Good morning and welcome to the TriSalus Life Sciences KOL event. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations. If you'd like to submit a question, you might do so by using the Q&A text box at the bottom of the webcast player. As a reminder, this call is being recorded, and a replay will be made available on the TriSalus website following the conclusion of the event. I'd now like to turn the call over to Mary Szela, Chief Executive Officer and President of TriSalus Life Sciences. Please go ahead, Mary.
Welcome, everyone, and thank you so much for joining. This is the first, or our inaugural, webinar in a series of webinars that help illustrate the value of our technology. I'm very excited to report that we have two distinguished physician guests, Dr. Nicole Lamparello and Dr. Francis Kang, who are going to take us through the discussion on uterine fibroid embolization, a very important alternative for patients who suffer from uterine fibroids, and this is a very preferable alternative to surgery. Before we begin, I'd like to give just a quick overview of TriSalus to set the stage and provide some background before they get into their presentations. TriSalus is a mission-driven company. We're focused on improving drug delivery to pancreatic, liver, and solid tumors. We're also developing a drug called nelitolimod, an immunotherapeutic that can help reverse immunosuppression in tumor.
All of these are aiming to improve patient outcomes who suffer from very serious cancers, and we believe a local regional approach can improve patient outcomes in a very significant way. Our platform contains a technology that actually modulates pressure and flow, and this is very important in terms of delivering more therapeutic to the tumor and less to the normal tissue to improve outcomes for patients. We have a unique procedural code that allows physicians and hospitals to get reimbursed for this and make it widely available to patients. This is a very significant market. There really hasn't been innovation in drug delivery in decades, and this technology, pressure-enabled drug delivery that modulates pressure and flow and delivers more therapeutic to tumors, is a significant advancement in improving outcomes for patients. Let me just give you a little overview of what the problem is.
What you're looking here at the left is a tissue sample, and you're looking at an environment in the solid tumor. What you see is a collapsed vessel. What happens in these solid tumors is the cancer cells are replicating very rapidly. The vessels that support the cancer are also growing very rapidly, and they're very immature and often don't have the vasculature, and contents leak out into the surrounding area. The lymphatic system isn't really working properly, so that fluid sits in the tumor as cells are replicating. This creates a very high-pressure environment. We've actually measured the pressure in the tumor, and the pressure in the tumor is often much higher than what your heart can pump at. The ability to actually deliver therapeutics in these tumors is hampered significantly.
In fact, there's data that demonstrates that less than 1% of systemically administered drugs can get into the tumor. That's why local regional approaches are so critical for these patients. Our platform contains a range of different technologies. These are 510(k) cleared. In the core of our technologies, what you see is that umbrella-like structure that we call the SmartV alve. When it's placed in the vessel, it actually changes the vessel, is sensitized to the presence of that Smart Valve, and it can actually change the pressure and flow around it. It vasoconstricts in the blood flow, vasoconstricts in the normal tissue, pushing more blood flow into the vessel. Through the SmartV alve, when it's administered, it can open up those collapsed vessels, and you can get substantially better perfusion and more equally distributed perfusion into the tumor.
This is a range of tools that we've developed in combination with physicians, many of the ones that are on the call today, and we've customized it to the various anatomies that they encounter. Here you can see that we have a range of either larger size, more flexible. The anatomy that you're going to see in some of the images today is so tortuous. These are tools that were designed to actually help them get to the location that they need to actually deliver the therapeutic. I'm very excited to talk today about the launch of our TriNav XP. This was actually developed in conjunction with these two distinguished physicians. We changed the inner diameter of our technology to allow for much faster flow and larger beads to actually move into the tumor.
It also has a flexible distal tip that allows them to navigate that much more easily and get around the tortuous anatomy. They will show you some examples of how this technology can help facilitate the drug delivery. Before I turn it over to the physicians, I just wanted to mention that our core focus is in the liver, but this technology can be used across many other types of solid tumors. Getting more drug into these tumors, we believe, improves patient outcomes. We know more drug into the tumor is better for patients, less drug into the surrounding normal tissue avoids complications, and we believe this is a significant innovation for the future. Now I am going to hand it over to Dr. Marshall, who is going to introduce our two distinguished physician guests.
Thank you, Mary, and thank you to everyone who's joining us today. We're excited to have you with us as we take a closer look at the landscape of uterine fibroids and how TriSalus is focusing on helping us improve treatment delivery with the TriNav Infusion System. This leverages our proprietary Pressure-Enabled Drug Delivery approach to impact therapeutic delivery and help protect healthy tissue. To bring a clinical perspective to today's discussion, we're honored to be joined by two highly respected interventional radiologists who have extensive experience treating patients with uterine fibroids and can speak to current approaches and clinical needs. First, Dr. Nicole Lamparello is an associate professor of radiology at Weill Cornell Medicine, and she's an attending radiologist at New York Presbyterian Hospital. Dr.
Lamparello is co-director for the Skills Acquisition and Innovation Laboratory and serves as Chair of Quality Improvement for the Fibroid and Adenomyosis Center at Weill Cornell Medicine. She's also the Program Director for both the integrated and integrated interventional radiology and independent interventional radiology residency programs at Weill Cornell, and she's deeply involved in advancing care for women with fibroids and leads several initiatives focused on quality improvement and training the next generation of interventional radiologists. We're also joined by Dr. Francis Kang, a partner radiologist at the University Radiology Group and Clinical Chief of Interventional Radiology at Rutgers Robert Wood Johnson University Hospital. Dr. Kang is also a faculty advisor, Program Director of integrated and independent IR residency programs at Rutgers Robert Wood Johnson Medical School. Dr. Kang's journey is characterized by a commitment to excellence in patient care, education, and research.
