Nyxoah (NYXH) Company Report

Nyxoah (NYXH) reported strong initial progress in its U.S. launch, with 128 surgeons trained and 108 FAC committee submissions (half approved with a 100% approval rate) as of early December 2025, along with 100% approval on all pre-authorizations from major private payers and CMS.
The company is expanding its U.S. sales force by 15 new territory managers, increasing the total to 40 and aiming to cover 200 high-volume accounts.
Nyxoah provided Q4 2025 revenue guidance of EUR 3.4 million to EUR 3.6 million , and indicated that recent financing provides a cash runway into early 2027.
Gross margins are expected to remain in the low 60s for FY2026, with potential for improvement to the low 80s by late 2026/early 2027 driven by new product versions and volume.
Key pipeline updates include expected 12-month follow-up data for the ACCESS study (CCC indication) in August 2026, with FDA approval anticipated Q4 2026 or Q1 2027 , and first-in-human implants for Ansa cervicalis (dual stimulation) within five to six months.

3 days ago

Transcript

Nyxoah Provides U.S. Launch Update, FY26 Outlook, and Pipeline Timelines

NYXH

Product Launch

Guidance Update

New Projects/Investments

Nyxoah (NYXH) is making significant progress in its U.S. launch, with 128 surgeons trained and 100% approval on all pre-authorizations from private payers and CMS. The sales force is expanding by 15 territory managers, bringing the total to 40 and covering 200 high-volume accounts by early Q2 2026.
The company provided Q4 2025 revenue guidance of EUR 3.4 million to EUR 3.6 million. While not providing FY26 guidance, management noted that street estimates of EUR 28-29 million imply a 3% market share, which they expect to be higher in their focused accounts.
A significant reimbursement change for CPT code 64568 will increase the facility fee by 40-50% starting January 1, 2026, which is expected to motivate hospitals and benefit Nyxoah, especially in Ambulatory Surgical Centers (ASCs).
Key pipeline updates include the ACCESS study for the Complete Concentric Collapse (CCC) indication, with 12-month follow-up data expected in August 2026 and potential FDA approval in Q4 2026 or Q1 2027. Additionally, the first in-human implants for Ansa cervicalis (dual stimulation) are anticipated within 5-6 months.
Recent financing, including equity and convertible debt, has provided enough cash to fund operations into early 2027, supporting U.S. commercialization efforts.

3 days ago

Transcript

Nyxoah SA Announces Combined Equity and Debt Offerings

NYXH

Debt Issuance

Convertible Preferred Issuance

New Projects/Investments

On November 13, 2025, Nyxoah SA entered into a private placement for ordinary shares at €4.00 per share, expecting approximately €17.0 million in aggregate gross proceeds. The closing is anticipated on or about November 18, 2025.
Concurrently, the company agreed to a registered direct offering of ordinary shares at U.S.$4.6304 per share, projected to generate approximately U.S.$5.6 million in aggregate gross proceeds before deducting related offering expenses. This offering is also expected to close on or about November 18, 2025.
Additionally, Nyxoah SA entered into a Notes Offering agreement for up to €45.0 million in amortizing senior unsecured convertible notes, with an 8.0% original issue discount and an interest rate of 6.5% per annum. The gross proceeds from the Notes Offering are expected to be approximately €41.4 million.
The proceeds from these offerings are intended to launch commercialization activities in the United States, advance the Genio system internationally, fund research and development, and for general corporate purposes, including working capital.

Nov 14, 2025, 1:09 AM

6-K

Nyxoah SA Reports Q3 2025 Results and FDA Approval

NYXH

Earnings

Product Launch

Legal Proceedings

Nyxoah SA reported revenue of €4.4 million for the nine months ended September 30, 2025, an increase from €3.3 million in the prior year, while its net loss widened to €66.6 million from €42.1 million.
Cash and cash equivalents and financial assets significantly decreased to €22.5 million as of September 30, 2025, from €85.6 million at the end of 2024.
The Genio® system received FDA approval on August 8, 2025, initiating US commercialization and contributing to a 75.4% increase in selling, general and administrative expenses for the nine months ended September 30, 2025.
The company is facing a patent infringement lawsuit filed by Inspire Medical, Inc. in May 2025.

Nov 13, 2025, 10:02 PM

6-K

Nyxoah Reports Q3 2025 Revenue Growth and Strong U.S. Genio Launch Momentum

NYXH

Earnings

Guidance Update

Product Launch

Nyxoah reported Q3 2025 revenue of EUR 2 million, marking a 56% increase compared to Q3 2024, and provided Q4 2025 global revenue guidance between EUR 3.4 million and EUR 3.6 million.
The U.S. launch of Genio following FDA approval on August 8th generated EUR 231,000 in revenue during Q3 2025, with 15 implants performed across nine accounts by the end of October.
Key indicators for the U.S. launch include 111 surgeons trained, 35 value analysis committee approvals received, and reimbursement secured with Medicare and 10 private payers.
The company secured up to $77 million in new capital through a private placement and a convertible bond, which is expected to provide a cash runway into Q1 2027.

