BlueWind Medical News
17 articles
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BlueWind Medical Brings Revi Implantable Tibial Neuromodulation Device to Patients in Shreveport, Louisiana
BlueWind Medical, a company specializing in patient-centric implantable Tibial NeuroModulation (iTNM) solutions for urge urinary incontinence (UUI), has announced that its Revi device is now available in Shreveport, Louisiana. Revi, the first FDA-approved, battery-free iTNM implant, is designed to be minimally invasive and patient-adjustable. The device is implanted near the ankle and uses a wearable to power and control it. The FDA granted a De Novo marketing request for Revi on August 16, 2023, and the device has also received a final Current Procedural Terminology (CPT) code from the American Medical Association (AMA) CPT Editorial Panel.
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BlueWind Medical's Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence
BlueWind Medical has received FDA approval for its Revi System, a tibial neuromodulation therapy for treating urgency incontinence. The approval was based on results from the OASIS pivotal trial, which demonstrated significant improvement in reducing symptoms of urgency urinary incontinence (UUI). The Revi Implant is a small, battery-free device implanted near the ankle that stimulates the posterior tibial nerve to provide relief from UUI. The Centers for Medicare and Medicaid Services has proposed a national average payment rate of $21,377 for the procedure.
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Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting
BlueWind Medical, Ltd. has announced successful results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of Overactive Bladder (OAB). The study showed significant improvement in urgency urinary incontinence (UUI) symptoms, with 78% of those implanted and 82% of patients completing the study achieving at least a 50% reduction in UUI episodes at 12 months. The results were presented at the American Urological Association (AUA) 2023 Annual Meeting and are currently under review by the FDA.
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BlueWind Medical to Present Positive Results from its Pivotal Trial in Patients with Overactive Bladder at the 2023 AUA Annual Meeting
BlueWind Medical, a developer of implantable tibial neuromodulation therapy for Overactive Bladder (OAB), announced that it will present the efficacy results of its OASIS pivotal clinical study at the American Urological Association (AUA) 2023 Annual Meeting. The study evaluates the safety and efficacy of BlueWinds implantable neuromodulation device for the treatment of patients diagnosed with urgency incontinence. The company believes the positive results from the study demonstrate the potential of their solution to provide significant benefits for people managing symptoms of OAB.
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BlueWind Medical Announces Key Milestone as AMA Issues Unique Category III CPT Code for Subfascial Placement of Tibial Neurostimulators
BlueWind Medical, a medical device company, has announced that the American Medical Association (AMA) has issued a new Current Procedural Terminology (CPT) code for the subfascial implantation of a tibial neuromodulation device for Overactive Bladder (OAB). The new code will become effective on January 1, 2024. This is a significant achievement for BlueWind Medical as it establishes a standard reimbursement pathway for the BlueWind System. The new code will enable physicians, hospitals, and surgery centers to submit claims for the BlueWind System using this code, providing access to a new therapy for OAB.
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BlueWind Medical Appoints Dr. Liz Kwo to Board of Directors
BlueWind Medical has announced the appointment of Liz Kwo, M.D., MBA, MPH, Chief Medical Officer at Everly Health, to its Board of Directors. Dr. Kwo brings expertise in data science, automation, and artificial intelligence, with a focus on leveraging innovative technology to enhance the patient experience and improve population health. BlueWind Medical aims to revolutionize neuromodulation therapy for overactive bladder (OAB). Overactive bladder affects over 33 million Americans and is a chronic, debilitating condition. The company has developed a miniature tibial neuromodulation (iTNM) solution for OAB that is implanted near the ankle. The OASIS study, conducted under an Investigational Device Exemption (IDE) from the FDA, has completed enrollment in November 2021.
Partners
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BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder (OAB) Treatment
BlueWind Medical, developer of the RENOVA iStim implantable tibial neuromodulation device, has closed a $64 million Series B funding round led by ConvaTec. The funding will be used to support the companys commercial footprint and potential FDA marketing clearance for the RENOVA iStim device. The device is being studied as a solution for the treatment of urgency incontinence. BlueWind Medical recently completed patient enrollment for a pivotal clinical study and plans to submit an application for FDA marketing clearance in 2022. The RENOVA iStim device targets the nerves that control the bladder and is implanted near the ankle in a short outpatient procedure. ConvaTec, a global medical products and technologies company, believes in BlueWind Medicals vision for less invasive care and greater customer control.
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BlueWind Medical appoints new CEO
BlueWind Medical has appointed Daniel Lemaitre as its new CEO. Lemaitre, who previously served as the chairman of the board, will take over from Guri Oron, who will become the president & GM. BlueWind Medical is developing miniature, wireless neurostimulators for the treatment of various indications. Their Renova neursostimulation system has CE Mark approval but is not yet cleared for marketing in the U.S. The company aims to revolutionize the treatment of over-active bladder (OAB) and plans to conduct a pivotal study in Europe and the U.S. with the goal of becoming a leading player in the neuromodulation market. Rainbow Medical, BlueWinds largest investor, expressed confidence in Lemaitres leadership and the potential of the companys technology.
