One-year Pivotal Study Results from ARTISAN-SNM to be Presented at Plenary Session
IRVINE, Calif.–(BUSINESS WIRE)–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 bladder and bowel dysfunction, today announced it will exhibit its FDA approved1 r-SNM® System at the joint scientific meeting of the American Urogynecologic Society (AUGS) and the International Urogynecological Association (IUGA) (www.augs-iuga2019.org) being held at the Music City Center in downtown Nashville, Tenn., from September 24 – 28.
As a platinum sponsor of the meeting, Axonics will be displaying the Axonics r-SNM System in the exhibit hall (booth #501) and is sponsoring a lunch symposium on Thursday, September 26, during which physician investigators from its ARTISAN-SNM pivotal study will be discussing their experience and their patients’ feedback with the Axonics System.
In addition to the exhibition and lunch symposium, the one-year results of the ARTISAN-SNM study will be presented at a plenary session on Saturday, September 28, by the study co-PI Felicia Lane, M.D., Vice Chair, Clinical Affairs, OBGYN, School of Medicine at the University of California, Irvine. At one-year, patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in bladder symptoms and quality of life.
“AUGS/IUGA is the first major medical conference at which our U.S. commercial team is on hand to present our recently approved system and meet physicians who are experienced at implanting SNM devices,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “As a platinum sponsor of the conference, we have established broad exposure of the Axonics brand and a maximum visibility location to detail the Axonics r-SNM System. The long-lived nature of the device, designed for 15+ years in the body, should result in a significant reduction in the serial replacement surgeries associated with the legacy non-rechargeable implant. We believe that benefit, along with our published clinical data and additional differentiating features, will prove to be highly attractive to this audience of health care providers.”
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. 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.axonicsmodulation.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.
1The FDA approval grants Axonics the right to market its product in the U.S. for the clinical indication of fecal incontinence. The Company has an additional PMA currently under review with the FDA and anticipates approval in the coming weeks for the clinical indications of overactive bladder and urinary retention.
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
Investor & Media Contact
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