Observe Medical ASA (OSL:OBSRV)
Norway flag Norway · Delayed Price · Currency is NOK
1.195
+0.075 (6.70%)
At close: Apr 24, 2026
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Trading Update

Oct 7, 2025

Rune Nystad
CEO, Observe Medical

Good morning and welcome to this trading update from Observe Medical. It's now close to 10 months ago that we launched our latest addition to our portfolio, the Oona Meter Safety Plus. We would like to give you an update on the progress on the commercial side, but also on our product development side. Just a short recap on who we are and what we're doing, what is our mission here as a company and our ambition level. We have, as you all know, a number of proprietary products that we have already launched. We have now, with this launch back in January, all the Comatec products on the market and we are seeing the effect of that.

As a second leg of our strategy, we are working on an approach for the Nordic innovative ecosystem where we do see an opportunity that we can actually strengthen both the companies that we can work with, but also ourselves in bringing those innovations to market. Growth and optimization is a continuous effort that we do. We do have an increasing footprint in the medtech scene, both European-wise, but even globally. We do see opportunities coming our way and we will act on those as we see them coming. This is our position as we have it now. We have the Oona Meter family in the market now, all of it. We are very, very happy with this. We see a very nice traction in the market, a very positive feedback from customers in terms of product quality and positioning. I'm very happy about that.

We do also still have the beam in our portfolio, not first priority definitely, as already communicated, but certainly part of our ambition level. We talk about the platform that we are standing on, that we have now spent close to three years building. We have the third-party manufacturing platform in a cost-effective situation in Zushu. Product development, yes, we are doing product development work. We have done already and we are launching new products very shortly. Sales and distribution, we do now cover all interesting markets in Europe and continue to expand into Asia and South America. Quality and regulatory definitely a cornerstone in what we do and certainly also from a competency perspective, also a cornerstone on what we are. What has happened in 2025, also an extremely interesting year from our perspective. We are looking at a situation where we now have sales to 44 countries.

We were able to communicate that Oona Meter Safety Plus and the rest of the family grew 61% here at half year compared to last year. Happy with that. We want to keep that momentum going forward. We did complete also a private placement during the summer period. We have also managed during the last 10 months to go through a very, very significant debt reduction. We are talking about a debt reduction from NOK 110 million to around NOK 40 million, which has changed our perspective quite dramatically also on the financial and the attractiveness of our company. We did also, as part of this exercise, make a new agreement with Comatec where we have now acquired and taken over the IP rights of the Oona Meter family, basically two years before it was originally planned.

We are very happy that we are now in full control of our portfolio, very important for us. We also quite recently have a new cornerstone investor as part of our platform. We do believe that this is going to change also our position going forward. Right now, as it has been for the last couple of years, focus has been very much on the order intake, exploiting the portfolio we have, and we are seeing a very nice development in that. We have earlier communicated that we would launch or prepare the launch of Safety Max and upgrade of the Safety Plus and launch that into the market this year. This is still our ambition and we are progressing as planned on that one. This is what we promised and this is what we delivered. We are very proud of that situation.

When we look at the order intake on a 12 months rolling basis, we are in a situation now where we are, as I mentioned, in 43 countries across many regions, with the center of attention being Europe, but still South America and Asia is growing quite nicely, both in geographical coverage but also in business. We are basically having very much the same focus as Comatec did to reclaim that market position that we were sort of entitled to with the portfolio we now have. As you will see there, a very nice curve that we are very proud of, obviously, because going back only two years, we had zero revenue, zero order intake. We did not have a portfolio. Now we have the full portfolio. We have now seen continuous growth in order intake for the last more than two years.

If you look at the development in the last 10 months since the launch of the Safety Plus product, we are now seeing an acceleration of the order intake and are now passing just now a very important threshold of NOK 25 million order intake on a 12-month rolling basis. Not to be underestimated, the fact that we are now present in all these markets and our distributors are out there bidding and winning tenders. That means that our business expectedly will continue to develop positively because our presence and our footprint is just increasing by the day. A little bit about the momentum we are looking at. We have talked about repeat orders earlier. If you look at the situation now, we are looking at a very, actually the largest part of our customer portfolio or country portfolio, we are seeing now more than 10 orders received.

