Nyxoah NYXH recently initiated its U.S. post-approval BREATHE study with the first patient implanted using the Genio system, marking an important step in expanding clinical evidence for its obstructive sleep apnea therapy following FDA approval.
The milestone reinforces Nyxoah's commercialization strategy by supporting broader physician adoption and future payer engagement in the U.S. market. As the company builds long-term real-world evidence for Genio, the study could strengthen confidence in the therapy's clinical profile and help support wider market penetration over time.
Likely Trend of NYXH Stock Following the News
Following the announcement, shares of NYXH lost approximately 8% in yesterday’s trading. Year to date, shares of the company have declined 64.8% against the industry’s 10.8% growth. However, the S&P 500 has risen 12.2% in the same timeframe.
The BREATHE study is likely to strengthen Nyxoah's long-term growth prospects by generating real-world U.S. evidence that can support broader physician adoption, payer reimbursement discussions and sustained commercialization of the Genio system following its FDA approval. With up to 229 patients being followed for five years across multiple clinical centers, the study could reinforce the therapy's long-term safety and effectiveness profile, helping Nyxoah expand its footprint in the large obstructive sleep apnea market and differentiate its bilateral hypoglossal nerve stimulation platform over time.
NYXH currently has a market capitalization of $62.8 million.
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More on the News
Nyxoah's Genio system is a patient-centered, leadless and battery-free bilateral hypoglossal nerve stimulation therapy designed for patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate or have failed standard positive airway pressure therapy. Unlike traditional sleep apnea therapies that rely on masks, the implanted device stimulates the hypoglossal nerves to help keep the airway open during sleep. The platform has steadily expanded its clinical foundation over the years, receiving a CE Mark in Europe in 2019, later extending indications to Complete Concentric Collapse (CCC) patients, reporting positive DREAM IDE pivotal study results in 2024 and ultimately securing FDA approval in August 2025.
The BREATHE study is Nyxoah's largest prospective Genio study to date and is designed as a multicenter, prospective, single-arm post-approval trial evaluating the therapy's long-term performance in adults with moderate to severe OSA. The study plans to enroll up to 229 patients across as many as 25 clinical centers in the United States, with participants being followed for up to five years after implantation. The co-primary effectiveness endpoints will measure Apnea-Hypopnea Index and Oxygen Desaturation Index responder rates at the 12-month mark, while safety assessments will track device- and procedure-related serious adverse events at 12 months and annually thereafter.
The first implant was performed by Dr. Rolando Molina of South Florida ENT Associates, while Dr. Edward Mezerhane of PharmaDev Clinical Research Institute serves as the site's principal investigator. According to management, BREATHE is intended to generate real-world evidence on how Genio performs in routine clinical practice across a broad network of sleep physicians and ENT surgeons, providing the type of long-term data that physicians, patients and payers increasingly expect following commercial approval.
Industry Prospects Favoring the Market
According to the data provided by Expert Market Research, the hypoglossal nerve stimulation therapy market was valued at $358.72 million in 2025 and is expected to expand at a CAGR of 12.10%, reaching $1.12 billion by 2035.
The market growth is driven by increasing OSA prevalence, favorable reimbursement policies and technological advancements in implantable devices.
Other News
Recently, Nyxoah announced that its ACCCESS U.S. pivotal study met its co-primary safety and efficacy endpoints in patients with CCC, supporting the planned expansion of the Genio system's U.S. indication for a patient group currently excluded from commercially available unilateral hypoglossal nerve stimulation therapies. The study reported a statistically significant 12-month Apnea-Hypopnea Index responder rate of 77.2% on a Full Analysis Set basis, a positive 12-month Oxygen Desaturation Index responder rate and zero device-related serious adverse events through 12 months.
Nyxoah SA Price
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NYXH’s Zacks Rank & Key Picks
Currently, NYXH has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Globus Medical GMED, Veracyte VCYT and West Pharmaceutical WST.
Globus Medical, currently carrying a Zacks Rank #2 (Buy), reported a second-quarter 2026 adjusted earnings per share (EPS) of $1.34, which surpassed the Zacks Consensus Estimate by 19.6%. Revenues of $789.6 million beat the Zacks Consensus Estimate by 0.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GMED has an estimated long-term earnings growth rate of 12.4%. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 27.9%.
Veracyte, currently flaunting a Zacks Rank #1, reported a second-quarter 2026 adjusted EPS of 54 cents, which surpassed the Zacks Consensus Estimate by 25.6%. Revenues of $150.3 million beat the Zacks Consensus Estimate by 4.1%.
VCYT has an estimated earnings growth rate of 8.4% for 2026. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 41.8%.
West Pharmaceutical, carrying a Zacks Rank #2 at present, reported second-quarter 2026 adjusted EPS of $2.37, which beat the Zacks Consensus Estimate by 13.9%. Revenues of $872.3 million surpassed the Zacks Consensus Estimate by 4.2%.
WST has an estimated long-term earnings growth rate of 16%. WST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 17.4%.
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