Doctors Lamparello and Kang will share their insights into uterine fibroid treatment, procedural overview, and discuss how TriNav may be beneficial in uterine artery embolization and share real-world case examples and data. Please join me in welcoming Dr. Lamparello and Dr. Kang.
Thank you, Richard. Hi, everyone. My name is Nicole Lamparello. Thank you for having me. Good morning. I'm going to be talking about the disease state of uterine fibroids and adenomyosis, and then I'll also go into a procedural overview of uterine artery embolization. My only disclosure is my consultant relationship with TriSalus. Let's just start with what is interventional radiology. The history of interventional radiology can be traced back to Dr. Charles Dotter, this guy right here. The story goes that Dr. Dotter saw a patient with critical limb ischemia and was given a script by the referrer to image, but do not treat. He did a diagnostic angiogram, which demonstrated a focal stenosis or area of narrowing in this artery in the leg, and he made the decision to inflate a balloon, which increased the diameter size of the vessel and improved the patient's symptoms.
This was the first described angioplasty in the literature. The field has really expanded and evolved over time. We now perform minimally invasive procedures throughout the body using image guidance, CT, ultrasound, fluoroscopy. These procedures are diagnostic, but also therapeutic. In 2012, IR became a primary specialty in medicine and now has its own residency program. Since its inception, year over year, it has become one of the most competitive specialties for medical students applying for residency. We perform innovative procedures with very rapidly evolving technology, as we're going to describe today. IR uses the blood vessel network in the body as almost like a subway map. We can get on and off at different stops to access different parts of the body and treat disease. IR is the intersection of many different disciplines in medicine.
For the purposes of the presentation today, we're going to focus on gynecology. Uterine artery embolization is the procedure that IRs perform to treat patients with uterine fibroids or adenomyosis. Fibroids are common benign tumors in the uterus. They have a multitude of different symptoms depending on their size and location. Women experience heavy menstrual bleeding, severe cramps, urinary urgency and frequency, and bulk symptoms, which are related to the size of the fibroids putting pressure in the abdomen. Women can also experience infertility. About 20%-40% of women who are over 35 have fibroids of significant size that exert symptoms. In the African-American population, this number closes to 50% of women. This table or graph on the right just shows that there are many different treatment options for fibroids.
Most of them are surgical, so hysterectomy, removal of the entire uterus, or myomectomy, removal of the fibroids themselves. Most women are receiving these surgical treatments. In dark blue is uterine artery embolization, showing you that only a small amount of women are getting this procedure. Adenomyosis is another condition that uterine artery embolization is used to treat. This is when the endometrial tissue, which is the inner lining of the uterus, grows into the muscular wall of the uterus. On MRI, this is described as thickening of the junctional zone. Women with adenomyosis experience a lot of symptoms that are similar to fibroids. They have heavy bleeding, pain, and bulk symptoms. Treatment involves conservative treatment, managing the bleeding. Women can be put on oral contraceptive medicine. We control their pain. We can transfuse them if they have heavy bleeding.
Otherwise, the only other surgical treatment is hysterectomy, removing the entire uterus. In the last decade, we've learned that uterine artery embolization is an amazing tool to treat these women through a minimally invasive technique. This procedure involves accessing a blood vessel and working our way into the uterine arteries on the right and the left to deliver medicine that blocks the blood vessels to the fibroids and leads to tissue death and infarction. This is an alternative to traditional surgical methods. Risks of uterine artery embolization include bleeding at the site of catheterization, pain or what we call post-embolization syndrome, which can last one to three days after the procedure, infection, less than 1%, fibroid expulsion in very rare cases, and potential for premature ovarian failure or premature menopause in women over a certain age of 45. Benefits are that it has tremendous symptomatic relief for patients.
This is an outpatient procedure, so they go home the same day. Quick recovery compared to surgery. They get to retain their uterus and more cost-effective than surgical alternatives. Overall, there is a lack of awareness from patients and even providers or referrers about uterine artery embolization. Many surveys have been distributed to look at this, and a most recent one that was published by the Society of Interventional Radiology called the Fibroid Fix showed that almost 49% or 50% of women have never even heard of uterine fibroid embolization, and one in six women thought that hysterectomy was the only treatment option for them. There are also financial barriers. In addition, the referral pathway from gynecologist to IR is not really well established in many practices and in many communities. A real multidisciplinary approach is needed.
We find that younger OB-GYNs who experience residency later maybe are more likely to refer for uterine artery embolization. Also, some hospitals mandate that if a patient is undergoing hysterectomy, they need to have a consultation visit with an interventional radiologist to hear about minimally invasive treatment options and that this is the only way for true informed consent. What's the data? The data is great. There have been many randomized controlled trials, so level one medical evidence showing that uterine artery embolization is as effective as surgical alternatives for the treatment of uterine fibroids. These are the REST trial and the EMMY trial. They looked at symptomatic relief and quality of life outcomes, and then also in long term, five and ten years after the procedure, and showed equivalent results to hysterectomy and myomectomy with a shorter length of hospital stay and lower major complications.
However, there was a slightly higher re-intervention rate, and in women with uterine artery embolization, about a quarter of them sought another treatment for fibroids in their lifetime. For myomectomy, this percentage is about 20%. A little bit about the actual technique for the procedure. The primary blood supply to the fibroids is uterine arteries. We can access the uterine arteries with a catheter and inject medicine that is made up of tiny particles, which are almost the size of grains of salt, to block up the fibroid arteries. The goal is to deliver this embolic, this medicine, to the fibroids, but not to the normal healthy myometrium or the muscle of the uterus. We select a particle size that is tightly calibrated, 500 microns-700 microns in size.
