Nyxoah (NASDAQ:NYXH) used its investor day presentation to outline early U.S. launch progress for its Genio hypoglossal nerve stimulation system, address reimbursement questions and describe its path toward profitability.
Chief Executive Officer Olivier Taelman said there is “a lot of excitement inside of the company” following the release of preliminary quarterly results, and said the company remains focused on U.S. commercialization, clinical expansion and long-term innovation in obstructive sleep apnea treatment.
Physicians highlight Genio’s differentiated positioning
Jain said hypoglossal nerve stimulation has helped broaden treatment options beyond continuous positive airway pressure, or CPAP. He said patients increasingly seek care when they understand they have alternatives, adding that treatment decisions are not only about apnea-hypopnea index, or AHI, but also lifestyle fit.
Huang, who said he has implanted 22 Genio patients since FDA approval last year, described Genio as “very differentiated” because of its bilateral stimulation approach and the absence of a second chest incision. He said about 40% of hypoglossal nerve stimulation patients in his practice are receiving Genio.
Both physicians said GLP-1 drugs could increase awareness and bring more patients into sleep medicine. Jain said GLP-1s can reduce AHI but may leave patients with residual obstructive sleep apnea, while Huang said many patients could remain candidates for hypoglossal nerve stimulation after weight loss or if they discontinue therapy.
Reimbursement experts say coverage remains intact
Nyxoah also hosted a reimbursement panel with Jolayne Devers and Carla Monacelli, partners at JD Lymon Group, alongside Chief Commercial Officer Scott Holstine.
Devers said CMS created facility reporting C codes for hypoglossal procedures that became effective in January, and said those codes were priced at parity with existing Category I CPT codes. Monacelli emphasized that the C codes apply to Medicare hospital outpatient and ambulatory surgery center payment and “does not impact coverage.”
The JD Lymon representatives said payers have added the codes to policies so claims can be adjudicated appropriately, and they did not indicate that coverage policies are being reopened. Devers said the American Medical Association CPT process is expected to provide additional clarity in January.
Taelman said fewer than 10% of Nyxoah’s current U.S. patients are covered by Medicare, with the rest covered by commercial payers. Devers said commercial plans generally contract above Medicare rates in implantable devices and that code changes do not typically lead to midyear contract renegotiations.
On the question of a dedicated Category I code for Genio, Devers said Nyxoah has not submitted an application for the September CPT editorial panel meeting and has instead been working with the American Academy of Otolaryngology–Head and Neck Surgery, which she said prefers to lead a holistic process. Holstine said any Nyxoah submission would likely be made in November for the February meeting, which would point to 2029 implementation.
U.S. launch indicators show growing adoption
Holstine said Nyxoah has trained 262 surgeons as of the prior week, up 27% from the first quarter, and is seeing enough demand to add additional surgeon training sessions on Saturdays. He also said value analysis committee approvals doubled to 180 from 90 at the end of the first quarter.
The company reported 123 ordering customers, nearly 1,200 unique patients identified by physicians, 900 patients consented into its Genio navigation system and 427 patients in prior authorization, up 77% quarter over quarter. Holstine said Nyxoah has seen a 100% approval rate on prior authorizations to date, including approvals obtained on appeal.
Holstine said Nyxoah reached a 15% market share in accounts where Genio launched during its first six months in the U.S. Taelman said the company entered the second quarter with 40 sales representatives and is hiring another 15 following its recent financing.
Clinical update focuses on complete concentric collapse
Chief Science Officer Jey Subbaroyan said Genio is not currently approved in the U.S. for patients with complete concentric collapse, or CCC, though he described the current status as a warning rather than a contraindication. Taelman said CCC is already on label in Europe.
Subbaroyan said the last patient follow-up in the ACCCESS trial is expected next week, with data to be presented before the International Surgical Sleep Society meeting in October. He said Nyxoah plans to submit a PMA supplement in the fourth quarter, and Taelman said the company expects a potential U.S. label update in the first quarter if the review is positive.
Company outlines profitability plan and CEO transition
Chief Financial Officer John Landry said Nyxoah’s annualized revenue break-even point is EUR 150 million, which he said represents about 15% of the U.S. hypoglossal nerve stimulation market. He said the company’s path to gross margins above 80% depends on the Genio 2.1 device, expected in the first half of 2027, and volume-based pricing under its contract manufacturing agreement.
Nyxoah reported preliminary second-quarter revenue of EUR 7.7 million, including EUR 5.2 million from the U.S. and EUR 2.5 million from international markets. First-half 2026 revenue was EUR 14.1 million, up from EUR 2.4 million in the first half of 2025. The company reiterated full-year 2026 revenue guidance of EUR 36 million to EUR 40 million and reported a preliminary cash balance of EUR 98 million.
Founder and Chairman Robert Taub said Nyxoah is focused on U.S. commercial execution and restoring investor trust “quarter by quarter.” He also said the company is searching for a U.S.-based American CEO, with the goal of completing the transition by the end of the year at the latest.
About Nyxoah (NASDAQ:NYXH)
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.
