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Axonics Modulation Technologies (NASDAQ: AXNX) has submitted a premarket approval supplement to the FDA for its implantable sacral neuromodulation systems, aiming to gain MRI conditional labeling with detachable extremity coils. This addition allows for enhanced MRI scanning capabilities, particularly for extremities, which comprise about 24% of all MRI scans. The expanded labeling would increase access and safety for patients during imaging. FDA review is expected within 180 days, and this move highlights Axonics' commitment to innovation in patient care.
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) has initiated a post-market clinical registry study called ARTISTRY to gather real-world data on the Axonics r-SNM® System for treating urinary and bowel dysfunction. The study aims to enroll up to 300 patients across 30 centers in the U.S. and Canada, assessing effectiveness, safety, and patient experiences over a year. The chief medical officer highlighted that bladder and bowel dysfunction often go undertreated, and the new registry will enhance clinical evidence supporting Axonics' innovative SNM therapy, improving quality of life for many.
Axonics Modulation Technologies (NASDAQ: AXNX) will release its third quarter 2020 financial results on November 4, 2020, after market close. A conference call will follow at 4:30 PM ET, accessible via phone and webcast. Axonics specializes in implantable sacral neuromodulation devices for urinary and bowel dysfunction, impacting millions in the U.S. and Europe. Their SNM therapy has proven effective in restoring pelvic floor function and has wide reimbursement support. The company is known for its first long-lived rechargeable SNM system, now widely available at medical centers.
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