The US Food and Drug Administration (FDA) has approved Neuspera Medical’s integrated sacral neuromodulation (iSNM) system for treating urinary urge incontinence (UUI).
The California-based company’s iSNM system is implanted near the sacral nerve, with therapy activated using an external disc worn against the lower back for around two hours each day.
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Neuspera’s FDA approval was based on data from its pivotal Phase II study. A total of 128 patients were enrolled in the single arm, multi-centre trial (NCT04232696) who had a UUI diagnosis greater than or equal to six months before the screening baseline visit date, having failed or proven not proven to be suitable candidates for alternative UUI treatments such as pelvic floor training or behavioural modification.
A total of 84.2% of patients treated with Neuspera’s iSNM system had a 50% or greater reduction in urgent leaks, with 84% of patients who responded to treatment classified as “super responders”, meaning they experienced more than a 75% reduction in UUI symptoms. 42% of patients reported being completely “dry”, with a 100% reduction in UUI symptoms at the six-month follow-up.
Commonly associated with an overactive bladder, UUI is a type of urinary incontinence in which individuals have a sudden, intense urge to urinate, often resulting in involuntary urine leakage before the toilet is reached.
Neuspera CEO Dave Van Meter commented: “Our mission is to remove barriers to care with a smart, patient-centred solution that truly improves quality of life for the millions impacted by UUI.
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By GlobalData“This FDA approval is a proud and meaningful moment for the entire Neuspera team and our clinical partners, whose passion and dedication made it possible.”
Founded in 2013, Neuspera has so far raised around $123m in financing, with its most recent funding round pulling in $23m in 2024.
Neuromodulation is being applied in a variety of areas, from managing chronic migraines to alleviating the symptoms of Parkinson’s disease.
According to a report by GlobalData, the global neurological devices market will reach a valuation of $20.9bn by 2033, up from $12.5bn in 2023.
