Full 12-Month Data from the ACCCESS U.S. Pivotal Study in Complete Concentric Collapse Patients Presented at ISSS 2026

The indication-expansion application seeks access to U.S. CCC patients, who currently have no commercially available neurostimulation option.

Rhea-AI Summary

Nyxoah (NYXH) presented complete ACCCESS pivotal study results showing a 74.3% median reduction in breathing disruptions with Genio at 12 months. The study evaluated patients with obstructive sleep apnea and complete concentric collapse (CCC) of the soft palate. Both co-primary endpoints were met: responder rates were 77.2% for the Apnea-Hypopnea Index (AHI), measuring breathing disruptions, and 87.7% for the Oxygen Desaturation Index (ODI), measuring oxygen drops, on a Full Analysis Set basis (both p<0.001).

In the per protocol population, mean AHI fell from 33.6 to 10.4 events per hour; mean ODI fell from 32.6 to 10.9. No device- or procedure-related serious adverse events occurred through 12 months; four unrelated serious events were reported. Nyxoah submitted an FDA premarket approval supplement seeking to expand Genio’s indication to CCC patients. Follow-up will continue for three years post-implant.

8 points · 1 major

PositiveiHow this balance works

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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

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Rhea-AI Sentiment measures something else, the tone of the wording.

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0 major · 2 points

How the balance works

Positive

• Major pointBoth co-primary endpoints met: AHI responder rate 77.2% and ODI responder rate 87.7%, Full Analysis Set (both p<0.001).
• Moderate pointFDA premarket approval supplement submitted to expand Genio’s indication to CCC patients.
• Minor pointPer protocol AHI decreased from 33.6 to 10.4 events/hour; median reduction 74.3% at 12 months (p<0.001).
• Minor pointPer protocol ODI decreased from 32.6 to 10.9 events/hour; median reduction 71.9% at 12 months (p<0.001).
• Minor pointNo device- or procedure-related serious adverse events were reported through 12 months.

3 minor points

• Minor pointMean Epworth Sleepiness Scale score improved by 5.3 points (p<0.001), indicating reduced daytime sleepiness.
• Minor pointMean Functional Outcomes of Sleep Questionnaire score improved by 2.3 points on FOSQ-10 (p<0.001).
• Minor point94.7% of patients reported improvement; 97.4% were satisfied and would choose the implant again.

Negative

• Moderate pointU.S. CCC indication expansion remains unapproved; the submitted FDA supplement seeks that expansion.
• Minor pointFour serious adverse events were reported, all unrelated to the device or procedure; overall rate was 7.5%.

Key Figures

AHI responder rate: 77.2% ODI responder rate: 87.7% Median AHI reduction: 74.3% +5 more

AHI responder rate

77.2%

Full Analysis Set; co-primary endpoint; p<0.001

ODI responder rate

87.7%

Full Analysis Set; co-primary endpoint; p<0.001

Median AHI reduction

74.3%

Per-protocol population; at 12 months

Median ODI reduction

71.9%

At 12 months; p<0.001

Overall serious adverse events

4 SAEs (7.5%)

All unrelated to the device or procedure; none device- or procedure-related reported

ESS score improvement

5.3 points

Mean improvement

FOSQ-10 score improvement

2.3 points

Mean improvement

Patients satisfied and would choose implant again

97.4%

Patient-reported outcome

Historical Context

1 past event · Latest: Sep 02

1 event

1. Sep 02

   Clinical data

   24h Move

   +16.6%

   Earlier top-line results met co-primary endpoints; this release supplied complete follow-up results.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

apnea-hypopnea index, oxygen desaturation index, premarket approval, drug-induced sleep endoscopy, +1 more

5 terms

apnea-hypopnea index medical

"Apnea-Hypopnea Index (AHI) responder rate"

A measure of how often a person has pauses or shallow breaths during sleep, calculated as the average number of these events per hour. Investors care because this single number is used by doctors and insurers to diagnose sleep-disordered breathing and decide on treatments and device coverage, so higher or lower values can affect demand for diagnostic tools, therapies, and related healthcare spending—think of it as counting traffic jams per hour to judge road congestion.

