Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference Mont-Saint-Guibert, Belgium – December 29, 2025, 10:05pm CET / 4:05pm 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) through neuromodulation, today announced that the management team will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, Jan. 15, 2026. The ...

Nyxoah Announces Issuance of First Tranche of Convertible Bonds Mont-Saint-Guibert, Belgium – December 19, 2025, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA) through neuromodulation, today announced the issuance of the first tranche of the convertible bond financing entered into with an entity managed by Heights Capi ...

Core Viewpoint - Nyxoah is actively participating in the Piper Sandler 37th Annual Healthcare Conference, showcasing its innovative solutions for Obstructive Sleep Apnea (OSA) treatment [1]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [3]. - The company aims to improve the quality of life for OSA patients, allowing them to enjoy restful nights [3]. Product Development and Regulatory Approvals - The Genio system received its European CE Mark in 2019 following the successful completion of the BLAST OSA study [4]. - Nyxoah has completed two successful IPOs, one on Euronext Brussels in September 2020 and another on NASDAQ in July 2021 [4]. - The company expanded its therapeutic indications to include Complete Concentric Collapse (CCC) patients after positive outcomes from the BETTER SLEEP study, which are currently contraindicated in competitors' therapies [4]. - Nyxoah announced positive results from the DREAM IDE pivotal study and received FDA approval for a subset of adult patients with moderate to severe OSA, specifically those with an Apnea-Hypopnea Index (AHI) of 15 to 65 [4].

Core Viewpoint - Nyxoah has secured financing commitments totaling up to U.S. $77 million to support the U.S. commercialization of its Genio system, which is designed to treat Obstructive Sleep Apnea (OSA) through neuromodulation [1][2]. Financing Details - The financing includes a €22 million private placement of equity, a U.S. $5.6 million registered direct offering, and a convertible bond financing of up to €45 million [2][7]. - The private placement involves the issuance of 5,481,678 new ordinary shares at a subscription price of €4.00 per share, generating gross proceeds of approximately €25 million [3]. - The registered direct offering consists of 1,215,964 new ordinary shares priced at U.S. $4.6304 per share, totaling approximately U.S. $5.6 million [5][6]. - The convertible bonds will have a maximum principal amount of up to €45 million, with the first tranche of €22.5 million expected to close in December 2025 [7]. Use of Proceeds - The net proceeds from the financing will be allocated to support U.S. commercialization activities, gather clinical data, finance research and development, and explore collaboration opportunities in OSA monitoring and diagnostics [8]. Company Background - Nyxoah is focused on developing innovative solutions for OSA, with its lead product being the Genio system, which is a leadless and battery-free hypoglossal neurostimulation therapy [10]. - The Genio system received its European CE Mark in 2019 and FDA approval for certain adult patients in August 2025 [11][12].

Core Insights - Nyxoah reported strong initial results following the U.S. launch of its Genio system for treating Obstructive Sleep Apnea (OSA), achieving first revenue within a month post-FDA approval [2][4][5] Financial Highlights - Revenue for Q3 2025 was €2.0 million, a 56% increase year-over-year from €1.3 million in Q3 2024 [8][9] - The company reported a gross profit of €1.2 million with a gross margin of 60.5% for Q3 2025, compared to a gross margin of 62.0% in Q3 2024 [9][11] - Operating loss for Q3 2025 was €24.4 million, up from €15.0 million in Q3 2024, primarily due to increased selling, general, and administrative expenses [13][12] Market Launch and Strategy - The company executed a two-pronged launch strategy targeting high-volume hypoglossal nerve stimulation centers and building referral networks with sleep physicians [5][6] - As of October 31, 2025, 111 surgeons were trained on the Genio system, with 9 accounts having implanted the device [6] Reimbursement Progress - Significant progress was made in securing reimbursement coverage, with updates from major payors like Health Care Service Corporation and Blue Cross Blue Shield of Michigan, impacting over 26 million members [7][8] Cash Position - As of September 30, 2025, cash, cash equivalents, and financial assets totaled €22.5 million, down from €43.0 million at the end of June 30, 2025 [14]

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 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 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 - 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].