FDA approves integrated sacral neuromodulation system for urinary urge incontinence

The FDA has granted clearance to Neuspera Medical’s integrated sacral neuromodulation (iSNM) system for the treatment of patients with urinary urge incontinence (UUI), the company announced in a news release.¹

Overall, 84.2% of patients achieved at least a 50% reduction in urgent leaks

The iSNM system is intended to provide an alternative to traditional SNM for these patients. According to Neuspera, “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 2 hours daily. When not in use, the therapy disc charges wirelessly, like a smartphone.”

"FDA approval of Neuspera's iSNM system represents a major advancement for millions of patients with UUI," said Howard B. Goldman, MD, vice-chairman of urology at the Cleveland Clinic, Cleveland, Ohio, in the news release.¹ "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."

The approval is supported by landmark results from the pivotal phase 2 SANS-UUI trial (NCT04232696), which were presented at the 2025 Winter Meeting of the Society of Urodynamics Female Pelvic Medicine & Urogenital Reconstruction (SUFU) in Rancho Mirage, California, and shared in news release from Neuspera.^2,3

The study included a total of 128 patients with UUI who were implanted with the battery-free percutaneous SNM device. Overall, 84.2% achieved at least a 50% reduction in urgent leaks. According to Neuspera, these results are “on par with reported rates in recent SNM studies.”

Further, 84% of those who responded to treatment achieved a greater than 75% reduction in UUI symptoms, and 42% of responders achieved a 100% reduction in UUI symptoms. Data also showed a 3.5x clinically significant improvement in quality of life.

The prospective, single-arm SANS-UUI study enrolled adult patients with UUI who were screened and implanted with the device across 34 centers in the US and Europe. Patients included in the study had failed or were not a candidate for more conservative treatment.⁴

Phase 1 of the SANS-UUI study assessed the utilization of the device and determined a length of hours for daily stimulation to be used in phase 2 of the trial. Data from phase 1 of the study were presented at the 2022 SUFU Winter Meeting and showed that among the 34 patients implanted with the device, 90% demonstrated at least a 50% improvement in UUI symptoms at 6- and 12-month follow-up with 2 hours of daily stimulation. Further, 52% of patients were completely dry at 12-month follow-up.⁵

The investigators concluded that 2 hours per day of stimulation led to statistically significant improvements in UUI in this patient population.⁶

Phase 2 of the study is further assessing the safety and efficacy of the system at the length of time determined in phase 1 of the study. The primary efficacy end point is the percentage of patients who experience at least a 50% change in UUI episodes from baseline to 6 months. The primary safety end point is the incidence of device-related serious adverse events at 6 months.

Secondary end points include those outcomes at 12-month follow-up, in addition to other quality of life measures.

Final completion of the SANS-UUI trial is expected in December 2026.

"Neuspera is setting a new standard in UUI therapy with the first integrated SNM system," said Dave Van Meter, CEO of Neuspera, in the news release.¹ "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."

REFERENCES

1. Neuspera Medical receives FDA approval for first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence. News release. Neuspera Medical. Published online and accessed June 18, 2025. https://www.prnewswire.com/news-releases/neuspera-medical-receives-fda-approval-for-first-integrated-sacral-neuromodulation-isnm-system-for-urinary-urge-incontinence-302484795.html

2. Padron O, McCrery R, Sutherland S, et al. Treatment of OAB symptoms using Neuspera’s ultra-miniaturized system: 6-month results of the SAN-UUI phase II study. Presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2025 Winter Meeting. February 16 – March 1, 2025. Rancho Mirage, California. Abstract 46. https://sufuorg.com/docs/meetings/sufu2502/program-book-full.aspx

3. Neuspera Medical announces landmark six-month clinical trial results for the first battery-free percutaneous sacral neuromodulation (pSNM) system for urgency urinary incontinence management. News release. Neuspera Medical Inc. February 26, 2025. Accessed June 18, 2025. https://www.prnewswire.com/news-releases/neuspera-medical-announces-landmark-six-month-clinical-trial-results-for-the-first-battery-free-percutaneous-sacral-neuromodulation-psnm-system-for-urgency-urinary-incontinence-management-302385607.html

4. Neuspera’s implantable sacral nerve stimulation system in patients with symptoms of urinary urgency incontinence (UUI). ClinicalTrials.gov. Last updated May 22, 2025. Accessed June 18, 2025. https://clinicaltrials.gov/study/NCT04232696

5. Neuspera Medical announces first successful implant of the Nuvella System in the second phase of its sans-UUI IDE Clinical Trial. News release. Neuspera Medical Inc. October 10, 2022. Accessed June 18, 2025. https://neuspera.com/neuspera-medical-announces-first-successful-implant-of-the-nuvella-system-in-the-second-phase-of-its-sans-uui-ide-clinical-trial/

6. Padron O, Hanson C, McCrery R, et al. Treatment of urinary urgency incontinence (UUI) with an ultra-miniaturized sacral nerve modulation (SNM) system: Outcomes of the SANS-UUI feasibility study. Presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction 2022 Winter Meeting; February 22-26, 2022; San Diego, California. Abstract 18. https://sufuorg.com/docs/meetings/sufu2202/abstracts.aspx