Some of them are way beyond 30, 40 orders. That's a very nice situation that we now have continuation. Our business, remember that, is a recurring revenue model. When you have a one attender, the business will continue because our products are used on an intensive care ward for six, eight days, and then a new product is being used. It's a single-use product. When you have the platform, it's a repeating situation where the orders will keep on coming in. We now are in a situation where all markets have placed more than one order, I mean two orders and upwards. Some smaller markets are still in the lower parts because they have been only recently introduced to our portfolio. Generally speaking, we see now a repetition of our business, which is exactly the position that we have been hoping to gain.

As you will also see, in 91% of the geographical coverage that Comatec had, they had a revenue equal to NOK 360 million in 2021 in today's currency and prices. We are now present in 91% of the geography that created this revenue. Also a significant step for us, indicating also very much the potential of this platform. Product development. These are the unmet challenges that we want to meet because these are those that our customers, the final customers, the ICU wards are facing every day. Those are the ones that our product portfolio is aiming to solve, offer products that have superior value to our customers, to our users. The four elements that we are looking at are the infection control element. The catheter-associated urinary tract infection is the most common nosocomial or hospital-acquired infection that exists in, I would say, the Western world, the industrialized world.

We play with the Oona Meters a very significant role in having an opportunity to limit that risk of the patients of getting a urinary tract infection. Very, very important for us. There are a number of other elements, the manual measurement inaccuracy, suboptimal measurement frequency. Those two elements of measuring, this is when you talk about urine output measurement, you do that every hour. It is difficult for the nurse and the staff to be precise on the hour. It's also very important that you are precise on the reading. There's a huge opportunity to be more precise in doing that because there's a reason why they do it every hour. That is to prevent the risk of AKI, acute kidney injury. The last bit, very important also these days, is the unnecessary staff time expenditure.

The situation is that the urine measurement is one of the very last manual processes in an intensive care unit. We are looking at developing products and already have actually products that solve the issue of not having to manually go and read and document that urine output. We have earlier communicated that our planning is to launch the upgrade of the Oona Meter Safety Plus already this year. Still our plan. We are right now, as the photo indicates, in the phase of doing a pilot study on the infection control elements. What you see here is our colleague Raisa, who is doing right now, as we speak, it started yesterday, a pilot study on these infection controlling elements. It's going to continue over the next couple of weeks. In order to do that, obviously, we need the product.

The situation is that we have now spent the last five, six months finalizing the physical product. We can basically start manufacturing this product tomorrow. Now we are in the phase of validating the clinical output of the infection control element and also thereby creating the basis for the claims that we're going into the market with and also the technical file and the regulatory approval under the MDR. That's where we are with this product. We are quite, quite confident that we will be able to keep the timelines as indicated. It's also a little bit about ambition level. The product will work. We are confident about that. We want to make sure that we get out there with a product that offers superior value documented. If you go for documented, you can have the strongest claim. You can also have the best price positioning, etc., etc.

Very important for us. Progress is there. As we speak, we see that we are on track. Oona Meter Safety, next generation of urine output measurement devices. As you all know, it's been in our portfolio for quite a while now. We changed a little bit the strategy when we got access to the mechanical urometers from Comatec. This is now building our platform that I've just shown you, the commercial and also the distribution platform. Safety, very important for us still. This is next up in terms of what we want to do. We also do want to recognize the fact that it's only 10 months ago that we, through this network of distributors, launched or relaunched the Oona Meter Safety Plus, the best product, a well-documented product in the market. Our distributors are working with that now.

We are now promising them a next generation mechanical urometer of the Safety Max in only six months' time. We will take a good close look at what is the right timing of Safety because we have a number of resources available and when can our distribution platform best carry the Safety product into the market. This is very strategically very important for us. We are monitoring going into the next six months, how fast should we be on that product. This is the summary of the journey we've had and gone through. As you will see here, just a repetition, we have now relaunched the three products that combined had a sales-to-market in 2021 from Comatec of around NOK 360 million. These are now out there. We have reestablished 91% of the geographical coverage. Now we are taking the next step into innovation, true fundamental innovation.

