Nyxoah S.A. (NYXH): Business Model Canvas [Dec-2025 Updated]

You're looking at Nyxoah S.A. right as they pivot from clinical trials to a full-blown commercial play following that crucial August 2025 FDA nod for the Genio system. Honestly, the near-term story is a classic high-stakes launch: they need to rapidly capture the U.S. market to cover the significant cash burn, evidenced by Q3 2025 costs hitting nearly €25.6 million in combined SG&A and R&D while only booking €2.0 million in revenue. Their unique value-a leadless, MRI-compatible implant-is compelling, but the real test is whether their 50-member U.S. team can translate that into the projected €3.4 million to €3.6 million in Q4 revenue to keep the runway open. Let's break down the nine blocks of their Business Model Canvas to see exactly how Nyxoah S.A. plans to manage this transition from early-stage growth to market capture.

Nyxoah S.A. (NYXH) - Canvas Business Model: Key Partnerships

You're looking at the core relationships Nyxoah S.A. needs to make its U.S. commercialization strategy work, especially after the FDA approval in August 2025. The real key here is getting the money side sorted so they can scale the implantations.

For reimbursement in the U.S., the focus is on securing coverage from major private and government payers. Nyxoah S.A. reported that the first commercial Genio implants in the U.S. were supported by widespread payer coverage, which helped drive initial revenue as of November 13, 2025. This coverage is critical for adoption by providers like Medicare, Blue Cross Blue Shield, and Anthem, even if specific coverage percentages aren't public yet.

Here's a quick look at the main partnership categories and the hard numbers associated with them as of late 2025:

The relationship with Key Opinion Leaders (KOLs) and implanting surgeons is about building a base of expertise. To support the U.S. launch, Nyxoah S.A. has been actively training the field. As of October 31, 2025, the Company had trained 111 surgeons on the Genio system. This group is essential for driving the initial case volume and providing feedback on the minimally invasive procedure.

Financially, maintaining liquidity for the U.S. scale-up is paramount. A key partnership here involves the financial institutions backing the debt. You should track the term debt facility, which had €27.5 million remaining availability noted in the current structure. Also, note that strategic investors like ResMed participated in the November 2025 financing round, where ResMed secured a 4.62% stake in Nyxoah S.A.. That kind of backing from a major player validates the technology for other partners, for sure.

You'll want Finance to track the utilization rate of that debt facility against the planned U.S. commercial spend by the end of Q4 2025.

Nyxoah S.A. (NYXH) - Canvas Business Model: Key Activities

You're looking at the core engine driving Nyxoah S.A. (NYXH) right now, which is all about executing the U.S. market entry post-FDA clearance. This is where the capital raised is being deployed, so the numbers here tell the real story of their operational focus as of late 2025.

U.S. commercial rollout and market penetration of the Genio system

The U.S. launch started in earnest following the FDA approval received in August 2025. The first commercial implants in U.S. patients happened in September 2025, which immediately generated the first U.S. revenue that month. For the third quarter ending September 30, 2025, total revenue hit €2.0 million, a 56% year-over-year growth, largely fueled by this initial U.S. traction. To support this, Nyxoah S.A. had already assembled a 50-person commercial team in the U.S. by the first quarter of 2025, all hired and trained in anticipation of the clearance. By October 31, 2025, the company reported that 9 accounts had implanted the Genio system, showing the initial adoption curve.

Here's a snapshot of the early commercial execution metrics:

The company is defintely shifting its focus, even though selling, general and administrative expenses for Q3 2025 rose to €12.7 million to support this scale-up.

Ongoing Research and Development (R&D) for next-generation devices and indications (e.g., CCC)

Research and Development remains a significant cost center, reflecting the commitment to pipeline expansion beyond the initial FDA-approved indication. For the third quarter ending September 30, 2025, R&D expenses were reported at €12.9 million. This investment supports the work toward expanding the therapeutic label, specifically for Complete Concentric Collapse (CCC) patients, for whom Nyxoah S.A. already holds a CE mark approval following the BETTER SLEEP study. The company has closed patient enrollment for its ACCCESS U.S. IDE study, and management believes the existing data will be sufficient to demonstrate statistical significance for the CCC indication. Furthermore, the company has been actively reorganizing its global R&D function, expecting to transition all ongoing activities from Israel to the U.S. and Belgium.

