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
Acceleronix, IDEMIA Secure Transactions and Orange Announce Flexible, Single-SKU Manufacturing with Quantum-Safe IFPP4.11.2026 16:44:00 CET | Press release
One SKU. Every market. Connectivity decided at the end of production. Live at electronica 2026. Orange, one of the world’s leading telecom operators, has joined the global quantum-safe In-Factory Profile Provisioning (IFPP) program, jointly launched by Acceleronix and IDEMIA Secure Transactions at MWC Barcelona in February. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104070181/en/ Acceleronix, IDEMIA Secure Transactions and Orange announce flexible, single-SKU manufacturing with quantum-safe IFPP The program enables device makers to build a single product for every market and connect it to the Orange network before it leaves the factory. Acceleronix and IDEMIA Secure Transactions will demonstrate the solution live at electronica 2026, the international electronics trade fair, at Messe München, Hall C2, Stand 601, from 10 to 13 November. Most connected devices share the same weak spot: provisioning and testing on the pr
U.S. FDA Grants Priority Review to BeOne Medicines’ BRUKINSA Combination in First-Line Mantle Cell Lymphoma4.11.2026 15:13:00 CET | Press release
If approved, BRUKINSA plus rituximab would be the first and only chemotherapy-free, BTK inhibitor-based regimen for adult patients with previously untreated mantle cell lymphomaApplication supported by Phase 3 MANGROVE data, showing a 43% reduction in the risk of progression or death versus bendamustine plus rituximabFull MANGROVE results to be presented during the Plenary Scientific Session at the 68th American Society of Hematology Annual Meeting BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for BRUKINSA® (zanubrutinib) in combination with rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL). The application is supported by data from the pivotal Phase 3 MANGROVE study, in which this chemotherapy-free regimen significantly reduced the risk of dis
Rimini Street Awarded CANUT Third-Party Maintenance Framework Agreement4.11.2026 15:00:00 CET | Press release
This framework agreement provides all entities subject to the French Public Procurement Code with simplified access to a support alternative enabling them to control their costs, preserve their freedom of technological choice and free themselves from vendor-imposed upgrade cycles 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 that it had been selected as the awardee of the third-party support service lots (TMA) by CANUT, the French public purchasing center specializing in digital technology and telecommunications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261104431817/en/ Rimini Street Awarded CANUT Third-Party Maintenance Framework Agreement Eligible public organizations subject to the French Public Procurement Code can now benefit from Rimini Street services for their Oracle, SAP, VMw
Incyte to Present New Data Highlighting Progress Across its Hematology Portfolio at ASH 20264.11.2026 15:00:00 CET | Press release
New data in myeloproliferative neoplasms (MPNs) will include INCA033989, Incyte’s first-in-class, mutant calreticulin (mutCALR)-targeted monoclonal antibody, in first-line myelofibrosis (MF); and preclinical findings for Incyte’s next-generation mutCALR- and JAK2V617F-targeted compoundsUpdated results for INCA033989 in second-line MF and second-line essential thrombocythemia (ET) will build on previously presented datasetsLong-term Phase 1/2 data further characterize the potential of latarcibart (VGA039), an investigational Protein S-targeting antibody, as prophylaxis in adolescents and adults with von Willebrand disease (VWD)More than 30 abstracts will highlight progress across Incyte’s broader hematology portfolioIncyte will host an investor event and webcast on Saturday, December 12, 2026 from 7:30 – 9:00 p.m. CT (8:30 – 10:00 p.m. ET) Incyte (Nasdaq:INCY) today announced that new data highlighting progress across its hematology portfolio will be presented across more than 30 abstra
Zenitar Announces Initiation of International Randomized Study of Flonoltinib Maleate in Patients with Myelofibrosis and Related American Society of Hematology 2026 Meeting Presentations4.11.2026 15:00:00 CET | Press release
Chengdu Zenitar Biomedical Technology Co., Ltd. (Zenitar) is developing flonoltinib maleate (FM), a first-in-class oral JAK2/FLT3/CDK6 inhibitor for myeloproliferative neoplasms (MPNs), including myelofibrosis (MF) and polycythemia vera (PV). Zenitar launched randomized Phase 2 FM-MF-02 (NCT07750574) in the US, Canada and Brazil to select Phase 3 dose for JAKi-naïve and refractory MF. Randomized FMF-02 (NCT06457425) met its week-24 endpoints: superior SVR35 and TSS50 with FM 50/100mg versus ruxolitinib; previous data presented orally at ASH24 (#486) and ASH25 (#908). ASH 2026 presence covers FMF-02 long-term follow-up (oral presentation, #411, December 12, 4:30pm) and refractory PV Phase 2 data (poster, #3765, December 13, 6pm), both in Session 634. “Over the 15 years since the initial FDA approval of Ruxolitinib, JAKi have markedly improved the prognosis of many patients with MF. The long-term data show significant room for improvement for this key therapeutic class in terms of both e
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
