Nyxoah at Cantor Global Healthcare: Strategic Focus on US Launch

On Thursday, 04 September 2025, Nyxoah (NASDAQ:NYXH) presented at the Cantor Global Healthcare Conference 2025, outlining its strategic focus on launching the Genio system in the US market. The innovative neuromodulation device, designed for obstructive sleep apnea patients non-compliant with CPAP therapy, received FDA approval in August. While Nyxoah anticipates significant revenue generation in 2026, the company faces rising R&D and SG&A expenses as it expands its US operations.

Key Takeaways

• Nyxoah’s Genio system, approved by the FDA in August, targets CPAP-intolerant patients with obstructive sleep apnea.
• The US launch is a primary focus, with material revenue expected in 2026.
• The company plans to increase R&D and SG&A expenses significantly to support its US expansion.
• Nyxoah had €43 million in cash as of June, with a reduced cash burn rate from €23 million to €20 million in Q2.
• Future device iterations aim to introduce a "smart implant" concept with automatic adjustments and reduced reliance on external devices.

Financial Results

• Nyxoah reported €43 million in cash as of June.
• Cash burn decreased from €23 million to €20 million in Q2.
• R&D spending is projected to rise by mid-single digits year-over-year.
• SG&A expenses are expected to increase by 67% to 75% compared to 2024 due to US market expansion.
• The company targets a revenue breakeven point of $200 million, lower than competitors.

Operational Updates

• Nyxoah’s Genio system features bilateral stimulation, enhancing MRI compatibility and eliminating surgical battery replacements.
• The technology launched in the US on August 11, following FDA approval on August 8.
• The US launch strategy focuses on high-volume sites, with a team of 53, including 25 territory managers, supporting the rollout.
• The company is collecting data through a registry to refine the technology and support health economic data for payers.

Future Outlook

• Nyxoah plans to develop a "smart implant" with live feedback and automatic stimulation adjustments.
• Future device iterations will focus on patient-friendly features and reducing reliance on external wearables.
• The company is evaluating options to raise capital to extend its cash runway beyond 2025.

Q&A Highlights

• CEO Olivier Valmont emphasized the importance of FDA approval and the strategic focus on the US market.
• CFO John Landry highlighted the company’s targeted approach to commercialization and cost management.

For further details, please refer to the full transcript provided below.

Full transcript - Cantor Global Healthcare Conference 2025:

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Alright. Great. Let’s go ahead and get started. My name is Ross Osborne. I’m the med tech and diagnostics analyst at Cantor.

And today, we have Nexoa, and we have the company’s CEO, Olivier Dalman, and CFO, John Landry. So with that, would you go ahead and provide a brief background on yourselves?

Olivier Valmont, CEO, Nexoa: Yes. Definitely. So first, thank you for having us. Always a pleasure. For myself, Olivier Valmont.

I’m born and raised in Belgium. I moved, however, last year to The US with my family. So it has been really an experience. From a background perspective, I started my career in the pharmaceutical use team with Eli Lilly. And I switched off for roughly ten years to the med tech space by joining Medtronic, where I was also working always in neuromodulation for the last ten years.

Then built some store of experience at Navro. And since the last seven years, almost seven years, I am also leading as their CEO.

John Landry, CFO, Nexoa: Hi, Ross. Thank you so much for having us at the conference and thank you to the entire cancer team for having us here to share a little bit more about Nexo today. My name is John Landry. I’ve been in the medical device space for the past twenty years. Two different companies, Salient Surgical Technologies and then more recently as Vapotherm CFO.

I recently joined the Nexola team in November and very excited about bringing the Genio solution to patients here in The US as well and growing this into a very large business going forward.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. Libya, maybe let us set the room. Who is Nexoa? What do you guys do? How was the company started?

Olivier Valmont, CEO, Nexoa: Yes. So Nexoa is a medical technology or a medtech company with an innovative solution to treat obstructive sleep apnea patients. I think as you are well aware, obstructive sleep apnea, it’s a huge market. If you look in The U. S, you see that there are millions of patients who are suffering from one type of, let’s say.

