributors across Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260121405485/en/ TVCMALL at MWC 2026: Leading Mobile Accessories Wholesale and Smarter Sourcing At MWC Barcelona 2026, TVCMALL highlights its role as a leading one-stop mobile accessories wholesaler in Europe, with a clear focus on making wholesale and sourcing easier, faster, and more reliable. With more than 18 years of experience, TVCMALL works closely with 30+ leading retail partners across Europe, supp
Biocytogen Announces Clinical Milestone with First Patient Dosed in Phase 1 Trial of IDEAYA’s First-in-Class B7H3/PTK7 Bispecific TOP1 ADC IDE03428.2.2026 01:00:00 CET | Press release
IDE034 is a B7H3/PTK7 bispecific TOP1 ADC designed to target tumor cells expressing both B7H3 and PTK7 preferentially, and is being evaluated as monotherapy and in combination with IDEAYA’s PARG inhibitor IDE161. IDEAYA has dosed the first patient in its Phase 1 trial of IDE034, initially evaluating safety, tolerability, and PK. First dosing triggers a $5 million milestone payment to Biocytogen under the companies’ option and license agreement. Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315), a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies, today announced that its partner IDEAYA Biosciences, Inc. (“IDEAYA”; Nasdaq: IDYA) has dosed the first patient in IDEAYA’s Phase 1 dose-escalation/expansion clinical trial of IDE034, an investigational B7H3/PTK7 bispecific TOP1 ADC. Pursuant to the companies’ option and license agreement, first patient dosing triggers a $5 million
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
