AUA/SUFU Guideline on the Treatment of Overactive Bladder Allows Access to Revi™ System Earlier in Treatment Journey

• New Guideline Now Includes Implantable Tibial NeuroModulation (iTNM)
• Transitions Away from Step Therapy Requirement

PARK CITY, Utah, April 29, 2024 /PRNewswire/ -- BlueWind Medical, Ltd., a pioneer in implantable Tibial NeuroModulation (iTNM) and the developer of Revi^TM, a patient-centric solution for urge urinary incontinence (UUI), announced today that the Revi System, a minimally invasive therapy, is now included in the American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) clinical practice guideline on the diagnosis and treatment of idiopathic overactive bladder (OAB). The revised guidelines are a major affirmation of the importance of Revi as a therapy for patients with UUI. First, the guidelines were updated to include iTNM as an acceptable minimally invasive therapy.  In addition, the revised guidelines shift away from traditional step therapy approaches, allowing physicians and patients to bypass behavioral and pharmacotherapy before considering minimally invasive therapies, including Revi.

Revi is the only minimally invasive implant with an indication that matches the new guidelines and does not require that patients fail or not tolerate more conservative therapies first. Revi, which was granted De Novo marketing request by the US Food and Drug Administration (FDA) in August 2023, is an innovative device implanted near the ankle during a single outpatient procedure performed under local anesthesia, with or without sedation, and without the reintervention due to lead fracture, migration and battery depletion seen with other UUI therapies. For activation, a lightweight wireless wearable is placed around the ankle at the patient's convenience once to twice daily to provide stimulation to the posterior tibial nerve to provide relief.

"The understanding and treatment of voiding dysfunction and OAB is truly in an evolutionary phase," said Roger Dmochowski, MD, MMHC, and BlueWind Medical Chief Medical Officer. "These recent guideline modifications reflect a modern understanding of how to attain improvements in practice, patient access, and hoped-for advancements in patient outcomes and patient acceptance of therapy."

"We are delighted to witness the transformation of the new OAB treatment guideline by the AUA/SUFU. This guideline represents a significant turning point in physicians' approach to OAB management," commented Dan Lemaitre, Chief Executive Officer of BlueWind Medical. "Consistent with the guideline, Revi's unique indication eliminates the need for patients to try and fail step therapy, instead empowering clinicians and patients to make shared treatment decisions. As partners in the care of people living with UUI, we reaffirm our commitment to advancing patient-centric solutions."

OAB is a chronic condition that requires consistent and long-term therapy to manage symptoms. Drug therapy is often used to manage OAB and UUI; however, concerns have emerged regarding the long-term use of anticholinergics, the most common medications used. Anticholinergics, in addition to poor tolerability, have in recent years come under the spotlight due to significant associations between their use and increased risk of cognitive impairment and dementia.¹ Increasingly, providers are discontinuing anticholinergic prescriptions, and alternative medications for OAB such as β₃-adrenergic receptor agonists are cost-prohibitive for many patients due to price and limited access through insurance.² Revi presents a safe and effective long-term solution for people suffering with UUI.

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 urge 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. Revi is the only neuromodulation therapy on the market that allows physicians to use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System rather than mandating "step-therapy."

For additional information about BlueWind Medical, please visit https://bluewindmedical.com/

1. Clinical Consensus Statement: Association of Anticholinergic Medication Use and Cognition in Women With Overactive Bladder. Female Pelvic Med Reconstr Surg. 2021;27(2):69-71. doi:10.1097/SPV.0000000000001008

2. Dmochowski RR, Newman DK, Rovner ES, Zillioux J, Malik RD, Ackerman AL. Patient and Clinician Challenges with Anticholinergic Step Therapy in the Treatment of Overactive Bladder: A Narrative Review. Adv Ther. 2023;40(11):4741-4757. doi:10.1007/s12325-023-02625-8

SOURCE BlueWind Medical