Neuspera Medical Submits IPO Filing Highlighting Breakthrough pSNM Therapy with 84.2% of UUI Patients Achieving ≥50% Reduction in Urinary Leaks

Mar 03, 2025 21:45 CST Updated 21:45

NeuSpera

Developer of Implantable Medical Devices

Neuspera MedicalPresented six-month clinical data on its battery-free percutaneous sacral nerve stimulator, NeuSpera, at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) meeting; the study showedNeusperaComparable clinical efficacy to traditional sacral nerve stimulators.

Specific Study Data (6-Month Postoperative Follow-Up of 128 Patients with Urinary Incontinence)

84.2% of implanted patients experienced a ≥50% reduction in urgency urinary incontinence, with efficacy comparable to that reported in recent SNM studies
84% of responders achieved the "super-response" criterion (>75% reduction in UUI symptoms)
42% of responding patients achieved a completely "dry" state (100% elimination of UUI symptoms)
Quality of life index significantly improved by 3.5-fold, with concurrent reductions in urinary frequency and urgency episodes

PI Evaluation

"These results confirm that pSNM technology offers an innovative, implant-free battery option while maintaining efficacy comparable to traditional SNM. The treatment can"Accessibility is crucial for patients. On the basis of providing sustained relief from urgency urinary incontinence (UUI) symptoms, pSNM eliminates the limiting factors associated with conventional therapies for certain patients. We look forward to this regimen bringing benefits to more patients after its approval.

---Colin Goudelocke Ochsner Health System

Executive Evaluation

“Key trial results validate our founding vision—achieving a revolutionary breakthrough in SNM therapy by eliminating the need for implanted batteries. Our device offers a transformative alternative to traditional SNM, avoiding the physical and psychological burdens associated with invasive implantation surgeries and subsequent battery replacements.”

---Alexander Yeh, Founder and Chief Technology Officer of NeuSpera Medical

"Although sacral neuromodulation technology has significantly improved patients' quality of life for decades, implanted batteries have always been the main technical bottleneck. For millions of patients awaiting better options, we are about to provide a more user-friendly solution. As the FDA approval process advances, pSNM technology is expected to redefine the standard of care for UUI treatment."

---Dave Van Meter, Executive Chairman of NeuSpera Medical

Neuspera

NeusperaIt is the first ultra-miniaturizedPeripheral NerveStimulator(PNS), which is smaller than the smallest commercially availableThe pulse generator is 75 times smaller, and compared to currently available technologies, it providesPhysicians have the opportunity to target deeper anatomical sites.

NeusperaComposed of micro-implantable electrodes, a wearable wireless generator, and an app.

Micro-implantable electrode

The micro-implantable electrode has a diameter of only 2 mm and a volume of just 0.03 ml. Its modular structure enables compatibility with various neural interfaces.Micro-implantable electrodeIt features a range of programmable stimulation parameters, including frequency, pulse width, and amplitude (voltage) for current control, thereby offering significant flexibility in addressing common neurostimulation applications.

NeusperaUtilizing proprietary Mid Field Powering technology, enabling wearable wireless generators to powerLong-Distance Micro-Implant ElectrodesCharging, Depth of ChargeAchievable10cmThe above.

Meanwhile, the micro-implantable electrode employs a proprietary sealing technology, thereby reducing its size to only that of traditionalNeuSpera’s 1% neural modulator simplifies and controls the entire implantation procedure, reducing postoperative pain and complications for patients.

Wearable Wireless Generator

The wearable wireless generator is compact and lightweight, capable of being deeply implanted within the body.Wireless Charging of Micro-Implantable Electrodes. In addition to wireless charging, the transmitter features automatic detection (of micro-implant electrodes and human tissue), automatic power steering, and automatic data collection.

APP

Patients can access NeuSperaInstalled inOn the mobile phoneNeuspera APP, adjust their treatment parameters, modulate stimulation status, and perform other functions.

NeuSpera Demo

Neuspera Medical

Neuspera MedicalNeuSpera Medical, Inc. is an innovative medical device company dedicated to developing implantable medical devices to improve the lives of patients battling chronic diseases. The NeuSpera platform aims to provide patients and physicians with new, potentially earlier, less invasive, and more adaptable treatment options. These therapies are designed to help patients restore their health and well-being, thereby enhancing their quality of life.