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]

Company Overview & Financial Performance - Inspire Medical Systems highlights a significant underpenetrated U S market valued at over $10 billion[7] - The company reported revenue of over $800 million in 2024, marking a 28% year-over-year growth[7, 10] - The company has surpassed 100,000 patients receiving Inspire therapy[7, 75] - The company's gross margin for the first quarter was 84.7%[75] - FY2025 revenue is projected to be in the range of $940 million to $955 million, representing a 17%-19% growth over FY2024[70] Inspire Therapy & Market Dynamics - The company has reimbursement coverage in all 50 states, covering over 300 million U S lives[7, 9] - The domestic OSA market presents a substantial opportunity, with approximately 500,000 Inspire-eligible individuals[25] - Inspire patients experience a median AHI reduction from 33 events/hr at baseline to 10.2 events/hr at 12 months[44] - 91% of patients say Inspire is better compared against their previous experience with CPAP[47] GLP-1s and OSA - Claims data identified over 1,500 patients who were on a GLP-1 at the time of Inspire implant[122] - The BMI of Inspire patients was roughly 20% lower at the time of implant than all other OSA patients at the time of their OSA Dx[123]

Core Viewpoint - Vivos Therapeutics, Inc. is acquiring The Sleep Center of Nevada to expand its obstructive sleep apnea (OSA) treatment offerings in the Las Vegas area, enhancing its market position and patient access to its FDA-cleared oral appliance treatments [1][3][6]. Company Overview - Vivos Therapeutics, Inc. is a medical technology company focused on developing non-invasive treatments for OSA and related sleep disorders, with FDA-cleared devices for both adults and children [8][10]. - The Sleep Center of Nevada, founded in 2008, is the largest operator of medical sleep centers in Nevada, serving approximately 3,000 new patients monthly and generating high seven-figure annual revenues [4][8]. Acquisition Details - Vivos will pay up to $9 million for SCN's operating assets, including $6 million in cash and $1.5 million in Vivos common stock at closing, with an additional $1.5 million contingent on future financial milestones [5][6]. - The acquisition is expected to close later this quarter or in the third quarter, subject to customary conditions [2][5]. Strategic Implications - The acquisition aligns with Vivos' mission to provide accessible, clinically proven OSA treatments, leveraging SCN's infrastructure to enhance service offerings and patient acceptance [3][6]. - Vivos anticipates that SCN patients will prefer its treatment options over traditional CPAP devices, as evidenced by a previous strategic alliance where two-thirds of OSA patients chose Vivos treatments [6][7]. Market Context - OSA affects over 1 billion people globally, with a significant portion undiagnosed, indicating a substantial market opportunity for effective treatment alternatives [9]. - The acquisition is part of Vivos' broader strategy to create collaborations with key players in the sleep clinic sector, aiming to reach a larger patient volume and improve cash flow [7][9].