|Axonics SNM System--Courtesy of Axonics|
Barely 6 months after raising a $38.5 million Series B to advance its neuromodulation implant to treat overactive bladder and fecal dysfunction, Axonics Modulation Technologies won a CE mark for the device.
In addition to the EU marketing approval, Irvine, CA-based Axonics has also received approval from some centers in Western Europe to start a 65-patient postmarket clinical follow-up (PMCF) study, Axonics said in a statement. According to ClinicalTrials.gov, the University College London Hospital in the U.K. will host one of these studies, but has yet to start recruiting. Axonics did not disclose plans for U.S. trials.
The Sacral Neuromodulation System (SNM) implant is comprised of a four-electrode-tined lead, a remote control, a wireless charging system and a dedicated touchscreen tablet for lead placement and programming. It is 60% smaller than Medtronic's ($MDT) FDA- approved InterStim SNM implant, which is intended to increase patient comfort. It is also the first rechargeable implant for this indication and has a 15-year life span, said to be three times longer than Medtronic's device.
While the device can spare patients from additional procedures to replace the device, it also reduces costs for the U.S. healthcare system by as much as $12 billion over the next 15 years, Axonics said in the statement. Currently, patients with non-rechargeable devices require replacements, and therefore surgeries, every four to 5 years, Dr. Karen Noblett of the UC Riverside School of Medicine said in the statement
An estimated 85 million adults in the U.S. and Europe suffer from an overactive bladder, while another 40 million are affected by fecal incontinence. More than 200,000 patients have undergone SNM therapy in the U.S. and Europe, and the therapy has proven superior to standard drug treatments. With its durability and size advantages, the company hopes Axonics' implant has the potential to challenge Medtronic's domination in the space.
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