So with our internal mobilization solution, we are extremely excited that we can say that we have obtained FDA approval on August 8, on Friday. I will this day will be burned in my memory. So since Monday, August 11, we are actively launching our technology in The U. S. When we go a little bit deeper in the technology as such, it’s clear that with the bilateral stimulation aspect, putting the patient really at the center, we want to differentiate from our competitors because there is only one other company active in epiglottis stimulation, and we are extremely pleased to be able to recover the content going forward.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And maybe before we dive into Gneo, can we discuss the sleep apnea market? How many people suffer from moderate to severe sleep apnea? And how are they treated historically?

Olivier Valmont, CEO, Nexoa: Yeah. So I can start with prevalence and go all the way to insulin, but as I was mentioning, it’s a huge market. So what we have seen when we talk about hypoglossal nerve stimulation, we are focused on patients suffering from moderate to severe obstructive sleep apnea, mild to moderate to severe swallowing when patients are having minimum of skin intense every hour with some kind of obstruction. They become severe patients when it comes to 30 obstructions in all. Now when you ask market size in The U.

S. Alone, we are talking about trophy or home closure patients that would be eligible for treatments with the AGNS based on their severe, not always safe. So if you then also start calculating a little bit further, if you would have been a company, people would say you have blockbuster potential because it’s a market only and you are the listed because you can deliver a lot of market opportunity.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And then CPAP has been around for a while. Yes. Some people like it, some people don’t. Where do people see the push back? How does AT

Olivier Valmont, CEO, Nexoa: and S fit in? Well, so first of all, I do think CPAP is still the golden standard in the treatment of obstructive sleep apnea. It’s a very effective technology, but to your point, you need to be compliant. You need to wear your mask. And what we have learned is that there are quite a substantial amount of patients that are simply saying after a period of two to three years, it can go up to almost 50.

People are saying, I don’t like my mask, I don’t tolerate the mask, I would like to have something else. If those patients that are also in the category of multiple 2C period, let’s say, that’s where the EGN has, that’s where EGDO can step in. And then also in Germany, for example, I would be collaborating with the device from ResMed that by showing joint process that we can either accelerate therapy penetration in general, but that we also can make sure that the right patient will get the most optimal treatment that suits this patient with sleep other quarters as well as the standard of the story.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then moving on to Jineo, how does your device work?

Olivier Valmont, CEO, Nexoa: So I was always saying we offer neuromodulation solution. So we stimulate the nerve for muscle mass to neutralize. Through nerve stimulation, we will provoke a muscle contraction, a genial gluco muscle that is contracted, that is attached in the back of the throat to the upper airway. And by providing mild stimulation, in that particular stimulation of the pancreas, we will see that the muscle is contracting and maintaining the airway open during sleep. Now what makes us different compared to what is out there is that we stimulate bilateral.

Why is this important? You respect the anatomy of the intercostal nerve. You see that there is a left or right branch. By stimulating both branches, we need less energy. I think that’s an important aspect because while you stimulate, there is always a little bit of paresthesia that the patient can feel.

Now if you are sleeping, the last thing you don’t do is the very copper patient. That’s why it’s important that with, let’s say, mild stimulation settings, you can obtain extreme spots anywhere open, and that is driven by bilateral stimulation. For the next thing where we differentiate, I think it’s crucial from the two perspective is that we do not have an implantable battery. So we have an external direct spin off, this is for the patients, but good MRI compatible technology is one aspect. Second spin off of having another compatible battery is that when it’s depleted, you also then need a real operational surgery to get a new battery.

And the last one is that excites the battery. We also have software available for the moment. So when you would like to have software upgrade or to have a new one, it’s like with the iPhone. No, we can just put the proof. We don’t even need to come back to the hospital.

We don’t need the surgery. We just can’t back the data and the latest software update.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then maybe just discuss the patient journey from diagnosis to implant.

Olivier Valmont, CEO, Nexoa: Yes. So first of all, it starts most of the time by visiting a GP and I’m not complaining, I don’t feel well rested, I cannot function, I feel daily sleepiness. And once the GP is is hearing those kind of signals, so what they do is all day set you up for a home sleep test where you get your first diagnosis. And then the next step would be go to sleep sleep physician in the sleep lab, and you get a full polysomnography sleep exam, where we get all the unknowns and the precise criteria of sleep apnea. What is it mild?

