Nyxoah to Showcase FDA-Approved Sleep Apnea Tech at J.P. Morgan

By George Millen

MONT-SAINT-GUIBERT, BELGIUM – December 29, 2025 – Medical technology company Nyxoah announced today it will present at the influential 44th Annual J.P. Morgan Healthcare Conference in San Francisco this coming January. The presentation, scheduled for January 15, 2026, marks a pivotal moment for the company as it steps onto one of the world's most significant healthcare investment stages, fresh off securing a critical U.S. Food and Drug Administration (FDA) approval for its innovative sleep apnea therapy.

For growth-stage MedTech firms, the J.P. Morgan conference is more than a presentation; it's a high-stakes arena for deal-making, attracting investment, and setting the strategic tone for the year. Nyxoah's presence signals a new phase of its corporate journey, moving from development and clinical trials to full-scale commercial ambition in the lucrative U.S. market. The company will be looking to leverage this platform to articulate its value proposition to a discerning audience of investors, analysts, and potential strategic partners.

A New Paradigm in Sleep Apnea Therapy

At the heart of Nyxoah's story is its lead solution, the Genio system. It's a hypoglossal neurostimulation (HGNS) therapy designed to treat Obstructive Sleep Apnea (OSA), a condition affecting millions worldwide and linked to severe health risks, including cardiovascular disease and increased mortality. While traditional Continuous Positive Airway Pressure (CPAP) machines are effective, patient adherence is notoriously low due to discomfort and inconvenience. This has created a substantial market for less intrusive, more patient-friendly alternatives.

The Genio system aims to fill this void with a unique, patient-centered design. Unlike established competitors, Genio is leadless and battery-free. The therapy involves a tiny stimulator implanted under the chin that is powered externally by a disposable patch worn during sleep. This design eliminates the need for tunnels to be created for leads to be placed in the chest area and, critically, circumvents the requirement for future surgeries to replace an implanted battery, a significant advantage for long-term patient quality of life and a reduction in lifetime healthcare costs.

"The push for therapies that improve not just clinical outcomes but also the patient's daily experience is a major trend," noted one sleep medicine specialist not affiliated with the company. "A device that is less invasive and removes the need for battery replacement surgery is a compelling proposition for both physicians and the patients we treat."

Further strengthening its clinical profile, Nyxoah has already secured a CE Mark in Europe for an expanded indication to treat patients with Complete Concentric Collapse (CCC), a specific pattern of airway collapse that often disqualifies patients from competitor therapies. This ability to treat a wider patient population, combined with its recent FDA approval for a subset of adult OSA patients in August 2025, positions the Genio system as a versatile and disruptive new entrant.

Charting a Global Course from Europe to the U.S.

Nyxoah's journey represents a notable European success story in navigating the complex and demanding global MedTech landscape. Founded in Belgium, the company has methodically executed a strategy aimed at global leadership. Following the successful completion of its BLAST OSA study, it received its initial European CE Mark in 2019, allowing for commercialization across the continent.

Recognizing the need for significant capital to fund further trials and global expansion, Nyxoah completed two successful Initial Public Offerings (IPOs)—first on the Euronext Brussels in 2020 and subsequently on the NASDAQ in 2021. This dual-listing strategy provided access to both European and American capital markets, fueling the pivotal DREAM IDE study that ultimately paved the way for its recent FDA approval.

The U.S. market is the largest and most competitive medical device market in the world. Securing FDA approval was the most critical milestone for Nyxoah's American ambitions, but the challenge now shifts to commercial execution. The company will be going head-to-head with established players, most notably Inspire Medical Systems, which has had a significant head start in building market awareness, physician networks, and, crucially, insurance reimbursement pathways.

The Competitive Landscape and Market Opportunity

Entering the U.S. market requires more than just an approved device; it demands a robust commercialization strategy. Industry analysts point out that reimbursement is the key hurdle for any new medical device. Nyxoah will need to work diligently to secure coverage from Medicare and private insurance payers to ensure patient access and drive adoption among ear, nose, and throat (ENT) surgeons and sleep specialists.

Inspire Medical has already laid much of the groundwork in establishing HGNS therapy as a recognized standard of care for CPAP-intolerant patients, which could paradoxically benefit Nyxoah by validating the treatment category. However, Nyxoah must now prove that its differentiators—the leadless, battery-free design and its potential efficacy in CCC patients—are compelling enough for physicians and hospitals to adopt a new system.

The market opportunity is vast. An estimated 25 million adults in the U.S. suffer from OSA, and a significant portion of them are unable or unwilling to use CPAP therapy long-term. Nyxoah's FDA approval, which covers a subset of adults with moderate to severe OSA, opens the door to this multi-billion dollar addressable market. The company's presentation at the J.P. Morgan conference will be closely watched for details on its U.S. launch strategy, including sales force expansion, physician training programs, and its roadmap for securing broad reimbursement coverage. The investor community will be looking for a clear and credible narrative that demonstrates not just technological innovation, but a clear path to commercial success and profitability in a challenging healthcare environment.