Neuspera Medical Shares Trial Data for Integrated Sacral Neuromodulation System

Neuspera Medical Inc. has released positive 12-month outcomes¹ from its pivotal trial of the Neuspera SNM System, an integrated sacral neuromodulation (iSNM) device for urinary urge incontinence (UUI). The company also announced new data suggesting just 30 minutes of daily iSNM therapy may provide UUI symptom relief.

The 12-month outcomes data for all 128 implanted patients demonstrated:

• 94% of test-phase responders achieved at least 50% reduction in urgent urinary incontinence episodes
• 81% of therapy responders were classified as super-responders with at least 75% reduction in UUI episodes
• 43% of therapy responders were completely dry with 100% reduction in UUI episodes

An ultra-miniaturized, implanted solution powered with an external transmitter, the Neuspera system is designed to address common shortcomings of conventional SNM, such as battery replacements, infections, and implanted battery-related revision surgeries; these battery-related issues may become more frequent with weight loss associated with widespread GLP-1 agonist use. As anticipated, the Neuspera SNM System maintained an excellent safety profile, with no serious device-related adverse events (AEs) and no infections through 12 months, the company reported. Device-related AEs were rare, generally mild, and resolved quickly, with incident rates of 0% to 3% for all AE categories.

In addition to the Neuspera system study results, the company also shared promising initial data using a reduced therapy regimen of a 30-minute daily stimulation. At one month, all patients experienced UUI episode reductions ranging from 73% to 100%, consistent with outcomes from longer therapy durations in the pivotal trial. Neuspera will present additional data on shorter stimulation durations at the American Urological Association Annual (AUA) Meeting later this year.

“It’s exciting to see the durability of the therapy response over time since sustained effectiveness is ultimately what matters for patients,” said Andrea Pezzella, M.D., Southern Urogynecology Wellness and Aesthetics. “Additionally, seeing meaningful clinical benefit with shorter daily stimulation sessions is very encouraging. Reduced therapy time could improve the patient experience while maintaining outcomes, and I look forward to further clinical evaluation of this approach.”

Neuspera’s integrated SNM system (iSNM) 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 with a battery worn against the lower back for a daily therapy session. 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.^2,3

“We are very encouraged by these 12-month outcomes and initial data of a reduced therapy regimen,” Neuspera Medical CEO David Van Meter stated. “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 United States and in Europe whose partnership is helping bring this innovative therapy to patients.”

Neuspera Medical develops advanced, directionally adaptive energy systems that power tiny medical implants. 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 U.S. Food and Drug Administration in June 2025.

References
¹ Pezzella, Andrea et al. “Neuspera’s Ultra-Miniaturized Sacral Neuromodulation (SNM) System for UUI: 12-Month Outcomes from the SANS-UUI Phase II Study.” SUFU 2026 Winter Meeting Abstracts. Neurourology and Urodynamics, 45(S1), S7-S219.
² Bretschneider CE, et al. “Device-Related Reoperations 8 Years Following Sacral Neuromodulation Implantation in Older Women”. Int Urogynecol J. 2024 Dec;35(12):2349-2355.
³ Padron, Osvaldo, et al. “MP30-12 Results of the SANS-UUI, Phase II Study: Safety Outcomes at 6-Months for Patients with OAB Symptoms Using Neuspera’s Ultra-Miniaturized System Compared to the Published Standard of Care.” Journal of Urology 213.5S (2025): e1029.