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Axonics To Host Presentation Of Full 2-Year Clinical Results From ARTISAN-SNM Pivotal Study On Sept. 9

Axonics® to Host Presentation of Full 2-Year Clinical Results from ARTISAN-SNM Pivotal Study on September 9 Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is

· 09/02/2020 10:01

Axonics® to Host Presentation of Full 2-Year Clinical Results from ARTISAN-SNM Pivotal Study on September 9

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, will host a webinar on September 9 during which principal investigators of the ARTISAN-SNM pivotal study will present full 2-year clinical results.

Axonics previously announced topline results of the study at 2-years, which demonstrated that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life.

Complete detailed study results on efficacy, quality of life improvement, patient satisfaction, recharge experience, and safety will be presented by Felicia Lane, M.D., FPMRS, of the University of California, Irvine and Andrea Pezzella, M.D., FPMRS, FACOG, of Southern Urogynecology in West Columbia, South Carolina. The discussion will be moderated by Karen Noblett, M.D., FPMRS, chief medical officer of Axonics.

The live webinar will begin at 8:00 p.m. Eastern Time / 5:00 p.m. Pacific Time on Wednesday, September 9. Interested parties are requested to register in advance of the webinar by visiting axonicswebinars.com. A replay of the webinar will be available shortly after the conclusion of the event.

ARTISAN-SNM study

The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study to evaluate the safety and efficacy of the Axonics r-SNM System. The study was conducted in 14 centers in the U.S. and five centers in Western Europe. All patients diagnosed with urinary urge incontinence were implanted with a tined lead and the Axonics miniaturized rechargeable neurostimulator in a non-staged (no external trials) procedure. Pre and post implant efficacy data was collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a satisfaction questionnaire. Therapy responders at follow-up were identified as patients with at least a 50% reduction in urinary urgency incontinence episodes compared to baseline. Any patient that did not meet the reduction criteria or who dropped out of the study were counted as non-responders. A total of 121 participants completed the 2-year follow-up visit, which concludes the ARTISAN-SNM study.

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.

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