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]

Nyxoah Conference Call Summary Company Overview - **Company**: Nyxoah - **Industry**: Medical Technology, specifically focused on obstructive sleep apnea (OSA) treatment Key Points and Arguments Innovative Technology - Nyxoah offers a next-generation neuromodulation solution for moderate to severe OSA patients, utilizing hypoglossal nerve stimulation with bilateral stimulation and single-incision implants [3][4] - The system is designed to be fully MRI compatible and does not require an implantable battery, eliminating the need for re-surgery when the battery is depleted or when software upgrades are needed [3][4] Clinical Evidence and DREAM Study - The DREAM pivotal study aimed to reduce the apnea-hypopnea index (AHI) by at least 50% and bring the overall number of events below 20 [5][6] - The study reported a severe obstructive event percentage of 8.7%, significantly lower than the competition's nearly 20% [6] - Median reduction in AHI was reported at 70%, with 82% of participants achieving an AHI below 15, which is a critical threshold for treatment eligibility [8][9] FDA Approval and Market Entry - Nyxoah received FDA approval on August 8, allowing the company to launch its product in the U.S. market [10][11] - The approval includes specific indications for patients with extreme difficult airway openings, which are contraindicated for current AGNS technology [10][11] Commercial Strategy - The company has a two-pronged launch strategy targeting both sleep physicians and ENT surgeons, emphasizing the role of sleep physicians in patient management [15][17] - Nyxoah has already trained over 100 physicians and aims to expand its commercial team to increase market penetration [13][36] Market Penetration and Competition - Nyxoah aims to capture high-volume implanting sites, with a goal of reaching 400 sites that represent 80% of the total volume in the U.S. [18][20] - The company has successfully captured a 25% market share in Germany within two years and aims to replicate this success in the U.S. [20][21] Reimbursement Strategy - Nyxoah is actively working with payers to ensure reimbursement for its technology, leveraging existing CPT codes and engaging with major commercial payers [22][23] - The company has received positive feedback from Medicare regarding coding acceptance, which is crucial for scaling up operations [23][24] Future Innovations and R&D - Nyxoah is focused on continuous innovation, including developing a more intelligent implantable device and a wearable component that provides real-time feedback to patients [44][45] - The company is exploring the potential for a pillow charging concept for its devices, aiming for a seamless user experience [45][49] Patient Profile and Market Trends - The ideal patient profile for Nyxoah's treatment includes individuals aged around 53-54 who are health-conscious and motivated to maintain a healthy lifestyle [29][30] - The emergence of GLP-1 therapeutics may expand the patient pool by enabling weight loss in individuals with higher BMIs, which could lead to increased demand for Nyxoah's technology [33][35] Access Trial and Clinical Validation - The ACCESS trial aims to validate the effectiveness of Nyxoah's technology for patients with complete concentric collapse (CCC), with a submission for label expansion expected by Q1 2027 [50][52] Differentiation and Manufacturing - Nyxoah emphasizes the differentiation of its technology through bilateral stimulation and the scalability of its platform, which is designed to benefit patients significantly [54][55] Additional Important Insights - The company has made strategic decisions to manufacture in the U.S. for the U.S. market, which is seen as a beneficial move given current market dynamics [54]