BlueWind Medical™ Ltd. Completes OASIS Study Patient Enrollment
BlueWind Medical, a medical device company, announced today that it has successfully completed patient enrollment in the OASIS pivotal clinical study for its RENOVA iStim implantable neuromodulation device. The OASIS study is a 150-patient prospective clinical study designed to demonstrate the safety and efficacy of Bluewind Medical’s RENOVA iStim System to reduce symptoms of urgency incontinence, including urinary urgency and urinary frequency.
Patients were screened and implanted at 23 centers in the United States, the United Kingdom, The Netherlands, and Belgium. The company plans to submit six-month and 12-month safety and efficacy data to the FDA in 2022, with plans to follow OASIS patients for up to 36 months post-device activation to demonstrate sustained efficacy.
“I am proud of our courageous field team that traveled throughout the pandemic, who along with our R&D colleagues in Israel, collaborated to ensure investigative sites and patients had optimal support during the study’s enrollment period,” said Dan Lemaitre, Chief Executive Officer of Bluewind Medical. “What sets the RENOVA iStim apart from other available devices is our patient-centric approach to managing the symptoms of urgency incontinence,” said Dr. Roger R. Dmochowski, MD, Bluewind Medical’s Chief Medical Officer and renowned leader in the fields of urology, OAB, and incontinence. “RENOVA can be adjusted to meet the individual needs of the patient, meaning that a patient can change stimulation parameters, or wear the control unit for as much or as little as the patient feels they need to improve their symptoms.”
Bluewind Medical plans to seek FDA marketing clearance in the United States based on the OASIS study. “While too soon to gauge study outcomes, we remain optimistic that the results of the OASIS study will take us closer to a time when RENOVA will help mitigate the debilitating effects of urgency incontinence for the millions of patients that suffer from this affliction,” added Lemaitre.
Overactive bladder is a chronic, debilitating condition affecting over 33 million Americans, according to the American Urological Association. Bluewind Medical was founded in Israel in 2010 to capitalize on unique neuromodulation technology that has the potential to treat multiple medical conditions. The CE Mark for use in the treatment of overactive bladder was obtained in 2016. For additional information, please visit BluewindMedical.com. For press inquiries, please contact Daniel Dean at RothIvy, 818-665-6188.