Core Viewpoint - Nyxoah is making a significant investment to expand its manufacturing capacity in Belgium to support growth in the U.S. and international markets [1][2][3] Group 1: Investment and Expansion - Nyxoah has signed an agreement with LégiaPark to create a nearly 2,000 square meters manufacturing facility, including a state-of-the-art cleanroom [2] - The investment aims to enhance Nyxoah's product development activities and strengthen its strategic partnership with Noshaq, contributing to local job creation [2][3] Group 2: Manufacturing and Technology - The new cleanroom facility is designed to be scalable, allowing for future growth alongside Nyxoah's manufacturing needs [3] - ABN Cleanroom Technology is collaborating with Nyxoah to develop the cleanroom, emphasizing innovation and local expertise in Belgium [3][9] Group 3: Company Overview - Nyxoah specializes in developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a battery-free neurostimulation therapy [4][5] - The Genio system received its European CE Mark in 2019 and has expanded its therapeutic indications following successful studies [5]

Core Insights - Nyxoah reported strong preliminary results for Q4 and full year 2025, driven by successful U.S. commercialization of its Genio system for Obstructive Sleep Apnea (OSA) treatment [1][3] - The company anticipates continued revenue growth, with guidance indicating a 25% increase in U.S. net revenue for Q1 2026 compared to Q4 2025 [8] Financial Performance - For Q4 2025, gross revenue is expected to be approximately €6.3 million, with net revenue around €5.7 million, marking a 348% increase from €1.3 million in Q4 2024 [7] - Full year 2025 gross revenue is projected at €11.0 million, with net revenue of approximately €10.0 million, representing a 122% increase from €4.5 million in 2024 [7] - U.S. gross revenue for Q4 2025 is expected to be about €3.9 million, with net revenue around €3.5 million after deferred revenue deductions [7] Market Expansion and Strategy - The company has trained 145 surgeons on the Genio system and activated 57 accounts in the U.S. as of December 31, 2025 [7] - Nyxoah aims to expand Genio adoption in the U.S. throughout 2026, supported by a waiting list for additional surgeon training and patient implants [3] Upcoming Events - Nyxoah will present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026, at 12:00 p.m. Pacific Time [5]

Core Viewpoint - Nyxoah will present at the 44th Annual J.P. Morgan Healthcare Conference, highlighting its innovative treatment for Obstructive Sleep Apnea (OSA) through the Genio system [1][2]. Company Overview - Nyxoah is a medical technology company focused on developing and commercializing 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, who are at increased risk for mortality and cardiovascular issues [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 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 also announced positive results from the DREAM IDE pivotal study and received FDA approval in August 2025 for a subset of adult patients with moderate to severe OSA [4].

Core Viewpoint - Nyxoah SA has successfully issued the first tranche of convertible bonds amounting to €22.5 million as part of a larger financing plan of up to €45 million, aimed at supporting its operations and commercialization efforts in treating Obstructive Sleep Apnea (OSA) [1][2]. Group 1: Convertible Bonds Issuance - The first tranche of convertible bonds was issued for a nominal amount of €22.5 million, consisting of 225 bonds with a nominal value of €100,000 each, fully subscribed by Heights Capital Management (HCM) [2]. - A subscription fee of €1.8 million, equivalent to 8.0% of the principal amount, was paid to HCM, satisfied by set-off against the subscription price [2]. - The bonds carry an interest rate of 6.5% per annum and have a three-year maturity with quarterly amortization payments starting February 18, 2026 [3]. Group 2: Amortization and Conversion Rights - HCM has the right to bring forward the payment of up to two amortized payment amounts between scheduled amortization payment dates [4]. - HCM can convert the outstanding principal or any amortized payment amount at any time during the bond's term, with an initial conversion price set at €5.00 [5]. - Payments of amortized amounts can be made in cash or through the issuance of new ordinary shares, with the issue price determined by specific conditions [6]. Group 3: Future Tranche and Conditions - The company has the option to issue a second tranche of convertible bonds for an additional €22.5 million, contingent upon certain conditions being met between July 18, 2026, and August 18, 2026 [8]. - As of December 16, 2025, certain conditions precedent for the second tranche were not met, including daily traded values and market capitalization thresholds [10]. - The second tranche will be issued on similar terms as the first tranche, with the conversion price based on the lowest VWAP of the shares on the closing date [11]. Group 4: Cash Runway and Use of Proceeds - The issuance of the first tranche and the closing of capital increases will extend the company's cash runway into the third quarter of 2026, potentially extending to the first quarter of 2027 if the second tranche is issued [12]. - Net proceeds from the first tranche will be utilized for commercialization activities in the U.S., clinical data gathering, research and development, and general corporate purposes [13].

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]