For those not yet familiar with Sedana Medical, could you briefly describe the company, your technology, and how you position yourselves within your market?

Sedana Medical is a Stockholm-headquartered medtech and pharmaceutical company. We consider ourselves the pioneers of inhaled sedation for intensive care patients. Patients on a ventilator in the ICU are by definition very sick, often in a life-threatening condition, and most need to be sedated to stay calm and comfortable while the machine breathes for them. For decades, the standard of care has been intravenous sedation, drugs like propofol administered through an IV line.

We do it differently: by delivering sedation as a gas, together with the air the patient breathes, through a small device called Sedaconda ACD. The device is inserted into the ventilator’s breathing circuit, and combined with our own drug, Sedaconda isoflurane. Compared to propofol, patients wake up faster, need less opioids, breathe more spontaneously, and many leave the ICU earlier, which also means real cost savings for hospitals.

We are approaching one and a half million devices sold and have treated hundreds of thousands of patients in well over a thousand hospitals across around 50 countries. Our centre of gravity is still Europe, but we are now working towards approval in the United States – which is by far our largest growth opportunity.

You reached profitability in your core business (ex-US) for the full year 2025. What were the most important drivers behind that, and how do you view the prospects for continued profitable growth in Europe?

The turnaround started a few years ago, when we came out of COVID-19 and made it a priority to turn our European business profitable before launching in the US. It was important to have a stable platform in Europe first, if you have a leaking bucket in Europe and then add another leaking bucket in the US, that’s simply not sustainable.

We changed two things:

First, costs: we significantly downsized everything that is not customer-facing. For instance our Swedish head office now runs with half the people it used to. We reinvested part of the savings into the front line and became a much more customer-centric company. Investments into sales teams were also selective: we doubled down in countries with strong growth and profitability and pulled back where that wasn’t yet the case.

Second, we improved gross margins by acquiring our main supplier, a manufacturing plant in Malaysia, which lowered the cost of goods for our main device significantly. That said, more of the profit improvement actually came from the restructuring than from the acquisition. 

Together, this took us from the biggest loss in the company’s history in 2022 to full-year profitability in our ex-US business for the first time in 2025. This year, year to date, we’re breaking even at group level too. As the business scales and the US starts contributing, we see a path to a long-term EBITDA margin of around 40%.

How would you describe Sedana Medical’s current strategic direction, and what key priorities are most important going forward?

We have a vision of making inhaled sedation the standard therapy in intensive care. As we are a relatively small company of around 130 people, including our Malaysia plant,
I’m a big believer in focus, so everything we do revolves around three priorities: 

First, growth in our core markets, Germany, Spain, France, the UK, where we’re the only company with an approved inhaled sedation indication in intensive care, and there’s still room to deepen penetration.

Second, growing EBITDA profitability, to prove this business generates profit, not just growth.

Third, conquering the US, our biggest prize. We just submitted our New Drug Application to the FDA in June, a huge milestone after years of clinical and regulatory work.

Profitability and cash flow have become increasingly important focus areas. How are you working to strengthen margins and improve operational efficiency?

 It comes back to the same two levers behind our turnaround – cost discipline and gross margin. Our gross margin has improved meaningfully, to 73% in the second quarter of 2026, largely because we now control production of our main device ourselves instead of buying it from an external supplier.

We run a leaner, more focused organisation than a few years ago, and stay disciplined about where we invest by backing markets and activities with clear returns, cutting back where they don’t yet show results. As sales grow on top of that leaner cost base, more of each additional krona of revenue falls through to EBITDA, which is what will get us towards our long-term target of around 40%.

How do you view your current geographic exposure, and where do you see the strongest growth opportunities ahead?

Europe is where the vast majority of our business is today, with Germany being our historically largest market, followed by Spain, France and the UK. Germany has represented around half of group sales; this year it’s been affected by markedly lower ICU occupancy, tied to a lighter respiratory infection season rather than anything to do with our competitive position. More than half of German ICU hospitals are already customers, representing more than two thirds of the market potential, so our opportunity there is mostly about deepening usage rather than winning new accounts.

