Nyxoah Details Early U.S. Genio Launch, Reimbursement Update at Oppenheimer MedTech Conference 2026

• Nyxoah’s U.S. launch is underway targeting ~400 high‑volume sites; the company covered 125 target accounts early, secured >70 VAC approvals with active implants at 50+ accounts, and reported $4.5 million of U.S. revenue in Q4 with management forecasting strong double‑digit growth.

• The Genio system differentiates via minimally invasive, single‑incision, battery‑free bilateral stimulation and an “implant for life” label (12‑year longevity); pivotal DREAM data showed a 63.5% AHI responder rate and strong supine performance with 82% of implanted patients achieving AHI <15 at 12 months.

• Reimbursement is largely intact—commercial payers account for >90% of current business—and CMS mapped both technologies to APC level 5 with a facility fee of $31,526; Nyxoah targets profitability at about EUR 150 million revenue assuming >80% gross margins, aided by cost reductions like a new activation chip.

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Nyxoah (NASDAQ:NYXH) used its presentation at Oppenheimer’s MedTech and Services Conference 2026 to outline the company’s early U.S. launch progress for its Genio system, a neuromodulation therapy for obstructive sleep apnea (OSA), and to address investor questions around reimbursement and operating leverage.

Management described the U.S. OSA opportunity as “roughly” a $10 billion market and said it remains highly underpenetrated. Nyxoah emphasized that it is now an active U.S. market participant following FDA approval in August of last year, positioning Genio as a second option alongside the existing unilateral hypoglossal nerve stimulation approach.

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The company reviewed the clinical rationale for OSA treatment, noting that repeated nightly airway obstructions can lead to oxygen deprivation and are associated with increased risks of cardiovascular disease, stroke, and heart failure. Nyxoah said it is focused on moderate to severe OSA, which it defined as patients experiencing at least 15 obstructions per hour, up to 65 per hour for very severe cases.

Nyxoah characterized Genio as differentiated from a pacemaker-style system, emphasizing a minimally invasive, single-incision implant under the chin with no implanted battery. The company said Genio provides bilateral stimulation, which it believes enables stronger airway opening and may help address more complex obstructions.

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The system includes three main elements:

• Implant: A passive implant placed via a single incision, with management citing an average “skin-to-skin” procedure time of about 60 minutes. Nyxoah said it is full-body MRI compatible at 1.5 and 3 Tesla.

• Wearable: A smart sleep wearable worn under the chin that powers the implant via induction and controls therapy using patient-specific settings. Patients use a disposable patch to position the wearable and recharge the unit for repeat use.

• App: A patient app that monitors sleep data, provides feedback, and allows patients to personalize stimulation within physician-set boundaries. Nyxoah said the data can support health economic analysis and patient management over time.

Management also highlighted what it called an “implant for life” concept, citing 12-year longevity incorporated into the label and the ability to deliver software upgrades externally without requiring a re-surgery.

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Nyxoah pointed to results from its DREAM pivotal study, which supported FDA approval. The company reported a 63.5% AHI responder rate under its definition (at least a 50% reduction in events and an AHI below 20). It also cited a 71.3% oxygen desaturation index (ODI) responder rate.

Management said safety was strong, referencing an average of 8.7 severe adverse events and noting that severe events were categorized by an independent panel. Nyxoah added that among responders, the median AHI reduction reached 71% at 12 months.

A key differentiator emphasized in the discussion was supine sleep performance. Nyxoah said it has data showing therapy remains effective when patients sleep on their back, a position that can significantly increase obstruction frequency. The company said 82% of implanted patients achieved an AHI below 15 at 12 months.

In addition, management referenced its completed CCC study for “another very complex airway obstruction” where a competing therapy is contraindicated, with 12-month data expected in June and the company stating it expects the results could support a label expansion.

Nyxoah said its U.S. launch strategy centers on roughly 400 high-volume implanting sites that account for about 70% of hypoglossal nerve stimulation procedure volume. The company said it built a U.S. commercial organization of approximately 60 people, including 40 sales representatives or category managers.

In response to a question about site penetration, management said Nyxoah covered 125 of the 400 target accounts “right after launch.” In its first full quarter post-approval (Q4), the company said it had trained surgeons and completed value analysis committee (VAC) submissions at 119 of those 125 accounts. It reported:

• More than 70 VAC approvals obtained by the end of Q4

• Active business (implanted patients) at more than 50 of those approved accounts

• $4.5 million of U.S. revenue generated in Q4

Management said these early indicators gave it confidence heading into Q1, with an expectation of “strong double-digit growth.”

Nyxoah also described its demand drivers as primarily physician interest in having an alternative therapy option. Management said internal research indicated “up to 15%” of patients who present to ENT surgeons for a device refuse a battery-implanted, pacemaker-like platform. Beyond optionality, the company cited its supine data as a clinical driver and also said patients value the single incision, the lack of battery replacement, and the potential to receive future software upgrades.

Reimbursement was a central topic in the Q&A. Nyxoah said hypoglossal nerve stimulation continues to have broad coverage under commercial payers and CMS, and emphasized that the discussion is not about eliminating coverage for the category.

Management said commercial payer reimbursement is continuing “as usual,” adding that more than 90% of Genio business at present is coming from commercial payers. For CMS, Nyxoah described the situation as complex and evolving, saying it is working with internal teams and external experts.

Nyxoah pointed to a CMS communication “last Friday” that it said provided clarity on facility fee mapping. Management said both Genio and the competing technology received C codes and were mapped to APC level 5, with a facility fee of $31,526 for the implant—described as aligned with the prior CPT code approach.

The next area of attention, Nyxoah said, is physician fee treatment and whether a modifier would apply, potentially moving reimbursement within a range it cited of roughly $660 to $725. Management’s overarching message was that reimbursement is continuing, commercial payers are not impacted, and CMS is providing step-by-step clarity as it moves toward dedicated codes.

In closing comments, CFO John (as introduced on the call) discussed operating leverage and said Nyxoah expects to reach revenue break-even at about EUR 150 million in revenue, assuming 80%+ gross margins. He said the company has a defined pathway to those margins, including a new activation chip intended to reduce disposable patch costs and improvements tied to contract manufacturing pricing at scale.

On operating expenses, he said the organization is largely built out on the G&A side, with the primary incremental investments expected around U.S. sales expansion, including the addition of 15 sales representatives referenced during the discussion. He also reiterated that Nyxoah intends to keep direct-to-consumer spending targeted and well below the level he attributed to the company’s competitor.

Management noted that Nyxoah planned to share additional detail on its upcoming earnings call later that week.

Nyxoah SA, headquartered in Mont-Saint-Guibert, Belgium, is a medical technology company focused on neuromodulation therapies for sleep‐disordered breathing. Established in 2018, the company’s primary offering is the Genio® system, a minimally invasive bilateral hypoglossal nerve stimulator designed to treat moderate to severe obstructive sleep apnea (OSA). By electrically stimulating the genioglossus muscle, the device helps maintain airway patency during sleep, reducing apnea events and improving overall sleep quality.

The Genio system comprises a small, implantable stimulator positioned submentally and an external activation unit worn by the patient.

The article “Nyxoah Details Early U.S. Genio Launch, Reimbursement Update at Oppenheimer MedTech Conference 2026” was originally published by MarketBeat.