The thought is, or the reality is that these particles are enough to go into the hypertrophied or larger uterine arteries, but not small enough to travel distally to the arteries that supply the muscle of the uterus. Larger particles do not reach the smaller vessels, and that is how we selectively are able to treat the fibroids while preserving the uterus. Post-procedure, in the short term, we are really focused on pain control. When we block the supply to the fibroids and adenomyosis and cause infarction to these tumors, that leads to inflammation and pain, also nausea. We make sure our access site has good hemostasis. Most patients are discharged on the same day. A small percentage can stay overnight for pain control. Long term, we follow all of our patients. We see them in clinic to make sure they are recovering well.
We often get repeat imaging a few months later to see the before and after and confirm that all fibroids are treated. I'm going to now just show a couple of my cases that I've used the TriNav catheter for in the last year. This patient was 50 years old, and she had menorrhagia, so heavy bleeding and bulk symptoms and urinary urgency. This is before I did the uterine artery embolization procedure. On the left is a coronal image of the patient. The uterus is, you can see my mouse, I think. The uterus is here in the middle. You can see these hypo-intense fibroids, these dark round circles. She has many of them in the muscle of her uterus.
On the right is a sort of a side view where we see her spine, the bladder, which is really compressed by this enhancing structure and enlarged uterus filled with multiple enhancing fibroids. After the procedure, or this is the pictures of the procedure, we have a catheter into the uterine artery. Then through that, we have a microcatheter, which is the TriNav catheter. It's a little hard to see. I'm going to go back one more. You can see two radiopaque markers, and that is the front and back part of the TriNav catheter. We're deep in the uterine artery, and we see an angiogram with enhancement of the fibroids. I'm sorry, I'm getting these. The picture on the left is also an access through the left uterine artery. I'm showing here, sorry, my video, okay, the left video is playing now.
That's the left uterine artery showing a hypertrophied and tortuous vessel. In the middle is after we embolize through the TriNav catheter showing complete stasis of blood flow. This is after we saw the patient, about eight months later. She reported complete improvement of her heavy bleeding. We see 100% infarction of the fibroids and a 57% total reduction in uterine volume. This is another companion case of a 38-year-old woman who also had heavy bleeding and anemia, and she needed blood transfusions. The images on the left are after the procedure. The images on the right are before. You can see that the uterus is much smaller, 50% decreased in size, and there is 100% fibroid infarction. She reported now afterwards that her periods were "normal" and that her life was changed. I also wanted to show a few cases of patients who have pure adenomyosis.
This patient has adenomyosis, which on this MRI is defined by these bright cystic spaces that are expanding the junctional zone of her uterus. Here are pictures during the procedure using the TriNav catheter. You can see that her uterine arteries are extremely tortuous and hypertrophied, and the TriNav catheter was able to track through all of these tortuous vessels to get deep into the uterine artery to inject the medicine. Afterwards, I had before and after, before on the left, after on the right, where you can see that the uterus is significantly decreased in size. It was about 64% decreased in size with 100% necrosis of the fibroid, which on the bottom right image you can see is this non-enhancing dark circle. Here is another case of a 42-year-old woman who had menorrhagia, pelvic pain, and bulk symptoms.
We also see before and after where the uterus has tremendously decreased in size. Now it is not pushing on the bladder as much. On the post-contrast images, the whole area of adenomyosis tissue is completely infarcted. She had a great improvement of her symptoms as well. I am now going to turn it over to Dr. Kang.
Hello everyone. Good morning. My name is Francis Kang. Thank you for having me today. You have learned about, I am sure I learned a lot about uterine artery embolization from Dr. Lamparello with her extensive description of the procedure and her background and her cases. I am going to share some clinical evidence behind the uterine artery embolization. These are my disclosures. All right. We are going to talk about the clinical evidence behind the TriNav in U.A.E.
This was our institutional retrospective single-center analysis on 23 patients who underwent U.A.E. for symptomatic uterine fibroids using TriNav catheter. The procedure exhibited an outstanding safety and success profile with 100% technical and clinical success defined by improvement in menorrhagia and/or dysmenorrhea. Crucially, zero complications were directly attributable to the catheter itself. For the clinical efficiency, we assessed the clinical success using a visual analog scale, VAS score from 0 to 10. The mean heavy menstrual bleeding VAS score decreased from 6.6 pre-procedure, which is shown by this light blue column here, and 2.1 at the six-month period. For the pain score at six months, this was clinically significant. We also looked at the mean pain VAS score for dysmenorrhea, which decreased from 5.4 pre-procedure to 1.5 at six-month period, which was also clinically significant.
We also looked at composite VAS score combining both symptoms, and it's not shown here, but it decreased from 7.5 pre-procedure to 2.8 at six-month period, which was, again, also clinically significant. More importantly, we also looked at the fibroid volume reduction to see how clinically effective the catheter was compared to what's written in the literature. The device achieved dominant fibroid volume reduction ranging from 69%- 89%. This compared favorably to previously published reductions, which was ranging from about 42%- 58%. This is the mean reduction in dominant fibroid volume. Our patients had fibroid volumes ranging from 46 mL to 25,000 mL. We also looked at the procedural efficiency as this procedure has been around for a long time. We wanted to look at how efficient these procedures could be using the TriNav catheter.