Management Changes
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BlueWind Medical Appoints New Executive Chairman
BlueWind Medical has announced that Daniel T. Lemaitre will assume the role of Executive Chairman. Lemaitre brings more than three decades of medical device experience and is expected to lead BlueWinds efforts to garner market clearance and commercialize its neuromodulation therapy platform. The company is initially targeting the Over Active Bladder (OAB) market and plans to commence a pivotal study for FDA approval in 2019. BlueWind Medical, founded in 2010 by Rainbow Medical, is developing a platform technology of miniature, wireless neurostimulators for the treatment of multiple indications. The company aims to transform neuromodulation with its patient-friendly products.
Management Changes
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BlueWind Medical Announces Positive Long-Term Results of the BLUEWIND-RENOVA™ Implantable Tibial Nerve Neuromodulator
BlueWind Medical, a developer of neurostimulation technology, has announced the publication of long-term clinical results for its RENOVA iStim™ platform. The study demonstrated sustained positive clinical data for the treatment of overactive bladder (OAB). The RENOVA iStim™ device showed a 75% long-term reduction in OAB symptoms for patients three years after implantation. The device also provided long-term improvement in patients quality of life. BlueWind Medical believes that its wireless neuromodulation technology has the potential to help millions of patients with OAB and other indications. The company was founded in 2010 by Rainbow Medical, a private investment company that supports start-ups in the medical field.
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BlueWind Medical Appoints Dr. Roger R. Dmochowski, MD, MMHC, as Chief Medical Officer
BlueWind Medical has appointed Dr. Roger R. Dmochowski as the companys chief medical officer. Dr. Dmochowski will lead clinical efforts, including an upcoming pivotal trial for the management of overactive bladder. The study is expected to commence in early 2019. BlueWind Medical is a developer of a miniature, wireless neurostimulation platform for the treatment of multiple clinical indications. The company was founded in 2010 by Rainbow Medical.
Management Changes
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BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder
BlueWind Medical has received FDA approval for its pivotal study design of the RENOVA iStim system, a miniature wireless neurostimulation platform for the treatment of overactive bladder. The OASIS pivotal trial will evaluate the safety and effectiveness of the system in patients with urinary urgency incontinence. The study will enroll 250 patients across multiple European countries. BlueWind Medical expects patient enrollment to begin in early 2019. The company previously received a CE Mark for the RENOVA iStim system in 2016.
Customers
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BlueWind Medical Announces the Publication of Breakthrough Results for BLUEWIND-RENOVA™ Implantable Tibial Nerve Neuromodulator
BlueWind Medical, a developer of a wireless neurostimulation platform, announced the publication of clinical results of the OPTIMIST Study. The study tested BlueWinds implantable Tibial Nerve Neuromodulation System for the management of overactive bladder (OAB) complaints. The results showed that the system has a low-risk safety profile and is an effective treatment option for OAB management. The study also demonstrated improvements in patients quality of life. BlueWind Medical is supported by Rainbow Medical, its main investor.
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BlueWind Medical Announces CE-Mark for the BlueWind VIVENDI™ Miniature Implanted Wireless Stimulator to Treat Peripheral Pain
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Now there's needle-free Botox for your bladder
Israeli company BlueWind Medical has developed a miniature wireless neurostimulation platform for the treatment of overactive bladder (OAB). The OAB-1000 System, recently approved for use in Europe, is a matchstick-sized implant placed near the tibial nerve. The device is 90% smaller than existing neurostimulators and contains the controls and battery in a wearable ankle device. BlueWind plans to present the results of its clinical study at an upcoming conference and is also developing a smaller, injectable version of the device. The company is exploring additional clinical indications for its neurostimulation platform. Two other Israeli companies, Vensica and UroGen Pharma, are also developing non-narcotic solutions for OAB.
Customers
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BlueWind Medical Announces CE-Mark for the First in the World Miniature Wireless Neurostimulator to Treat Overactive Bladder
Bluewind Medical has received CE-Mark for its OAB-1000 System, a miniature wireless neurostimulator to treat Overactive Bladder (OAB). The device is 90% smaller than typical neurostimulators and allows for a minimally invasive procedure. It electrically stimulates the tibial nerve and is powered wirelessly by an external control unit. The company plans to present the results of a clinical study at upcoming conferences. Bluewind Medical was founded by Rainbow Medical, an investment company that develops breakthrough medical devices.
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BlueWind Medical Announces Successful Completion of Patients' Follow-Up for its Peripheral Neuropathic Pain (PNP) Study Toward a CE Mark
BlueWind Medical has completed a study for its wireless neuro-stimulation device to treat peripheral neuropathic pain. The study was successful and the results will be presented at an upcoming conference. Peripheral neuropathy affects approximately 20 million people in the US alone. The Reprieve neurostimulator, developed by BlueWind Medical, provides immediate relief to patients by stimulating the tibial nerve. The device is small and can be implanted in a minimally invasive procedure. BlueWind Medical plans to make the product available to physicians and patients soon.
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