{"_id":"agxzfmlsbGlzdHNpdGVyGAsSC05ld19Db21wYW55GICAgN6k-7sJDA","lastupdate":"2024-02-19T00:00:00.000Z","update_date":"2024-02-19T00:00:00.000Z","lastModified":"Sep 28, 2024","active":1,"confidence_score":99,"confidence_score_reason":"video or image, markets","urlname":"bluewind-medical","minimal_profile":null,"status":"","fullstatus":"","acquired":0,"hide_reason":null,"hide_reason_data":null,"hide_reasons":[{"id":"8257rxn4P8EFQOmS5hAAauHyYMhhxrA5u6yWX4XUShpybX3AMNo3Y9","reason":"Pending approval - External entity"},{"id":"aOIaOiiqfpA8UMw6VCTh8ueRmkG3lzDy1NGqEOaJbe11OrCzMTCCd6","reason":"The company is a service provider"},{"id":"ddgjKuc3GgH8E5UehSVJviRl471BCajL1plO8HtGoOojy2NivYqQ7x","reason":"Owner asked to delete"},{"id":"EjOKM211H1ira9J63oaGPuUxvr7Oba55TZo3NWsFO5uhbNu7o4x4zD","reason":"The company is not Israeli"},{"id":"J7fQJtnT3GdWWSE3MD8rzaW65LJ4jEIKxSZnneQiReONdZjG3zIqWe","reason":"Owner asked to hide in the meantime"},{"id":"NxlAC3ReFb5ksiYNLp2FnUyluoJzwRCYfcF7xpTZaPM53SdWQ5kv0B","reason":"Pending approval"},{"id":"RhC1tlwXzioK0MfzBII3H2wepEfQOfKVktmdwqeqTJjGi3ZaBWUqZo","reason":"The company is not innovative"},{"id":"S0Ed46vNI6vZYVxLedANWGjas23K6hY0QdsCtiGYL7lshqIEdLV3sA","reason":"The company ceased operations in Israel"},{"id":"VTANq7bEvlsEcPjp0ghelXfShaCosgndONGjgU730aAOxXtaDIF5j3","reason":"This is a product of an existing company"}],"type":"Startup","logokey":"$sy0SAey7A0BFuz2ebsVe8x9w0kqrBeEfxEYEplQ71My7LDVQxk73y4","name":"BlueWind Medical","oneliner":"Neuromodulation Therapy for Urge Urinary Incontinence ","registrar":"514504208","website":"https://bluewindmedical.com","careerspage":"https://www.linkedin.com/company/bluewind-medical/jobs/","founded_month":12,"founded_year":2010,"formernames":[],"sociallinks":{"twitter":"https://twitter.com/bluewindinc?lang=en","youtube":"","facebook":"https://www.facebook.com/bluewindmedical","linkedin":"https://www.linkedin.com/company/2243132","instagram":""},"social":["https://www.facebook.com/bluewindmedical","https://www.linkedin.com/company/2243132","https://twitter.com/bluewindinc?lang=en"],"flattenedsociallinks":"https://www.facebook.com/bluewindmedical|https://www.linkedin.com/company/2243132|https://twitter.com/bluewindinc?lang=en","apps":{"appstore":"","googleplay":""},"is_claimed_by_owner":1,"employees":"51-200","employees_exact":97,"patent":1,"raised":64000000,"stage":"B","public_stage":"B","primary_sector_key":"agxzfmlsbGlzdHNpdGVyJAsSF0Jhc2VDbGFzc2lmaWNhdGlvbk1vZGVsGICA4LuwgtgKDA","primary_sector":"Health Tech & Life Sciences","alternativenames":[""],"about":"BlueWind Medical is an innovative medical device company that aims to transform neuromodulation therapy for urge urinary incontinence (UUI).\n\nThe company developed Revi. Its advanced implant design allows for the device to be miniature in size without the need for replacement surgeries for battery change, lead migration, or lead fracture. Its innovative external wearable technology powers the implant for a patient-centric approach to therapy allowing for increases in energy and stimulation sessions based on the patients’ needs, giving patients the flexibility to ensure the best possible outcome.\n\nBlueWind Medical has successfully completed several clinical studies with excellent results and is focused on bringing its implantable tibial neuromodulation system for the treatment of urge urinary incontinence to the market.