The mean fluoroscopy time was 19.5 minutes with TriNav catheter versus 20.1 minutes-21.9 minutes. That is what is reported in the literature. Interestingly, we had the experience using TriNav XP catheter, the newer one, and we were able to achieve just 13.9 minutes using this catheter, meaning it is very efficient using this XP catheter. The mean embolic vials we used were 2.1 vials per treated artery. The mean embolization time, especially spent embolizing each artery, was 7.5 minutes on the left side and 6.1 minutes on the right side. In conclusion, the combined advantages of accelerated procedural times, superior fibroid shrinkage, and catheter-related safety record position the TriNav microcatheter as a potentially transformative tool in U.A.E, optimizing both procedural workflow for interventional radiologists and therapeutic outcomes for patients.
I'm going to go over some case examples, one using the TriNav catheter and then one using the TriNav XP catheter. The first case was done with the TriNav catheter. This was a 44-year-old female with a recent history of uterine fibroids and associated menorrhagia and dysmenorrhea as well as anemia requiring transfusion. This was a pre-procedural MRI that was performed looking at the sagittal images, looking at the patient's uterus from the side. You can see the multiple fibroids there that are exhibited by on the T2 image with the dark circles here on the right side of the images. Those are all enhancing on the left side of the image here. This was an angiogram performed from the left uterine artery using the TriNav catheter. You can see the hypertrophied uterine arteries with the enhancement of the fibroids that are really big.
This was the post-embolization angiogram after we finished embolizing the left uterine artery. We used a total of one vial of 300 micron-500 micron Embospheres and then one vial of 500 micron-700 micron Embospheres. You can see that there is no residual enhancement of the fibroids here. This was a right-sided uterine artery angiogram looking at the right side. The images looking at the patient on the table are flipped, so this is the right side for those of you who are not familiar. This was after we finished the embolization looking at the devascularized fibroids. We used a 300 micron-500 micron Embosphere and one vial of 500 micron-700 micron Embospheres to complete stasis. This was a six-month follow-up MRI.
You can see that the uterus size is almost normalized, and then the fibroids have shrunken down to almost nothing here. This is just for the direct comparison to look at how much shrinkage we had in associating with the fibroids that were there before. You can see that the uterus is almost back to normal size. We had over 80% in fibroid reduction in this case. After six-month follow-up, the patient continues to have normal regular menstrual cycles without menorrhagia, and the bulk symptoms were gone at that time. The second case I am going to share is going to be the one that was actually performed with the TriNav XP. This was just recently performed. This was a 44-year-old female with a recent history of uterine fibroids and associated dysmenorrhea. You can see that it is a very big uterus.
Literally, it spans its 25 cm. It goes above the belly button. It's how big they were. These had two dominant fibroids, each measuring about 15 cm. This was the abdominal aortogram that we performed. We wanted to make sure there was no supply from the ovarian artery supplying the fibroids given how big these fibroids were. There was hypertrophy of the left ovarian artery, but it was not supplying the fibroids. We performed the hypogastric nerve block given that we expected that she would have a lot of pain after the procedure. This was the left common iliac artery angiogram looking at the blood vessels supplying the uterine artery. You can see that the tortuous blood vessel on the very far right of the screen of the imaging, that's the big tortuous uterine artery.
This was a little more selective left uterine artery angiogram using the actual guide catheter. You can see that this left uterine artery was supplying the dominant fibroid that was on the top of the uterus. This was the left uterine artery angiogram performed using the TriNav XP catheter. Again, this injects really well, like I'm injecting with the actual guide catheter, which is actually bigger. You can see the enhancement of the fibroids is actually a little more than the actual enhancement of the fibroids using just the guide catheter. We performed the left uterine artery embolization. That is the start of the left uterine artery embolization. The right side, the second image, is at the end. It took only about 10 minutes to embolize the left side uterine artery. We used 4.5 vials of 500 micron-700 micron Embospheres.
Obviously, this took a lot more embospheres, but it only took 10 minutes to embolize using 4.5 vials, meaning we spent about two minutes per vial, which is very efficient. This is the post-embolization angiogram for the left uterine artery. You see the stasis there, which was successful. We turned to the right side. This is just a right common iliac artery angiogram looking at the vessels supplying the uterine artery. As you see that, there is a tortuous artery there supplying the uterine artery. This more selective right internal iliac artery angiogram shows that there is a big vessel supplying that big fibroid in the center of the pelvis. This is the distal right uterine artery angiogram using the TriNav catheter.
Again, you can see that this right uterine artery was supplying the fibroid that was in the bottom of the uterus here. These are the images of the videos of the right uterine artery embolization, initial injection, and at the end, the final image. This one, we took about seven minutes to do the embolization on the right side. Again, we still used 4.5 vials of 500 E mbospheres - 700 Embospheres, but only took about seven minutes to do so. This was the right uterine artery post-embolization angiogram showing that we had a good stasis with no residual fibroid enhancement seen. That is the end of the case. All right. The safety information indication for use is that it is intended for use in angiographic procedures. It delivers radiopacque media and therapeutic agents to selected sites in the peripheral vascular system.
Contraindication is that it's not intended for use in the central nervous system, including the neurovasculature or central circulatory system, including coronary vasculature. Obviously, for the safe and proper use of the TriNav Infusion System, refer to its instruction for use.
Team, thank you so much. To Dr. Kang and Dr. Lamparello, thank you so much for the incredible conversation. We will now open it up for Q&A.