However, the strongest momentum right now is outside Germany – Spain, France and the UK have all been accelerating, by applying the playbook that’s worked well in Spain – targeting high-potential hospitals and building strong key opinion leader networks – to other markets too. But the biggest step-change in geographic exposure will come from the United States, which represents roughly three times the addressable market we serve today.

You have completed your pivotal US studies with positive results and submitted your NDA to the FDA in June 2026. What are the most important steps and risks on the path to a US launch?

We submitted the file in mid-June, a little earlier than promised. We’re now in the validation period where the FDA is checking the file and will decide whether to accept it. We expect to hear back in August or September, and if accepted, they’ll set a so-called PDUFA date, the target date for completing their review. At the same time, they’ll decide on our request for priority review, which would cut the review period from ten to six months.

On risk, the profile changes at each stage. Early on, it’s mostly clinical risk, which we’ve addressed by hitting our primary endpoint in both pivotal studies, reaching meaningful differentiation in our secondary endpoints, and having no new safety findings. Then there’s regulatory risk, whether the FDA accepts everything we’ve done. We’ve stayed close to the agency throughout and prepared systematically for the review period, for example by bringing in former FDA inspectors to audit our manufacturing plant, quality systems, clinical trial oversight and suppliers. If that goes well, the focus shifts to execution risk. At that point, you’ve been approved and can sell commercially. This is where we bring substantial experience from building a profitable business in Europe, complemented by local expertise and talent.

We’ve also studied the FDA’s database of rejection letters for comparable drug-device combinations to reduce risks of our own dossier as much as possible. But any FDA review deserves humility, there are usually surprises. What gives me confidence is that our clinical trial results are strong; that’s the one thing you can’t easily fix if something’s wrong, whereas most other questions, like statistics or human factors, are usually fixable.

Looking at the broader market, how do you view the competitive landscape for inhaled sedation versus traditional intravenous sedation, and what is required for inhaled sedation to become an established standard of care?

We’re the only company with an approval for inhaled sedation in the ICU, so our real competition isn’t another inhaled sedation therapy, it’s the standard of care itself: intravenous sedation with drugs like propofol, which has been standard practice for decades simply because it’s what everybody is used to.

Adoption usually starts with clinical evidence, studies showing patients wake up faster, need less opioids, and leave the ICU sooner. But the most powerful driver is ‘seeing is believing’: when a doctor sees a patient wake up quickly and clearly, day after day, they start using inhaled sedation routinely.

Our selling model starts with the clinicians – understanding how they manage patients today and gradually building trust. Sometimes, that takes time. There’s often three to six months between first contact and first use. That’s part of why our most effective salespeople are former ICU nurses, who speak the same language as the doctors and nurses. It takes time to get in, but once they start using inhaled sedation, it’s usually there to stay.

Looking ahead, where do you see Sedana Medical one year from now?

In a year, we hopefully have our US approval in hand, possibly already launched under a priority review, or close to launch under a standard review. Alongside that, I’d expect continued scaling of sales and profitability in Europe. You’d be looking at a company with a true proof of concept and, at the same time, enormous growth potential in the US – a company that’s definitely fun to be a part of.

Finally, can you give three reasons why Sedana Medical is an interesting investment case at this stage?

When I look at investment opportunities in life science, I look at three things.

First, does the product bring a real benefit to both patients and hospitals? For Sedana, clearly yes, proven in several clinical studies.

Second, is there proof of concept? Yes, a healthy, profitable business in Europe, hundreds of thousands of patients treated, around one and a half million devices sold.

And third, is there a near-term inflection point that could change the shape of the company? For us, that’s the US opportunity, which would roughly quadruple our addressable market once approved – and it’s no longer a distant fantasy, since we’re now in FDA review. 

That combination – patient and hospital benefit, proof of concept, and a near-term inflection point – is what makes for a genuinely compelling investment case in my view.