Key R&D and Pipeline Activities:

• R&D Expenses (Q3 2025): €12.9 million
• CE Mark for CCC Indication: Secured
• ACCCESS U.S. IDE Study Enrollment: Closed
• Operating Expenses for Q2 2025 (including R&D): Approx. €20.7 million

Securing and maintaining widespread payer reimbursement and hospital Value Analysis Committee (VAC) approvals

Securing reimbursement was a critical activity that preceded and supported the first U.S. revenue. Nyxoah S.A. achieved reimbursement with Medicare and private payers, reporting a 100% approval rate on prior authorization submissions from major payers like United Healthcare, Blue Cross Blue Shield, and Anthem. The accepted reimbursement mechanism uses the CPT code 64568. To gauge hospital acceptance, the company tracks VAC submissions. As of October 31, 2025, Nyxoah S.A. had completed 102 Value Analysis Committee submissions, resulting in 35 approvals. On the prior authorization front, 63 submissions were made through the Genio Access Program (GAP), yielding 21 approvals. The coverage secured includes major regional players, with HCSC and BCBS of Michigan representing over 26 million members across six states.

Reimbursement and Access Milestones (as of October 31, 2025):

Manufacturing and quality control of the Genio neurostimulation device

The successful FDA Pre-Market Approval (PMA) in August 2025 was contingent on satisfactory completion of a review of manufacturing facilities, methods, and controls. This indicates that the quality control processes met the necessary U.S. standards. The company's gross margin for the third quarter of 2025 was 60.5%, which is a direct reflection of the efficiency and cost structure within the manufacturing and supply chain activities. This margin compares to 62.0% in the third quarter of 2024, showing a slight compression likely due to the scale-up and initial U.S. commercialization costs.

Nyxoah S.A. (NYXH) - Canvas Business Model: Key Resources

When you look at the foundation of Nyxoah S.A.'s business right now, late 2025, the Key Resources are heavily weighted toward regulatory milestones and the initial commercial build-out in the U.S. market. These are the assets you absolutely need to execute the strategy.

The most critical intangible asset is the Genio system's intellectual property (IP), which underpins the entire value proposition. This IP is now validated by two major regulatory achievements. The system already held its European CE Mark since 2019, allowing for broader indication use, including for Complete Concentric Collapse (CCC) patients. More recently, the Company secured the crucial U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) on August 8, 2025, for a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) with an Apnea-Hypopnea Index (AHI) between 15 and 65 events/hour. This approval is the gateway to the world's largest market.

Financially, you need to track the burn rate against the available capital. As of September 30, 2025, Nyxoah S.A. held cash, cash equivalents, and financial assets totaling €22.5 million. This figure is down from €43.0 million at the end of the second quarter, June 30, 2025, reflecting the acceleration of commercial investments, particularly in the U.S.. To support this, the Company announced a financing transaction securing up to $77 million, which management indicated provides runway into the first quarter of 2027.

The physical and human resources dedicated to the U.S. commercialization are significant, as this is the current focus area. You have a dedicated 50-member U.S. commercial team for sales and support in place, ready to execute the launch strategy. This team is targeting high-volume implanting accounts, with plans to scale the field organization further.

The clinical evidence supporting the system is a core resource, as it drives physician adoption and payer coverage. The DREAM pivotal trial data, published in the Journal of Clinical Sleep Medicine, provides the necessary proof points.

Here's a quick look at the key clinical performance metrics that form this evidence base:

Furthermore, adherence data supports the system's usability, which is key for long-term revenue. You can see the usage statistics below:

• Nightly device usage greater than 4 hours in more than 70% of nights was achieved in 84.3% of participants completing diary entries in the three months preceding the 12-month visit.
• Overall, the device was used over 70% of the nights by 85.9% of the participants.
• Snoring score was reduced from 83.5% at baseline to 30.4% at 12 months for those who started with significant snoring.

Finance: draft 13-week cash view by Friday.

Nyxoah S.A. (NYXH) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose Nyxoah S.A. (NYXH)'s Genio system over other options for treating Obstructive Sleep Apnea (OSA). The value here is built around technical differentiation and clinical outcomes, which is starting to show up in the financials now that the U.S. commercial launch is underway.

