Axonics Modulation Technologies (NSDQ:AXNX) said today that results from its Artisan-SNM pivotal study highlighted durable outcomes and significant improvements in patients implanted with the Axonics r-SNM system for patients with urinary and bowel dysfunction.
The announcement came one day after the company said it entered into an exclusive agreement to supply the Axonics r-SNM System to Adult Pediatric Urology & Urogynecology in Omaha.
The r-SNM sacral neuromodulation system, which won FDA clearance last month, is designed to treat urinary and bowel dysfunction in adults and features a neurostimulator about the size of a USB drive that lasts 15 years in the body.
The one-year Artisan-SNM study was a single-arm, prospective, multi-center, unblinded pivotal clinical trial with 129 patients observed at 14 U.S. centers and five more in Europe. Results were presented last month at a plenary session at the joint scientific meeting of the American Urogynecologic Society and the International Urogynecological Assn.
Results showed that 89% of patients responded to the therapy, as urgency incontinence episodes across all patients reduced from an average of 5.6 per day at baseline to 1.3 per day at six months. A total of 77% of therapy responders had a reduction in their urgency incontinent episodes greater than 75%.
A 34-point improvement on the ICIQ-OABqol score showed that patients experienced a clinically meaningful improvement in quality of life, while there were no serious device-related adverse events.
In total, 124 of the 129 patients remained in the study at one year post-implant, as 93% of those treated were satisfied with the r-SNM therapy.
“AUGS/IUGA was the first major medical conference at which our U.S. commercial team was on hand to present our system and meet physicians who are experienced at implanting SNM devices – a key milestone and a truly successful event for Axonics,” CEO Raymond Cohen said in prepared remarks. “We accomplished our objective of establishing broad exposure of the Axonics brand and generating significant interest in our product among top SNM implanters. We were particularly pleased with the attendance at the sponsored symposium which exceeded our expectations. In addition, the presentation of comprehensive one-year clinical results, which highlighted clinically significant symptom relief to patients, was also well received by the audience of health care providers.”
The agreement to supply the r-SNM system to the ADPU comes after the Nebraska-based company has been implanting SNM devices for over a decade. ADPU purchases approximately $2.5 million of SNM devices annually, according to a news release.
Axonics said ADPU is the first large group practice in the United States to make Axonics the sole supplier of r-SNM systems for its patients.
“We are excited to be the first private group practice in America to work exclusively with Axonics,” ADPU’s Dr. Rebecca McCrery said in prepared remarks. “We believe the advantages of the Axonics System are significant compared to the legacy product. The small size of the implant and long-lived nature of the rechargeable system will mitigate numerous replacement surgeries. The easy-to-use programmer, intuitive accessories and MRI compatibility combine for a superior patient experience. Axonics is clearly committed to this market, and we encourage our fellow implanters to make the switch.”
Shares of AXNX were up 2.6% at $26 per share in late-morning trading today.
