Axonics Modulation Technologies said today it won CE Mark approval in the European Union for its SNM sacral nerve modulation system and announced the publication of a cost-efficacy study of the device in Neurourology and Urodynamics.
The SNM rechargeable neuromod system is designed to treat overactive bladder, urinary retention and fecal incontinence through sacral nerve stimulation, the Irvine, Calif.-based company said.
The company did not announce plans for commercialization of the device in the region, but said it is preparing to launch a 65-patient post-market clinical follow up study.
“Axonics has successfully developed a unique product to deliver SNM therapy that we believe will greatly improve the patient and clinician experience. We look forward to treating patients in our upcoming PMCF study,” CEO Raymond Cohen said in a press release.
Newly published data from a study of the device, which aimed to assess cost savings to U.S. healthcare payers through the use of the system, indicated a possible savings of more than $12 million over the next 15 years, the company said.
“The Axonics device promises increased patient comfort given its small size and moreover, the fact that it is rechargeable and can function 3 times longer in patients will eliminate the need for repeat surgeries to replace non-rechargeable devices that currently require replacement every 4 or 5 years. Our economic study findings clearly show the Axonics System has the ability to also lower healthcare costs potentially allowing more patients to benefit from SNM therapy that has been proven over many years to improve the quality of life of patients suffering from urinary and fecal dysfunction,” Dr. Karen Noblett of the University of California Riverside School of Medicine said in a prepared statement.
Last December, Axonics said it raised $38.5 million in a Series B financing round for its SNM device.
Proceeds from the round were used to fund a clinical study of its neurmod device in treating overactive bladder patients, which began enrollment in early 2016 in Europe and North America.
The round was led by Edmond de Rothschild Investment Partners and joined by new investors Advent Life Sciences and Cormorant Asset Management, and returning investors NeoMed Management, Legend Capital, The Alfred E. Mann Foundation and select private individuals.