Neuspera Medical Announces 12-Month Pivotal Trial Results for the Company's Integrated Sacral Neuromodulation System for Urinary Urge Incontinence

• 94% of Test-Phase Responders Achieved Significant Symptom Relief with Zero Serious Device-Related Adverse Events
• New Data Suggests 30 Minutes of Daily iSNM Therapy Provides UUI Symptom Relief

SAN JOSE, Calif., March 5, 2026 /PRNewswire/ -- Neuspera^® Medical, Inc., the leading developer of integrated technologies powering the future of neuromodulation, announced 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 findings were presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting, Feb. 27, 2026.

Presented by Andrea Pezzella, MD, URPS, FACOG, Southern Urogynecology Wellness and Aesthetics, 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

The Neuspera system, an ultra-miniaturized, implanted system powered with an external transmitter, 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 zero serious device-related adverse events (AEs) and zero infections through 12 months. Device-related AEs were rare, generally mild, and resolved quickly, with incident rates of 0-3% for all AE categories. 

Dr. Pezzella also presented promising initial data using a reduced therapy regimen of just 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 Dr. Pezzella. "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."

"We are very encouraged by these comprehensive 12-month outcomes and initial data of a reduced therapy regimen," said David Van Meter, CEO of Neuspera Medical. "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."

How Neuspera's iSNM System Works
Neuspera's integrated SNM system (iSNM) offers all the capabilities of traditional SNM in a highly advanced form factor. A smart, miniaturized neurostimulator is carefully 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

About Neuspera Medical, Inc.
Neuspera^® Medical, Inc. is a leader in 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 FDA in June 2025. Learn more at neuspera.com and on LinkedIn.

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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.

SOURCE Neuspera Medical