Research analysts who have asked questions during Nyxoah earnings calls.
Suraj Kalia
Oppenheimer & Co. Inc.
4 questions for NYXH
Adam Maeder
Piper Sandler Companies
3 questions for NYXH
David Rescott
Baird
3 questions for NYXH
Ross Osborn
Cantor Fitzgerald
3 questions for NYXH
Jonathan Block
Stifel Financial Corp.
2 questions for NYXH
Jon Block
Stifel, Nicolaus & Company, Incorporated
2 questions for NYXH
David Rescot
Robert W. Baird & Co. Incorporated
1 question for NYXH
Edward White
H.C. Wainwright & Co.
1 question for NYXH
Laura Roba
Degroof Petercam
1 question for NYXH
Michael Polark
Wolfe Research
1 question for NYXH
Michael Pollock
Wolfe Research, LLC
1 question for NYXH
Paige Chamberlain
Wolfe Research, LLC
1 question for NYXH
Recent press releases and 8-K filings for NYXH.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Quarterly earnings call transcripts for Nyxoah.
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