There's not been any innovation in this market as far as we see it since the launch of Oona Meter Safety Plus back in 2007. With us bringing these products to market, we will definitely take a global position as the leader within this segment. It is in many ways a niche segment from a medtech perspective, but has tremendous potential for us, for growth, and for differentiation through this innovation we're looking at. Coming back to the unmet needs that I was referring to in a couple of slides back, these are the four unmet needs that an intensive care unit will face when dealing with urine output measurement. What we're seeing is actually that when taking the first step with Safety Max, we will be truly innovative in bringing an infection controlling element into the market that has not been seen before.

When we bring Safety in, we will cover all four of these elements because the manual measurement, suboptimal measurement, and staff time reduction are elements that the Safety will bring to the market. All in all, we actually feel that our pipeline is well suited to manage the challenges that the hospitals and the intensive care units are facing looking into a urine output measurement. A small recap back to what markets we are playing in. We are looking at, if you look at the left-hand side, that is the mechanical urometers. That is the playing field we are in right now. It's a market of NOK 1.5 billion. We are playing in the darker blue NOK 679 million market with the design that we are having.

When we add the design that you see below, what is often referred to as a front-mounted system, we will be playing on the full playing field of NOK 1.5 billion. Not only that, we will be bringing in more value to the end users with the Safety Max. Therefore, we expect to be able to expand that market and also to take real-size bites of the NOK 870 million that is right now owned by the front-mounted system. By adding the Safety Max, we will add additional value that will take users of the front-mounted into a top-mounted system that we offer. The next step for us, and we will definitely have that as our primary goal, is to take the market from currently around NOK 1.5 billion to a market value of around NOK 4 billion. What will be driving that is mainly Safety.

When we have a full conversion to Safety, that is when we are looking at a NOK 4 billion market size. This will take some time. We will need to launch the product successfully with the right claims. We have all that in our plan. Having the opportunity to take on new geographies where U.S. markets are the primary target, but also large parts of Asia are preferring the US-style version. Actually, with Safety, we will be able to take on the journey of bringing the market from around NOK 1.5 billion to a market potential of NOK 4 billion. Very important for us. We take a big step there. There is no one out there trying to do what we will do with Safety, meaning convert from the mechanical systems into the digital world.

No one is doing that. There are some smaller markets, some smaller ambitious companies with digital versions. They are much more niche-oriented compared to our approach. That's the update that we wanted to share today. It's time for a little Q&A. Please, if you have anything, please share. We will pick up those that we can now. Otherwise, please feel free to use the contact points that are on our homepage and all our newsletters where you can have both my contact details, but also Johan's, our CFO's contact details. Feel free anytime to reach out to discuss or to have any questions. Let me just check if there's any questions. Yeah. The question is, how much turnover do you need in a quarter to cover costs or to be cash positive? Our run rate right now is around, on a cost side, is around $2 million.

We are having a rather lean and mean approach to our OpEx base. We are very focused on making sure that our OpEx is developing in the same speed or less than we see the top line developing. I've just shown you the order intake development that will obviously turn into revenue effects soon. This is a discussion of when do we take in new OpEx, new cost for more resources and to implement our ambitions. We will not do that before we see that the top line is actually supporting that. No specific guiding right now on when that will happen. This is because it's a mixed effect in terms of how quickly do we ramp up the cost and how quickly do we see the order intake continue to accelerate. This is obviously our main focus to create a cash-positive situation. I think that's it for now.

As again said, don't hesitate to reach out, give a call, or a mail. We will expand on any topic that might be interesting for you or if there's any questions still remaining. Other than that, please continue to follow us where you can see the progress. We will continuously be as open as we've been so far in terms of the progress. We expect to bring you those news that will show you that we are continuing to develop as we have promised. We look forward to that. Thank you very much for your attention. Talk to you soon.

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