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Axonics® Announces Publication of ARTISAN Clinical Study Results in the Journal of Urology

Axonics Modulation Technologies, Inc. (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 results from its ARTISAN-SNM study were published online in the peer-reviewed Journal of Urology (https://doi.org/10.1097/JU.0000000000000458).  This is the first journal publication to detail outcomes for patients in the United States treated with a rechargeable sacral neuromodulation system. The study, conducted under a U.S. Food & Drug Administration (FDA) Investigational Device Exemption (“IDE”), found that 90% of all implanted patients with the Axonics r-SNM® System had successful therapy outcomes. Read more.

Source: Business Wire, July 29, 2019

product approval introduction

Axonics® Receives IDE Clearance from US FDA to Conduct Pivotal Study

Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States.  “During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients.” Read more.

Source: Pharmaweb, November 7, 2017

Florence Italy ICS 2017

Positive Results for the Axonics® RELAX-OAB Clinical Presented at ICS

Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter clinical study at the 2017 International Continence Society (ICS) Congress in Florence, Italy.  The presentation, entitled “A prospective multicenter clinical study evaluating a miniaturized rechargeable sacral neuromodulation system for the safe and effective treatment of overactive bladder (RELAX-OAB study),” was delivered by Bertil F.M. Blok, M.D., PhD, Dept. of Urology, Erasmus University Medical Centre, Rotterdam, Netherlands.  Read more.

Source: Business Wire, September 13, 2017

product approval introduction

Axonics Sacral Neuromodulation System for Urinary and Fecal Dysfunctions

Axonics Modulation Technologies won European regulatory approval for its Sacral Neuromodulation System (SNM), a product designed to treat overactive bladder, urinary retention, and fecal incontinence.  The device is rechargeable, and so can be used for longer periods than similar devices that have to be replaced with new batteries periodically.  Read more.

Source: Medgadget, June 7, 2016