Senzime AB (publ) (SEZI) Earnings Call Transcript & Summary

All right. For those of you who just joined, good morning and good afternoon, depending on where in the world you are. We're just going to give it one more minute so that we can have more attendees to join the official webinar. So we're so glad to have you just hang back for a minute, and we'll get started shortly. All right. Looks like we have a pretty good full house here. We're so thrilled to have you guys joining us. This is one of the biggest days that we've all been looking forward to officially unveil and launch the next-generation TetraGraph. But before we officially get started, there's just a few housekeeping items that I want to make note of. First of all, everyone has been placed on mute to help create an optimal listening experience for all attendees. So if you have any questions at any point during the webinar, please feel free to enter them into the chat box, and we will address them in the order that they are received. There is also going to be a Q&A portion towards the end where we will address some of those great questions that you might have. Also just a reminder, this webinar is being recorded, and we will send a link to the recording towards the end of this week via e-mail. It will also be posted on our website at senzime.com. And lastly, if you are viewing this on a smaller screen such as your mobile device or tablet and struggling to see the slides, simply hide the chat box or your right-hand panel and it will help enlarge the presentation screen for you. So with that, I'm going to go ahead and officially kick us off here. And hopefully, everyone can see my screen here. So I am really excited to introduce this incredible panel here. First of all, I am host, Michael Noble, the VP of Global Marketing here at Senzime. And next, we have Dr. Sorin Brull. He is the Professor Emeritus at Mayo Clinic. He trained at Yale University and spent 40 years in Clinical Anesthesia. He is a mentor and researcher in neuromuscular physiology and pharmacology and has published over 200 peer-reviewed scientific works. Dr. Brull has a long-standing commitment to improving patient care, participating in Anesthesia Patient Safety Foundation as well as the Federal Food and Drug Administration here in the United States. And next, I have the great pleasure of working with this very special person, Linnea Troeng. She is our Global Product Manager here at Senzime and is really the big force behind this next-generation TetraGraph launch. She graduated with a Master of Science degree in Molecular Biotechnology from Uppsala University in Sweden, where she cultivated her passion for life science and health care technology with over a decade of successfully leading the development and launch of innovative medical products that enhance patient care, including this exciting next-generation TetraGraph. And so before we officially dive in covering the key features and benefits of the next-generation TetraGraph as well as how this impacts patient care. And then lastly, but certainly not least, how you can implement this technology, we are going to play this video here to showcase the device as well as how this can look in your operating room or operating theater. And so with that, I'm going to go ahead and officially play this video. [Presentation]

Well, we hope you enjoyed that exciting video and get to really see how this next-generation TetraGraph can easily fit into your operating room or operating theater. So that brings us to the official webinar. And so I'd like to turn this over to Sorin. So tell us about how we got to this exciting stage with the next-generation TetraGraph device.

Yes. Thank you, Michael, and thank everybody online here. It's exciting to present this. I'd like to very briefly go through the time line that showed the monitors growth. So I'm really proud to say that the TetraGraph was developed over many years by a practicing anesthesiologist, that would be me. And I was always surrounded my clinical work by giants in our specialty who have instilled in me the curiosity for new discovery and I hope the dedication to patient safety and to improving clinical care. To me, the TetraGraph has always been more than a commercial endeavor. So a brief walk down the memory lane may be in order at this point. So I guess the story, if you want to call it that, started in 1984, as I had started my residency, and I experienced my first encounter with a postoperative patient who appeared very weak, was described to me by my attending Professor [ Jen Errenworth ] as a so-called floppy fish. The complication really piqued my curiosity and started my research and the search for answers. So in 1988, as I was a senior resident, my first abstract presentation at the ASA Annual Meeting in San Francisco was entitled Problems of Recovery and Residual Neuromuscular Blockade Pancuronium versus Vecuronium. Many of you in the audience probably have never used Pancuronium. But this abstract was published in the Journal of Anesthesiology and really is the first -- my first foray into research into patient safety and neuromuscular monitoring. And over the next 20 years between '88 and 2008, I did many clinical studies with various EMG-based neuromuscular monitors. And I was actually involved with Biometer, the company that developed the TOF-Guard, which then later became the TOF-Watch AMG or acceleromyography monitor. In 2009, one of my engineer colleagues, Dr. David Hampton and I finished the first design of the monitor called the [ Reversograph ]. And over the next decade, we developed the [ BEACON ] and then the first-generation TetraGraph. And then in 2017, after partnering with Senzime, we finished the TetraGraph design, which continues to be used clinically today. And then in 2019, Senzime partnered with Fukuda Denshi of Japan and produced the integrated monitor that is being used clinically in Japan. In 2023, as we know, the ASA and the European guidelines were finally published, hopefully, to help with the adoption of quantitative monitoring in routine clinical care. Finally, and most importantly, in 2024, the next-generation TetraGraph was unveiled and was introduced at the ASA Annual Meeting in Philadelphia just about a week ago. So now let me bring in Linnea for some additional information about the latest next-gen TetraGraph monitor. Linnea, can you tell us more about why we saw a need to develop the next-generation TetraGraph?