\n\nBlueWind Medical was founded by the Rainbow Medical Group.","climatetech_description":null,"is_climatetech_relevant":null,"phone":"+972747218900","country":null,"address":{"israeli":[{"id":"fab65d60-1ac7-4c5a-a710-753eb3246128","city":"Herzliya","type":null,"address":"Maskit Street 6, Herzliya, Israel","placeid":null,"notactive":0,"openeddate":null,"registrarid":null,"firstrdcenter":0,"registrarname":null}],"officesabroad":[{"id":"19cd4675-8fbc-44f2-8132-ffbc231d6995","city":"Park City","address":"1389 Center Drive, Park City, UT 84098, USA","country":"United States","placeid":null}]},"headquarter_address":null,"district":"Center District","news":[{"id":"j87qCkFGWcymPaoMlPJKTZ6rWeeO5mwpASeuDQaI0S75xy8Ehgm729","date":"Dec 21, 2023","link":"https://www.prnewswire.com/news-releases/bluewind-medical-brings-revi-implantable-tibial-neuromodulation-device-to-patients-in-shreveport-louisiana-302020713.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"Medical Device, Urinary Incontinence","company":"BlueWind Medical, Ltd.","layoffs":"N/A","summary":"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.","partners":"Christus Surgery Center, Dr. Gerard Henry","customers":"Patients in the tri-state region of Louisiana, Arkansas, and Texas","investors":"N/A","confidence":9,"key_topics":"Urge Urinary Incontinence, FDA Approval, Revi Device, Tibial Neuromodulation, Patient Care","date_of_event":"2023","valuation_amount":"N/A","impact_on_company":"growth-positive","investment_amount":"N/A","structured_issues":"Customers, Expand","acquisition_amount":"N/A","structuredIssuesShow":"#Customers, Expand","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"7nt3c4EoehTBqVtFKHNX7T4cE3mck6zBrngB3pDRfrD0DSFDuxEkgo","news_summary":"BlueWind Medical Brings Revi Implantable Tibial Neuromodulation Device to Patients in Shreveport, Louisiana","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"FAMksdwUbozRCcoA7dMNKpc1zCQ6AXejYGg66T2pFw1qHNNunlDL4Z","date":"Aug 16, 2023","link":"https://www.prnewswire.com/news-releases/bluewind-medicals-revi-system-secures-us-fda-de-novo-classification-grant-for-the-treatment-of-urgency-incontinence-301903199.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"Medical Device, FDA Approval","company":"BlueWind Medical, Ltd.","layoffs":"Not mentioned","summary":"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.","partners":"US Food and Drug Administration, Centers for Medicare and Medicaid Services","customers":"Patients with urgency urinary incontinence","investors":"Not mentioned","confidence":9,"key_topics":["FDA Approval","Revi System","Urgency Incontinence","Clinical Trials","Medicare Payment"],"date_of_event":"Not specified","valuation_amount":"Not mentioned","impact_on_company":"growth-positive","investment_amount":"Not mentioned","structured_issues":["Customers","Partners"],"acquisition_amount":"Not mentioned","structuredIssuesShow":"#Customers  #Partners","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"4hSeP6PrIHnjepBCIG8R9AtaBckuYSlokocEDnDoNqwJ5gLp5xNsxx","news_summary":"BlueWind Medical's Revi™ System Secures U.S. FDA De Novo Classification Grant for the Treatment of Urgency Incontinence","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"GNIXEhMNRM2IEIzaZIPY8yY9dDjTNcemhEXZ6Bq1bagMP5D5s7Qo3C","date":"May 1, 2023","link":"https://www.prnewswire.com/news-releases/clinical-study-results-of-the-bluewind-system-for-patients-with-overactive-bladder-featured-at-the-2023-aua-annual-meeting-301811486.