Is it moderate? Is it severe? What is your oxygen desaturation? How will you be able to do that you’re having? And also referring to what kind of treatment would you need in order to treat your OSA.

That’s where CPAP still is the golden standard. And what we’re also seeing is that immediately when CPAP is not accepted as an option or when patients after using CPAP for a certain period are coming back saying, we’re looking for something else, that is where Genio steps in and starts filling the gap. Then the patient will be referred to an ENT surgeon, will be able the implants. And once the implant is done, then we will do some P and P surgeons became specialists in sleep, and they will follow-up patients. Some others are bringing the patient back to sleep position.

Patient. Perfect. Have

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And to your point, and congratulations again on US approval, what’s the game plan for targeting US market?

Olivier Valmont, CEO, Nexoa: So it’s something that the entire company has been working on from the ground in getting access to margin and to be scheduled in U. S. Market. What’s simple is that it’s the largest market, the existing, where if you look at the last year results, we are talking close to $708,100 dollars of revenue. And this year, the market could either eventually engage the market.

So we want to be there in this one aspect. How do you wanna be there? We show them for a focused launch or a launch where we go in personal events after. And for you, we will also love samples. We know where we are.

We call them out to them. So

John Landry, CFO, Nexoa: Got it.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And then when thinking about these high volume sites, do you think there’s an opportunity for there to be your competitive offering there as well as you guys, or will it look beyond the Nexoa side and then the Aspire side?

Olivier Valmont, CEO, Nexoa: So in the beginning, actually, we shared in France. We love in all sources of the.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Right. And then there are two indication or the future indication oriented aspects of your device that may be interesting relative to your competitor. Can you discuss the CCC population

Olivier Valmont, CEO, Nexoa: and the Bundes you find and the Bundes you find? Yes. Actually, first, I would like to come back to our visit. For reason, think, so I still make sure treatment to we put have the patient in the center. And this is caused by buffering and maintaining an airway openings and an effective therapy.

Igor, that’s what sleep position you are in. I already was very pleasant today. When we sleep, we will spend time in the supine position. You will sleep on the side, you can sleep on the tummy. I think it’s crucial that when you get an implant, you know, that you always have an efficient technology.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: And so how are those patients treated today? So they they have the CBAF. Exciting opportunity for you guys. And then maybe moving on to the model side of things. You have approval ramping up initial commercialization activities, but there will obviously be a a lag in revenue.

Discuss the dynamics of back approvals, achieving reimbursement, etcetera.

John Landry, CFO, Nexoa: Well, absolutely, Ross. So from a timing perspective, the rest of this year is going to be really foundational setting. We’ve had the commercial team, they put the ground running. So we had the approval on August day. They put the ground running, reaching out to our the Pentium customers, specifically getting set up in customer systems as a qualifying supplier to obtaining back approvals with a very very value analysis committees within these centers and then working through the various preoperative processes.

That’s really we’re gonna be putting the building blocks

Olivier Valmont, CEO, Nexoa: in place over the last, you know, the last four months of

John Landry, CFO, Nexoa: the year to really set the stage for revenue growth in 2026. We don’t expect material revenue

Olivier Valmont, CEO, Nexoa: in the

John Landry, CFO, Nexoa: back 2025.

Olivier Valmont, CEO, Nexoa: We expect it to start

John Landry, CFO, Nexoa: coming in 2026 when we harvest all the fruits of this labor over this last four months of the year. From a first implant perspective, we’d expect that later this month or early next. And we’re very excited to see that and very positive reaction from the customers when presented with our technology.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Absolutely. And then would you discuss the associated spend? Because we’ve obviously been investing a lot ahead of approval on.

