Neuspera Medical has received the US Food and Drug Administration (FDA) approval for its integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI).
iSNM offers a novel alternative to traditional sacral neuromodulation (SNM), addressing a condition that affects approximately one in five women in the US.
The system provides a patient-friendly solution, eliminating the discomfort and surgical risks associated with traditional SNM therapies.
Neuspera CEO Dave Van Meter said: “Neuspera is setting a new standard in UUI therapy with the first integrated SNM system.
“Our mission is to remove barriers to care with a smart, patient-centred 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.”
iSNM therapy leverages a miniaturised neurostimulator implanted near the sacral nerve.
The system is activated by wearing an external disc against the lower back for approximately two hours daily, with wireless charging capabilities.
Its advanced design addresses common patient concerns, offering effective neuromodulation therapy without compromising performance.
The FDA approval follows a six-month clinical trial that showed comparable efficacy to existing SNM treatments, without the need for implanted batteries.
The Phase 2 clinical study involved 128 patients and revealed promising outcomes. Results showed that 84.2% of patients experienced a 50% or greater reduction in urgent leaks.
In addition, 84% of responders were classified as ‘super responders’, achieving more than a 75% reduction in UUI symptoms, while 42% of responders were completely ‘dry’.
Cleveland Clinic urology vice-chairman Howard Goldman said: “FDA approval of Neuspera’s iSNM system represents a major advancement for millions of patients with UUI.
“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.”
Last year, Neuspera secured $23m in a Series D funding round, led by Vertex Ventures HC and Treo Ventures, with participation from Action Potential Venture Capital, Windham Venture Partners, Olympus Innovation Ventures, and another strategic investor.
