Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, announced today that it has received the CE mark for its Sacral Neuromodulation External Trial System.
Axonics received CE mark in June 2016 for its miniaturized implantable neurostimulator, tined lead, programmers, charger and related accessories. The External Trial System is an additional element of the Axonics r-SNM System used to help identify responders to Sacral Neuromodulation therapy prior to a permanent implant. It is composed of a temporary, single-use disposable external stimulator that is connected to either a Tined Lead or a temporary Peripheral Nerve Evaluation (PNE) Lead, depending on the preferred trial method.
This EU regulatory approval coincides with the commercial launch of the Axonics r-SNM System in the United Kingdom. Additional regulatory approvals in Europe are expected in the near term, including full-body MRI conditional labeling.
Axonics is currently conducting a 120-patient pivotal clinical study under a U.S. Food & Drug Administration (FDA) Investigational Device Exemption for urinary dysfunction and on June 27, 2018, announced completion of the enrollment and implant phase. The Company anticipates FDA approval in the United States after the 6-month post-implant endpoint has been reached for all patients and the FDA has completed its review of the pre-market approval (PMA) application for the Axonics r-SNM System.
“To date, over 225 patients have been implanted with an Axonics r-SNM System in Europe and North America, the vast majority of which without undergoing an external trial period before permanent implant. We demonstrated that with quality lead placement and confirmation of intraoperative responses, outstanding clinical results can be achieved without an external trial,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “However, from a commercial standpoint, having an External Trial System is necessary given that payors prefer to reimburse permanent implants after confirming that the patient is a trial responder. We are confident that Axonics is now well positioned to capture significant worldwide share and, due to the benefits of our product offering, accelerate growth in the large $700 million Sacral Neuromodulation market.”
In April 2018, Axonics raised its latest round of capital to support commercialization activities in Europe and in the U.S. Since March 2014, with the support of a number of the world’s highest profile venture firms located in the U.S., France, the United Kingdom, the Netherlands, Switzerland and China, Axonics has raised over $114 million in equity capital in addition to a $20 million venture loan from Silicon Valley Bank.