John Landry, CFO, Nexoa: Yes, absolutely. So from an OpEx perspective, and we don’t provide specific numbers in terms of guidance, but I can provide some color, if that’s helpful. So from an R and D perspective, we’d expect our R and D spend this year to be up over prior year, kind of like in the mid single digit percentage perspective. On the patent litigation expenditures that were incurring, those hit R and D from our perspective, from a GAAP perspective. So there’ll be a little bit of an increase there.

And then from an SG and A perspective, we won’t quite double our SG and A spend year over year, but we’ll probably be in the two thirds to 75% increase as compared to 2024, given the investments we made in the U. S. Commercial organization, which right now, we have 53 people in the US commercial organization. They’re supporting the initiatives, and we have 25 quota quota carrying territory managers in the ranks at this point.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then looking ahead, you know, once implants have been done, do you plan to establish a registry or collect the old data? Yes. Definitely.

Olivier Valmont, CEO, Nexoa: So I think it’s important that you collect data that you learn from your data to further with your technology where you need it. On the other hand, also to store your health economic data, you can provide that to to payers to make sure and maybe also prefer to expand and call it earlier in the cloud brain. So, yes, one of the short answer is yes. We are capturing all data, all the applications in the data that I just

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Great. And then I realize you just received approval, and we’re just getting out of the gate here. But when thinking of the future, what do future iterations of the device look like?

Olivier Valmont, CEO, Nexoa: So first of all, it always has been our goal to become a leading company as a local population in the brain and OSCE and there we will continue investing in this. We also always put the patient at the center. We try to integrate data. We are looking at our relevant components to make it look more patient friendly. When I say this is providing live feedback on the quality of sleep.

I think it degrades when you wake up and you can say, oh, I slept so many hours. So what’s going on? What’s going I’ve had an oxygen dissertation that was going slower than 96 or 97%. I think this will only motivate patients also to become even more compliant and to also I feel better in their lifestyle also returning to work and playing with their grandchildren, you know, doing things they like. But that’s something that we are investing heavily in and our and our technology is allowing this.

From an implant perspective, it’s also very clear that we do rather go to an implant for a life concept. So once implant, don’t need to worry, don’t need to think that you are implanted with only the other patients. And then if we combine everything, over time, you are looking at five year out from now, I do think we will evolve to a smart implant that can detect when to stimulate, at what settings, automatically adapt, also in making sure that the airway maintains open without any wearables, are looking at a pillow floater concept where you would put your head on a pillow, you would act like a battery on a nightstand, you have kind of closed loop system. And the great thing about gHill is that all this is already in technology platform available. And then I think my patients will definitely definitely appreciate this.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Definitely. And then maybe turning to your balance sheet. Can you discuss the current

Olivier Valmont, CEO, Nexoa: burn rate? Back.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Yeah. I’ve had some reason. Always see. Something exciting, and then I’ll come back to reality, I guess, for a little bit. How are you thinking about burn, capital needs, and how can we get to breakeven?

John Landry, CFO, Nexoa: Sure. Absolutely. So from a cash perspective, we had €43,000,000 of cash at the June. So we decreased our cash burn from 23,000,000 to 20,000,000 in the second quarter this year. Given some of the initiatives we had this year to defer certain expenses to align with the delayed FDA time line, that’s resulted in the fact that we don’t have an immediate pinch point.

We need to raise capital today. That said, we’ll we’ll be evaluating different options to raise capital, put cash on the balance sheet to allow us to execute on our strategy and go out and drive revenue from The US market very specifically and support The US launch. We’re looking towards that over the course of the year. We got enough cash to get into 2026 at this point. So we’ll be evaluating those options to us.

In terms of our revenue breakeven point, given the very directed and targeted nature of our U. S. Commercialization efforts and focusing on high volume centers as well as DTC spend in very specific centers that provide those referrals as well, We believe our revenue breakeven point will be more around the $200 level, which will allow us to get to a revenue breakeven point, which is, you know, less than what

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: maybe our

John Landry, CFO, Nexoa: competitor got at that point. So definitely, that’s where we stand today.

Ross Osborne, Med Tech and Diagnostics Analyst, Cantor: Any questions from audience? Alright. If not, thinking about next year, any milestones or catalysts we should be watching out for.

Olivier Valmont, CEO, Nexoa: Of course.

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