Good afternoon and welcome to the TriSalus Life Sciences virtual KOL event. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations. 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 at TriSalus Life Sciences. Please go ahead, Mary.
Thank you, and thank you all for joining today. I'm really excited to kick off this session with Dr. Juan Camacho, who has innovated a very innovative new approach for thyroid artery embolization. And before we dive into that information, let me do a quick overview of TriSalus. So if you can advance the slide to just the brief overview slide, I think it's in two. And TriSalus is a company that is focused on improving outcomes for patients with solid tumors in the liver, the pancreas. And you can go to the next slide, Dr. Camacho. Keep going to the next one. This one at TriSalus at a glance. And so our mission is to improve outcomes in patients who have tumors in the liver, in the pancreas, and other solid tumors.
And we do that through a platform technology that can actually modulate pressure and flow to deliver more therapy into the tumor and prevent any off-target delivery. We know that if we get more therapy into the tumor, that can improve patient outcomes. And we know if we can reduce off-target delivery, we can reduce complications. We also have a technology for the pancreas, a separate one that can deliver directly into a pancreatic tumor. And we have a drug, nelitolimod, a TLR9 agonist that can help modulate the immune environment in the tumor environment. We currently promote for our technology primarily in the liver, where interventional radiologists deliver small beads of either chemoembolization or chemotherapy or radiation, and they infuse it into the tumor to actually kill the tumor tissue. We currently have less than 10% share.
It's roughly under a $500 million market opportunity, and we're growing very, very rapidly. What we found is that our technology can be used for many other embolization applications, and that's what you're going to hear from Dr. Marshall and Dr. Camacho today about how pressure-enabled drug delivery can be quite unique and offer significant benefits in those applications as well. So you can go to the next slide, and I'll show you the problem that we're solving. This is something we're learning quite a bit about. What you're seeing to the left is a picture of the tumor microenvironment. It's this ecosystem all in itself. What you have is cancer cells rapidly expanding. You have new vessel formation to support those new cancer cells, and you have stromal tissue, and you have normal cells.
And what happens is, as those new vessels are forming, they're quite immature, and they can leak contents into the area because you don't have the lymphatic system to drain that away. And pressure can build in these tumors and actually collapse vessels. Dr. Rakesh Jain, out of Harvard, has done some seminal work, a biomedical engineer, of how this limits drug delivery into the tumor. And often the pressure of these tumors can be higher than what their heart can pump at. So if you move to the next slide, we'll show you how our platform technology, it's a catheter-based system, but we have a quite sophisticated valve on the end of the catheter that can modulate pressure and flow and perfuse therapy into the tumor. So what you're looking at right here is an interventional radiologist. He's trying to do a mapping procedure or simulation.
He wants to view the vasculature of the tumor prior to delivery. On the left, he's using a traditional microcatheter. It's a tube with two holes. It really can't modulate pressure or flow. What you see is that circle is the tumor, and you can see under fluoroscopy, he's trying to access that vasculature. You can see that dark area. It's actually, he can't get in. Then to the right, you see kind of that whole blush into the vasculature. If he was infusing a drug, he would actually have some off-target delivery into normal tissue, which can be quite challenging for many of these patients because they may have limited liver function left or they're quite compromised. What you see on the right, which is just a few minutes apart, he places a TriNav catheter in the vessel feeding the tumor.
I wish you could see it on a fluoroscopy screen because it just lights up the whole tumor. You can see it down to the microvascular bed. And we've done various different studies that demonstrate, depending on the modality, anywhere from 40%-500% more therapy into the tumor. So you can go to the next slide. We're very fortunate with this technology, and I'd like you to focus on the third row below, that we received a unique reimbursement from CMS, the Centers for Medicare and Medicaid Services. And they gave that to us. It's really a proprietary code for our own technology because they saw the unique benefits. We are able to demonstrate that we can statistically deliver more drug to the tumor and also prevent complications.
