Inspire Vs. Nyxoah: The Patent Battle Behind Competition

BACKGROUND

In May 2025, Inspire Medical Systems (Plaintiff), a market leader since 2014, filed a lawsuit against Nyxoah SA, a new entrant in the market, alleging that Nyxoah’s Genio (Defenedent) device infringes three of its patents. In response, Nyxoah countered the claims, asserting that inspire itself has infringed on three of its patents. Three months later, Nyxoah filed a countersuit, and now both companies are locked in a legal battle in the U.S. District Court for the District of Delaware. The case’s outcome could decide who takes the lead in the $3 billion sleep apnea treatment market.

Inspire sued Nyxoah for patent infringement. Inspire accuses Nyxoah’s “Genio” sleep apnea treatment system of infringing three of its own patents: US10898709B2, US11806526B2, and US11850424. The lawsuit is asking the court to issue an injunction to prevent Nyxoah from entering the U.S. market and to recover damages. Nyxoah revealed that it has filed a suit against inspire. Nyxoah claims that Inspire’s new devices, the Inspire IV and Inspire V, infringe on three of its patents: US8700183, US9415215, and US9415216 Nyxoah also seeks relief and damages.

A NEW FRONTIER IN SLEEP APNEA TREATMENT: THE RISE OF HYPOGLOSSAL NERVE STIMULATION (HNS)

Obstructive Sleep Apnea (OSA) affects over 25 million people worldwide. It occurs when the airway collapses during sleep, cutting off oxygen flow, far more serious than simple snoring. The condition is chronic and has been linked to heart disease, stroke, and even premature death. For decades, patients had limited and often frustrating treatment options. CPAP machines, though effective, are uncomfortable and lead many to abandon treatment. Surgical procedures, on the other hand, are costly, invasive, and not always successful.

Then came a game-changing innovation, Hypoglossal Nerve Stimulation (HNS). Think of it as a pacemaker for the tongue: a small device that gently stimulates the muscles to keep the airway open during sleep.

Inspire Medical Systems pioneered this breakthrough technology in the United States, receiving FDA approval in 2014. For more than a decade, Inspire enjoyed a near monopoly in the market until Nyxoah, a Belgian startup, entered the scene with a new, potentially disruptive approach.

A NEW CHALLENGER APPEARS: NYXOAH’S GENIO DEVICE

In 2024, Belgian medtech company Nyxoah made a bold entry into the U.S. market with its Genio device, a next-generation solution for Hypoglossal Nerve Stimulation (HNS). Unlike Inspire’s long-dominant system, Genio introduced a series of meaningful advancements aimed at improving patient comfort and treatment efficiency. The device offers bilateral stimulation, activating both sides of the airway instead of just one, along with full-body MRI compatibility, an area where Inspire’s devices still face limitations. It also features wireless charging, which eliminates the need for periodic replacement surgeries, and a leadless design that reduces the number of implanted components. In short, Nyxoah entered the market with better technology and a smarter design and inspire, the established leader, responded the only way many incumbents do when threatened by filing a lawsuit.

CORE CLAIMS

This is where things start to get really interesting, where the story moves from medical innovation to the world of patents and legal battles that can shape the future of healthcare technology.

Inspire’s Claims (3 patents)

Inspire alleges that Nyxoah’s Genio device copies the core of its patented technology:

• US10898709B2 Link– Nerve stimulation through specific electrical patterns.
• US11806526B2 Link – Advanced device architecture and stimulation protocols.
• US11850424 (Link) – General electrical stimulation methods for sleep apnea.

In simple terms, Inspire’s message is clear: “We created this technology first — you can’t just make small changes and claim it as your own.”

Nyxoah’s Counterclaims (3 Patents)

Three months later, Nyxoah countersued, claiming Inspire infringed their innovations:

• US8700183 Link – Flexible electrode carriers placed under the chin.
• US9415215 Link – A specific method to activate the genioglossus muscle.
• US9415216 Link – A bilateral activation design.

Their arguments are “We advanced your idea; that’s our innovation now.”

Now, both companies are going head-to-head in the U.S. District Court for the District of Delaware, and the court’s decision could ultimately decide who takes control of the $3 billion sleep apnea market.

CORE DISPUTE: INNOVATION VS. IMPROVEMENT

At its core, this case raises a fundamental question: If you build on someone else’s invention, are you innovating or infringing?

Inspire was the first to develop unilateral stimulation, which activates one side of the airway. Nyxoah took that concept further with bilateral stimulation, activating both sides for potentially better results. Now, the court must decide whether Nyxoah’s approach represents a genuinely new and non-obvious innovation; as Nyxoah claims or just an obvious extension of Inspire’s existing technology, as Inspire argues.

Under patent law, you can’t claim ownership of something that would be “obvious” to an expert in the field. So, if the court decides that Nyxoah’s technology was an expected next step, Inspire wins. But if it’s seen as a real leap forward, Nyxoah takes the victory and with it, control over a multi-billion-dollar market for the next decade.

SUMMARY OF PATENTS

INSPIRE’S PATENTS:

US10898709B2, US11806526B2, and US11850424

These patents detail a comprehensive system for stimulating an airway-patency related nerve, such as the hypoglossal nerve, to treat sleep disordered breathing. They cover the methods for how the device is sued, the physical design and components of the stimulation element, and the specific electrical signals used achieve a therapeutic effect.

NYXOAH PATENTS:

US8700183, US9415215, and US9415216

The patents collectively disclose an implantable neurostimulation systems for treating obstructive sleep apnea by electrically stimulating the hypoglossal nerve. The devices use flexible carries with electrodes implanted under the chin to active specific tongue muscles, particularly the genioglossus, to keep the airway open.

WHY THIS MATTERS:

Firstly, for market control, winner gets monopoly control over $3B+ HNS market for 10 years. Secondly, impact on investors that is the patent outcome is equal to 50-100% valuation impact for both companies. Lastly, innovation paradox, that is the patent should protect innovation, but may block superior competitors.

THE BEST WAY FORWARD: COOPERATION OVER CONFLICT

The most practical and beneficial outcome for both companies would be a settlement. Instead of continuing an expensive and time-consuming legal battle, they could choose to collaborate. A fair resolution might involve Inspire licensing Nyxoah’s bilateral stimulation technology, while Nyxoah gains access to Inspire’s core HNS patents. This way, both companies could operate in the same market, competing on innovation rather than litigation.

Such an arrangement would benefit patients, who would gain access to better treatment options, and encourage healthy competition, driving further technological progress and stabilizing prices.

KEY TAKEAWAYS

• The core issue is market access, with patents being used as tools to block competition rather than promote innovation.
• The bilateral stimulation dispute raises the question of whether Nyxoah’s approach is genuine innovation or patent infringement.
• A settlement appears likely (60–70%), as both companies have valid and defensible claims.
• The winner will control the market for the next decade, enjoying monopoly-like protection.
• Patents don’t always protect innovation; in many cases, they primarily safeguard market share.
• With a $3 billion market and over 25 million patients worldwide affected, the stakes are enormous.
• This case could set a major industry precedent, defining how far established companies can go in defending their dominance through patents.

Author: Mr. Chetan Wagh, in case of any queries please contact/write back to us via email to [email protected] or at IIPRD.