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"Medical Research, Clinical Trials","company":"BlueWind Medical, Ltd.","layoffs":"Not mentioned","summary":"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.","partners":"Not mentioned","customers":"Patients with Overactive Bladder","investors":"Not mentioned","confidence":9,"key_topics":["OASIS Study","Overactive Bladder","Urgency Urinary Incontinence","Implantable Tibial Neuromodulation Therapy","Clinical Trial Results"],"date_of_event":"April 30, 2023","valuation_amount":"Not mentioned","impact_on_company":"growth-positive","investment_amount":"Not mentioned","structured_issues":["Customers"],"acquisition_amount":"Not mentioned","structuredIssuesShow":"#Customers","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"NqqjnuFVlgqKcsHgzN3lGbmhByilkXn5sPjAEmUROWVodpPDo7FK0A","news_summary":"Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"wHmU2LVLxev9Gv9uaLlzthnVUsf4d9Gfon6D4HJ1tyl924I3gLZIzG","date":"Apr 24, 2023","link":"https://www.prnewswire.com/news-releases/bluewind-medical-to-present-positive-results-from-its-pivotal-trial-in-patients-with-overactive-bladder-at-the-2023-aua-annual-meeting-301805010.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"Clinical Study, Medical Device","company":"BlueWind Medical, Ltd.","layoffs":"N/A","summary":"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.","partners":"American Urological Association","customers":"Patients diagnosed with urgency incontinence","investors":"N/A","confidence":9,"key_topics":["OASIS Clinical Study","Overactive Bladder Treatment","Neuromodulation Therapy","AUA Presentation","Medical Innovation"],"date_of_event":"April 27th - May 1st, 2023","valuation_amount":"N/A","impact_on_company":"growth-positive","investment_amount":"N/A","structured_issues":["Customers"],"acquisition_amount":"N/A","structuredIssuesShow":"#Customers","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"O731m9a1AmlIeaR8Hpstk4K8tywNlbJJwwtaHjcBr2depEsj7mqTRP","news_summary":"BlueWind Medical to Present Positive Results from its Pivotal Trial in Patients with Overactive Bladder at the 2023 AUA Annual Meeting","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"SqNh25mFoyqsHt7509p1TUdFUGJuARR898BKIL5H8mWfVGFALZTcmY","date":"Mar 8, 2023","link":"https://www.prnewswire.com/news-releases/bluewind-medical-announces-key-milestone-as-ama-issues-unique-category-iii-cpt-code-for-subfascial-placement-of-tibial-neurostimulators-301765120.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"Medical Device, Reimbursement","company":"BlueWind Medical, Ltd.","layoffs":"N/A","summary":"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.","partners":"American Medical Association, American Urological Association","customers":"Physicians, hospitals, and surgery centers","investors":"N/A","confidence":9,"key_topics":["BlueWind System","CPT Code","Reimbursement","Overactive Bladder","Neuromodulation Therapy"],"date_of_event":"February 2023","valuation_amount":"N/A","impact_on_company":"growth-positive","investment_amount":"N/A","structured_issues":["Customers"],"acquisition_amount":"N/A","structuredIssuesShow":"#Customers","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"c3EUqOn9uFFyrgOE1itHhslYjPuKrFq1bn2joXWja2WjU6iZ4J8kqZ","news_summary":"BlueWind Medical Announces Key Milestone as AMA Issues Unique Category III CPT Code for Subfascial Placement of Tibial Neurostimulators","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"wMMXWtwFIBc2RjtJo2Os89nI4TtB6dNCjCmRp4fpiTAPvvedZoC0XQ","date":"Sep 27, 2022","link":"https://www.prnewswire.com/news-releases/bluewind-medical-appoints-dr-liz-kwo-to-board-of-directors-301633532.