Obstructive Sleep Apnea (OSA) treatment
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Nyxoah Announces the Signature of a Memorandum of Understanding with Sheikh Shakhbout Medical City Hospital to Improve OSA Therapy Management and Accelerate Access to Genio in the Middle East
Globenewswire· 2026-02-18 21:05
Core Insights - Nyxoah has signed a Memorandum of Understanding (MoU) with Sheikh Shakhbout Medical City (SSMC) to enhance Obstructive Sleep Apnea (OSA) therapy management and improve access to its Genio® therapy in the Middle East [1][2] Group 1: Partnership and Strategic Focus - The MoU aims to position SSMC as a leading regional center for Genio therapy, focusing on developing a high-volume implant program centered on patient care [2] - The collaboration includes establishing SSMC as a training hub for Genio therapy, educating surgeons, sleep physicians, and healthcare professionals across the region [3] Group 2: Clinical and Research Initiatives - Discussions are ongoing to explore clinical research and collaboration in sleep apnea and chronic disease management [3] - The initiative aligns with Nyxoah's vision to provide new treatment options for OSA patients and investigate the impact of advanced OSA management on chronic diseases like type 2 diabetes [4] Group 3: Company Overview and Product Information - Nyxoah specializes in developing innovative solutions for OSA, with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies, including the BETTER SLEEP study and DREAM IDE pivotal study [6]
Vivos Therapeutics Announces Closing of Exercise of Warrants for $4.64 Million Gross Proceeds
Globenewswire· 2026-01-20 22:31
Core Viewpoint - Vivos Therapeutics, Inc. has successfully closed the exercise of outstanding warrants, raising approximately $4.64 million to support its operations in the sleep-related breathing disorder market, particularly obstructive sleep apnea (OSA) [1][4]. Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues, particularly OSA and snoring [7]. - The company’s devices have received FDA clearance for treating OSA in adults and children aged 6 to 17, with its Complete Airway Repositioning and Expansion (CARE) devices being the only FDA 510(k) cleared technology for severe OSA in adults [7]. Market Context - OSA affects over 1 billion people globally, with 90% remaining undiagnosed, highlighting a significant market opportunity for innovative treatments [8]. - Traditional treatments like CPAP often fail to address the root causes of OSA, indicating a need for more effective solutions [8]. Financial Activity - The company exercised warrants to purchase up to 1,982,356 shares at a reduced price of $2.34 per share, originally priced between $3.83 and $5.05 [1]. - In exchange for the cash exercise of existing warrants, Vivos issued new unregistered warrants to purchase up to 3,964,712 shares at an exercise price of $2.09 per share [3]. Use of Proceeds - The net proceeds from the warrant exercise will be utilized for working capital and general corporate purposes [4].
Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Netherlands
Globenewswire· 2025-12-17 06:05
Core Insights - Nyxoah has announced the commercial launch of its Genio® system in the Netherlands, with successful implants performed at OLVG West and Zuyderland hospitals [1][2] - The Genio system is designed as a breakthrough therapy for Obstructive Sleep Apnea (OSA), providing an alternative for patients who cannot tolerate CPAP [2][3] - The launch reflects Nyxoah's ongoing expansion in Europe and the growing adoption of its bilateral, externally powered Genio therapy [2] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating OSA, with its lead product being the Genio system, which is leadless and battery-free [3] - The company aims to improve the quality of life for OSA patients, who face increased mortality risk and cardiovascular issues [3] Product Features - The Genio system stimulates both branches of the nerve, is MRI-compatible, and can be upgraded via an external activation chip, making it a promising long-term solution [2] - The absence of an implanted battery and reliable performance in the supine position are highlighted as significant advantages of the Genio system [2] Regulatory Milestones - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4] - Nyxoah has also completed IPOs on Euronext Brussels and NASDAQ, and received FDA approval for a subset of adult patients with moderate to severe OSA in August 2025 [4]
Vivos Therapeutics Announces Grand Opening of Affiliated Sleep Center Near Detroit, Michigan
Globenewswire· 2025-12-16 13:45
Core Insights - Vivos Therapeutics, Inc. is expanding its operations with the grand opening of a new sleep testing and treatment center in Auburn Hills, Michigan, as part of its national expansion strategy to address obstructive sleep apnea (OSA) [1][3] - The new center operates under a capital-efficient affiliation model, allowing Vivos to partner with existing sleep clinics rather than solely relying on acquisitions, which enhances scalability and reduces capital intensity [2][4] - Vivos aims to provide innovative diagnostic and therapeutic solutions for OSA patients, leveraging its proprietary FDA-cleared products to improve patient outcomes and generate higher revenue for affiliated practices [3][4] Company Overview - Vivos Therapeutics focuses on developing and commercializing diagnostic and treatment methods for sleep-related breathing disorders, particularly OSA, with FDA-cleared devices for both adults and children [6][8] - The company emphasizes a non-invasive and non-pharmaceutical approach to treating OSA, known as The Vivos Method, which aims to address the root causes of the disorder rather than relying on traditional treatments like CPAP [9][7] Market Context - OSA affects over 1 billion people globally, with a significant portion undiagnosed, highlighting a substantial market opportunity for Vivos to provide effective treatments [7] - The sleep testing industry has faced pricing pressures, leading to closures and consolidations, which Vivos aims to counteract by offering differentiated treatment options through strategic affiliations [4][5]
Vivos Therapeutics Schedules Release of Third Quarter 2025 Financial Results and Conference Call
Globenewswire· 2025-11-19 13:30
Core Viewpoint - Vivos Therapeutics, Inc. is set to release its third quarter 2025 financial results and will discuss strategic collaborations that may impact revenue growth and cash burn during a conference call scheduled for November 19, 2025 [1][2]. Company Overview - Vivos Therapeutics, Inc. specializes in medical devices and healthcare services for sleep-related breathing disorders, particularly obstructive sleep apnea (OSA) [5]. - The company has developed proprietary treatments and diagnostic procedures, with its devices cleared by the FDA for various severity levels of OSA in both adults and children [5]. - Vivos' Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first for moderate to severe OSA in children [5]. Market Context - OSA affects over 1 billion people globally, with 90% undiagnosed, linking it to serious chronic health conditions [6]. - Traditional treatments like CPAP often fail to address the root causes of OSA, indicating a need for innovative solutions [6]. Strategic Initiatives - Vivos aims to enhance its market position through technology, education, and collaborations with sleep healthcare providers to better address OSA patients' needs [7]. - The company promotes The Vivos Method, a proprietary, clinically effective, nonsurgical, noninvasive, and nonpharmaceutical solution for OSA [8].