Sure. Thank you, Sorin, and good morning, good afternoon, everyone. Yes. So over the years, we have consistently refined our products based on invaluable feedback from our customers. And for the last 12 months or so, we have been listening to clinicians all over the world, gaining insights from key opinion leaders. So they have really been instrumental in shaping the development of the next-generation TetraGraph monitor. And we have been iterating this user interface prototypes several times and making sure that we capture all this great feedback from our users. So thank you so much for that. I know some of you are listening in today. So in the end, it came down to a few key things that we really wanted to make sure that we include in this new monitor. So if we go to the next slide, we can take a look on that. So one of the areas where we received significant feedback was the need to simplify the use of quantitative monitoring in the OR. So when speaking to clinicians, we have understood that many users do not fully understand the train-of-four ratio, counts, PTC and how does that translate into what level of block their patients are at. So we decided to implement this guiding level of blockage in the user interface. It's basically aligned with the current guidelines, both in the U.S. and Europe, and it's translating the numbers and the bar graphs into something a bit more intuitive. And initial feedback has been great so far. We have heard that now medical students and someone who has very limited knowledge in TOF monitoring can easily just with a glance on the high-resolution nonreflective screen, understand basically where their patients are in the level of block. And of course, we have still -- we still include the bar graph, the EMG curve, together with the TOF numbers for those who are more experienced users. And if we go to the next slide, we can take a look at another challenge that we have heard from our customers. It's a stressful environment and the lack of time to integrate with a lot of different complex monitoring during a case is a fact today. So one of the feature of the Next-Gen monitor is the adaptive intelligence that we call it. It's like an umbrella of features, all with the same aim, and that is to support the end user and to minimize the interaction with the device. So the one button start that you can see here on the screen on the device in the background, it's basically the only time that you need to integrate with the device. The rest is automatically run by TetraGraph and the device is adapting to the changes that you will see in neuromuscular responses. So if we look a little bit more -- if we go to the next slide, we can look a little bit more into the adaptive intelligence features here. We know that placing the sensor correctly over -- on a nerve and on the correct position of the muscle on the hand, that's essential to get a successful and correct measurement during a case. So that's why we put a lot of effort developing like sensor placement optimization features giving feedback to the user on how well they have placed the sensor by providing this quantitative signal strength and also with supportive questions. So if you receive poor sensor placement, you have a chance to replace the sensor and restart the case. And one of the new interesting features where we saw an area of improvement when talking to customer was the fact that a lot of time, you need to start postparalytic. We know that's quite common during stressful induction phases of a case. And until now, our user has not really had a chance to have -- to know if they have placed the sensor correctly or not when starting postparalytic. So the Next-Gen monitor, it can actually provide an estimated signal strength for cases when starting postparalytic and give feedback to the user how well they have placed the sensor. Another feature, the adaptive PTC, basically means that you automatically enters deep block when the TetraGraph detects a TOF count at 0. And it's using a single simulation to check the response amplitude before entering PTC. So this feature allows you to measure deep block in a safe and efficient way. And also the adaptive time intervals is, of course, changing from every 15 seconds to every -- or every second minutes for post-tetanic stimulation. And if you don't use the full automatic adaptive PTC mode, the adapt time interval more kind of operates in the background. So it's prolonging the time intervals between reading if TOF count 0 remains for a long time. And as soon as the patient is starting to come back from deep block mode, the time interval between readings will decrease. So this all ensures that the clinician does not miss any recovering periods between readings basically. So Sorin, with your clinical experience, would you mind tell us a little bit more what do you see as the most important improvements with the next-gen monitor?

So reflecting on my own practice, I often think how beneficial a comprehensive device like this would have been when I was training and how much better it would have allowed me to care for my patients. So it's clear that the next-generation TetraGraph is the whole package. It's simply intelligent and offers an intuitive design, features a new level of block gauge, which simplifies neuromuscular monitoring, particularly for those clinicians who may not be very familiar with quantitative monitoring. It's designed for accuracy with its sixth-generation EMG technology and noise canceling features, which streamline the clinicians' workflow and allow them to concentrate on actual patient care. In terms of value beyond the product, Senzime offers best-in-class support for implementation and ongoing education to achieve meaningful adoption. And I know this to be true from personal experience. Clinicians who adopt the TetraGraph will get a future-proof device that can be upgraded to keep providing the most up-to-date care. Additionally, the TetraGraph is engineered to fit various workflows with multiple mounting options and integration pathways. The compact portable design makes it adaptable for different settings, including the tucked arm, the prone laparoscopic and robotic cases. So Michael, would you please transition us to our next topic?

Yes, absolutely. And well said, Linnea and Sorin, and thank you so much for giving us a good overview of exactly what is the next-generation TetraGraph and what it brings. So let's transition into translating this. What does this mean in terms of impact on patient care and, of course, patient safety. So with that, maybe I'll turn it over to you, Sorin, to kind of outline what clinical problem are we trying to solve for.

