Neuspera Medical has reported encouraging 12-month pivotal trial results for its integrated sacral neuromodulation system (iSNM), Neuspera SNM, in patients with urinary urge incontinence (UUI).
The results were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting and also included new data indicating that 30 minutes of daily therapy may be sufficient for symptom relief.
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Southern Urogynecology Wellness and Aesthetics’ medical director Andrea Pezzella presented outcomes from all 128 implanted patients. Key findings included 94% of test-phase responders experienced at least a 50% decrease in episodes of UUI.
Furthermore, 81% of therapy responders were identified as super-responders, demonstrating a reduction of at least 75%, and 43% became completely dry, showing a total elimination of symptoms.
The Neuspera system features an ultra-miniaturised implant powered by an external transmitter. It is designed to overcome shortcomings found in conventional SNM devices, including issues with infections, battery replacements, and battery-related revision surgeries, which may become more common with weight loss linked to glucagon-like peptide-1 (GLP-1) agonist use.
Over 12 months, the Neuspera SNM System showed an excellent safety profile with zero serious device-related adverse events and zero infections. Device-related adverse events were rare, mild and resolved quickly, with incidence rates between 0% and 3% across categories.
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By GlobalDataNeuspera Medical CEO David Van Meter said: “We are very encouraged by these comprehensive 12-month outcomes and initial data of a reduced therapy regimen.
“Neuspera continues to advance the treatment of urinary urge incontinence by combining the gold-standard efficacy of sacral neuromodulation with an improved safety profile and patient experience compared to traditional systems.
“We extend our sincere thanks to the investigators and clinical teams across the US and in Europe whose partnership is helping bring this innovative therapy to patients.”
In June 2025, the US Food and Drug Administration approved Neuspera Medical’s iSNM system for treating UUI.
