Neuspera Medical’s percutaneous sacral neuromodulation (pSNM) has hit the “gold standard”, with 84.2% of patients suffering incontinence benefitting from a 50% reduction in urgent leaks and a more than three-fold improvement in quality of life.
The US medical device company’s Phase II pivotal clinical trial (NCT04232696) comparing its pSNM system against published data from traditional sacral neuromodulation (SNM) devices also saw 42% of patients declared completely ‘dry’ – a 100% reduction in leaks.
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Six-month results from the company’s single-arm trial also saw 84% of patients with urinary urgency incontinence (UUI) classified as “super responders,” meaning they experienced more than a 75% reduction in symptoms.
Neuspera says its pSNM device is different from other SNM devices in that it is both implanted percutaneously near the sacral nerve through a small cannula and able to be powered by way of a proprietary belt-worn disk that powers the device wirelessly.
The company also claims that its percutaneous approach allows it to avoid the potentially painful infections associated with the devices’ placement.
Trial investigator Dr Colin Goudelocke said: “These results demonstrate that Neuspera’s pSNM technology provides similar effectiveness to traditional SNM devices while offering an alternative to a traditional implanted battery.
“Having options available for our patients is so crucial, and pSNM provides consistent relief from UUI while removing what can be an obstacle for some. I look forward to offering this option to my patients once it receives regulatory approval.”
Neuspera submitted a request for premarket approval (PMA) to the US Food and Drug Administration (FDA) in September 2024. Research by GlobalData’s Medical Device Intelligence Center estimates that in 2023 the urology devices market brought in $34.06bn, with that figure predicted to rise to $64.33bn by 2032, driven by an ageing population and greater prevalence of conditions such as diabetes or obesity.
GlobalData is the parent company of Clinical Trials Arena.
UUI is typically a symptom of conditions such as overactive bladder. Research by the US National Institutes of Health (NIH) found that up to 40% of women and 30% of men in the country have overactive bladder with the condition becoming more common past the age of 65.
Neuspera’s executive chairman Dave Van Meter said: “SNM has delivered life-changing symptom relief for decades, but implanted batteries remain a significant limitation.
“Neuspera is poised to offer a more patient-friendly solution to the millions of patients waiting for a better option. With FDA approval expected this year, we believe the pSNM technology will establish a new standard in UUI therapy.”
Elsewhere in the field of incontinence, FemPulse is set to enter the pivotal clinical trial with its neuromodulation system to treat overactive bladder after the FDA granted the company an investigational device exemption (IDE).
Pharmaceutical options include Pfizer’s Detrol (tolterodine), an FDA-approved oral muscle relaxant to treat overactive bladders with symptoms of urge urinary incontinence, urgency, and frequency.