Thank you to our speakers. At this time, we'll be conducting a question-and-answer session. As a reminder to the webcast audience, if you'd like to submit a question, please use the Q&A text box at the bottom of the webcast player. To our covering analysts who are joining us live, please raise your hand to indicate you have a question. Please hold for a brief moment while we pull for questions. Our first question comes from Frank Takkinen at Lake Street Capital. Please go ahead, Frank.
Great. Thank you for taking the questions, and thanks for a great presentation. Very helpful. Thank you for your time. Wanted to maybe start with just thought process around when to use a conventional catheter versus the TriNav and why on the back of that. And then maybe as a second part to that and an extension of it, Dr. Kang, it would be interesting to hear when TriNav XP makes more sense than TriNav traditional.
Thank you so much for the question, Frank. Dr. Kang, would you like to go ahead and kick us off?
Yes. Obviously, when we use the PEDD catheters, I prefer it because I can use it to embolize uterine arteries much quicker than an end-hole catheter. When we're using the end-hole catheter, like other brands, it's just that you have to put in an embolic material. You have to wait until it washes out before you can use more embolic materials. There is a significant increase in time for embolization when we use those. The other issue is that you're going to keep injecting, wait for it to wash out, inject again, wait for it to wash out. You may actually end up over-embolizing a lot of times, which can cause myometrial necrosis. Obviously, it's going to take more time, so your procedural efficiency goes down.
A lot of times, I just prefer to use the TriNav catheters because it does have the anti-reflux capability. When we're embolizing, I'm not really stopping to watch it wash out. I'm constantly embolizing until I see the endpoint of complete stasis. My procedural efficiency goes up significantly, as I had mentioned in the clinical evidence. However, when a vessel may be too small, like in case sometimes some of the small adenomyosis cases can have small uterine arteries, in those cases where I need a smaller microcatheter than the 2.4 French TriNav catheter, then I may switch to a traditional end-hole catheter in those cases. Did that answer the question?
Yes. Thank you, Dr. Kang. Would you like to comment on the use of TriNav XP versus the original TriNav in U.A.E?
Yes. The TriNav XP, I prefer a lot more because we did have clogging issues using 500 micron-700 micron Embospheres when we were using the TriNav, standard 2.4 French microcatheter. With improvement in techniques, the clogging issue was somewhat resolved. When we were using the XP, it just said you get a much more angiographically satisfying picture. Also, you can embolize much quicker with that. There were zero clogging issues at all. For UAE, I think I prefer XP over TriNav a lot of times.
Thank you, Dr. Kang. Dr. Lamparello, would you share your experience as well?
Sure. I can weigh in because I used the XP catheter for two patients yesterday. I agree with Dr. Kang. Any clogging issue was completely resolved, and I was able to embolize all vessels extraordinarily fast, and I got great pictures. It tracked deep into the uterine arteries very well.
Thank you very much. Frank, if that answers your question, we'll take the next question.
Perfect.
Thank you for your questions, Frank. Our next question comes from Justin Walsh at Jones Trading. Please go ahead, Justin.
Hi. Thanks for taking the question. Dr. Lamparello mentioned that these embolization procedures are less common than perhaps the clinical data suggests they should be. I'm wondering what the KOLs think could help change this paradigm and maybe improve collaboration between interventional radiologists and the broader physician community treating these women.
Thank you so much for your question. Dr. Lamparello, would you like to kick us off?
Yeah. I think it's a very complex topic and something that we've been investigating in our society for a long period of time. At my institution, a multidisciplinary fibroid practice is really crucial. We spoke to our OB-GYNs in the hospital, and they agreed that patients should have informed consent. When we really educated them on the data, they were on board. I think there's a lot of misconceptions among gynecologists on when we can do U.A.E. and on what patients. When they learn that really we can do it on almost every single patient with fibroids in a safe way and that it's not contraindicated in someone who wants future fertility, et cetera, when they really learn about it, it helps. We're also investigating at my hospital, educating residents, so trainees in the gynecology side early so that we can also dispel myths when they're in training.
I think it's just education of the refers and then also just getting straight to the patients, letting patients know about it. Because a lot of women come to us who've done their own research and learned about it. And more and more people want a minimally invasive procedure. If you can get the same results and not have a big incision, have a shorter hospitalization stay, less pain, it's a no-brainer.
Dr. Kang, would you like to add anything?
Yeah. We work with multiple hospital systems and at smaller hospitals, including smaller hospitals and bigger hospitals. I think we continuously work with the patients and also the multiple referring physicians. Because a lot of times, as Dr. Lamparello mentioned, in the community, there is not that much awareness in the small community where patients and referring providers, they are used to a more traditional way of treating these fibroids, either using the hysterectomy or sometimes myomectomy. We have been doing increasing efforts to increase awareness in the community through the referrals, and directly to the patients, and also through their primary care physicians as well, and increasing the awareness. I think we have been doing more of this throughout the years, throughout our society in IR.
Thank you, Dr. Kang. Mary, would you like to add anything?
Yeah. One of the things that we'd like to do as a company, and I think now that we have a tool that really meets physicians' needs, one of the things that we'll do is we feel it's our responsibility to also educate patients. We know that women first go to the internet. They actually search about options. If we can offer them education, when they come to their physicians, they can ask physicians about it. We also believe that with that type of patient education, it just empowers the patient to really search for a solution that's going to work for them. Often, if they don't have any knowledge of it, they'll just go to their OB-GYN.
