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]

Nyxoah Announces Upcoming Investor Events Mont-Saint-Guibert, Belgium – September 2, 2025, 10:30pm CET / 4:30PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that the Company will participate in the following events during September: 2025 Wells Fargo Healthcare ConferenceSeptember 3rd – Boston, MA Cantor Global Healthcare Conference 2025 September 4 ...

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]

Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4] - The company's lead product is the Genio® system, which is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA [4] Financial Results Announcement - Nyxoah will release its financial results for the second quarter of 2025 on August 18, 2025 [1] - A conference call will be hosted by company management on the same day to discuss the financial results, starting at 10:30 PM CET / 4:30 PM ET [1] Webcast Information - A webcast of the earnings call will be available on the Investor Relations page of Nyxoah's website [2] - For participants wishing to ask questions, registration is required to receive dial-in details and a unique access code [3] Recent Developments - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [5] - The company received CE mark approval for expanding therapeutic indications to Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study [5]

Core Insights - Nyxoah's DREAM pivotal study data has been published, demonstrating the safety and efficacy of the Genio® system for treating Obstructive Sleep Apnea (OSA) [1][2][4] Study Results - The DREAM study showed that over 70% of nights had device usage greater than 4 hours in 84.3% of participants, with 85.9% using the device over 70% of the nights [2] - Patient satisfaction with the therapy was reported at 90%, and snoring scores decreased from 83.5% at baseline to 30.4% at 12 months [3] - The study achieved co-primary endpoints with an AHI responder rate of 63.5% (p=0.002) and an ODI responder rate of 71.3% (p<0.001) [4][5] Device Performance - The Genio® system resulted in a median AHI reduction of 66.6% in supine positions and 70.8% across all sleeping positions at 12 months [5] - Quality of life improvements were noted, with a mean increase of 2.3 points in the Functional Outcomes of Sleep Questionnaire and a reduction of 3.4 points in the Epworth Sleepiness Score [6] Company Overview - Nyxoah focuses on innovative solutions for OSA, with the Genio® system being a leadless and battery-free hypoglossal neurostimulation therapy [7] - The company received its European CE Mark in 2019 and has completed successful IPOs on Euronext Brussels and NASDAQ [8]

Core Insights - Vivos Therapeutics has received approval from the Centers for Medicare & Medicaid Services (CMS) for its VidaSleep™ oral appliance, which is designed to treat mild to moderate obstructive sleep apnea (OSA) and snoring in adults [1][4][5] - The approval allows Vivos to significantly expand its market presence, as it now has two Medicare-covered oral appliances, enhancing its competitive position in the sleep therapy market [5][6] Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on innovative treatments for OSA and snoring, with its products cleared by the FDA for various severity levels of OSA [10][12] - The company aims to address the structural root causes of OSA through its proprietary oral appliances, which are non-invasive and non-pharmaceutical [13] Market Opportunity - With over 80% of OSA cases in the U.S. undiagnosed and an estimated 80 million Americans affected, Vivos is positioned to capture a significant share of the underpenetrated sleep therapy market [4][11] - The dual-PDAC approval of VidaSleep™ and mmRNA® appliances allows Vivos to serve a broader range of patients, from Medicare beneficiaries to those covered by commercial payers, tapping into the estimated $36 billion sleep therapy market [6][8] Clinical and Commercial Advantages - The VidaSleep™ device is designed to be a standalone therapy or an adjunct to CPAP, providing flexibility for both providers and patients [7][8] - The streamlined design and efficient manufacturing process of VidaSleep™ enable Vivos to offer high-impact therapy at a cost-effective price, increasing adoption across Medicare and commercial insurance networks [8] Health Implications - OSA is linked to severe comorbidities such as heart disease, stroke, and dementia, yet remains largely underdiagnosed [9][11] - Vivos' oral appliances have shown significant improvements in airway patency and symptom resolution, as evidenced by peer-reviewed studies [9]

Summary of Inspire Medical Systems (INSP) 2025 Conference Call Company Overview - **Company**: Inspire Medical Systems (INSP) - **Event**: 2025 Conference Call - **Date**: June 13, 2025 Key Points Industry and Market Dynamics - Discussion focused on the **Obstructive Sleep Apnea (OSA)** market and the competitive landscape surrounding it [2][10] - Emphasis on the **Inspire five** launch and its implications for the OSA treatment market [2][10] Inspire Five Launch - **Inspire five** features a **20% reduction in implant time** and improved sensing technology integrated into the neurostimulator [10][26] - The new device incorporates an **accelerometer** for respiration sensing, eliminating the need for a separate pressure sensing lead, thus simplifying the implant procedure [14][21] - The device allows for **Bluetooth communication** with a patient app and integrates with **SleepSync**, a cloud-based patient management system [11][12] Clinical Data and Performance - Clinical trials showed that **Inspire five** improved **inspiratory phase overlap** from **78% to 83%**, enhancing treatment effectiveness [22][24] - A study in Singapore indicated that the average nightly usage post-implant was **six hours**, demonstrating strong patient adherence [27] - The **St. Luke's Health** study reported over **80% success rate** in positional sleep apnea, indicating improved efficacy compared to previous trials [31][32] Surgeon Feedback and Adoption - Surgeons reported positive feedback regarding the ease of implantation without the pressure sensing lead, leading to reduced operating room (OR) time [41][42] - The transition to **Inspire five** is expected to increase the number of procedures performed by surgeons due to improved efficiency [64][70] Financial and Market Outlook - The company anticipates continued growth in adoption of Inspire therapy, with a focus on penetrating the **single-digit percentage** of the overall target market [38][39] - The **2025 guidance** includes expectations for increased capacity and productivity from surgeons, despite some anticipated competitive trials [82][83] Competitive Landscape - The emergence of **GLP-1 medications** for weight management in sleep apnea patients was discussed, with the potential for these treatments to complement Inspire therapy [98][104] - The company is monitoring the impact of GLP-1 on patient demand and treatment eligibility, noting that Inspire therapy remains effective for patients with tongue-based obstruction [100][103] Future Developments - Inspire is already working on **Inspire six**, which aims to enhance therapy adherence by detecting sleep states and automatically adjusting stimulation [90][91] - The integration of **SleepSync** with Inspire five is expected to facilitate better patient management and data collection for future improvements [92] Conclusion - Inspire Medical Systems is positioned for growth with the launch of Inspire five, leveraging advanced technology to improve patient outcomes and streamline surgical procedures. The company is optimistic about its market penetration and future innovations while navigating competitive pressures from emerging therapies.

Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA) [4] - The company's lead product is the Genio® system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA [4] Recent Developments - Nyxoah will participate in the Jefferies Global Healthcare Conference from June 3 to June 5, 2025, in New York [2] - CEO Olivier Taelman will present on June 4, 2025, at 4:55 PM ET, with a webcast available on the company's Investor Relations website [3] - The company will also hold one-on-one meetings with institutional investors during the conference [3] Product Milestones - The Genio® system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [5] - Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021 [5] - The company received CE mark approval for expanded therapeutic indications to treat Complete Concentric Collapse (CCC) patients, which are currently contraindicated in competitors' therapies [5] - Positive outcomes from the DREAM IDE pivotal study have also been announced [5]