Nov 13, 2025, 9:30 PM

Transcript

Nyxoah Provides Update on U.S. Genio Launch, Reimbursement, and Future Growth Initiatives

NYXH

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Nyxoah is actively launching its Genio system in the U.S., having trained 121 surgeons across 125 high-volume accounts out of a target of 400 top accounts. The company plans to expand its reach by adding 75 new accounts and 15 new territory managers quarterly, aiming for 425 accounts by Q3 2026.
Genio has achieved no rejections for reimbursement using code 64568 from Medicare or major private payers, including Blue Cross Blue Shield, Anthem, UnitedHealth, and Cigna. Pre-authorization and payment approvals are consistently processed within approximately two business weeks.
The company views GLP-1s as a net tailwind, expecting them to expand the treatable patient population by reducing BMI for individuals who would otherwise be outside Nyxoah's current BMI 32 label.
Nyxoah projects a significant market opportunity with its solution for Complete Concentric Collapse (CCC). Following the Axis trial enrollment completion in July 2025, a potential label expansion is anticipated in Q4 2026 or Q1 2027.
Nyxoah is evaluating funding options to support at least four to five quarters of U.S. commercial success and is investing in next-generation technology, aiming for a no-wearable component system with self-learning capabilities by 2030.

Nov 11, 2025, 2:20 PM

Transcript

Nyxoah Provides Update on U.S. Genio Launch, Reimbursement, and Future Growth Initiatives

NYXH

Product Launch

New Projects/Investments

Guidance Update

Nyxoah is actively expanding its U.S. commercial presence for Genio, with 121 surgeons trained out of 125 high-volume accounts currently targeted. The company plans to add 75 new accounts and 15 new territory managers each quarter, aiming to cover 425 accounts by Q3 2026.
The company has seen no rejections for reimbursement submissions using code 64568 from Medicare or major private payers like Blue Cross Blue Shield, Anthem, UnitedHealth, and Cigna. Pre-authorization and post-implant payment approvals are consistently processed within approximately two business weeks.
Nyxoah views GLP-1s as a net tailwind, expecting them to increase the eligible patient pool by helping individuals reduce their BMI to within Genio's BMI 32 label.
Enrollment for the Axis trial, which aims to expand the label for Complete Concentric Collapse (CCC), concluded in July 2025, with a potential label approval anticipated in Q4 2026 or Q1 2027. The company is also exploring options to fund at least four to five quarters of U.S. commercial success.

Nov 11, 2025, 2:20 PM

Transcript

Nyxoah Details U.S. Commercial Traction and Reimbursement Success

NYXH

Product Launch

New Projects/Investments

Nyxoah commenced its U.S. Genio launch on August 11 and currently has 25 territory managers targeting 125 high-volume accounts. The company plans to expand by adding 75 new accounts and 15 new territory managers each quarter, aiming to reach 425 accounts by Q3 next year.
All reimbursement submissions for Genio, including to Medicare and major private payers such as Blue Cross Blue Shield, Anthem, UnitedHealth, and Cigna, using code 64568, have been approved without rejection. The pre-authorization to approval cycle is approximately two business weeks.
The company has successfully trained 121 surgeons out of its initial 125 targeted accounts and has achieved over 100 Value Analysis Committee (VAC) submissions, with half already approved.
Nyxoah is seeking capital to fund at least four to five quarters of U.S. commercial success. The Axis trial for complete concentric collapse (CCC) concluded enrollment in July, with a potential label approval in Q4 2026 or Q1 2027. The company anticipates GLP-1s will be a net tailwind by expanding the treatable patient population.

Nov 11, 2025, 2:20 PM

Transcript

Nyxoah to Release Third Quarter 2025 Financial Results

NYXH

Earnings

Product Launch

Nyxoah will release its third quarter 2025 financial results on Thursday, November 13, 2025.
A conference call to discuss these results will be hosted on the same day, beginning at 10:30pm CET / 4:30pm ET.
The company's Genio system, a treatment for Obstructive Sleep Apnea (OSA), received U.S. FDA approval in August 2025.

Oct 30, 2025, 9:10 PM

Press Release

Nyxoah Announces First U.S. Commercial Implants of Genio® System

NYXH

Product Launch

Nyxoah announced that the first U.S. commercial patients have been successfully implanted with its Genio® system following FDA approval, marking a significant milestone for bringing this therapy to Obstructive Sleep Apnea (OSA) patients in the U.S..
The company reports strong physician demand, successful pre-authorizations, and widespread payor coverage, including CMS, for the Genio® system.
Dr. Andrew T. Huang, the first surgeon to perform commercial Genio® implants in the United States, completed five implants in one week.
Nyxoah is tracking metrics such as the number of surgeons trained, value analysis committee submissions, prior authorization submissions, and accounts opened as leading indicators of future revenue growth.