Urinary incontinence is a significant concern for many individuals, and Neuspera Medical has developed an implantable sacral neuromodulation (SNM) system to address this issue. The company’s device has met the primary endpoint in its trial, showing promise for treating urinary urge incontinence. With these positive results, Neuspera is preparing to submit the data to the US Food and Drug Administration (FDA) for regulatory approval.
The SANS-UUI multi-centre, single-arm clinical study aimed to demonstrate the safety and efficacy of Neuspera’s SNM implant. Participants received two hours of stimulation daily for six months, and the trial successfully met its primary endpoint, significantly improving symptoms of urge urinary incontinence over this period. The SNM system includes a micro-implant that delivers neurostimulation therapy through a wireless platform, featuring a wearable transmitter and an iPad-based clinician programmer. The device is implanted in a single procedure and wirelessly powered via an external device for short daily durations.
Innovative Urinary Incontinence Treatments: Neuspera and UroMems Lead the Way
This innovative approach to treating urinary incontinence is part of a broader trend in the medical device industry to address various types of incontinence. Most existing devices primarily target stress incontinence. For instance, UroMems is testing an implantable device called MyoElectroMechanical for managing stress urinary incontinence in both men and women. This device is placed around the urethral duct and adjusts the sphincter opening based on the patient’s activity, thereby helping to manage incontinence.
Neuspera’s recent progress is supported by substantial financial backing. Earlier this month, the company raised $23 million in Series D financing to fund the premarket approval process for its SNM implant. This financial boost comes on the heels of the device being cleared by the FDA as a peripheral nerve stimulation (PNS) device to treat chronic pain in April.
Urinary Incontinence Market Sees Advancements with Pelvital’s Flyte Device
Other companies are also making strides in the urinary incontinence market. In February, Pelvital published results from a study of its Flyte device, which is designed to treat women with stress urinary incontinence (SUI) and weakened pelvic floor muscles. The trial involved 119 participants, and an impressive 71% achieved dry or near-dry status within two to 12 weeks. Remarkably, all respondents maintained their improved quality of life two years post-treatment.
These advancements reflect a growing recognition of the importance of innovative solutions for urinary incontinence, a condition that significantly impacts the quality of life for millions of individuals. Neuspera’s SNM implant represents a promising development in this field, offering a novel approach to managing urinary urge incontinence through minimally invasive neurostimulation therapy.
With the successful completion of its clinical trial, Neuspera is now poised to seek FDA approval. If approved, the SNM implant could provide a much-needed treatment option for patients suffering from overactive bladder symptoms, particularly urinary urge incontinence. The company’s commitment to addressing this widespread issue underscores the potential of cutting-edge medical technologies to improve patient outcomes and enhance quality of life.
In summary, the field of urinary incontinence treatment is witnessing significant advancements, with Neuspera’s SNM implant standing out as a promising solution. As the company moves forward with its FDA submission, the future looks hopeful for those seeking effective treatment options for urinary urge incontinence. The continued innovation and investment in this area highlight the ongoing efforts to provide relief and improve the lives of individuals affected by urinary incontinence.
Resource: Medical Device Network, July 24, 2024
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