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"medical device","company":"BlueWind Medical, Ltd.","layoffs":null,"summary":"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":["Everly Health"],"customers":null,"investors":null,"confidence":8,"key_topics":["neuromodulation therapy","overactive bladder","medical device","Board of Directors","healthcare"],"date_of_event":null,"valuation_amount":null,"impact_on_company":"growth-positive","investment_amount":null,"structured_issues":["Partners"],"acquisition_amount":null,"structuredIssuesShow":"#Partners","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"sIA3jujq0o84S5Xm4JXIYpeFnQNxT6nBike1C4j97TCQ6mh6hBH4ov","news_summary":"BlueWind Medical Appoints Dr. Liz Kwo to Board of Directors","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"bcd4fc45-62e2-465b-b280-7959c0c11dd7","date":"May 9, 2022","link":"https://www.prnewswire.com/news-releases/bluewind-medical-raises-64-million-to-fund-innovative-technology-for-overactive-bladder-oab-treatment-301542554.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":["medical","funding"],"company":"BlueWind Medical","layoffs":null,"summary":"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.","partners":["ConvaTec"],"customers":null,"investors":["ConvaTec"],"confidence":8,"key_topics":["RENOVA iStim","treatment","OAB","funding","FDA marketing clearance"],"date_of_event":null,"valuation_amount":null,"impact_on_company":"growth-positive","investment_amount":"$64 million","structured_issues":["Investment"],"acquisition_amount":null,"structuredIssuesShow":"#Investment","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"tpd4qI0AbNplb8vga9v4iKx4vUinZ9pmkUsbgDk6guL4oQtCwy7pWD","news_summary":"BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder (OAB) Treatment","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"23d63e91-f79a-4104-8a53-e5b2c16c646a","date":"Jan 7, 2020","link":"https://www.massdevice.com/bluewind-medical-appoints-new-ceo/","source":"www.massdevice.com","visible":1,"analysis":{"tags":"appointment","company":"BlueWind Medical","layoffs":null,"summary":"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.","partners":null,"customers":null,"investors":"Rainbow Medical","confidence":8,"key_topics":["CEO appointment","Neurostimulation device","Renova neursostimulation system","Pivotal study","Over-active bladder market"],"date_of_event":"2022-01-01","valuation_amount":null,"impact_on_company":"growth-positive","investment_amount":null,"structured_issues":["Management Changes"],"acquisition_amount":null,"structuredIssuesShow":"#Management Changes","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"sfcCYpdRhj9ty0EHrHAJ2EG62HuqfHjSCuung46u5vuIsT9XfyodkJ","news_summary":"BlueWind Medical appoints new CEO","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"08511475-a3fb-496d-8bec-99d938aa224b","date":"Nov 19, 2018","link":"https://www.newswire.ca/news-releases/bluewind-medical-appoints-new-executive-chairman-700824831.html","source":"www.newswire.ca","visible":1,"analysis":{"tags":"neurostimulation, medical device","company":"BlueWind Medical","layoffs":null,"summary":"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.","partners":["Rainbow Medical"],"customers":null,"investors":null,"confidence":8,"key_topics":["Daniel Lemaitre","neurostimulation platform","Executive Chairman","market clearance","commercialize BlueWinds neuromodulation therapy platform"],"date_of_event":"2018-11-19","valuation_amount":null,"impact_on_company":"growth-positive","investment_amount":null,"structured_issues":["Management Changes"],"acquisition_amount":null,"structuredIssuesShow":"#Management Changes","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"RjoTUUiOx6I4BmgF0qdHUejHeZsY7tXO0CqWPVOmeUnNFfGRQ4wtjP","news_summary":"BlueWind Medical Appoints New Executive Chairman","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"0e6a4a29-db8b-4104-950a-98edd8101005","date":"Aug 30, 2018","link":"https://www.prnewswire.com/news-releases/bluewind-medical-announces-positive-long-term-results-of-the-bluewind-renova-implantable-tibial-nerve-neuromodulator-820282084.