Neuspera Medical Reveals Groundbreaking pSNM Clinical Trial Findings
Neuspera Medical Pioneers a Battery-Free Solution for UUI
Neuspera Medical, a leader in the development of wireless energy technology, has made significant strides in bioelectronic medicine by introducing its innovative battery-free percutaneous sacral neuromodulation (pSNM) system. This system addresses a common yet distressing condition known as urgency urinary incontinence (UUI). Recent pivotal clinical trial results indicate that this groundbreaking system delivers efficacy comparable to traditional sacral neuromodulation (SNM) devices while enhancing patient comfort and experience.
Understanding UUI and Its Impact
UUI is a key player in overactive bladder (OAB), a condition affecting around 300 million individuals globally. Within the U.S., one in five women experience UUI, making it a widespread concern that significantly hampers quality of life. The rising demand for effective treatments has spurred innovations aimed at reducing the burdens associated with traditional treatments.
Introducing Neuspera's pSNM System
Neuspera's pSNM system sets itself apart by being the first device of its kind—completely wireless and battery-free. This design mitigates many complications associated with traditional systems, such as surgical procedures to implant batteries, infections, and the discomfort of visible implants. The simplicity of Neuspera's pSNM offers a user-friendly alternative that addresses patients' most pressing concerns.
Clinical Trial Results Highlight Efficacy
The six-month pivotal clinical trial involved 128 patients and revealed compelling results. Key findings included:
- 84.2% of patients
- 84% of treatment responders
- 42% of participants
- Participants noted a 3.5x improvement
Dr. Colin Goudelocke, a urologist involved in the clinical trial, emphasized the importance of having alternatives available for patients. He noted that Neuspera's pSNM technology stands as a testament to effective treatment options while alleviating the burden of battery implants.
Transformative Patient Experience
Neuspera's pSNM therapy fundamentally alters how patients experience treatment. Traditional systems often require multiple surgical interventions and involve implants that can result in various complications. In contrast, Neuspera's approach involves a simple implantation of the ultra-miniaturized neurostimulator, which is vastly smaller than traditional devices.
How Does the Therapy Function?
The pSNM system consists of just two components: a small neurostimulator located near the sacral nerve and an external therapy disc. The neurostimulator is inserted through a minimally invasive procedure requiring no stitches, leading to quicker recovery. Patients activate the therapy using the disc for just two hours daily—making it an appealing option for those who lead active lifestyles.
Future of UUI Treatment with Neuspera
Neuspera is on the verge of reshaping the landscape for UUI treatments. With the anticipated regulatory approval from the FDA, expected soon, the pSNM technology is set to become a new standard in UUI therapy. The company received approval for its Premarket Approval (PMA) application and eagerly awaits the next stages of implementation, poised to deliver on its commitment to enhance patient outcomes.
About Neuspera Medical
Neuspera Medical, Inc. spearheads the innovation of wireless, adaptive energy systems designed for the intricate demands of bioelectronic medicine. As part of their mission, Neuspera aims to redefine treatment for conditions like UUI, expanding access through less invasive, battery-free solutions. With a view to revolutionize the booming overactive bladder market, which is currently valued at $1 billion, Neuspera foresees making substantial strides towards patient-centered care.
Frequently Asked Questions
What is Neuspera Medical's primary innovation?
Neuspera Medical's primary innovation is the pSNM system, which is a battery-free and wireless method for treating urgency urinary incontinence.
How does the pSNM system improve patient experience?
By eliminating the need for an implanted battery, the pSNM system reduces surgical invasiveness and complications like infections and discomfort.
What results did the clinical trial reveal?
The clinical trial showed that a significant percentage of patients experienced substantial relief from UUI symptoms, with many proving to be 'super responders.'
How is the pSNM device different from traditional SNM systems?
Unlike traditional systems, the pSNM device requires only a minimal implantation procedure and operates without the complications associated with batteries.
What is the expected timeline for FDA approval?
Neuspera anticipates receiving regulatory approval from the FDA soon, following their recent PMA submission.
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