Axonics Modulation Technologies, Inc. (NASDAQ:AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) system, today announced it achieved two milestones that expand its commercial reach in France and Norway. Specifically, the French Haute Autorité de Santé (“HAS”) published a positive recommendation required to gain reimbursement in France, and in Norway, a contract was awarded to supply the Axonics r-SNM® System to SNM-implanting hospitals in key cities.

The technical and clinical evaluation by HAS concluded that the therapeutic benefit of the Axonics r-SNM System for the treatment of Overactive Bladder is sufficient for registration on the Liste des Produits et Prestations Remboursables (“LPPR”). Registration is anticipated by the end of Q1 2020 following approval by the French Department of Health. HAS noted the advantages of the Axonics r-SNM System compared to InterStim®, in particular the opportunity to reduce the number of surgical procedures related to neurostimulator replacements as a result of the Axonics 15+ years long-lived implant, as well as the ability for patients to undergo full-body MRI scans without the necessity of having the device explanted. Approximately 1,000 patients receive an SNM implant in France every year.

In Norway, Axonics now has the opportunity to supply SNM products to six hospitals that were part of an evaluation process conducted by the national hospital procurement trust, Sykehusinnkjøp HF. The award states that buying decisions will be left up to implanting physicians to determine if the Axonics r-SNM System or that of the incumbent is best suited for individual patients. If a physician deems the systems to be equally suitable for a patient, it is the lifecycle costs that should determine which SNM system is selected. Approximately 500 SNM systems are envisioned to be implanted over the next four years in Norway.

 Raymond W. Cohen, CEO of Axonics, commented, “While we are keenly focused on the U.S. commercial launch following our recent FDA approval, we continue parallel efforts to selectively expand our global reach, focusing on countries where reimbursement levels and the volume of implants allow our rechargeable SNM system to benefit more patients. This positive French HAS recommendation is based on an in-depth review of our technical and clinical evidence, and is testament to the technology benefits and quality of work at Axonics.”

Cohen continued, “In Norway, we look forward to supplying our product to this network of hospitals. We are confident that given a choice, patients and providers will choose and benefit from Axonics’ technology, and the healthcare system will capture the cost savings associated with our long-lived device.”