One of the ones they noted was we showed a 50% reduction in patients being readmitted post-procedure, largely due to the prevention of complications. And you can go to the next slide. And what we have is a whole portfolio of different technologies dependent on the type of vascular case that a physician may encounter. Either it's highly tortuous, or it's larger, or he may need to perfuse at a very high rate. We have developed a set of tools, and we're going to be launching one more, hopefully by the end of the year, that can get into very tiny vessels so they can get that pressure-enabled drug effect and deliver more therapy into each tumor. You can go to the next slide. And so here's what our portfolio looks like. Today, when we started this several years ago, we were primarily focused on the liver.
We have a wide array of different products, and that TriNav Advance that I spoke about will be the next final complete innovation to that portfolio, but what you're going to hear about today is the thyroid artery embolization, and this is something Dr. Camacho saw our technology and has innovated a very, I think, highly differentiated approach for patients multinodular goiter to avoid surgery, but we've also seen our technology used in other procedures like uterine artery embolization and also genicular artery embolization, and essentially, our IFU, we can use our technology anywhere in the body except for in the cerebral vasculature or the coronary vasculature, and you can go to the next slide, so this is the market opportunity that we see today.
Really, there hasn't been a significant amount of innovation in the catheter marketplace, and we think that our technology can dramatically improve outcomes for patients on a wide array of embolization procedures, and you can see we have significant potential in the liver. Dr. Camacho and Dr. Marshall will talk multinodular goiter, another $400 million market opportunity, and the remainder of these that we can pursue with our whole portfolio of products. You can go to the next slide, so what I'd like to do is just do a very brief introduction before they dive deeply into this. Multinodular goiter is quite a significant market opportunity, but also a significant issue for patients. About 5% of patients are affected. I was just sharing with them prior to the call that my niece might need this quite soon. She's being treated with drugs that have really not been successful.
She really doesn't want surgery due to all the complications, and this could be a very significant opportunity. But I'll turn it over to Dr. Marshall so he can do an introduction to Dr. Camacho. And before we do that, I just want to thank Dr. Camacho for his leadership. It's through physicians like him that innovate these incredible new options for patients. A surgery is quite traumatic, significant, and very invasive and costly. This approach is something that everything the patient would want, but none of the complications and the invasiveness. And so we're very excited to partner with him on bringing this new procedure to patients. So Dr. Marshall.
Thank you, Mary, and thank you everyone for joining us today. I'm excited to introduce our speaker today, Dr. Juan Camacho. Dr. Camacho is an interventional radiologist and a clinical associate professor at Florida State University with deep expertise in image-guided thyroid therapies. He's completed an interventional radiology training at Emory University, and he went on to hold faculty roles at leading academic centers, including the Medical University of South Carolina and Memorial Sloan Kettering Cancer Center. Dr. Camacho has authored over 80 peer-reviewed publications, and he's been invited to lecture both nationally and internationally. His research spans the full spectrum of minimally invasive thyroid intervention, from preclinical studies to clinical treatments for both benign and malignant thyroid diseases. He's currently at the forefront of developing Pressure-Enabled Thyroid Artery Embolization, a promising minimally invasive alternative to surgery that we're excited to discuss further today. Dr. Camacho.
I really appreciate that kind introduction, and thank you for the opportunity to talk about something that I'm really passionate about. I think we really have something special here, and I hope that with these, we can continue to help many patients. These are my disclosures. Probably the most important one is that I am not an endocrinologist or a head and neck surgeon or an endocrine surgeon, and this is just how I understand the disease, and obviously based on science and based on my knowledge as an interventional radiologist.
So today, what we're going to plan to cover is a little bit of background multinodular goiter and thyroid nodules, what is the general treatment paradigm with some basic clinical algorithms on how patients are being driven into the minimally invasive thyroid therapies, some thyroid artery embolization concepts, because there's a traditional way of performing these procedures that has been around for over 30 years. However, we have been innovating on what other people have built, and we're going to talk about our specific innovation, which is pressure-enabled thyroid artery embolization, and I'm going to show some case examples of patients that we have been able to help, so the most important thing is that, like every innovation in medicine, requires a multidisciplinary approach.