If we can educate them beforehand and they discuss it, the physician's going to want to get them to the physician that they can talk to and they can make the right decision. We also see that some patients will go directly to an interventional radiologist when they read about it. We will do our own social media education. We can hyper-target that around hospitals that use TriNav so we can help with the referral patterns. The other area that we will play a big role in is this is a big difference in terms of cost and work-benefit issues with payers. We have been educating payers that this is an alternative. One other option is many of these procedures require prior authorization. Payers can also help and ask patients to get a consultation with an interventional radiologist.
That's another mechanism of how we'll be able to educate it. Not all situations are going to be appropriate for this patient, but we want to make sure that patients are educated and they can make the right decisions for them. The surgical procedure, this is a long, we just had an employee who went through it. It was a long process for her to feel better. Frankly, with embolization, this is a cost-saving, easy procedure, reduces symptoms, and can potentially preserve their fertility. This is just a better option for a lot of patients.
Thank you.
Mary, I'd like to add that one of the other major things that we see as a big gap for this procedure is data, recent data. This procedure has been the same for the last 25 years. What we're doing at TriSalus with TriNav, we're doing pressure-enabled delivery. It's a different technique. It's a game-changing technique for embolization. Dr. Kang's data is highlighting that. We are publishing the science and pursuing that for not only providers, but women are seeking these types of studies out on the internet. They are educating themselves prior to undergoing surgeries and uterine fibroid embolizations. To see the results of something like this scientifically will help influence how people make decisions.
Thank you, Dr. Marshall. Thank you for the question.
Thank you for your questions, Justin. Our next question, actually, I'll now turn it over to Andrea Marasso, Vice President of Marketing, to read any written questions we have received from analysts or webcast participants.
Thank you so much. We have received several written questions, and I'll begin with the first one. What percentage of embolization cases do you use TriNav versus a microcatheter, and how do you make that determination? We did discuss this a little bit. Dr. Kang or Dr. Lamparello, is there anything you'd like to add here?
Hi. I can answer that question. Whenever I'm using an embolization case where I'm using particles, we've had extensive experience in using TriNav catheters in liver-directed therapies. I use it for my Y90s, TACE cases. I also use it for AML embolization in kidneys. I also use it, obviously, for uterine artery embolizations. Anytime when I'm using particles and the vessel size is big enough to accommodate a TriNav catheter, I use it all the time compared to the end-hole catheters. I prefer to use it because it provides the anti-reflux capability, and it gives you also pressure-enabled delivery. I try to use it as many times as it allows for me to do it safely.
Thank you, Dr. Kang. If I could add on to that question, what was the process of getting the TriNav available for use in your institution given the price?
Okay. Yeah, so for us, I knew about the device during my training. When it became available to be tried, we had a discussion with the rep, and we brought it into our institution through a VEC committee. We discussed the value analysis committee process that each product goes through. We had a discussion, and then it got approved. Then it goes through the contractual agreement, and then it becomes available in our hospital system.
Thank you so much. Mary?
Yeah. One of the things I'd like to comment on is, as a company, one of the things that was really important for us with our technology, we know just healthcare costs are so high. We wanted to make sure that if this technology could be used, the people who pay for it, payers and CMS, we wanted to make sure they had the clinical evidence on our technology of how this technology, when it's used, can actually be cost savings. That was one of the reasons why we were able to get our own unique embolization procedural code. We presented data to CMS that demonstrated that when a technology, a TriNav technology, is used, it's actually cost savings to the system. That is what really gave us that embolization code so rapidly.
In fact, we had gone back to them about six months later to get a simulation code, and they responded very rapidly. They did their own research in terms of using this type of catheter prevented off-target complications, which was significantly more expensive than the cost of this catheter. They were convinced. This is also data that we presented across the board to payers. While the price is higher to use this technology, the overall treatment cost of those patients are substantially lower. What Dr. Kang and Dr. Lamparello talked about is you get better delivery to the therapy to the tumor and less to the off-target or normal tissues. Those complications can be very, very costly. That is where it is cost saving for the procedure for this patient.
Thank you, Mary.
I can add I had a similar process where I practiced. I brought the clinical data to our value analysis committee along with the CPT codes. The committee reviewed the CPT codes, cost of the catheter, and saw the scientific evidence behind it. It was a straightforward approval. TriSalus has been supportive of that through lots of institutions providing that information.
Thank you, Dr. Marshall. Next question. How do you best decide between embolization and surgery? What do you believe the patient split is, and where do you expect that to go over the next 12 months? Let's start with the beginning part of that question. Dr. Lamparello, would you like to kick us off? How do you best decide between embolization and surgery, or how does that happen in your institution?
Sure. At my institution, as I mentioned earlier, we have a multidisciplinary fibroid clinic. Nearly every woman with fibroids sees both minimally invasive gynecologic surgery and IR. We usually just present the information and leave it up to the patient because often patients can go either way. You can do uterine artery embolization on almost any woman who has fibroids as long as the fibroids are really enhancing on the MRI. I think the patients that we would not really take for fibroid embolization or we would counsel them beforehand are women who have fibroids that are extraordinarily large where even if we shrink the fibroids by 50%, that would mean that their uterus is still up to the level of the umbilicus.
In someone who has, we call it a uterus that might be over five months gestation size, they might not be as ideal of a candidate. Nearly everyone else can get fibroid embolization.
Dr. Kang, would you like to add?
No, I absolutely agree. Sometimes we use a combination of embolization and surgery. We do an embolization beforehand, and then the patient can get a safe hysterectomy as well in certain cases. Just like Dr. Lamparello said, most of the women can get uterine artery embolizations because it also doesn't preclude them getting the surgery as well. It also gives them an option, a minimally invasive option to undergo uterine artery embolizations to see how their symptoms are afterwards. Sometimes they won't need a surgery when we expect that they needed a surgery, things like that.
