ARTISTRY will enroll up to 300 patients across 30 centers in North America and include patients across all four clinical indications for Axonics Therapy
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, has launched a new post-market clinical registry study to collect and analyze real-world data of patients treated with the Axonics r-SNM® System.
The Axonics Sacral Neuromodulation System Registry (ARTISTRY), a prospective, multicenter registry, anticipates enrolling up to 300 patients across 30 centers in the United States and Canada. Patients with symptoms of urinary urgency incontinence, urinary urgency frequency, non-obstructive urinary retention and fecal incontinence will be included in the study. ARTISTRY will collect real-world data on technical aspects of the procedure, effectiveness, safety, and patient experience with the Axonics System. Patients will be followed for one year, with clinical data documented and assessed at various time points over the course of the study.
Karen Noblett, M.D., FPMRS, chief medical officer of Axonics, said, "Patients with bladder and bowel dysfunction are significantly undertreated and struggle to find long-term relief. Sacral neuromodulation, which historically has been used as a therapy of last resort, is now experiencing a renaissance based on Axonics bringing new and effective technology to the market. As a result, SNM has the potential to meaningfully improve quality of life for millions of patients. This registry will be an important contribution to expanding the body of clinical evidence for Axonics and further demonstrate that there is a long-lived, easy-to-use, highly effective treatment available to those suffering from these debilitating conditions."
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. Axonics SNM therapy, which has been clinically proven to reduce symptoms and restore pelvic floor function, is now being offered at hundreds of medical centers across the U.S. and in dozens of select hospitals in Western Europe. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. The Axonics System is the first long-lived rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit 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 "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.
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