I have the fortune to be in an institution that supports this and understands this and allows all the different specialties to be set at the same table, so we collaborate closely with endocrine surgery, with head and neck surgery, with endocrinology, with radiation oncology, with medical oncology when needed when we're talking about malignancies in the head and neck, and we have the fortune as well of sharing a physical space in our clinic, and we have also all the other ancillary services that are required to run a program like this, which include nursing, nutrition, nuclear medicine, psychology, etc., so diving into the numbers of these very prevalent diseases, about 50% of our population has one or more thyroid nodules. These numbers are specific to the United States. Multinodular goiter in general as a whole is a very, very common disorder.
It's been calculated that about 12% of the adult population worldwide actually has multinodular goiter, out of which the risk of malignancy is extremely low. And I want to point these out is because we do a lot of surveillance, we do a lot of testing, and ultimately, many patients are driven into resection. However, this is an entirely benign condition that causes a lot of morbidity, but is not necessarily one that is going to cause extraneous mortality. Something to keep in mind is that up to a third to two-thirds of all of the patients that have multinodular goiter, they will develop hyperthyroidism throughout their lifetime. And hyperthyroidism is something very important when it comes to morbidity and potential mortality when you develop it in the scenario of multinodular goiter. And I'll talk about it in a couple of slides.
Another thing that is important is that as a whole, in the United States, approximately 100,000 thyroidectomies or a little bit over that occur on a yearly basis, and approximately 65% of all the thyroidectomies are actually because of these benign disorders, so this is something that is happening on a clinical basis very, very frequently, and one data point that made me dive into how can we actually provide solutions for our patients is that sadly, in the United States, and has changed over the years, but since the year 2000- 2010, approximately out of all of these surgeries, approximately 50%-70% of them are actually performed by general surgeons. And that means that only a third of the population is being treated by expert hands.
We know that there is significant disparity in outcomes when you're treated by an expert in thyroid and parathyroid surgery compared to a general surgeon. What is a multinodular goiter? A multinodular goiter is simply the increase in volume associated with the formation of nodules within the thyroid itself. We define it as greater than 25 mL in males and approximately 19 mL in females. Now, the natural history is that when you acquire multiple nodules and your gland starts increasing in size, there is a very good possibility about a third of the cases will actually end up developing autonomous function. Autonomous function means that those thyroid nodules will start secreting hormones independently of the brain control. When that happens, that can lead to significant morbidity.
In North America, we have been able to actually demonstrate that each nodule can grow about 39% in volume over the course of five years. And we know that, and that's on a nodule basis, but when we take the same kind of growing paradigm and apply it to multinodular goiter, we have been able to determine that the growth is about 5% annually. And in those patients that start their history and their thyroid journey as multinodular goiter, approximately 10% of those will develop hyperthyroidism over a period of 10- 12 years. So why we should also focus on the hyperthyroidism, and the reason is that hyperthyroidism can lead not only to goiters, but to significant long-term morbidity, mortality, and impaired quality of life, which is predominantly driven by cardiovascular complications such as heart failure.
We know that many of these diseases actually occur in the fertile population in the females, and that can lead to deleterious pregnancy outcomes. Patients that develop cardiovascular issues can also end up developing cardiac arrhythmias. Some of these patients that have increased thyroid hormone can develop unintended weight loss and osteoporosis. So it's something that can lead to significant stress, not only within the healthcare system, but also within a patient. Most patients actually present multiple large-sized lesions, and actually with an extension into the mediastinum. And when they extend into the mediastinum, you start generating compressive or bulk symptoms such as dyspnea, dysphagia. And when you have hormonal manifestations, those can lead to tachycardia, anxiety, and sleep disturbances.