I'll also add that in some women who come to the hospital and are acutely sick, acutely anemic from fibroids, they might need a more urgent procedure. Sometimes counts make it that they're not safe for surgery. We can also intervene when surgery is not possible on these patients, and we need quick control of blood loss from fibroids. It works really well for that.
Dr. Marshall, anything to add?
Yes. In my clinic, I see a lot of patients who are not candidates for surgery for various other reasons, whether it's diabetes, obesity, some sort of medical history that makes them a higher risk surgical candidate. For these patients, we typically perform these procedures under moderate sedation. We give them a little bit of IV medication to relax them, and then we can do the procedure. It is a much safer approach for those patients. That is a population that I'm focused on.
Great. Just curious if we could go back around, Dr. Lamparello, what do you estimate the split is between hysterectomy versus embolization? If you're able to estimate, and if you're not, that's okay.
In my hospital, when we see women, I would say that almost 70% of the patients I see for first-time fibroid consultations end up booking their procedure with me, maybe almost 80%. I think when they—we know from the data that I presented from the fibroid fix that many women have never heard of uterine artery embolization. When they do hear about it, it seems like they are more likely to pick a minimally invasive procedure.
Dr. Kang?
For me, it's a little hard to predict because we get the referrals from the OB-GYN in our community. So it's hard to say what % they're getting the surgery versus the fibroid embolization. Usually, a lot of the patients that are referred to us are given options of uterine artery embolization and surgery. Most of the women actually choose uterine artery embolization as long as there's good indication and it has a good indication.
Thank you, Dr. Kang. Dr. Marshall?
It's hard for me to capture because I don't see all the hysterectomies that are performed. There is some data out there on that. The numbers for uterine fibroid embolization can certainly have room to grow. What I see as trends are for, in my institution, patients that are medically complicated. As Dr. Lamparello and Dr. Kang mentioned, patients who have really large fibroids in which they undergo a complicated surgery with fibroids are very vascular. The risks of bleeding are very high. As we move overall as a medical field from open surgeries, laparotomies, to robotically assisted surgeries, I have started performing a lot more uterine artery embolizations in a preoperative setting, especially for fertility-sparing patients who have huge fibroids that want them taken out. I still do have—my patient population is lots of women who come to me already knowing about this.
They're very well educated, and they have heard about fibroid embolization through the internet. That makes it a very easy consultation for me because they've already basically heard everything about it.
Thank you, Dr. Marshall.
We have another question from Frank Takkinen at Lake Street Capital. Please go ahead, Frank.
Great. Thank you. Maybe just the concept around expanding the patient pool. Has this expanded the amount of patients that you can treat with embolization? Is that maybe towards the more minor group that you're a little bit more confident with? Is it maybe towards the more advanced stage of disease that you feel like you can get a better outcome with? Maybe as a second part, broader speaking, what do you think your peers in the industry need to hear or see to adopt this more aggressively?
Dr. Marshall, would you mind kicking us off?
Sure. This is a great question. As far as expanding the patient population that we can treat, I think the standard therapy and TriNav patient population are very similar. Where I think the growth is going to occur is that we're seeing better results. Dr. Kang's uterine fibroid embolization volume reductions are outstanding from his case series. We're seeing that not only we're taking a procedure that's minimally invasive, but we're making it better. I think that is how we address physicians who are doing this in the traditional way. It's also how we address OB-GYNs who may be leery of fibroid embolization. They could take the patient to the operating room and do a hysterectomy.
If we have data showing that not only is this procedure, which is thought by many to be equivocal, so why would you choose sending the patient out to a different physician when you could just take the uterus out yourself if the outcomes are fairly similar? We are seeing better outcomes, greater volume reduction, increased procedural efficiency. We are making the procedure itself better. I think that is how we reach people, interventional radiologists who want to perform this procedure more or who are on the fence about switching to TriNav for it, and OB-GYNs who might say, "Well, I have got this alternative procedure that I could just do myself and get paid for it," that the patient would truly do better with a uterine fibroid embolization.
Dr. Kang or Dr. Lamparello, anything to add?
Yeah. I think the adoption becomes kind of easy once people try them. I have many faculty who were initially, "Oh, my traditional method works." But then once they started using it, they saw how efficient it can be and how easy it becomes as you use more. I think they all kind of switched over now because they just feel like it's more efficient and that saves time, procedural times, less radiation for the patient, and then operate themselves. I think that kind of procedural efficiency kind of brings in more would bring in more broader application for the different operators.
If I can comment on that, we're talking about procedural efficiency. What does that actually do? In a world where we don't have enough interventional radiologists, we don't have enough rad techs and nurses, and we have procedure rooms that typically operate from 8:00 A.M. until 3:00 P.M., if we can save an hour in the day, if we can do this, let's say somebody has a couple, two or three uterine fibroid embolizations on their schedule, they could potentially fit a fourth or maybe another case. That takes their fixed costs and increases revenue that way.
I think this is a win for lots of different ways, not only for, "I care greatly about the radiation that I'm exposed to." Anything I can do to reduce my radiation exposure through decreased fluoroscopy time, radiation protection, things like that, I find very attractive. I don't think I'm alone on that.
Dr. Lamparello, would you like to add anything?
