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02/08/2024

BlueWind Medical Brings Revi Implantable Tibial Neuromodulation Device to Patients in Central Ohio

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Revi is a minimally invasive, patient-centric solution that empowers patients and redefines the treatment of urge urinary incontinence

PARK CITY, Utah, February 8, 2024 — BlueWind Medical, Ltd., a pioneer in the development and commercialization of a patient centric implantable Tibial NeuroModulation (iTNM) solution for urge urinary incontinence (UUI), is excited to announce that Revi is now available in Springfield, Ohio

at Ohio Valley Surgical Hospital with urologist Dr. Eric Espinosa.

“I am thrilled to have a new solution to offer patients with Urge Incontinence—a common condition that has a profound impact on quality of life. Revi is proven to be a safe and effective therapy reducing the number of leaks patients have and it stands out for its patient-centric design, allowing for tailored adjustments to optimize therapy,” stated Dr. Eric Espinosa. “My patients like the fact that Revi is placed in the ankle region in an outpatient procedure under local anesthesia, which makes it a more appealing and convenient option for them. The ease of Revi also allows me to perform several procedures back-to-back, as I did today.”

Revi is the only minimally- iTNM implant that is activated by a battery-operated external wearable unit. Revi is implanted near the ankle during a single outpatient procedure performed under local anesthesia, and without the potential adverse events seen with other surgical UUI therapies. When activated, the Revi implant stimulates the posterior tibial nerve to provide relief from UUI. For activation, a lightweight wireless wearable is placed around the ankle once or twice daily to provide stimulation at the patient’s convenience. 

BlueWind has achieved several milestones with Revi recently that demonstrate its commitment to innovation in patient care. The US Food and Drug Administration (FDA) granted a De Novo marketing request on August 16,2023, for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. In October, the American Medical Association (AMA) CPT Editorial Panel announced the final Current Procedural Terminology (CPT) code to describe the subfascial tibial neuromodulation implant procedure, 0817T. In November, the Centers for Medicare & Medicare Services (CMS) finalized the 2024 facility payment (unadjusted national average of USD $20,854 related to hospital outpatient services) for subfascial procedures for tibial neuromodulation that pertain to the Revi device.

“Revi has the potential to revolutionize the treatment landscape for UUI by giving patients more control, comfort, and convenience. We are honored that Dr. Espinosa is bringing this life-changing technology to the people of Central Ohio. We know that millions of people suffer from UUI and we feel privileged to help them regain their confidence and dignity,” said Dan Lemaitre, Chief Executive Officer of BlueWind Medical.

About BlueWind Medical Ltd.

BlueWind Medical is transforming the field of neuromodulation therapy through the development of innovative, patient-centric medical technology for the treatment of disease. BlueWind is committed to enhancing the quality of life and overall wellbeing of patients with an initial focus on those living with urgency urinary incontinence (UUI). BlueWind’s Revi System is the first and only implantable tibial neuromodulation device activated by a battery-operated external wearable to receive FDA marketing authorization for patients with UUI.

For additional information about BlueWind Medical, please visit www.bluewindmedical.com