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BlueWind Medical Reaches 100th Patient for the OASIS Study of the RENOVA™ iStim System


Bluewind Medical, a leading innovator of neuromodulation medical devices for the treatment of overactive bladder (OAB), announced that the 100th patient has been enrolled in the OASIS clinical pivotal study using their innovative medical device, the RENOVA™ iStim System. The OASIS study is designed to test the safety and efficacy of the device in providing Tibial Neuromodulation (TNM) therapy to female patients suffering from urinary incontinence. The milestone marks an important step towards FDA clearance for the device.

The RENOVA™ iStim System is composed of two parts: a miniature implanted stimulator and a mobile, wearable device. Patients undergo a simple procedure under local anesthesia implanting the stimulator, a tiny device just over an inch in length and the width of a matchstick. After implantation, patients wear the wearable device on their ankle, which communicates wirelessly with the stimulator to perform TNM treatment. Treatments are performed twice a day for half an hour, and patients can choose to be mobile or stationary during the therapy.

“Several advantages make RENOVA iStim innovative neuromodulation system an interesting option for patients with overactive bladder symptoms who do not respond to, or cannot tolerate, conventional medical therapy,” said Dr. Alex Digesu, Consultant Obstetrician & Gynecologist.

Results from Bluewind’s pilot clinical study have been optimistic, showing that over 70% of patients receiving treatment were responders as measured by composite OAB symptoms, with 28% of patients becoming fully “dry.”

“The 100th patient is an important milestone for Bluewind since the pace of enrollment is indicative of a large unmet clinical need that our RENOVA system will address,” said Dan Lemaitre, Chairman and CEO of Bluewind Medical.

The company will receive $20 million in funding as a result of hitting this milestone which provides the capital needed to complete enrollment in the OASIS study this year and to prepare for a commercial launch in 2023.

About OAB:
According to the American Urological Association, OAB is a chronic, debilitating condition affecting over 33 million Americans.

About Bluewind Medical:
Bluewind Medical, founded in 2010, is developing the RENOVA™ iStim, a miniature, wireless neurostimulator to treat Overactive Bladder (OAB). The CE Marked RENOVA™ system is an investigational device and not cleared for marketing in the United States. For more information on the company, visit: Media Contact: Daniel Dean, 818-665-6188