I was just going to echo what Dr. Marshall and Dr. Kang said. The decreased procedural time translates to room efficiency and decreased radiation for the patient and the operator. Also, potentially we're seeing decreased embolic needed to get the same kind of results. That is less embolic, which is a decreased cost again, especially for OBLs and outpatient labs, and potentially decreasing pain, which is still under investigation, but we have a lot of anecdotal evidence about that.
Thank you, Dr. Lamparello. Mary?
Yeah. I wanted to comment too that part of what we'd like to do is partner with our physicians that this is where through digital education, when patients have pain, the first place they go is the internet, and they search for options. If we can hyper-target that around institutions that are using TriNav, this is where we can get them to the physicians who are doing that, get them to get interviewed and see this as an option. We'll spend a lot of time and energy around where people are using TriNav to also inform the education. Additionally, like Dr. Marshall said, we're investing in the clinical data and evidence that the societies, both the OB-GYN Society as well as the Interventional Radiology Society can use, but more importantly, even the payers.
This is data where if we can show that type of information to them, they can be very persuasive in ensuring that a patient gets that education and is considered that option that they can choose the right path for them.
Thank you, team. We'll take the next question. For the physicians, what is the training curve for adopting TriNav in U.A.E, and how do you see that progressing over time? Just curious if you could share a little bit about your initial experience.
Sure. I can take this. There really is no learning curve for TriNav. Any interventional radiologist who's familiar with catheter work, which is all of us, can use it. I think the only thing we need to learn in the beginning is just how to protect the valve when entering it into the base catheter. That is something that the rep can show you on day one, and then you'll know for the future and also the need for an extra side flush. There is really nothing special that we have to do using the TriNav catheter, from my experience.
I also want to add that a lot of our physicians are familiar with this catheter already from their use in the liver. It is just a different part of the body that they are putting it in. It is not everybody. We kind of have two groups of users, and those are new users who are, let's say, using a TriNav catheter for the first time. As Dr. Lamparello mentioned, it is very similar to other catheter work. It is a microcatheter with a SmartValve on it, and physicians use microcatheters, interventional radiologists all the time. It is not a big leap. Many of them have already used it in the liver. They understand how to advance it, what it is capable of, what arteries it should go into, and what arteries it should not go into.
Dr. Kang?
Yeah. I think just like Dr. Lamparello and Dr. Marshall said, it's really easy to use. Because the nice thing is that there's no secondary mechanism to allow the anti-reflux capability, right? Like some of the other catheters that are on the market where it requires a separate thing to activate it to do that, whereas TriNav catheter, you can just use it as it is. There's no separate mechanism to activate things like that. I think that makes it really easy to use other than just putting the side flush and things like that. I think most of my faculty, they were just able to use it on their day one, and they become comfortable by the second time they use it.
Thank you. This will be our last question for the day. I'm curious, for those on the line who can comment beyond uterine fibroids, what other areas in practice have you seen the benefits of TriNav? Do you use or see areas of use for the technology beyond liver in U.A.E? Dr. Marshall, would you kick us off?
I can certainly kick you off. One of the things, one of the ways my practice has grown in the last couple of years is thyroid artery embolization. Some of you may know that we have a registry that's ongoing called the PROTECT registry to evaluate the use of TriNav in thyroid goiter embolization. Dr. Juan Camacho out of Sarasota, Florida, published earlier this year on a 22-patient experience in which he showed, just like fibroid embolization, a volume reduction of the overall thyroid gland by about 70%. That's a tremendous volume reduction without surgery, without incisions, without risks of laryngeal nerve injury, which can occur especially in larger goiters. I also use it not only for goiters, but for hyperfunctioning thyroids. To reduce the number of medications that patients are on, sometimes patients are unable to control their hyperfunctioning thyroid with simple just medication use.
This is a great adjunct for that. I use it in the liver. Obviously, that's kind of our number one area. Any other site where I want reflux protection? Dr. Kang, I'm going to ask you to comment on your AML experience. This is angiomyolipoma tumors that occur in the kidney and sometimes in the adrenal gland.
Yeah. I have been using TriNav catheters in the renal AMLs. As long as the vessel size can accommodate the TriNav catheter, I have been using it. It has worked really well because it provides an anti-reflux capability. I feel like I can put in more particles that way into these AMLs. It worked really nicely. I have used it in, obviously, the liver. Some of our partners have also used it for their genicular artery embolizations as well with great success.
I think for genicular artery embolization, it's the same concept. We're able to inject contrast and get it to go into the inflamed arteries or the hypertrophied arteries much better and protect some of the normal tissues. It's really valuable for anti-reflux protection in the knee because if you get non-target, if basically particles go where they're not supposed to go, they can go down into the foot and cause toe necrosis and other complications. We've seen a lot of use with that. We actually have a 20-patient pilot study going on right now to evaluate that. It's been submitted to the Society of Interventional Radiology, which will occur in the early part of 2026. Dr. Kang's data has also been submitted there for uterine fibroid embolization.
Thank you.
I'll mention briefly that we have a Pancreatic Infusion System that's in development. We could probably talk about that for an hour, but I'll leave it at it's been used in some clinical trials and our data. The trials have enrolled, and the data is being analyzed right now, and we're expecting publication on that in hopefully 2026. Stay tuned.
Thank you. Any further comments on this question? All right. I just wanted to take a moment to thank all of our presenters, Dr. Marshall, Dr. Lamparello, Dr. Kang, and Mary. Thank you so much for being with us today. Thank you to all who dialed in as we continue to educate on this important application and alternative for women and opportunity for TriSalus and for the TriNav Infusion System. Thank you and have a great day.
Thank you, everyone. Bye-bye.
Thank you. Bye-bye.
Thank you.