CE Mark for the Sacral Neuromodulation External Trial System to treat urinary dysfunction.- Axonics Modulation Technologies, Inc.

Axonics Modulation Technologies, Inc., announced that it has received the CE mark for its Sacral Neuromodulation External Trial System to treat urinary dysfunction. 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.

Comment: Axonics is currently conducting a 120-patient pivotal clinical study under a 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.