Overview

BlueWind Medical is a bioelectronic medical device company developing the Revi System, the only FDA-cleared implantable tibial neuromodulation device for urgency urinary incontinence in overactive bladder patients. The company was founded in 2010 by Rainbow Medical Group, the Israeli medical device incubator that has been the source of several bioelectronic-medicine portfolio companies. BlueWind operates out of Israel with a US commercial organisation supporting its FDA-cleared Revi launch.

The Revi System

Revi is implanted near the ankle in a single outpatient procedure under local anaesthesia. The small implant sits adjacent to the posterior tibial nerve, the peripheral nerve that carries signals controlling bladder function. Patients activate the implant at home by wearing a lightweight external wearable for short sessions; the wearable transmits power and signal to the implant, which delivers targeted electrical stimulation to the tibial nerve.

The architecture contrasts with the two prior pathways for treating urgency urinary incontinence. Sacral neuromodulation (Medtronic InterStim, and the Axonics R20 line that Boston Scientific acquired in November 2024 for approximately $3.7 billion in equity value) implants a larger pulse generator in the upper buttock with a lead running to the sacral nerve roots near the spine. Percutaneous tibial nerve stimulation (PTNS) delivers similar tibial-nerve stimulation but requires repeated in-office sessions with a needle electrode and no implantable component. Revi keeps the tibial-nerve target but replaces in-office sessions with an at-home wearable that activates a permanent implant.

OASIS clinical data

BlueWind has reported three-year follow-up data from its pivotal OASIS trial, published in the Journal of Urology. The 36-month data showed sustained reduction in urgency urinary incontinence episodes, a favourable safety profile, and 95% patient satisfaction at three years. The two-year readout was published earlier in the same journal.

May 2026 financing

BlueWind closed $47.8 million in combined equity and debt financing on 14 May 2026, with new and existing institutional healthcare investors participating. The company has not publicly named a lead investor. Proceeds will fund continued expansion of the US commercial sales organisation and market-access work to broaden insurance coverage and provider adoption.

Competitive context

Implantable tibial neuromodulation now has two FDA-cleared options: BlueWind’s Revi (the first entrant) and Medtronic’s Altaviva (approved September 2025, the second entrant). Medtronic positions Altaviva inside its broader Neuromodulation portfolio alongside InterStim sacral neuromodulation, while BlueWind is the focused single-product company in the implantable tibial neuromodulation category.