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Graduate Stimvia exits NYU Stern's prestigious accelerator, aiming U.S. LAunch for bladder therapy gadget

New York University Stern alumnus, Stimvia, is now directing U.S. marketing efforts towards their bladder therapy device, URIS, following successful completion of the elite EFL program.

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NYU Stern alumnus Stimvia launches into the American market with a bladder therapy device as their...
NYU Stern alumnus Stimvia launches into the American market with a bladder therapy device as their primary focus

Graduate Stimvia exits NYU Stern's prestigious accelerator, aiming U.S. LAunch for bladder therapy gadget

The Stimvia URIS System, a non-invasive neuromodulation device developed by Czech MedTech company Stimvia, has recently made its mark in the competitive U.S. market for Overactive Bladder (OAB) treatment.

Stimvia URIS System: FDA Clearance Status

As of mid-2025, the Stimvia URIS System has received FDA clearance for the treatment of Overactive Bladder. The device falls under the Class II medical device category, often cleared through the 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. This clearance allows the Stimvia URIS system to be marketed and used clinically in the U.S. for OAB management. The device is designed for peripheral neuromodulation, often targeting nerves like the tibial nerve to modulate bladder activity.

Overview of Stimvia URIS System

The Stimvia URIS System is a minimally invasive neuromodulation therapy that typically employs transcutaneous or percutaneous electrodes to stimulate nerves that influence bladder control. It offers an alternative to more invasive treatments like sacral nerve stimulation (SNS) devices. The focus on patient convenience, safety, and ease of use sets it apart from other devices in the market.

Competitors in the U.S. Neuromodulation Market for Overactive Bladder

The neuromodulation market for OAB treatments is competitive, with several key players and devices. Some of the leading competitors include:

  1. Medtronic InterStim™ System - The market leader in sacral nerve stimulation (SNS). FDA-cleared and widely used for refractory OAB treatment. Surgically implanted device targeting sacral nerves (usually S3). Offers a proven record of efficacy but involves a surgical procedure.
  2. Axonics r-SNM System - A rechargeable, implantable sacral neuromodulation device FDA-cleared for OAB, fecal incontinence, and urinary retention. Smaller device size and longer battery life compared to InterStim. Provides full-body MRI compatibility.
  3. BlueWind RENOVA™ iStim - A minimally invasive implant targeting the tibial nerve. FDA cleared via the de novo or 510(k) pathway. Offers an outpatient procedure with a small implant. Competes in the peripheral neuromodulation segment.
  4. Bioness StimRouter™ Neuromodulation System - Primarily aimed at chronic pain but exploring OAB indications. Percutaneous stimulation options.
  5. Innovo™ and similar devices - External neuromodulation devices for OAB using transcutaneous stimulation. FDA cleared as non-invasive options, but typically have different mechanisms and efficacy profiles.

Market Position Summary

The Stimvia URIS System competes primarily in the peripheral neuromodulation segment, especially targeting tibial nerve stimulation with minimally invasive or non-invasive approaches. Its key differentiators may include device design, ease of use, treatment protocols, and cost. It provides an alternative to more invasive SNS implants, appealing to patients who want to avoid surgery or who have contraindications to implantable devices.

The market still favours established players like Medtronic and Axonics for implantable SNS due to long-term data and clinician familiarity. Peripheral systems, including Stimvia URIS, are growing rapidly as first-line or adjunct therapies in OAB management.

Summary Points

| Aspect | Stimvia URIS System | Leading Competitors | |-------------------------------|---------------------------------------------|----------------------------------------| | FDA Clearance | Yes (510(k) cleared for OAB) | Medtronic InterStim, Axonics r-SNM, BlueWind RENOVA iStim | | Mode of Neuromodulation | Peripheral nerve stimulation (e.g., tibial) | Sacral nerve stimulation (implantable) | | Invasiveness | Minimally invasive or external | Surgical implant (Medtronic, Axonics) | | Patient Convenience | High; often outpatient procedure | Implantation requires surgery | | Market Segment | Peripheral neuromodulation | Sacral neuromodulation (SNS) |

For the latest FDA documentation or clinical trial results for the Stimvia URIS System, consulting the FDA’s device database or the manufacturer's official publications is recommended, as new indications and clearances can evolve rapidly in this field.

  1. The FDA clearance granted to the Stimvia URIS System falls under the Class II medical device category, demonstrating substantial equivalence to a legally marketed device as part of the 510(k) pathway.
  2. In the healthcare and wellness sector, the Stimvia URIS System competes primarily in the peripheral neuromodulation segment, focusing on tibial nerve stimulation with minimally invasive or non-invasive approaches.
  3. The digital health industry observes rapid growth in the market for peripheral neuromodulation systems, such as the Stimvia URIS System, as first-line or adjunct therapies in OAB management.
  4. Investors have shown interest in the medical plastics industry, as advancements in science lead to the development of innovative neuromodulation devices like the Stimvia URIS System, which cater to various medical-conditions like Overactive Bladder.

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