Company Announces U.S. Registry Study to Advance Understanding of Treatment Patterns and Outcomes
IRVINE, Calif.--(BUSINESS WIRE)--May 19, 2020--
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the publication of the 1-year results from its ARTISAN-SNM study in the peer-reviewed journal Neurourology & Urodynamics (“NAU”)https://doi.org/10.1002/nau.24376. Axonics also plans to launch a multi-center registry study in the United States to collect additional real-world clinical evidence on the performance, safety and patient experience with the Axonics r-SNM® System across all approved indications to advance physician knowledge and patient access to rechargeable sacral neuromodulation therapy.
“People with urgency incontinence are undertreated and struggle to find long-term relief. The persistent robust response and satisfaction with the Axonics r-SNM System demonstrates that there is a promising new option for people that have been suffering with this condition,” said Karen Noblett, M.D., a board-certified urogynecologist and chief medical officer of Axonics. “Neurourology & Urodynamics is the official journal of both the Society for Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) and the International Continence Society (ICS), so it has wide distribution among our target clinician audience. We look forward to sharing the 2-year ARTISAN results when available in the fall to add to our growing body of clinical data.”
The publication in NAU confirms the quality and relevance of the ARTISAN study outcomes. Using a conservative "as treated" analysis method, the 1-year results found that 89% of all implanted patients with the Axonics r-SNM System had successful therapy outcomes, and 93% of treated patients were satisfied with their r-SNM therapy. Currently, 2-year follow-up visits in the ARTISAN study are ongoing.
About Axonics Modulation Technologies, Inc.
Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. 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 world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonics.com.
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 “plans,” “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.
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Source: Axonics Modulation Technologies, Inc.