Israeli bladder treatment company BlueWind Medical today announced the closing of a $64 million Series B financing round led by ConvaTec, a global medical products and technologies company focused on therapies for the management of chronic conditions including continence care.
BlueWind Medical has developed the RENOVA iStim implantable tibial neuromodulation device under investigation for the treatment of incontinence and overactive bladder (OAB). BlueWind was founded in Israel in 2010 by Rainbow Medical, an innovation and investment house focused on the invention, creation, and monetization of proprietary medical technologies.
The device has the CE mark for marketing in the EU and is undergoing trials for US FDA approval. The company has offices in Utah in the US and Herzliya in Israel.
BlueWind Medical chairman and CEO Dan Lemaitre said, "Proceeds from the financing will be used to support the ramp in our commercial footprint in anticipation of potential FDA marketing clearance for BlueWind Medical's RENOVA iStim implantable neuromodulation device."
According to the American Urological Association, OAB is a chronic, debilitating condition affecting over 34 million Americans and can lead to urgency urinary incontinence (UUI).
BlueWind Medical has completed patient enrollment of the OASIS pivotal clinical study in November 2021 at 23 centers in the US, UK, The Netherlands, and Belgium. Interim safety data was recently announced at the SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction) Winter Meeting showing no device or procedure related serious adverse events. BlueWind Medical will submit an application for FDA
marketing clearance in the US later in 2022 based on the OASIS pivotal study.
The RENOVA iStim device utilizes neuromodulation to target the nerves that control the bladder. RENOVA iStim is implanted near the ankle in a single short outpatient procedure of approximately 30 minutes utilizing local anesthesia.
Published by Globes, Israel business news - en.globes.co.il - on May 9, 2022.
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