oxygen desaturation index medical

"Oxygen Desaturation Index (ODI) responder rate"

Oxygen desaturation index (ODI) is a measure of how often a person’s blood oxygen level drops by a set amount during sleep, reported as events per hour. Investors care because ODI is a common clinical and regulatory measure used to diagnose and track sleep-disordered breathing and to judge the effectiveness of devices or drugs; changes in ODI can directly affect product approvals, reimbursement, market demand and clinical trial outcomes. Think of it like counting how many times an alarm goes off at night—more alarms signal a bigger problem.

premarket approval regulatory

"submitted a premarket approval (PMA) supplement"

Premarket approval is the formal regulatory clearance required before certain medical devices can be sold, based on detailed evidence that the product is safe and effective. For investors, it’s a major milestone because receiving approval typically clears the way for commercial sales and reduces regulatory uncertainty, while failure or delays can block revenue and raise the risk profile; think of it like a safety certificate needed before a new car model can be sold.

drug-induced sleep endoscopy medical

"independent Drug-Induced Sleep Endoscopy (DISE) core laboratory"

A drug-induced sleep endoscopy is a diagnostic procedure in which a clinician gives medications to make a patient sleep-like and then uses a small flexible camera to observe the throat and upper airway in real time to locate where breathing is blocked. It matters to investors because clearer, individualized diagnoses can change which medical devices, surgeries or therapies are used, affecting demand and outcomes—think of it as mapping a clogged pipe to choose the right repair.

polysomnography medical

"12-month polysomnography (PSG)"

An overnight sleep study that records brain activity, breathing, blood oxygen, heart rate and body movements to diagnose sleep disorders such as sleep apnea or narcolepsy. Think of it as a multi-sensor recorder for the body during sleep: it turns overnight physiology into concrete data used by doctors and regulators. Investors watch polysomnography because findings drive demand for diagnostic equipment, wearable alternatives, therapies, reimbursement decisions and clinical trial outcomes in the sleep-health market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Full 12-Month Data from the ACCCESS U.S. Pivotal Study in Complete Concentric Collapse Patients Presented at ISSS 2026

Genio® bilateral stimulation delivered a 74.3% median reduction in AHI at 12 months, with no device- or procedure-related serious adverse events

PMA supplement submitted to the FDA to expand Genio’s indication to CCC patients

Mont-Saint-Guibert, Belgium – October 15, 2026, 10:05 pm CET / 4:05 pm 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 complete 12-month results of the ACCCESS U.S. pivotal study were presented at the International Surgical Sleep Society (ISSS) annual meeting, taking place October 15-16, 2026, in Los Angeles, California. The data were presented by Colin Huntley, MD, Co-principal Investigator of the ACCCESS study. They confirm the top-line results announced on September 2, 2026, and show strong efficacy and safety outcomes with Genio® bilateral stimulation in patients with Complete Concentric Collapse (CCC) of the soft palate, a population with no commercially available neurostimulation option in the United States today.

Key Highlights

• Efficacy
  • Both co-primary efficacy endpoints were met: Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria¹, of 77.2% and Oxygen Desaturation Index (ODI) responder rate of 87.7%, both on a Full Analysis Set basis (p<0.001).
  • In the per protocol population, mean AHI decreased from 33.6 to 10.4 events per hour, a median reduction of 74.3% from baseline. Mean ODI decreased from 32.6 to 10.9 events per hour, a median reduction of 71.9% (both p<0.001).
• Safety
  • No device- or procedure-related serious adverse events (SAEs) were reported through 12 months. Four SAEs were reported, all unrelated to the device or the procedure (overall SAE rate of 7.5%).
• Quality of life and patient-reported outcomes
  • Mean Epworth Sleepiness Scale (ESS) score improved by 5.3 points and mean Functional Outcomes of Sleep Questionnaire (FOSQ-10) score improved by 2.3 points (both p<0.001).
  • 94.7% of patients reported an improvement, and 97.4% were satisfied and would choose the implant again.

Patients evaluable in the ACCCESS study² had a mean baseline AHI of 33.1 events per hour, and close to two thirds (63.8%) presented with severe OSA. CCC was confirmed by an independent Drug-Induced Sleep Endoscopy (DISE) core laboratory, sleep tests were scored by an independent core laboratory, and adverse events were adjudicated by an independent Clinical Events Committee.

