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]

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]

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 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 ...

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]

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]

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]

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]

Core Viewpoint - Vivos Therapeutics, Inc. is set to release its second quarter 2025 financial results and will conduct a conference call to discuss these results and recent developments in the company [1][2][3] Company Overview - Vivos Therapeutics, Inc. specializes in developing and commercializing treatments for sleep-related breathing disorders, particularly obstructive sleep apnea (OSA) [4] - The company’s devices are FDA-cleared for all severity levels of OSA in adults and moderate to severe OSA in children aged 6 to 17 [4] - 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 [4] Market Context - OSA affects over 1 billion people globally, with 90% undiagnosed, linking it to serious chronic health conditions [5] - Traditional treatments like CPAP often fail to address the root causes of OSA, indicating a need for innovative solutions [5] Strategic Initiatives - Founded in 2016, Vivos aims to empower healthcare providers to better address the needs of OSA patients through innovative technology and collaborations [6] - The company promotes The Vivos Method, a proprietary, clinically effective, nonsurgical, noninvasive, and nonpharmaceutical solution for OSA [7]

Company Overview - Inspire Medical Systems has an underpenetrated U S market exceeding $10 billion[7,9,26] - The company achieved over $800 million in revenue in 2024, demonstrating a 28% year-over-year growth[7,10] - Inspire therapy has established reimbursement in all 50 U S states, covering over 300 million lives[7,9] - Over 100,000 patients have received Inspire therapy, highlighting a significant first-mover advantage[7,8,9,33] Financial Performance & Growth Strategy - The company projects FY2025 revenue between $900 million and $910 million, representing a 12%-13% growth over FY2024[65] - The gross margin for FY2025 is expected to be between 84% and 86%[65] - Inspire initiated the full launch of the Inspire V system in the U S in May 2025[70,71] - Second quarter revenue reached $217 1 million, an 11% increase year-over-year, with a gross margin of 84%[70] Therapy & Market - Inspire therapy demonstrates a median Apnea-Hypopnea Index (AHI) reduction from 33 0 events/hr at baseline to 10 2 events/hr at 12 months[43] - Inspire patients reported a median Epworth Sleepiness Scale (ESS) score reduction from 11 0 at baseline to 6 0 at the 12-month visit[44] - 91% of patients say Inspire is better than CPAP, and 93% would recommend Inspire to a friend or family member[46]