Inspire(INSP) - 2025 Q3 - Earnings Call Presentation
2025-11-03 22:00
Inspire Medical Systems, Inc. November 2025 NYSE: INSP Disclaimer This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ''may,'' ''will,'' ''should,'' ''expect,'' ''plan,'' ''anticipate,'' ''could,'' "future," "outlook," ''intend,'' ''target,'' ''project,'' ''contemplate ...
Nyxoah to Participate in the Stifel 2025 Healthcare Conference
Globenewswire· 2025-11-03 21:05
Core Insights - Nyxoah SA will participate in the Stifel 2025 Healthcare Conference on November 11, 2025, presenting at 9:20 AM Eastern Time via webcast [2][3] Company Overview - Nyxoah is a medical technology company focused on innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [4] - The Genio system received its European CE Mark in 2019 following the successful BLAST OSA study and has since expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients [5] - The company completed IPOs on Euronext Brussels in September 2020 and NASDAQ in July 2021, and received U.S. FDA approval for a Premarket Approval application in August 2025 [5]
Nyxoah Announces First U.S. Commercial Patients Implanted with Genio® System
Globenewswire· 2025-10-06 05:00
Core Insights - Nyxoah has successfully implanted the first U.S. commercial patients with the Genio® system, marking a significant milestone in the treatment of Obstructive Sleep Apnea (OSA) [1][2] - The company has achieved strong physician demand, successful pre-authorizations, and widespread payor coverage, including approvals from major payors like CMS [2] - The Genio system is a leadless and battery-free hypoglossal neurostimulation therapy, aimed at providing innovative solutions for OSA patients [3] Company Overview - Nyxoah is focused on developing and commercializing innovative solutions for OSA, with the Genio system as its lead product [3] - The company aims to improve the quality of life for OSA patients by providing effective treatment options [3] Product Development and Approval - The Genio system received its European CE Mark in 2019 and U.S. FDA approval in August 2025 as a prescription-only device [4][5] - The company has completed two successful IPOs, on Euronext Brussels in September 2020 and NASDAQ in July 2021 [4] Market Indicators - Nyxoah is tracking several metrics as leading indicators of future revenue growth, including the number of trained surgeons, value analysis committee submissions, prior authorization submissions, and accounts opened [7]
Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc.
Globenewswire· 2025-09-15 20:10
Core Viewpoint - Nyxoah has filed a patent infringement lawsuit against Inspire Medical Systems, claiming that Inspire's devices infringe on three of its patents related to Obstructive Sleep Apnea treatment [1] Group 1: Company Overview - Nyxoah is a medical technology company focused on innovative solutions for treating Obstructive Sleep Apnea (OSA) [3] - The company's lead product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA [3] - Nyxoah aims to provide patients with restful nights and improve their quality of life [3] Group 2: Product and Market Position - The Genio system received its European CE Mark in 2019 and has recently gained FDA approval as a prescription-only device in August 2025 [4][5] - The company has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4] - Positive outcomes from clinical studies, including the BETTER SLEEP study and the DREAM IDE pivotal study, have supported the expansion of therapeutic indications for the Genio system [4] Group 3: Legal Action - The lawsuit against Inspire Medical Systems was filed in the United States District Court for the District of Delaware, seeking injunctive relief and damages for patent infringement [1] - The patents in question are U.S. Patent Nos. 8,700,183, 9,415,215, and 9,415,216 [1] Group 4: Leadership and Commitment - Olivier Taelman, CEO of Nyxoah, emphasized the company's commitment to defending its intellectual property and providing a differentiated solution for OSA treatment [2] - The company has received positive feedback from physicians and patients following the U.S. commercial launch of the Genio system [2]
Nyxoah Announces Upcoming Investor Events
Globenewswire· 2025-09-02 20:30
Core Insights - Nyxoah is a medical technology company focused on developing innovative treatments for Obstructive Sleep Apnea (OSA) [4] - The company will participate in several investor events in September 2025, including the Wells Fargo Healthcare Conference and the Morgan Stanley Annual Global Healthcare Conference [2][3] Company Overview - Nyxoah's primary product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA, a condition linked to increased mortality and cardiovascular issues [4] - The Genio system received its European CE Mark in 2019 after the successful completion of the BLAST OSA study [5] - The company has completed two IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] - Following positive outcomes from the BETTER SLEEP study, Nyxoah expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - The company also announced positive results from the DREAM IDE pivotal study and received U.S. FDA approval for a Premarket Approval application in August 2025 [5]