The primary offering is a leadless and battery-free hypoglossal neurostimulation (HNS) implant. This is a patient-centered design that avoids the complexity of wired systems. The company reported revenue of €2.0 million for the third quarter ending September 30, 2025, up 56% year over year, showing early traction following the August 2025 FDA approval.

A key differentiator is the full-body 1.5T and 3T MRI-compatible solution. This is critical because patients often need MRIs, and other therapies can have limitations or exclusions. This extensive MRI labeling was a major factor supporting the FDA approval received on August 8, 2025.

The system delivers bilateral stimulation of the hypoglossal nerve, which is unique as the Genio system is the first bilateral HNS therapy approved in the U.S.. The clinical evidence from the DREAM pivotal trial backs this up with strong efficacy data, regardless of patient position. The median Apnea-Hypopnea Index (AHI) reduction was 70.8% overall.

Also, the non-implanted, upgradable wearable component eliminates need for future battery replacement surgeries. This design choice directly addresses a major long-term concern for implanted device recipients. The gross margin on the product was 60.5% in Q3 2025, indicating solid unit economics as they scale.

Here's a quick look at the clinical performance that underpins these value points:

• AHI responder rate (DREAM study): 63.5%.
• Oxygen Desaturation Index responder rate: 71.3%.
• Percentage of subjects with AHI scores below 15 or lower: 82.0%.
• Median AHI reduction while sleeping supine: 66.6%.

The financial health shows the investment required to bring this technology to market, with cash, cash equivalents, and financial assets at €22.5 million as of September 30, 2025, down from €43.0 million at the end of June 30, 2025. The expected 2026 Medicare reimbursement for the procedure code CPT 64568 is set to increase to approximately $45,000 in Hospital Outpatient Departments, a 48% rise compared to 2025 rates.

You can see the key technical and financial differentiators laid out here:

The system's ability to maintain efficacy regardless of sleeping position is a major clinical advantage, especially since people sleep supine about 35% to 40% of the night. This contrasts with the 74% year-over-year revenue growth seen in Q2 2025.

Finance: draft 13-week cash view by Friday.

Nyxoah S.A. (NYXH) - Canvas Business Model: Customer Relationships

You're focused on scaling adoption post-FDA approval, and for Nyxoah S.A. (NYXH), the customer relationship strategy hinges on removing access barriers for both the implanting physician and the patient. This means a very hands-on approach, especially in the critical early U.S. commercial phase following the August 2025 FDA clearance.

The high-touch model is evident in the structure built around the Genio Access Program (GAP). This program is designed to ensure that the clinical team, the sales team, and the patient are all supported through the complex steps of getting the therapy covered. To support this, each territory manager works with a dedicated case manager who acts as the central interface between the clinical team, the patient, and the sales force. Furthermore, the program includes a reimbursement helpline and a communication portal for real-time tracking of access progress.

A core promise tied to this support is achieving high prior authorization success. Nyxoah S.A. has stated achieving a 100% approval rate on all prior authorization submissions processed through the GAP, including those with major private payers like United Healthcare, Blue Cross Blue Shield, and Anthem. This success is anchored by the consistent acceptance of CPT code 64568 for all Genio hypoglossal nerve stimulation (HGNS) implants. While the overall success rate is highlighted, the raw numbers from the third quarter of 2025 showed that 63 prior authorizations were submitted via GAP, resulting in 21 approvals received as of September 30, 2025.

Scaling surgical capacity through physician training is a key metric for growth. Nyxoah S.A. is executing a focused launch strategy that requires significant upfront education for surgeons to use the Genio system effectively. The company has a clear hiring and targeting plan to support this relationship scaling.

Here's a look at the operational metrics supporting the surgeon and center relationships as of late 2025:

The plan to deepen relationships with high-volume centers involves aggressive scaling of the commercial team. The strategy is to add 75 new accounts quarterly, which necessitates hiring 15 new territory managers each quarter to maintain the ratio of 5 high-volume accounts per manager. The long-term goal is to be launching and focusing on 425 accounts by the third quarter of the following year, effectively blanketing the top 1,500 centers that account for about 75% of the procedure volume.

For the patient, the relationship is supported indirectly through the access program, which streamlines the path to therapy. The technology itself is positioned as an 'implant for life' option, which speaks to long-term device commitment. The focus on securing favorable reimbursement rates directly impacts patient access and adherence by reducing out-of-pocket risk.

