BlueWind Medical Revi™ Implantable Tibial Neuromodulation Device Now Available to Patients in Texas

2024-03-21

Revi is a novel patient-centric solution for the treatment of urge urinary incontinence delivered in a minimally invasive procedure under local anesthesia

PARK CITY, Utah, March 21, 2024 /PRNewswire/ -- 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 Urologists Dr. Henry Ruiz and Dr. Natalia Hernandez at the Urology Institute at Renaissance are the first providers of Revi in the state of Texas.

"Urge Incontinence, although a common condition with profound impacts on quality of life, has long been under-diagnosed and under-treated. With the advent of Revi, we now have a safe and proven patient-centric solution that can be tailored and optimized to meet the needs of patients," stated Dr. Ruiz. "Revi appeals to many with UUI because it doesn't require multiple procedures or general anesthesia. It's a therapy that they can deliver on their schedule. I'm excited to be at the forefront of making Revi standard of care."

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 in August 2023, for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency. In October 2023, 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 2023, 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 capacity to transform how we approach treating urge urinary incontinence (UUI), empowering patients with enhanced control, comfort, and convenience. We are fortunate to have the support of surgeons such as Dr. Ruiz and Dr. Hernandez as we launch our groundbreaking technology. We consider it a privilege to contribute to improving the quality of life for the millions living with urge incontinence," stated 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

SOURCE BlueWind Medical

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