Renova The iStim™ implantable tibial neuromodulator is being studied as a minimally invasive, patient-focused solution for OAB treatment.
Park City, Utah and HERZLIYA, IsraelAnd May 9, 2022 /PRNewswire/ – BlueWind Medical, Ltd. Innovative software developer Renova iStim implantable bronchodilator nerve modulator under investigation for treatment of urgent enuresis alone or in combination with urinary urgency and/or urinary frequency, announced today Close 64 million dollars Group financing round b. This round of funding was led by ConvaTec, a global medical products and technology company focused on treatments to manage chronic conditions including incontinence care.
“Proceeds from the funding will be used to support the ramp in our commercial footprint in anticipation of potential FDA marketing clearances for BlueWind Medical’s Renova iStim implantable device Dan LemeterChairman and CEO of BlueWind Medical.
According to the American Urological Association, OAB is a chronic, debilitating condition that affects more than 34 million Americans and can lead to urge incontinence (UUI), the involuntary leakage of urine associated with a sudden urge to void. People with UUI experience an irreversible condition that greatly affects their physical and mental health, and is significantly associated with depression, social isolation, obesity, and death.1 2 3
BlueWind Medical has completed patient enrollment in the pivotal OASIS clinical study in November 2021 in 23 centers in United StateAnd United kingdomAnd HollandAnd Belgium. Provisional safety data was recently announced at the SUFU (Society of Urodynamics, Female Pelvic and Genitourinary Reconstruction) winter meeting showing no device or procedure related to serious adverse events. BlueWind Medical will apply for Marketing Authorization from the US Food and Drug Administration (FDA) at United State Later in 2022 based on the pivotal OASIS study.
The Renova The iStim device uses neuromodulation to target the nerves that control the bladder. Renova The iStim is implanted near the ankle in a single short, outpatient procedure lasting approximately 30 minutes using local anaesthesia.
“At ConvaTec, we focus on solutions that improve the lives of those with chronic conditions such as incontinence. We believe BlueWind Medical’s vision of less invasive care with greater customer control will resonate with end users and providers alike.” Seth SiegelPresident and COO, Global Continence Care and Home Services Group of the ConvaTec Group Plc.
“The BlueWind team appreciates that ConvaTec and others share our vision for the potential of Renova iStim to transform OAB sponsorship,” concluded Lemaitre.
About BlueWind Medical Ltd.
BlueWind Medical was founded in Israel Founded in 2010 and has an extensive patent portfolio that includes 15 patent families, 35 filed and 24 issued patents. BlueWind Medical has obtained the CE Mark for Renova iStim in the treatment of overactive bladder in 2016. The OASIS study is under investigation device (IDE) exemption from the Food and Drug Administration. Renova iStim is not approved for use in the United States
For additional information visit BlueWindMedical.com
About Konvatec Group plc
ConvaTec is a global FTSE 250 medical products and technologies company focused on solutions for managing chronic conditions, with leadership positions in advanced wound care, ostomy care, critical condition control, and infusion care. ConvaTec has more than 10,000 associates and sells its products and services in more than 90 countries. ConvaTec’s vision is to pioneer trusted medical solutions to improve the lives you touch. ConvaTec products provide a range of clinical and economic benefits including preventing infection, protecting compromised skin, improving patient outcomes and reducing the total cost of care. Group revenue expired in 2021 2 billion dollars. To learn more about ConvaTec, please visit http://www.convatecgroup.com
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1 Coyne KS, Kvasz M, Ireland AM, Milsom I, Kopp ZS, Chapple CR. Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom and the United States. Euro Urol. 2012; 61 (1): 88-95. |
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Investor Relations Contact: Chuck Cargill, Chief Financial Officer Blowwind Medical (435) 565-1822 |
Public Relations Contact: Sandra Mullfield, Vice President of Marketing Blowwind Medical (435) 255-3061 |
SOURCE Bluewind Medical
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