And the sad thing is that in order to correct this problem, these patients have to submit to a very large surgery that can include a manubriotomy or a sternotomy, almost like performing an open heart surgery, essentially, because they have to dig in into the chest in order to take these big goiters out. So in terms of how we understand the disease, we know that this is a benign process. We know that this is something that is not necessarily going to kill a patient. However, it has the potential of generating significant morbidity and potential mortality. But like in every other benign process, we need to have the patient at the center of our care. So we first need to determine if, when you have a benign thyroid nodule or a goiter, if you're completely asymptomatic or not.
If you're completely asymptomatic, I think that most doctors will offer observation, but if you are symptomatic, whether it's functional, whether it's cosmetic, whether it's bulk, whether you have hyperthyroidism, then we really need to ask the patient, do you want an intervention? There are medications that can be used to control some of the symptoms derived from the increased thyroid hormone production, but there's really no significant medications that you can give a patient to get rid of the functional, cosmetic, or bulk symptoms, so that's why we need to ask the patient always, what is their desire? What is it that they want? Because every intervention that we perform has potential risk that everybody needs to be accounted for, so if those patients desire an intervention, obviously, the only way that we can definitely manage this pathology is with surgery.
But this is precisely what we're trying to avoid because of the potential side effects that can come with the surgery. And we're trying to preserve as much thyroid tissue as possible. Having your thyroid intact, it's critically important. Hormonal supplementation is not going to replace the natural hormones that your body produces. And what are those minimally invasive therapies that you have? You have radioactive iodine, you have percutaneous ethanol injection, you have ablation, percutaneous ablation, which is introducing a needle through the skin directly into the thyroid nodule, and you have thyroid artery embolization. But how do you make the determination which minimally invasive therapy is adequate for who? So if you have a benign nodule and that nodule is mainly cystic, then you can inject ethanol. It's a form of vascular therapy, and that should shut down that cyst.
If you have less than a 20% solid component, meaning an 80% cystic component, you can also try ethanol sclerotherapy, or you can use ablation, percutaneous ablation, to get rid of the solid component. Now, if that solid component is larger than 20 mL, and we'll talk about this, then thyroid artery embolization is probably the best shot. Now, if you have a nodule that is greater than 20% solid, then you can utilize ablation or thyroid artery embolization. So why is volume important? Volume is very important because we know in a very large study that was conducted in the United States, it was a retrospective study, yes, but with approximately 15 institutions throughout the country, demonstrated that in large nodules, in nodules that measure or goiters, well, I'm going to talk about nodules and goiters and volume interchangeably.
What I'm going to try to make reference is volume of thyroid tissue that you are actually effectively treating. So if you're treating a volume of thyroid tissue that exceeds 20 mL, we know that the recurrence and the nodule regrowth at approximately one year is greater than 90%. And that's truly where embolization has a role. So could you try in a nodule that is 20-30 mL percutaneous ablation? Yes, absolutely. However, we know that that's going to require multiple sessions. And we know in multiple retrospective series that multiple sessions lead to complications. So that's where thyroid embolization really fits within this minimally invasive thyroid treatment paradigm. What are the different scenarios that we can potentially treat with thyroid artery embolization? We're talking multinodular goiters, ideally those goiters in which the gland is significantly enlarged as a whole, 50 mL or more.
This is derived from papers that have compared radiofrequency ablation versus thyroid artery embolization, or nodules that on their own measure greater than 30 mL because of the large regrowth rate, as I was mentioning earlier. Now, obviously, it's more useful in those patients in which surgical management is not necessarily going to be an option because of comorbidities or because of the location or simply because the patient has refused this standard of care. In toxic goiters or autonomously functioning nodules that exceed 15 mL, it's also where we can apply this technology. The reason of the 15 mL cutoff point is because, again, in retrospective reviews, we have learned that when it comes to toxic goiters or autonomously functioning thyroid nodules that exceed these sizes, their recurrence rates are pretty high.
