Neuspera Medical Announces Milestone Case of Traditional Sacral Neuromodulation (SNM) System Removed and Replaced With the Company's Integrated SNM System for Urinary Urge Incontinence

Patient Struggled with SNM Battery Pain and Complications; Reports Full Complication Relief Following Implant of Neuspera's SNM Therapy

New Patient Registry to Track Outcomes of SNM to iSNM Procedures

SAN JOSE, Calif., Feb. 10, 2026 /PRNewswire/ -- Neuspera® Medical, Inc., the leading developer of integrated technologies powering the future of neuromodulation, today announced a milestone patient revision from a traditional sacral neuromodulation (SNM) system to the recently FDA-approved Neuspera SNM System, an integrated sacral neuromodulation (iSNM) system for urinary urge incontinence (UUI). 

The revision, a follow-up surgery that replaces or repairs an existing implant, was performed at University of Louisville Health (UofL Health) in Kentucky. The patient, a 21-year-old woman, experienced persistent battery discomfort and lead issues after receiving a conventional SNM implant, and a prior surgical revision with the conventional system did not improve her symptoms. After receiving the Neuspera iSNM system, the patient experienced immediate and complete complication relief, according to her surgeon. The case highlights the transformative potential of Neuspera's technology for patients seeking UUI symptom relief without the chronic pain, surgical risks, and restrictions caused by implanted batteries.

"I was in constant pain from the SNM battery and calling my doctor's office often. They tried an initial revision with another SNM battery device, and it still made no difference. Pain was negatively affecting my quality of life and making it even hard to get out of bed," said the patient. "After I received the Neuspera iSNM device, I couldn't believe the difference. The pain is gone, and I finally have my life back! And now my doctor's office is calling me to check in, because it's so strange that they haven't heard from me."

"This case demonstrates the impact of Neuspera's integrated design, resolving pain and complications associated with traditional SNM implanted batteries," said Dr. Kellen Choi, treating urologist at UofL Health. "It's rewarding to see patients regain their freedom and confidence so quickly, substantially improving their quality of life. In addition to the many patients who have not had any advanced treatment for their UUI, we also have many more patients in line who have these common complications of traditional SNM who would like to pursue this new option with no trade-off whatsoever in efficacy." 

Traditional Sacral Neuromodulation (SNM) Systems
Sacral neuromodulation (SNM) has long been considered the gold standard for advanced overactive bladder (OAB) therapy, offering significant symptom relief for patients who do not respond to conservative treatments. With marginal advancements in the past 30 years, traditional SNM systems have notable downsides, including the need for implanted lithium-ion batteries that can lead to pocket pain, infections, lead migration, and fractures; additionally, surgical battery replacement will be required up to 2-3 times during a patient's lifetime depending on age. These complications impact patient quality of life and drive substantial healthcare costs. Scaled across the U.S. healthcare system, these procedures contribute to significant fiscal burden, with revisions and replacements accounting for up to 30% of total SNM-related procedures and costs^1,2 — over $300 million annually.

How Neuspera's Integrated SNM System Works 
Neuspera's integrated SNM system 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 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.

FDA-approved in June 2025, the Neuspera SNM System matches the gold-standard efficacy of traditional SNM while eliminating implanted batteries. A pivotal study of 128 patients implanted with Neuspera's iSNM therapy found:  

• 91% of trial period responders achieved at least 50% reduction in urgent leaks at six months
• 84% of therapy responders were classified as "super responders" with at least 75% improvement
• 42% of patients who responded were completely dry, with 100% reduction in UUI symptoms

Additional pivotal trial data presented at the 2025 American Urological Association Annual Meeting demonstrated statistically significant reductions in complications such as battery pocket pain and infections compared to traditional SNM systems.³

"This case at UofL Health exemplifies how our design, free of implanted batteries, can restore freedom and confidence for patients limited by traditional SNM," said Dave Van Meter, chief executive officer of Neuspera Medical. "By addressing these common complications linked to conventional devices, Neuspera is offering an improved option and empowering individuals to reclaim control over their lives."

Building on this momentum, Neuspera is launching the FREEDOM Registry (Follow-up Revision Experience and Evaluation: Device Outcomes Metrics). This prospective registry will gather patient-reported survey data on experiences, quality of life, pain relief, and satisfaction among people who switch from traditional SNM to Neuspera's iSNM system, for patients experiencing complications (such as battery pocket pain, infections, or lead issues) and those undergoing battery replacements due to depletion.

For more on the Neuspera iSNM system or the FREEDOM Registry, visit www.neuspera.com.

About Neuspera Medical
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 on LinkedIn.

Media Contact: [email protected]

References:

1. 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.
2. Axonics Modulation Technologies, Inc.  Form 10-K for the fiscal year ended October 5, 2018. U.S. Securities and Exchange Commission, 2018. https://www.sec.gov/Archives/edgar/data/1603756/000119312518294804/ d609102ds1.htm#toc609102_9.
3. Padron, O., 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