BlueWind Medical

Company Overview

Snapshot

Founded in December 2010, BlueWind Medical is led by co-founder Yossi Gross and operates with 51–200 employees. The company has raised $64 million across one funding round from ConvaTec and Medtronic. In December 2023, BlueWind Medical expanded the availability of its Revi implantable tibial neuromodulation device to patients in Shreveport, Louisiana.

Business overview

BlueWind Medical is a medical device company focused on transforming neuromodulation therapy for urge urinary incontinence (UUI). The company developed Revi, a miniature, advanced implant designed to be battery-free and eliminate the need for replacement surgeries due to battery changes, lead migration, or lead fracture. Its innovative external wearable technology powers the implant, offering a patient-centric approach that allows for increased energy and stimulation sessions based on individual patient needs. BlueWind Medical serves the healthcare industry, specifically targeting patients with UUI and overactive bladder (OAB) through its implantable medical devices and therapeutic treatments.

Strategic signal

BlueWind Medical is demonstrating strong commercial momentum following regulatory approval. In December 2023, the company made its Revi implantable tibial neuromodulation device available to patients in Shreveport, Louisiana, expanding access to its FDA-approved, battery-free solution for urge urinary incontinence. This move signals the company's focus on market penetration and scaling its patient-centric therapy across the United States, indicating a positive growth trajectory for investors and innovation teams.

Company Intelligence Q&A

What is BlueWind Medical's primary product?

BlueWind Medical's primary product is Revi, an implantable tibial neuromodulation device designed for the treatment of urge urinary incontinence (UUI). The device is miniature, battery-free, and powered by an external wearable technology.

When did BlueWind Medical receive FDA approval for its Revi System?

BlueWind Medical's Revi System secured U.S. FDA De Novo Classification Grant for the treatment of urgency incontinence in August 2023. This approval was based on positive results from the OASIS pivotal trial.

What was a significant commercial milestone for BlueWind Medical in late 2023?

In December 2023, BlueWind Medical expanded the availability of its Revi implantable tibial neuromodulation device to patients in Shreveport, Louisiana, marking a key step in its commercial rollout following FDA approval.

What were the key findings from the OASIS pivotal trial for BlueWind Medical's system?

Results from the OASIS pivotal trial, presented in May 2023, showed significant improvement in urgency urinary incontinence (UUI) symptoms, with 78% of implanted patients and 82% of those completing the study achieving at least a 50% reduction in UUI episodes at 12 months.

When did BlueWind Medical raise its Series B funding round?

In May 2022, BlueWind Medical raised a $64 million Series B funding round, led by ConvaTec, to support its commercial footprint and potential FDA marketing clearance for its device.