• Hospital Outpatient Department (HOPD) reimbursement for CPT 64568 is set to increase by 48% to approximately $45,000 for 2026 over 2025 levels.
• Ambulatory Surgery Center (ASC) facility reimbursement for CPT 64568 will increase by 58% to $42,373 for 2026 over 2025 levels.
• The assignment of CPT Code 64568 to New Technology Ambulatory Payment Classification (APC) 1580 by CMS for CY2026 is a key structural element supporting future reimbursement relationships.

If onboarding takes 14+ days, churn risk rises, so the efficiency of the GAP team is defintely critical to maintaining physician satisfaction.

Finance: draft 13-week cash view by Friday.

Nyxoah S.A. (NYXH) - Canvas Business Model: Channels

You're looking at how Nyxoah S.A. gets its Genio system in front of the right surgeons and patients following the crucial 2025 FDA approval. The channel strategy is clearly focused on driving adoption in the newly opened U.S. market while maintaining European presence.

Direct Sales Force Targeting High-Volume HGNS Centers

Nyxoah S.A. is executing a focused, two-pronged launch strategy in the U.S. market, which began with the first commercial implants completed in September 2025. The initial push is centered on high-volume hypoglossal nerve stimulation (HGNS) implanting centers.

The scale of the opportunity driving this direct effort is substantial, with the moderate to severe Obstructive Sleep Apnea (OSA) patient population in the U.S. estimated at approximately 23.7 million individuals, representing an annual market opportunity of about $10 billion.

Hospital Operating Rooms and Surgical Centers for Device Implantation

Access to the operating room hinges on securing hospital buy-in and payer coverage. Nyxoah S.A. has made significant strides in establishing this channel, particularly in the U.S. following FDA approval in August 2025.

The early traction in securing access is quantifiable:

Furthermore, reimbursement coverage is a key channel enabler. Nyxoah S.A. secured reimbursement with Medicare and private payers, achieving a 100% approval rate on prior authorization submissions from United Healthcare, Blue Cross Blue Shield, and Anthem.

Sleep Physicians and ENT Specialists for Patient Referral

The commercial strategy includes developing strong referral networks with key specialists. This is the pull-through mechanism for the devices implanted in the operating rooms.

The referral channel is supported by the overall financial momentum and investment in scale-up:

• Q3 2025 Revenue: €2.0 million.
• Selling, General and Administrative expenses for Q3 2025: €12.7 million.
• The Company is actively developing referral networks with sleep physicians.

Investor Relations and Public Relations for Market Awareness and Capital Access

Investor relations and public relations channels are critical for funding the commercial expansion, especially given the high operating losses incurred during market capture. Nyxoah S.A. announced a significant capital event in November 2025 to support this growth.

Key financial and capital access metrics as of late 2025:

The financing transaction, announced on November 13, 2025, is comprised of equity investments, including from Cochlear, Resmed, and Nyxoah's Chairman and Management, and a convertible bond, all aimed at driving the U.S. commercialization.

Nyxoah S.A. (NYXH) - Canvas Business Model: Customer Segments

Adult patients with moderate to severe Obstructive Sleep Apnea (OSA) are defined by an Apnea-Hypopnea Index (AHI) in the range of 15-65.

The total estimated population in the U.S. with OSA is over 80 million Americans.

For the Genio system, following the August 2025 U.S. Food and Drug Administration (FDA) approval, the medically eligible patient pool falling under the AHI 15-65 label is estimated to be around 500,000 patients annually.

This segment explicitly includes patients who have either failed, did not tolerate, or refused PAP (Positive Airway Pressure) treatment.

The broader Hypoglossal Nerve Stimulation (HGNS) market in the U.S. is estimated at a $10 billion annual opportunity, with less than 100,000 patients implanted with current HGNS therapies to date.

The Company is targeting a specific subset within this population who present with Complete Concentric Collapse (CCC) of the soft palate.

Nyxoah S.A. has received CE mark approval for the expansion of its therapeutic indications to include these CCC patients.

For patients with CCC, no FDA approved treatment currently exists as of August 2025, representing a significant unmet need.