In autoimmune diseases such as Graves, which are kind of like the combination multinodular goiters with increased thyroid hormone production, that's another big target. The reason for this is that the surgery tends to be very morbid. These glands are extremely, extremely vascular. There are surgeries that are a little bit more complicated to perform. The reality is that the available medications can come with not only side effects, but also deleterious effects over the body when they are prolonged over time. Another very nice niche application is that many dedicated thyroid and parathyroid surgeons have now migrated to minimally invasive thyroid surgery, which is either transoral or transaxillary thyroidectomy.
There are some limitations to take thyroid tissue through the transoral or transaxillary approach, which is you cannot have a thyroid lobe that measures greater than 10 cm or a greater than 2-cm malignancy or a benign nodule that measures greater than 6 cm because your risk of conversion to an open surgery can be very high. The reason why they tend to convert is because when they are operating, these surgeries can be manipulating the goiter or the lesion itself can bleed significantly within the surgical field. It's not like patients are going to have a hemorrhagic shock or anything like that. It's just that it's a problem of visualization. If they cannot see the critical structures, they're going to have to convert to an open surgery.
So when we are talking about thyroid artery embolization as a minimally invasive treatment option compared with the standard of care, which is surgery, what are the benefits, the risks, and the different alternative matrix that the patients have? So obviously, thyroid artery embolization has the benefit that there is really no incision. There is no cosmetic issues. You can see on the right side of the screen a patient with a thyroidectomy and with a very robust scar. There's definitely faster recovery time because truly, there is really no recovery from these procedures. An outpatient procedure is something that you can perform with moderate sedation. Patients do not have to stay in the hospital. You also achieve a very quick volume reduction. And we know that approximately 50%-70% of the reduction that we see occurs within that first three-month timeframe.
That's very advantageous to the patients because they really improve symptomatically very quickly. And obviously, all of these patients that undergo this type of minimally invasive therapies, they will avoid hormonal supplementation. It does have risks. Like everything we do in medicine, the main risk is the risk of non-target embolization. I will dive into that in a few slides. But essentially, when you're performing an embolization and you're using particles or whatever other embolic that you're using, you have a target. Your target in this case is the thyroid. So anything that doesn't go into the thyroid is theoretically non-target embolization. And obviously, when we're operating above the clavicle, the risk of the non-target embolization, it's the highest stakes risk because it can terminate potentially in the circulation that goes into your brain and potentially cause strokes.
You can have puncture-related hematomas, and you can have transitory hyperthyroidism. This usually can be managed with medications. The puncture-related hematomas in the hands of an experienced interventional radiologist is way, way, way under 1%. What are the alternatives that these patients are usually offered? We've talked about surgery and thyroidectomy. Surgery has several potential complications that include hypoparathyroidism, which is a lesion to the parathyroid glands. Obviously, hyperthyroidism that will require thyroid hormone supplementation. Damage to the recurrent laryngeal nerve that in expert hands should not be a big deal. But as I pointed out, the vast majority of patients are being actually operated by general surgeons in the United States that have a higher risk of injury. You can also have paresthesias or numbing of the anterior portion of your neck and also kind of like all this scarring that we have talked about.
The risk with the other alternative is observation, but I already detailed the natural history. So what we know is that observation is clearly valid. However, it will eventually lead the disease will take its course and will continue to evolve. There's another alternative that we would necessarily have not talked about that is radioactive iodine. It's essentially radiation that comes in the form of a pill. You take the radiation. That radiation is accumulated inside the thyroid tissue, and it's emitted locally and will shrink your thyroid. However, it will also kill the normal thyroid. So we know that approximately 50% of the patients that undergo radioactive iodine therapy will end up developing hypothyroidism. And we know that the volume reduction rate with radioactive iodine, it doesn't exceed 30%. So it's not very significant for glands that are very large.
When it comes to ablation, ablation is definitely a valid alternative. However, it is limited by volume. It is limited by heat sink effect, which is related to when you have a very vascular tissue and that blood is circulating throughout that tissue. When you stick a probe that is trying to apply some form of energy into the tissue, the circulation around the probe will steal temperature from the tip of the probe itself. And that's what's called heat sink. And that's what leads to the vast majority of the failures. And it leads to the fact that these patients will require multiple sessions in order to get fully treated.
