BlueWind Medical Lands $47.8M to Scale 'Smart Ankle' UUI Therapy

SALT LAKE CITY, UT – May 14, 2026 – BlueWind Medical, Ltd., a medical technology firm at the forefront of neuromodulation, has successfully closed a $47.8 million financing round, signaling strong investor confidence and paving the way for the accelerated commercialization of its groundbreaking Revi® System for urgency urinary incontinence (UUI).

The capital, a mix of equity and debt from new and existing institutional healthcare investors, will be strategically deployed to expand the company's commercial sales force and bolster market access initiatives. The goal is to make the innovative therapy more widely available to the millions of individuals whose lives are profoundly affected by UUI.

"Urgency urinary incontinence affects millions of people, creating a significant need for effective, durable treatment options that fit seamlessly into patients’ lives," said Kerry Nelson, Chief Executive Officer of BlueWind Medical, in a statement. "This financing reflects deep conviction in our team, our technology, and the opportunity ahead to establish Revi as the new standard of care."

A New Approach to a Persistent Problem

Urgency urinary incontinence is more than a minor inconvenience; it's a debilitating condition that can dictate every aspect of a person's life, from social engagements to professional activities. The condition, a primary symptom of overactive bladder (OAB), affects an estimated 34 million Americans. For many, first-line treatments like behavioral changes and medications offer insufficient relief or come with undesirable side effects, leaving them in search of better options.

BlueWind Medical aims to fill this gap with its patient-centric Revi® System. The recent funding is a critical milestone in this mission.

"This financing is an important milestone for BlueWind and a strong validation of the progress we are making as a leader in Implantable Tibial Neuromodulation for urgency urinary incontinence," added Stephen Armstrong, the company's Chief Financial Officer. "The capital allows us to scale our commercial organization, expand market access, and ensure that more patients and providers can benefit from a clinically proven, patient-centric therapy."

The Science of Tibial Neuromodulation

The Revi® System represents a significant evolution in neuromodulation therapy. It is the first and only FDA-cleared Implantable Tibial Neuromodulation (ITNM) device that is activated by an external wearable. This unique approach leverages the posterior tibial nerve, located near the ankle, as an access point to the central nervous system to help regulate bladder control.

The system consists of a miniature, battery-free implant, roughly the size of a nickel, which is placed just under the skin near the ankle during a single, minimally invasive outpatient procedure performed under local anesthesia. This design elegantly sidesteps many of the complications associated with other implantable neuromodulation devices, such as lead fracture, migration, or the need for subsequent surgeries to replace internal batteries.

Patients take control of their own therapy at home. Using a lightweight, wireless wearable worn around the ankle, they activate a 30-minute stimulation session once a day. This patient-led approach is designed for convenience and long-term adherence, integrating treatment into a daily routine rather than requiring frequent clinic visits.

Backed by Robust Clinical Evidence

The strong investor confidence is built upon a foundation of compelling clinical data. The pivotal OASIS study, which followed 151 women with UUI, has demonstrated remarkable long-term success for the Revi® System.

Three-year results from the study confirmed the therapy's sustained effectiveness. An impressive 79% of participants were classified as therapy responders, meaning they experienced at least a 50% reduction in their UUI episodes. Furthermore, 63% of patients saw their UUI episodes decrease by 75% or more. The data also showed a significant decrease in nocturia, or waking at night to urinate.

Crucially, patient satisfaction has remained exceptionally high. At the 36-month mark, 95% of patients reported satisfaction with the therapy, and 82% felt "much better" or "very much better" since receiving the implant. The safety profile has been equally strong, with no device- or procedure-related serious adverse events reported throughout the three-year follow-up period.

Navigating a Competitive and Complex Market

BlueWind Medical enters a competitive landscape for advanced UUI treatments. The market has long been dominated by sacral neuromodulation (SNM) systems from industry giants like Medtronic and Axonics, which involve implanting a device near the sacral nerves in the lower back. While effective, these systems are more invasive and require battery replacement surgeries.

Other competitors in the tibial nerve stimulation space include percutaneous systems that require weekly clinic visits and, more recently, other implantable devices like Medtronic's Altaviva and Valencia Technologies' eCoin. However, Revi®'s unique design—a battery-free implant activated by an external wearable—sets it apart.

Successfully navigating the market requires more than just innovative technology; it demands a clear path to reimbursement. BlueWind has made significant strides here. The Centers for Medicare & Medicaid Services (CMS) issued a favorable decision for 2025, increasing the national Ambulatory Surgical Center (ASC) payment rate for the Revi® procedure by 40% to $19,839. This financial validation is critical for encouraging adoption by hospitals and clinics.

To further streamline the process for patients and providers, the company has established "Revi Access," a dedicated support program designed to assist with insurance authorizations, appeals, and billing complexities. These strategic moves in both the clinical and commercial arenas are positioning the Revi® System not merely as an alternative, but as a potential first-choice advanced therapy for a wide range of patients suffering from the burdens of UUI.