Yes. Thank you. Residual neuromuscular block, and we've heard about it almost ad nauseam, but it appears that we're still not doing so much about it. It's a serious postoperative complication that can lead to critical respiratory events such as pneumonia, atelectasis and need for reintubation. So these are not minor complications. But despite increased awareness of the problem, the incidence of residual block is reported to be high, still in the range of over 30% from studies that were done within the last 2 years. So this is pretty new information. And even when sugammadex is used, the incidence of residual paralysis is not 0 as many people think. It's around 10%. Now 10%, we wouldn't accept this level of significant complication for almost any other outcome. So I don't understand why we should accept residual neuromuscular block as a potential complication. So the length of stay in the postop -- PACU or postoperative care unit increases by upwards of 80 minutes in patients with a train-of-four ratio than 90%. And these data have been reported in several studies. Ensuring full neuromuscular recovery reduces the postoperative ICU admission threefold. And quantitative monitoring is actually money saving. We'll talk more about that, but the cost of reversal drugs is decreased by up to 70%, and by avoiding postoperative pulmonary complications, which are an obvious result of residual neuromuscular block, hospitals can save $35,000 for each case of pneumonia that is averted. So in short, the clinician's argument that neuromuscular monitoring is just too expensive is actually not based on reality. Neuromuscular monitoring not only improves care, but it is cheaper than not using neuromuscular block monitoring. So Linnea, will you show us some real-world examples of TetraGraph use?

Yes. Sure. Thank you, Sorin. Yes. So by using data from real cases and information from practicing anesthesiologist, we have built over the years a database of several thousand of cases. So this database has really worked now during the development of the next-gen to build the sixth-generation algorithm. And by analyzing the data, it's giving us the possibility to ensure that we really pick up the true EMG signals with the highest sensitivity. For this specific case that you can see here, we have an abdominal surgery on a 7-month pediatric patient. The surgeon wanted to keep the patient deeply blocked at post-tetanic counts less than 3. That was the information he gave. And as you can see here, the precise monitoring by the TetraGraph monitor allowed for timely redosing of muscle relaxants to keep the patient at that deep block and also ensuring a timing of when you give the reversal drug when the patient has had a reverse to TOF count of 1. So then basically, as you can see, you simply follow the measurements all the way back to a fully recovered patient here at TOF ratio of 93% before the patient was safely extubated. We can go to the next example, if we go to the next slide here, I just wanted to show you an example. This is also from our clinical database from a Swedish hospital. Here, we have a demonstration of spontaneous reversal. As you can see here in the graph in the middle, we precisely follow the patients all the way back to TOF ratio of 90%. And in this case, no need to use neither sugammadex or neostigmine was needed, basically since you can trust and easily follow the trend curve back to safe recovery. So we have stimulated how this would look like on the next-gen TetraGraph to the right. Here, you can easily review the full screen display and quickly get an overview of your case. You can zoom in and zoom out. And if you want to check a specific value at a specific time point, you can do so as well in the trend graph. You can easily also toggle between the screens on the monitor. To the left, here, you can again see the level of block gauge, confirming an acceptable recovery aligned with the current guidelines. And here, it's indicated in green in the gauge. So it's super easy to see from distance. This is throughout the case supported by the high and good signal strength. You can see the icon displayed up to the left here, basically ensuring that you can trust the data, you can trust that you have a correct value and that you have no overestimation of recovery throughout the case. So Sorin, when you now see some real data, maybe it could be interesting if you can comment on 2 new exciting studies that I know has just been published.

Thank you, Linnea, for the great explanations. As you mentioned, I will discuss a recent interesting and I think, very clinically relevant study that compared acceleromyography or AMG and EMG devices to a reference technology, mechanomyography or MMG, a monitor that, unfortunately, I think most clinicians, especially younger clinicians are not familiar with because it's not clinically available. So the study was published in the Journal of Anesthesiology just a couple of months ago. And it reported that the TetraGraph achieved similar accuracy to the reference MMG and had an even better. And by that, I mean a narrower range of responses than the standard MMG. In other words, it was more repeatable in its results than the MMG. All EMG monitors investigators -- investigated produced results similar to the reference standard, the mechanomyograph, reinforcing their reliability for monitoring with EMG throughout the perioperative period. And in another study, which was published literally 2 days ago, the investigators validated the TetraGraph against another mechanomyograph classically considered the so-called reference standard. The investigators found that the mean difference between the results obtained with the 2 monitors was actually very small. And this difference is also called bias. And the TetraGraph, importantly, was validated against the mechanomyograph at all levels of block, which includes minimal block, moderate block and deep block. And the authors actually finished their report stating that "The accuracy of quantitative EMG technology of the TetraGraph EMG system lends strong support for this monitor, along with other similarly validated EMG monitors to become a clinical standard for all phases of neuromuscular block in clinical practice." So Michael, I think you're back on. Please transition us to the final topic.