The Company is strengthening clinical evidence for this group through the ongoing ACCCESS clinical trial, which expects to close enrollment prior to reaching all 106 potential patients.

The table below details the characteristics and associated market data for the primary customer segments as of late 2025.

The financial context for supporting these segments includes Q3 2025 total revenue of €2.0 million.

Cash, cash equivalents and financial assets stood at approximately €43.0 million at June 30, 2025, which decreased to €22.5 million by September 30, 2025.

The Company has a term debt facility with €27.5 million of remaining availability.

The Genio system offers a leadless, battery-free design, which contrasts with competitor devices that may require additional surgeries for battery replacement.

The Genio system demonstrated a median 12-month AHI reduction of 70.8% in the DREAM trial.

• AHI responder rate (Sher criteria) in DREAM trial: 63.5%
• ODI responder rate in DREAM trial: 71.3%
• Patient satisfaction in DREAM trial: 90%
• Compliance rate in DREAM trial: 85.9%

Nyxoah S.A. (NYXH) - Canvas Business Model: Cost Structure

You're looking at the major expenses driving Nyxoah S.A. (NYXH)'s operations as they push the Genio system into the US market. The cost structure is heavily weighted toward commercial scale-up and product innovation right now. For the third quarter ending September 30, 2025, Selling, General and Administrative (SG&A) expenses hit €12.7 million. This significant spend was mainly to support the commercialization of the Genio system and the overall scale-up preparations following the FDA approval for the U.S. launch.

To be fair, innovation doesn't come cheap, especially in medical devices. Research and Development (R&D) costs were substantial in Q3 2025, totaling €12.9 million. This reflects ongoing activities for product defintely innovation and the transition of R&D functions to the U.S. and Belgium. The total operating loss for that quarter was €24.4 million, up from €15.0 million in Q3 2024, driven by these commercial and R&D increases, plus manufacturing activities.

Here's a quick look at the key cost line items from that third quarter:

• High Selling, General and Administrative (SG&A) expenses, which were €12.7 million in Q3 2025, to fund the U.S. launch.
• Significant Research and Development (R&D) costs, which were €12.9 million in Q3 2025, for product defintely innovation.
• Cost of goods sold (COGS) for the Genio system, which was €0.8 million in Q3 2025.
• Clinical trial expenses (e.g., ACCCESS study) and regulatory compliance costs.

We can map out those primary cost components for the period:

Also, you need to factor in the costs associated with proving the system works and getting it approved for wider use. This includes expenses for ongoing clinical studies, like the ACCCESS study, where enrollment was expected to conclude by summer 2025, and general regulatory compliance costs necessary to maintain market access and support the U.S. commercialization efforts.

Nyxoah S.A. (NYXH) - Canvas Business Model: Revenue Streams

You're looking at the early commercial phase for Nyxoah S.A. (NYXH), where revenue streams are directly tied to the adoption of the Genio hypoglossal neurostimulation implantable system by hospitals and clinics. This is the core of how Nyxoah S.A. (NYXH) is monetizing its FDA approval, which it secured on August 8, 2025. The initial revenue ramp is showing early traction, especially following the first commercial implants completed in the U.S. in September 2025.

The third quarter of 2025 saw revenue of €2.0 million. That figure represents a 56% year-over-year growth compared to the €1.3 million recorded in the third quarter of 2024. Honestly, getting that first U.S. revenue within a month of FDA approval is a strong signal of market readiness.

Here's a quick look at those recent top-line numbers:

The revenue from international markets is a foundational piece, as the Genio system was commercialized in Europe and other regions before the U.S. launch. Nyxoah S.A. (NYXH) has expanded its presence, generating revenue in countries including Germany, Switzerland, and the UK. Securing reimbursement in several regions outside the U.S. helps drive this established revenue base.

Looking ahead, the company has provided guidance for the immediate future. Projected global revenue for the fourth quarter of 2025 is set between €3.4 million and €3.6 million.

The revenue generation is supported by solid gross performance on the product itself, though operating losses are expected due to commercial investment. You should note these related financial metrics from the third quarter of 2025:

• Gross margin was 60.5%.
• Gross profit was €1.2 million.
• Cost of goods sold was €0.8 million.

The U.S. commercialization efforts, including expanding the commercial organization and surgeon training, are the primary drivers for the expected acceleration in revenue.