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"medical technology","company":"BlueWind Medical","layoffs":null,"summary":"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.","partners":null,"customers":null,"investors":null,"confidence":9,"key_topics":["clinical results","neurostimulation","overactive bladder","long-term performance","quality of life"],"date_of_event":"August 30, 2018","valuation_amount":null,"impact_on_company":"growth-positive","investment_amount":null,"structured_issues":["Customers"],"acquisition_amount":null,"structuredIssuesShow":"#Customers","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"YCBbuAD7s0UeGvTmKaXysVIK9EY3HH2C4hNUvyF5skE29NhKcqS3Vi","news_summary":"BlueWind Medical Announces Positive Long-Term Results of the BLUEWIND-RENOVA™ Implantable Tibial Nerve Neuromodulator","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"8411c392-bbd7-4fd7-b215-a2e7daddc7d0","date":"Jul 30, 2018","link":"https://www.prnewswire.com/news-releases/bluewind-medical-appoints-dr-roger-r-dmochowski-md-mmhc-as-chief-medical-officer-839643643.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"appointment","company":"BlueWind Medical","layoffs":null,"summary":"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.","partners":null,"customers":null,"investors":null,"confidence":8,"key_topics":["neurostimulation","clinical trial","overactive bladder","chief medical officer","platform technology"],"date_of_event":"July 30, 2018","valuation_amount":null,"impact_on_company":"growth-positive","investment_amount":null,"structured_issues":["Management Changes"],"acquisition_amount":null,"structuredIssuesShow":"#Management Changes","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"GtenkhcPuzHnftuWIwbiEDtpRab5WKS8cQ1mvtD1h1J90rCZzvRoWW","news_summary":"BlueWind Medical Appoints Dr. Roger R. Dmochowski, MD, MMHC, as Chief Medical Officer","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"c6b43766-28cc-4d47-9b0f-a057000ed5ef","date":"Jun 14, 2018","link":"https://www.prnewswire.com/news-releases/bluewind-medical-receives-fda-approval-for-pivotal-trial-design-of-renova-istim-implantable-tibial-nerve-neuromodulator-for-overactive-bladder-685557941.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"FDA approval","company":"BlueWind Medical","layoffs":"N/A","summary":"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.","partners":"N/A","customers":"N/A","investors":"N/A","confidence":9,"key_topics":["neurostimulation","RENOVA iStim","overactive bladder","pivotal study","Tibial Nerve Neuromodulation System"],"date_of_event":"June 14, 2018","valuation_amount":"N/A","impact_on_company":"growth-positive","investment_amount":"N/A","structured_issues":["Customers"],"acquisition_amount":"N/A","structuredIssuesShow":"#Customers","entityGrowthIconPath":"url(/assets/circle-green.svg);"},"sentiment":"growth-positive","analysisId":"MTmE2W7lAJDj7kZNRHrrgcW7XsHsSIRSdJwVt0n29ycaeZKngCSfQv","news_summary":"BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim™ Implantable Tibial Nerve Neuromodulator for Overactive Bladder","analysisStructuredIssuesDisplay":"block","analysisImpactOnCompanyDisplay":"block"},{"id":"15b0ce1c-785e-44f4-869a-334f50a6fd8f","date":"Jan 4, 2018","link":"https://www.prnewswire.com/news-releases/bluewind-medical-announces-the-publication-of-breakthrough-results-for-bluewind-renova-implantable-tibial-nerve-neuromodulator-668016233.html","source":"www.prnewswire.com","visible":1,"analysis":{"tags":"neurostimulation","company":"BlueWind Medical","layoffs":null,"summary":"BlueWind Medical, a developer of a wireless neurostimulation platform, announced the publication of clinical results of the OPTIMIST Study. 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