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Nyxoah (NYXH)

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Recent press releases and 8-K filings for NYXH.

Nyxoah Invests in Expanding Belgian Manufacturing Capacity
NYXH
New Projects/Investments
Revenue Acceleration/Inflection
  • Nyxoah SA announced an important investment to expand its Belgian manufacturing capacity to support continued growth in the United States and international markets.
  • This expansion includes an agreement with LégiaPark for a new 2,000 square meters manufacturing facility with a state-of-the-art cleanroom in the Liège region, developed with ABN Cleanroom Technology.
  • The investment aims to strengthen the company's gross margin profile and ensure readiness to meet demand for its Genio system, which received FDA approval in August 2025.
7 days ago
Nyxoah expands Belgian manufacturing capacity
NYXH
New Projects/Investments
Hiring
  • Nyxoah is making a significant investment to expand its manufacturing capacity in Belgium to support its continued growth in the United States and international markets.
  • This expansion involves an agreement with Légiapark for a nearly 2,000 square meters manufacturing facility, including a state-of-the-art cleanroom, developed in collaboration with ABN Cleanroom Technology.
  • The investment aims to strengthen Nyxoah's gross margin profile and ensure readiness to meet demand, while also contributing to local job creation.
Jan 21, 2026, 9:05 PM
Nyxoah Reports Strong Initial U.S. Commercial Launch and Future Growth Plans
NYXH
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Nyxoah (NYXH) is actively launching its Genio neurostimulation solution for obstructive sleep apnea in the U.S. after receiving FDA approval in August 2025.
  • The company reported strong initial U.S. commercial outcomes for its first full quarter, including $4.5 million in sales and training approximately 150 U.S. surgeons. Reimbursement has been de-risked with a CPT code and 100% acceptance of pre-authorization files from private payers and CMS.
  • Genio addresses a $10 billion market opportunity in the U.S. for 450,000-500,000 eligible patients, a market that is largely underpenetrated. The technology is differentiated by offering full-body MRI compatibility (no implanted battery), a single incision, and a lower serious adverse event rate of 8.7% compared to competitors.
  • Future growth initiatives include expected label expansion for Complete Concentric Collapse patients by early Q1 2027 and the introduction of a second-generation wearable component in 2026-2027.
Jan 15, 2026, 8:00 PM
Nyxoah Highlights Genio U.S. Commercial Outcomes and Strategic Vision
NYXH
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Nyxoah (NYXH) is actively launching its Genio neurostimulation product in the U.S. for obstructive sleep apnea (OSA) following FDA approval in August 2025, targeting a $10 billion market opportunity.
  • The company reported strong initial U.S. commercial outcomes for its first full quarter (Q4 2025), achieving $4.5 million in sales and training nearly 150 surgeons.
  • Genio features a differentiated, patient-first technology with bilateral stimulation, no implanted battery (enabling full-body MRI compatibility), and robust clinical evidence demonstrating high efficacy and a low serious adverse event rate of 8.7%.
  • U.S. reimbursement is secured with CPT code 64568, showing 100% acceptance from major private payers and CMS.
  • Nyxoah is pursuing a label expansion for Complete Concentric Collapse (CCC) patients, with 12-month clinical trial results anticipated in June 2026 and potential FDA approval by Q4 2026 or Q1 2027.
Jan 15, 2026, 8:00 PM
Nyxoah Provides Update on U.S. Launch and Growth Strategy at J.P. Morgan Healthcare Conference
NYXH
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
  • Nyxoah (NYXH) is actively launching its Genio neurostimulation solution in the U.S. market following FDA approval in August 2025, targeting a $10 billion opportunity in obstructive sleep apnea.
  • In its first full quarter of U.S. operations, the company achieved $4.5 million in sales, trained approximately 150 U.S. surgeons, and secured 100% acceptance for pre-authorization files from private payers and CMS.
  • The Genio technology features bilateral stimulation and no implanted battery, providing full-body MRI compatibility, with plans to cover all 400 high-volume U.S. sites by the end of 2026.
