Nyxoah — MarketDX

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Nyxoah Stock Falls Despite First U.S. Genio Implant in BREATHE Trial

Nyxoah SA has initiated its U.S. post-approval BREATHE study with the first patient implanted using the Genio system, a milestone for expanding clinical evidence of its obstructive sleep apnea therapy following FDA approval. The company's shares fell about 8% in the previous trading session despite the news, and are down 64.8% year to date, compared with the industry's 10.8% growth and the S&P 500's 12.2% rise. The BREATHE study, which is Nyxoah's largest prospective Genio study to date, plans to enroll up to 229 patients across as many as 25 U.S. centers, with follow-up for up to five years. The co-primary effectiveness endpoints measure Apnea-Hypopnea Index and Oxygen Desaturation Index responder rates at 12 months, while safety assessments track device- and procedure-related serious adverse events. The first implant was performed by Dr. Rolando Molina of South Florida ENT Associates, with Dr. Edward Mezerhane as principal investigator. The hypoglossal nerve stimulation therapy market was valued at $358.72 million in 2025 and is expected to grow at a CAGR of 12.10% to reach $1.12 billion by 2035, according to Expert Market Research.

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Nyxoah calls extraordinary shareholders' meeting for July 9 to renew authorized capital

Nyxoah SA has invited its securities holders to an extraordinary shareholders' meeting on July 9, 2026, at 2:00 p.m. CET at the company's seat in Mont-Saint-Guibert, Belgium. The board is seeking approval to renew its authorization to increase the share capital by an aggregate amount equal to the company's capital on the date immediately preceding the meeting, valid for five years from publication in the Belgian Official Gazette. A video conference will be available for registered holders to follow the meeting remotely and ask questions in writing, though voting must be done in advance by mail or proxy. The registration date is June 25, 2026, and holders must notify the company of their intention to participate by July 3, 2026. The meeting will also vote on granting powers to the notary to restate the articles of association.

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Nyxoah receives $15 million from European Investment Bank

Nyxoah has received $15 million from the European Investment Bank as the second tranche of its loan facility. The drawdown follows confirmation that the company met predefined criteria, and brings total new capital raised in June 2026 to approximately $110 million when combined with the proceeds of its recent underwritten public offering. The non-dilutive funding will primarily accelerate the commercial launch of the Genio system in the United States, while also supporting research and development and manufacturing scale-up. CEO Olivier Taelman called the financing transformative and a strong endorsement of the company's technology.

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