Axonics’ rechargeable sacral neuromodulation system is an implantable device that works by stimulating the sacral nerve, which is responsible for bladder and bowel function. It is designed to last for 15 years in the body, and already has approval in Australia, and in Canada. It does not yet have approval in the US, and Axonics has 2019 in its sights for premarket approval of their product to treat urinary and fecal dysfunction.
“Axonics seeks approval for it's rechargeable sacral neuromodulation system“
Axonics’ CEO Raymond Cohen said: “Axonics started about four-and-a-half years ago and we have developed a miniaturized neuromodulation device. We decided to go after the clinical indication of urinary dysfunction and fecal dysfunction. We decided that this was the place wanted to focus given we felt that the patient population was dramatically underserved, meaning that there are nearly six million to 10 million patients in the U.S. that are taking drugs that are not effective to treat their urinary dysfunction. We have completed the enrollment and implant stage of a pivotal study in the U.S. under an IDE and all of our patients have been implanted as of the end of June. All of our patients will reach the six-month-endpoint at the end of December and then the company will file with the agency and hopefully receive PMA approval within a relatively modest timeframe. I would invite every company that has any capabilities in this area to come on down and join the fray. The rising tide floats all boats and I would suggest that as we grow this market from $700 million to $1.5 billion we’ll get plenty of company. The other companies in the neuromodulation spaces that are adjacent will probably want to put their eyes on this urinary and fecal dysfunction market. We thank that’s fine and that competition is healthy. But here are the facts, we spent $115 million over four years with a crack engineering team motivated like crazy to build the perfect product for sacral modulation.”