Today, Nyxoah has submitted a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) to expand Genio’s indication to CCC patients. Patients in the ACCCESS study will continue to be followed for three years post-implant.

“In our daily practice, we regularly identify CCC patients for whom we currently have no commercially available hypoglossal nerve stimulation option to offer in the United States. The 12-month ACCCESS data show that Genio can address this need. Statistically significant reductions were reported in AHI and ODI, with no device- or procedure-related serious adverse events, and patients reported reduced daytime sleepiness and improved quality of life. This could give U.S. physicians an additional therapeutic approach for OSA patients with CCC,” commented Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute (Miami, Florida), and Co-principal Investigator of the ACCCESS study.

“We are pleased that ACCCESS delivered a 74.3% median reduction in AHI at 12 months, with no device- or procedure-related serious adverse events, in OSA patients with CCC. These patients have no commercially available neurostimulation option in the U.S. today, and this remains an important unmet clinical need. We have submitted our PMA supplement to the FDA, and we remain confident in our ability to bring Genio to more OSA patients and to deliver on our mission to make sleep simple,” commented Liam Kelly, Nyxoah’s Chief Executive Officer.

About the ACCCESS study

ACCCESS is a multicenter, prospective, open-label pivotal study conducted in the United States, designed to assess the safety and efficacy of the Genio system in adult patients with moderate to severe OSA and CCC of the soft palate who have failed, do not tolerate, or refused positive airway pressure treatment. The study’s co-primary efficacy endpoints are the AHI responder rate, per the Sher criteria, and the ODI responder rate, both assessed at 12 months post-implant, with patients followed for three years post-implant. CCC patients are currently contraindicated for unilateral hypoglossal nerve stimulation in the United States. Genio has been approved for CCC patients in Europe since 2021, while in the United States, no commercially available neurostimulation treatment option exists for this population today.

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and received approval from the FDA in August 2025, with the treatment of CCC patients included in the warning section of our indications for use.

For more information, please visit http://www.nyxoah.com.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or management’s current expectations regarding the Genio system; the ACCCESS study and the results thereof; the potential advantages of the Genio system; Nyxoah’s goals with respect to the potential use of the Genio system; the PMA supplement to the FDA and the timing and outcome of any FDA review; the Company's commercialization strategy and growth in the U.S. market; the Company's results of operations, financial condition, liquidity, performance, prospects, growth, future revenue and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 26, 2026 and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah

Loïc Moreau, Interim CFO

IR@nyxoah.com

Rémi Renard, Head of Investor Relations & Corporate Communication

IR@nyxoah.com

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¹ An AHI responder, per the Sher criteria, is defined as a subject with an AHI reduction of at least 50% from baseline and an AHI score of less than 20 events per hour on the 12-month polysomnography (PSG). An ODI responder is defined as a subject which demonstrates an ODI reduction of at least 25% from baseline on the 12-month PSG.
² An evaluable patient is defined as a patient that was implanted, activated and had at least one in-lab polysomnography post-activation.

Attachment

• ENGLISH_ACCCESS Data Presentation at ISSS_PR_FINAL

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Nyxoah’s ACCCESS study show at 12 months?

ACCCESS met both co-primary efficacy endpoints, with 77.2% AHI responders and 87.7% ODI responders on a Full Analysis Set basis (both p<0.001). In the per protocol population, the median AHI reduction was 74.3%. No device- or procedure-related serious adverse events were reported through 12 months.

How did Nyxoah’s ACCCESS study define treatment responders?

An AHI responder needed at least a 50% reduction from baseline and an AHI below 20 events per hour on the 12-month overnight sleep test. An ODI responder needed at least a 25% reduction from baseline on that test.

Which patients were studied in Nyxoah’s ACCCESS trial?

ACCCESS enrolled adults with moderate to severe obstructive sleep apnea and CCC who had failed, could not tolerate, or refused positive airway pressure treatment. It was a multicenter, prospective, open-label U.S. study. Evaluable patients had a mean baseline AHI of 33.1 events per hour, and 63.8% had severe obstructive sleep apnea.