Nyxoah to Participate in the Stifel 2025 Healthcare Conference Mont-Saint-Guibert, Belgium – November 3, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced that the Company will participate in the Stifel 2025 Healthcare Conference on Tuesday, Nov. 11, 2025. The Company is scheduled to present at 9:20am Eastern Time the same day via webcast. A live webcast of th ...

Core Points - Nyxoah will release its financial results for the third quarter of 2025 on November 13, 2025, followed by a conference call to discuss these results [1][2][3] Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA) through neuromodulation [4] - The company's lead product is the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy for OSA, a condition linked to increased mortality risk and cardiovascular issues [4] Recent Developments - The Genio system received its European CE Mark in 2019 after the successful completion of the BLAST OSA study [5] - Nyxoah 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, the company 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 - Wall Street anticipates a year-over-year decline in earnings for Nyxoah SA despite higher revenues, with actual results being crucial for stock price movement [1][2]. Earnings Expectations - Nyxoah is expected to report a quarterly loss of $0.61 per share, reflecting a year-over-year change of -10.9% [3]. - Revenues are projected to be $1.95 million, which is an increase of 40.3% compared to the same quarter last year [3]. Estimate Revisions - The consensus EPS estimate has been revised down by 6.1% over the last 30 days, indicating a reassessment by analysts [4]. - The Most Accurate Estimate for Nyxoah is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +19.67% [12]. Earnings Surprise Prediction - A positive Earnings ESP reading suggests a potential earnings beat, particularly when combined with a strong Zacks Rank [10]. - Nyxoah currently holds a Zacks Rank of 4, making it challenging to predict an earnings beat despite the positive Earnings ESP [12]. Historical Performance - In the last reported quarter, Nyxoah was expected to post a loss of $0.62 per share but actually reported a loss of -$0.63, resulting in a surprise of -1.61% [13]. - Over the past four quarters, Nyxoah has only beaten consensus EPS estimates once [14]. Industry Comparison - In the Zacks Medical Info Systems industry, Hims & Hers Health, Inc. is expected to report earnings of $0.09 per share, indicating a year-over-year change of +50% [18]. - Hims & Hers Health's revenue is expected to be $583.68 million, up 45.4% from the previous year [19].

Core Insights - Nyxoah has initiated the U.S. commercial rollout of its Genio system for obstructive sleep apnea (OSA) after receiving FDA approval, marking a significant advancement in the company's market presence [2][8] - The first successful implants in the U.S. indicate strong early demand from physicians and expanding payor coverage, setting the stage for nationwide adoption [3][9] Company Developments - The Genio system is a leadless, battery-free neurostimulation device that offers a minimally invasive treatment option for OSA, differentiating itself from traditional devices [11] - Nyxoah's market capitalization stands at $168.6 million, with an expected earnings growth of 8.8% by 2026 [6] Market Dynamics - The global sleep apnea devices market was valued at $4.5 billion in 2023 and is projected to grow to $6.9 billion by 2030, with a compound annual growth rate (CAGR) of 6.2% from 2024 to 2030 [13] - Factors driving market growth include an aging population, a significant number of patients with sleep apnea, and advancements in device technology [14] Competitive Position - Nyxoah's Genio system is positioned to become a preferred therapy in the sleep apnea market due to its innovative design and ease of use, potentially enhancing the company's competitive edge [12] - Early traction in the market, including surgeon enthusiasm and hospital approvals, suggests a strong foundation for revenue growth as procedure volumes increase [10][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]

Company Expansion - Nyxoah SA announced the expansion of its commercial footprint in the Middle East following the first successful Genio implant in Abu Dhabi in September 2025 [1][9] - The company aims to partner with healthcare institutions in Dubai, Kuwait, and Abu Dhabi to enhance access to the Genio system for OSA patients who cannot tolerate CPAP [3][9] Product Overview - Genio is the only leadless, externally powered bilateral hypoglossal nerve stimulation system for treating moderate-to-severe obstructive sleep apnea (OSA) [1][9] Market Potential - The global sleep apnea devices market was valued at $4.5 billion in 2023 and is projected to reach $6.9 billion by 2030, growing at a CAGR of 6.2% [4] - Factors driving market growth include an aging population, a significant patient pool with sleep apnea, and increased prevalence of comorbidities associated with sleep apnea [4] Competitive Landscape - Inspire Medical Systems reported strong revenue growth and market penetration in its second-quarter results, indicating a competitive environment in the OSA space [7] - Resmed Inc. launched the Sleep Institute to advance sleep health, reflecting ongoing innovation and focus in the industry [8][10] - LivaNova PLC initiated the commercial launch of the Essenz Perfusion System in China and reported solid revenue growth, showcasing competitive dynamics in the market [11]

Core Insights - Several small- and mid-cap biotech and medical stocks experienced significant after-hours trading activity on September 26, driven by clinical updates, investor presentations, and strategic announcements. Company Summaries - **Enanta Pharmaceuticals Inc. (ENTA)**: The stock surged 20% in after-hours trading to $9.48 after closing at $7.90, following the announcement of upcoming topline results from its Phase 2b study on zelicapavir for RSV treatment in high-risk adults [2][3]. - **Acumen Pharmaceuticals Inc. (ABOS)**: Shares rebounded 12.67% to $1.60 after closing at $1.42, driven by renewed interest in its Alzheimer's pipeline, particularly the Phase 2 candidate Sabirnetug (ACU193) [4]. - **Delcath Systems Inc. (DCTH)**: The stock gained 6.00% in after-hours trading to $11.39 after closing at $10.74, following renewed investor interest in its CHOPIN Phase 2 trial data presentation scheduled for ESMO 2025 Congress [5][6]. - **Vivos Therapeutics Inc. (VVOS)**: The stock climbed 4.81% to $3.27 after closing at $3.12, likely due to renewed interest following recent positive clinical trial results for its pediatric OSA treatment [7][8]. - **Xilio Therapeutics (XLO)**: Shares rose 4.28% to $0.83 after closing at $0.7959, driven by enthusiasm surrounding the initiation of a Phase 2 trial for its tumor-activated IL-12 candidate, which also triggered a $17.5 million payment from Gilead [9][10]. - **Nyxoah SA (NYXH)**: The stock increased 3.77% to $4.68 after closing at $4.51, supported by optimism regarding its international expansion and a recent patent infringement lawsuit against Inspire Medical Systems [11].

Core Insights - Nyxoah is expanding its presence in the Middle East with new centers in Dubai, Kuwait, and Abu Dhabi, following the first successful Genio® implant in the region in September 2025 [2][4]. Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5][6]. - The Genio system received its European CE Mark in 2019 and has undergone successful IPOs on Euronext Brussels and NASDAQ [6]. Market Expansion - The Middle East is identified as a significant and growing market for Nyxoah, with the company partnering with leading healthcare institutions to enhance access to the Genio solution for OSA patients who cannot tolerate CPAP [3][4]. - The expansion into Kuwait and Abu Dhabi is part of Nyxoah's strategy to broaden its commercial footprint and improve patient outcomes in the region [4].

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]

Company Overview - Nyxoah is introducing an innovative next-generation neuromodulation solution specifically targeting moderate-to-severe obstructive sleep apnea (OSA) patients through hypoglossal nerve stimulation [1] - The technology is characterized by bilateral stimulation and a single-incision implant, which differentiates it from existing solutions [1] Product Features - The system is designed to be fully compatible with body MRI from the outset, eliminating the need for an implantable battery [2] - The wearable component, which patients use during sleep, contains the battery and software, thus avoiding the need for resurgery when the battery is depleted [2]