Axonics Receives CE Mark for its Sacral Neuromodulation External Trial System
Axonics announced today that they received CE mark for their Sacral Neuromodulation External Trial System. The External Trial System is an additional element of their r-SNM System used to help identify responders to Sacral Neuromodulation therapy prior to a permanent implant.
What is Axonics Sacral Neuromodulation System?
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.”
Axonics received CE mark in June 2016 for its miniaturized implantable neurostimulator, tined lead, programmers, charger and related accessories.
Axonics has raised over $114 million in equity capital in addition to a $20 million venture loan from Silicon Valley Bank.
While Medtronic's Interstim II currently owns the U.S. market, there is a huge market opportunity for Axonics once they gain regulatory approval.
Here is a slide from Nuvectra, another potential competitor in the SNM space:
Based on data included in Nuvectra's investor deck, they project the SNM market to be valued at ~$690M.
Axonics is well positioned to be the next player in the market next to Medtronic as both the U.S. and European regulatory agencies recently asked Nuvectra for more information on their Virtis system.