PARK CITY, Utah--(BUSINESS WIRE)--BlueWind Medical, Ltd., a leader in implantable Tibial Neuromodulation (iTNM) and developer of the Revi® System for urge urinary incontinence (UUI), announced that the Centers for Medicare & Medicaid Services (CMS) has finalized a favorable payment adjustment for the 2025 Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center (ASC) Payment Systems Rule, favorably impacting reimbursement rates for the Revi System.
For CY2025, CMS has set the national unadjusted ASC payment rate for Category III CPT code 0817T, which includes the Revi System, at $19,839 – a 40% increase from the CY2024 rate. For the Hospital Outpatient setting, the CY2025 payment increased by 3% to $21,444. These adjustments highlight CMS’s recognition of the Revi System’s unique clinical benefits as a minimally invasive, effective solution for UUI.
“The CMS decision to increase the reimbursement rate for the Revi System in the ASC setting reflects the growing recognition of iTNM as an effective, minimally invasive therapy for urgency urinary incontinence,” said Steve Armstrong, Chief Financial Officer and General Manager of BlueWind Medical. “This update underscores the proven durability, safety, and patient satisfaction research behind the Revi System as an important and innovative approach to treat this distressing condition.”
The Revi System is the first and only FDA cleared iTNM device activated by an external wireless wearable for patients with UUI, enabling patients to initiate therapy at their convenience. This patient-centric approach, paired with provider flexibility in treatment planning, delivers tailored UUI relief by stimulating the posterior tibial nerve.
As the first iTNM device labeled for use without requiring prior failure of more conservative therapies, Revi aligns with newly updated 2024 guidelines from the American Urological Association and the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU). These guidelines recommend early consideration of minimally invasive treatments for UUI and emphasize shared decision-making in OAB and UUI management. Revi’s unique positioning enables it to be offered early in the continuum of care, providing patients and physicians with a minimally invasive option to address the unmet needs of those with UUI, many of whom are dissatisfied with current therapy options.
Recent clinical data supports Revi’s durable efficacy, safety, and patient satisfaction for UUI treatment. Two-year findings from BlueWind Medical's pivotal OASIS Study were presented at the American Urogynecologic Society (AUGS) Pelvic Floor Disorders (PFD) Week and the International Continence Society (ICS). Additional research from the company showed iTNM as an effective alternative to Sacral Neuromodulation (SNM) for OAB and UUI.
For additional information about BlueWind Medical and the Revi System, please visit bluewindmedical.com.
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.”
