BlueWind Medical to Present Positive Results from its Pivotal Trial in Patients with Overactive Bladder at the 2023 AUA Annual Meeting
PARK CITY, Utah, April 24, 2023 /PRNewswire/ — BlueWind Medical, Ltd., the developer of transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced that efficacy results of the OASIS pivotal clinical study will be presented in a late breaking session at the American Urological Association (AUA) 2023 Annual Meeting, being held in Chicago April 27th- May 1st. In addition, the company was selected to present at the inaugural AUA Innovation Nexus on April 27th and will exhibit its novel BlueWind System at the AUA conference.
This is the first publication of efficacy data from BlueWind’s OASIS pivotal clinical study evaluating the safety and efficacy of BlueWind Medical’s implantable neuromodulation device for the treatment of patients diagnosed with urgency incontinence (UUI) alone or in combination with urinary urgency and/or urinary frequency. BlueWind Medical will be presenting the 12 month data at the AUA Late-Breaking Abstract Session LBA01 on April 30th from 7:00 to 9:00 am CT in room S505. John Heesakkers, MD, the OASIS global primary investigator, Chairman of the Department of Urology of the Maastricht UMC, the Netherlands, and the International Continence Society General Secretary will present “Pivotal Study of a Novel Wirelessly Powered, Patient Tailored Programmed, Tibial Neurostimulator for the Treatment of Patients with Overactive Bladder”.
OAB can manifest in UUI, the involuntary leakage of urine associated with a sudden compelling desire to void. “Every day, millions of people experiencing OAB rely on drugs with significant side effects, treatment options that require frequent visits to their doctor’s office, or more invasive therapies that come with safety challenges,” said John Heesakkers, MD. “We are pleased with the positive results from OASIS and look forward to presenting these important data at AUA.”
“Based on OASIS data, we believe the BlueWind Medical solution has the potential to unlock the enormous benefits of neuromodulation therapy for people managing symptoms of OAB,” said Dan Lemaitre, Chief Executive Officer of BlueWind Medical. “These results are a critical milestone that underscores our longstanding commitment to bringing an innovative solution to those suffering from the debilitating effects of OAB.”
OASIS is a 151-patient prospective, interventional, multicenter, single-arm, open-label clinical study designed to demonstrate the safety and efficacy of BlueWind Medical’s implantable tibial neuromodulation system in reducing symptoms of urgency incontinence, including urinary urgency and urinary frequency. Patients were screened and implanted under local anesthesia at 23 centers in the United States, United Kingdom, the Netherlands and Belgium. The study is designed to evaluate changes in symptoms from baseline through 12 months of therapy. The OASIS study is being conducted under an Investigational Device Exemption (IDE) and results from the trial are under review by the FDA.
About BlueWind Medical Ltd.
BlueWind Medical is an innovative medical device company that is transforming neuromodulation therapy for the treatment of overactive bladder. The BlueWind System is implanted in the ankle region in a single, minimally invasive single procedure done under local anesthesia and stimulates the posterior tibial nerve to provide relief from OAB and Urgency Urinary Incontinence (UUI), the involuntary leakage of urine associated with a sudden compelling desire to void experienced with OAB. The miniature implant, with its novel battery-less design, is activated by an external wearable worn at the patient’s convenience. The battery-less implant allows for optimizing therapy parameters and treatment regimens according to a patient’s individual sensation and response without concern for battery life. The innovative BlueWind System was designed to empower patients by providing a safe, predictable, patient centric and personalized therapy. The OASIS study is being conducted under an Investigational Device Exemption (IDE). The BlueWind system is not approved for use in the U.S. For additional information, please visit BlueWindMedical.com.
SOURCE BlueWind Medical