Axonics Modulation Technologies said today it won FDA investigational device exemption clearance to engage in a pivotal study of its r-SNM rechargeable sacral neuromodulation system designed for treating overactive bladder and bowel dysfunction.
The Irvine, Calif.-based company said it expects to begin enrolling patients in the clinical study in November, aiming to enlist 120 patients at 15 centers in the US and Western Europe.
“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. 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,” CEO Raymond Cohen said in a press release.
The single-arm, prospective pivotal study will look to examine the safety and effectiveness of the r-SNM system as an aid to treating urinary urgency incontinence with patients who failed or couldn’t tolerate more conservative treatments, the company said.
“The endpoints of the Artisan-SNM pivotal study are comparable to published clinical literature for urinary dysfunction. We will be analyzing, among other things, the proportion of responders to SNM therapy at six months post-implant based on reduction in urinary urgency incontinence episodes from the patient’s baseline diary. There has been an overwhelming response from the Urology and Urogynecology community to be part of this pivotal study and, as a result, we have some of the most experienced and prolific implanters as study investigators,” chief medical officer Dr. Karen Noblett said in a prepared statement.
In July, Axonics said that it put another $21 million in its coffers in the second tranche of a Series C round for its sacral nerve modulation technology in treating overactive bladder syndrome.