"Neuspera Medical Receives FDA Approval for First Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence
Neuspera® Medical, Inc., the leading developer of integrated technologies powering the future of neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has approved its integrated sacral neuromodulation (iSNM) system for the treatment of urinary urge incontinence (UUI).
• Neuspera's iSNM system offers patients with UUI an alternative to traditional SNM.
• UUI is a major component of overactive bladder, a condition that affects approximately 1 in 5 women in the U.S.
• UUI has a major impact on quality of life, driving the demand for more effective and patient-friendly treatment options.
Six-month pivotal trial data showed the Neuspera iSNM device delivers efficacy comparable to established SNM therapies, while eliminating the discomfort, surgical risks, and cosmetic concerns of implanted batteries.1,2 The Phase II pivotal clinical study of 128 patients implanted with Neuspera's iSNM therapy found:
• 84.2% of patients had a 50% or greater reduction in urgent leaks3 – on par with reported rates in recent SNM studies.1,2
• 84% of patients who responded to treatment were classified as ""super responders,"" meaning they experienced more than a 75% reduction in UUI symptoms.
• 42% of patients who responded were completely ""dry,"" with 100% reduction in UUI symptoms.
• 3.5x clinically significant improvement in quality of life with a reduction in voids and urgent episodes.
• ""FDA approval of Neuspera's iSNM system represents a major advancement for millions of patients with UUI,"" said Dr. Howard Goldman, vice-chairman of Urology at the Cleveland Clinic.
• ""For too long, patients have had to weigh the benefits of SNM therapy against real concerns about complications related to implanted batteries and the need for surgeries to replace it. Neuspera's integrated system provides symptom relief without these additional burdens.""
• Neuspera's integrated Sacral Neuromodulation (iSNM) system offers all the capabilities of traditional SNM in a highly advanced form factor.
• A smart, miniaturized neurostimulator is implanted near the sacral nerve, and therapy is activated using an external disc worn against the lower back for approximately two hours daily.
• When not in use, the therapy disc charges wirelessly, like a smartphone.
• This intelligent system supports complex neuromodulation therapy delivery while eliminating complications related to implanted batteries, addressing common patient concerns without compromising performance.
• ""Neuspera is setting a new standard in UUI therapy with the first integrated SNM system,"" said Dave Van Meter, CEO of Neuspera.
• ""Our mission is to remove barriers to care with a smart, patient-centered solution that truly improves quality of life for the millions impacted by UUI. 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.""
• Neuspera® Medical, Inc. is a leader in advanced, directionally adaptive energy systems that power tiny medical implants deep within the body. The company is introducing a new class of neurostimulation technology, starting with the first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence (UUI), approved by the FDA in June 2025. Learn more at neuspera.com and LinkedIn.
Media Contact: media@capwellcomm.com
• Axonics Artisan Study: McCrery, Rebecca, et al. ""Treatment of Urinary Urgency Incontinence Using a Rechargeable SNM System: 6-Month Results of the ARTISAN-SNM Study."" The Journal of Urology, vol. 203, no. 1, 2020, pp. 185-192.
• Medtronic Interstim Micro Study: Goudelocke, Colin, et al. ""Evaluation of Clinical Performance and Safety for the Rechargeable InterStim Micro Device in Overactive Bladder Subjects: 6-Month Results from the Global Postmarket ELITE Study."" Neurourology and Urodynamics, vol. 42, no. 4, 2023, pp. 761-769.
• Neuspera SANS-UUI Study: Padron, Osvaldo et al. ""Treatment of OAB Symptoms Using Neuspera's Ultra-Miniaturized System: 6-Month Results of the SANS-UUI Phase II Study. Presented at: Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) 2025 Winter Meeting; February 25–March 1, 2025; Palm Springs, CA. Abstract, SUFU 2025.
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