  • Nyxoah anticipates 12-month clinical data in June 2026 for Complete Concentric Collapse (CCC) patients, which could lead to U.S. label expansion by early 2027, and is developing a second-generation wearable to enhance features and improve gross margins.
Jan 15, 2026, 8:00 PM
Nyxoah Announces Preliminary Q4 and Full Year 2025 Results and Q1 2026 Revenue Guidance
NYXH
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Nyxoah reported preliminary unaudited net revenue of €5.7 million for the fourth quarter of 2025, marking an increase of approximately 348% over Q4 2024 revenue.
  • For the full year 2025, preliminary unaudited net revenue is expected to be approximately €10.0 million, an increase of approximately 122% over 2024 revenue.
  • U.S. net revenue for Q4 2025 is expected to be approximately €3.5 million, contributing to a full-year 2025 U.S. net revenue of approximately €3.7 million.
  • As of December 31, 2025, the company had approximately €47.9 million in cash, cash equivalents, and financial assets.
  • Nyxoah expects U.S. net revenue for the first quarter of 2026 to grow by approximately 25% over the fourth quarter of 2025.
Jan 14, 2026, 9:05 PM
Nyxoah Announces Preliminary Q4 and Full Year 2025 Results and Q1 2026 Revenue Guidance
NYXH
Earnings
Guidance Update
Revenue Acceleration/Inflection
  • Nyxoah reported preliminary unaudited net revenue of approximately €5.7 million for the fourth quarter of 2025, representing a 348% increase over Q4 2024, and €10.0 million for the full year 2025, a 122% increase over 2024.
  • U.S. net revenue for Q4 2025 was approximately €3.5 million, contributing to a full-year U.S. net revenue of approximately €3.7 million.
  • The company expects U.S. net revenue for the first quarter of 2026 to grow by approximately 25% over Q4 2025.
  • As of December 31, 2025, cash, cash equivalents, and financial assets were approximately €47.9 million.
  • The company has trained 145 surgeons and activated 57 accounts in the U.S. as of December 31, 2025.
Jan 12, 2026, 9:05 PM
Nyxoah to Present at 44th J.P. Morgan Healthcare Conference
NYXH
Product Launch
  • Nyxoah's management will present at the 44th Annual J.P. Morgan Healthcare Conference on January 15 at 12:00 p.m. PT, where they will highlight the Genio system.
  • The Genio system is a leadless, battery-free hypoglossal neurostimulation therapy for obstructive sleep apnea, which holds CE mark clearance and FDA approval for a subset of patients.
  • The company has obtained CE mark approval to expand Genio's therapeutic indications to include Complete Concentric Collapse (CCC) patients and received FDA approval for adults with moderate-to-severe OSA following positive DREAM IDE pivotal-study outcomes.
Dec 29, 2025, 9:17 PM
Nyxoah to Present at J.P. Morgan Healthcare Conference
NYXH
Product Launch
New Projects/Investments
  • Nyxoah will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Thursday, January 15, 2026, at 12:00 pm PT. A live audio webcast of the presentation will be available on the company's investor relations page.
  • Nyxoah is a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, with its lead solution being the Genio system.
  • The Genio system received its European CE Mark in 2019 and later received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients.
  • The company also announced positive outcomes from the DREAM IDE pivotal study and received FDA approval in August 2025 for a subset of adult patients with moderate to severe OSA.
Dec 29, 2025, 9:05 PM
Nyxoah Launches Genio® Breakthrough Therapy in the Netherlands
NYXH
Product Launch
New Projects/Investments
  • Nyxoah SA announced the commercial launch of its Genio® system in the Netherlands on December 17, 2025, with the first implants successfully performed at OLVG West in Amsterdam and Zuyderland Hospital in Heerlen.
  • The Genio system is a patient-centric, leadless, and battery-free hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA), highlighted by features such as no internal battery, full body 1.5 and 3T MRI-compatibility, and upgradability.
  • The system received its European CE Mark in 2019 and FDA approval in August 2025 for a subset of adult patients with moderate to severe OSA.
Dec 19, 2025, 9:11 PM
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