BlueWind Medical Announces Key Milestone as AMA Issues Unique Category III CPT Code for Subfascial Placement of Tibial Neurostimulators

• CPT Code establishes a standard reimbursement pathway for the BlueWind System effective January 1, 2024

PARK CITY, Utah, March 8, 2023 /PRNewswire/ -- BlueWind Medical, Ltd., an innovative medical device company that aims to transform neuromodulation therapy for OAB by providing physicians and their patients with a patient-centric solution, is pleased to announce that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) code for the subfascial implantation of a tibial neuromodulation device for Overactive Bladder (OAB). This information was released by the AMA in the February 2023 Summary of Panel Actions from the February CPT Editorial Panel Meeting. The new code will become effective January 1, 2024. The specific procedure code with description will be published by the AMA in July 2023.

CPT codes provide a uniform nomenclature for coding medical procedures and services and are granted and maintained by the AMA CPT Editorial Panel. These codes are widely used by providers to report medical services and procedures to Medicare and commercial health plans for reimbursement. The release of this new CPT code represents a significant reimbursement achievement for BlueWind Medical as physicians, hospitals and surgery centers will be able to submit claims for the BlueWind System using this code. Consequently, this new code will provide physicians and their patients access to a groundbreaking new therapy for OAB.

The BlueWind therapy provides personalized relief from OAB in a single, minimally invasive procedure without the potential adverse events seen with other surgical OAB therapies, such as reoperation due to device migration or battery replacement. The subfascial procedure described in the CPT code is unique to BlueWind Medical. It allows for predictable placement in the ankle region under direct visualization with intraoperative testing and suture fixation to mitigate the risk of migration. The miniature, battery-less BlueWind implant is activated by an external wearable worn at the patient's convenience. Therapy parameters and treatment regimens are then optimized based on the patient's individual response.

"We believe the BlueWind Medical solution provides the key to unlock the enormous benefits of neuromodulation therapy for people managing the symptoms of OAB," said Dan Lemaitre, Chief Executive Officer of BlueWind Medical. "We appreciate the AMA adding this new code as it acknowledges the differentiation of the BlueWind subfascial procedure and we are grateful for the support from the American Urological Association (AUA) throughout the process. We look forward to future engagement with the Centers for Medicare and Medicaid Services (CMS) in establishing payment now that the new CPT code has been added. This code will allow for more precise cost and utilization data collection on subfascial procedures, which we believe will provide the agency with valuable insights to make informed decisions about payment levels in the future."

About Overactive Bladder
Overactive bladder causes a frequent and urgent need to empty your bladder. According to the National Association for Continence, OAB is a chronic, debilitating condition affecting over 33 million Americans. Urgency urinary incontinence (UUI) is the involuntary leakage of urine associated with a sudden compelling desire to void. OAB is a highly prevalent condition among men and women, with approximately 23% of U.S. adults affectedⁱ. However, OAB remains challenging to treat successfully and is fraught with unmet needs and frustration. OAB has a great impact on the life and overall health of those that suffer with the condition. Even mild cases of incontinence increase the possibility of presenting with depression by 40%ⁱⁱ, the risk of falling is increased by 35% with daily urge incontinence, and fractures are significantly associated with UUIⁱⁱⁱ.

About BlueWind Medical Ltd.
BlueWind Medical is an innovative medical device company that is transforming neuromodulation therapy for the treatment of overactive bladder. BlueWind Medical has developed a miniature tibial neuromodulation solution for OAB that is implanted in the ankle region in a minimally invasive outpatient procedure under local anesthesia. The patient-centric system allows for therapy customization to enhance patient response and includes a lightweight wearable device that fits around the ankle. The OASIS study is being conducted under an Investigational Device Exemption (IDE) from the FDA and completed one year follow-up in October 2022. The BlueWind System is not approved for use in the U.S. For additional information, please visit BlueWindMedical.com.

ⁱ Reynolds WS et al. The Burden of Overactive Bladder on US Public Health. Curr Bladder Dysfunct Rep. 2016 Mar; 11(1): 8-13. doi:10.1007/s11884-016-0344-9.

ⁱⁱ Nygaard I et al. Urinary incontinence and depression in middle aged United States women. Obstet Gynecol 2003; 101: 149 156.

ⁱⁱⁱ Brown JS et al. Urge urinary incontinence was associated with increased risk of falls and non-spinal, non-traumatic fractures in older women. J Am Geriatr Soc 2000 Jul;48:721–5.

SOURCE BlueWind Medical