BlueWind Medical has announced the successful completion of patient enrolment in the OASIS pivotal clinical study that will assess the company’s innovative Renova iStim implantable neuromodulation device for the treatment of urinary urgency incontinence, and form the basis on which BlueWind will seek US Food and Drug Administration (FDA) marketing clearance for this technology.
OASIS is a 150-patient prospective clinical study designed to demonstrate the safety and efficacy of the Renova iStim system to reduce symptoms of urgency incontinence, including urinary urgency and urinary frequency. Patients were screened and implanted at 23 centres in the USA, the UK, The Netherlands, and Belgium.
“We are thrilled that enrolment has been completed in the OASIS study,” said Dan Lemaitre, CEO of BlueWind. “I am proud of our courageous field team that travelled throughout the pandemic, who—along with our R&D [research and development] colleagues in Israel—collaborated to ensure investigative sites and patients had optimal support during the study’s enrolment period.”
“What sets the Renova iStim apart from other available devices is our patient-centric approach to managing the symptoms of urgency incontinence,” said Roger R Dmochowski, BlueWind’s chief medical officer and a renowned leader in the fields of urology, overactive bladder (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 intends to submit six- and 12-month safety and efficacy data to the FDA in 2022, according to a company press release. In addition, it plans to follow OASIS patients for up to 36 months post device activation to demonstrate sustained efficacy.
“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.