Neuspera Medical announced six-month pivotal clinical trial data highlighting the efficacy of its battery-free percutaneous sacral neuromodulation (pSNM) system.
Findings showed comparable efficacy with the pSNM system against traditional sacral neuromodulation (SNM) devices. it also aims to offer a significantly better patient experience for the treatment of urgency urinary incontinence (UUI).
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San Jose, California-based Neuspera plans to present results at the 2025 winter meeting of the Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction (SUFU) next week.
Neuspera’s discreet, non-invasive device received FDA clearance last year for the treatment of chronic pain of peripheral nerve origin. It’s currently an investigational device for treating urinary urge incontinence (UUI), a symptom associated with OAB. Neuspera’s pSNM approach aims to address common complaints reported in patient forums for UUI. That includes painful infections around the battery pocket, unwanted battery movement, persistent discomfort, visible bulging and additional required surgeries for battery replacement.
The company last year featured on our list of 7 neurotech companies you need to know. It also raised $23 million in a Series D round last summer.
Results from 128 patients implanted with the pSNM therapy found that 84% of patients had a 50% or greater reduction in urgent leaks. That landed on par with reported rates in recent SNM studies. Additionally, 84% of patients responding to treatment were classified as “super responders.” That means more than a 75% reduction in UUI symptoms.
Neuspera said that 42% of patients who responded registered as completely “dry” with 100% reduction in UUI symptoms. Quality of life improved by 3.5 times, the company said, with a reduction in voids and urgent episodes.
“The pivotal trial results validate the founding vision of Neuspera – that we could revolutionize SNM therapy by eliminating the need for an implanted battery,” said Alexander Yeh, Neuspera founder and chief technology officer. “Our device offers a transformative alternative to traditional SNM, removing the stigma and burden of an invasive surgical implant and eventual battery replacement surgery.”