Moving on to thyroid artery embolization and what is the background and how long has it been developed and what we know kind of like in the literature is that thyroid artery embolization, the first case at least that I could find, and I'm not certain about this, but the first case that I could find was a case report. It's not in the English literature. It was in 1994. And it was a patient that was under thyroid storm, and they decided to treat as such, and they noticed that the patient actually responded. That's the first documented case. It's a procedure that has been performed a little bit over 30 years. And across several studies, it has been shown that thyroid artery embolization can reduce the thyroid volume substantially, approximately 50%, and can normalize or improve thyroid hormone levels without necessarily causing hypothyroidism.
In other words, to this date and to my knowledge, there hasn't been the first hypothyroidism-related case secondary to thyroid artery embolization. Graves' disease has a pretty good chunk of the evidence. And we know that approximately 60%-70% of the patients will become euthyroid. That means that those patients will regain normal thyroid function. And we know that there's a couple of papers that have demonstrated that those results are maintained up to 15 months after embolization. And in patients with known Graves' hyperthyroidism, we know that the euthyroid conversion rate is about 86% at about six months.
The interesting thing has also been that even though if you do not achieve a euthyroid state, the procedure has been able to demonstrate that if you are on anti-thyroid medication, you will be able to reduce the dose of the medications that you need without requiring levothyroxine substitution, which means thyroid hormone replacement. The other very interesting thing is that in QOL or quality of life scores, there has been a significant improvement in quality of life, which ultimately it's what you really, really want when it comes to treating a benign process. Is your quality of life being improved? Are you preventing bad outcomes? There are complications that have been reported throughout the literature. The major complications are growing hematomas, which is related to the access, symptomatic hyperthyroidism requiring extended hospitalization. There's been a case report of myocardial infarction secondary to the hormonal release.
There are cases of non-target embolization, meaning strokes, non-target embolization into the brain. But these are rare to our knowledge or at least to my knowledge. There's approximately five of those cases reported in the literature. Minor complications include transient hoarseness because of inflammation. There can be neck pain. Some people have experienced vision changes, especially when they're embolizing the superior thyroid artery, which originates from the carotid artery, which can lead to non-target embolization into the ophthalmic artery, which is the one that goes into your eyes. We expect some degree of fevers and biochemical abnormalities that are not necessarily going to affect the patient, but it's just something that is related to the inflammatory response secondary to the embolization and the infarct that you're generating in the gland. The current literature does not establish a standardized patient selection criteria.
There are still some gaps in terms of which one is the optimal embolization technique, and we don't really have comparative efficacy versus alternative therapies. In other words, there's not a head-to-head comparison versus surgery. I think it will be unfair. There's not a head-to-head comparison versus radiofrequency ablation, and there's a single paper that has compared thyroid artery embolization versus radiofrequency ablation, in which thyroid artery embolization was proven to be a better alternative. There is also variability among the different embolic materials. Some series have used liquid embolics. Some others have used particles, the number of arteries that are being treated, and there is really no long-term data for malignant indications, which could potentially be an application for the future. What is the traditional approach to thyroid artery embolization?
The traditional approach to thyroid artery embolization implies embolizing three out of the four arteries that supply the thyroid. The superior thyroid artery originates in the carotid circulation. The inferior thyroid artery originates in the subclavian circulation. The subclavian is the artery that goes into your hand. So theoretically speaking, we feel that the higher stakes territory in terms of non-target embolization will be if you access the external carotid artery because that could potentially lead to non-target embolization into the internal carotid artery or into branches of the external carotid artery, which can potentially lead to stroke. We know that on the neurointerventional radiology guidelines, when it comes to head and neck embolization, there is a risk of up to 10% of stroke, and it's going to be higher when you're embolizing something close to the base of the skull.
It's going to be lesser when you are embolizing something close to the clavicle, such as that of the thyroid. So that's why we assume that the risk of non-target embolization or stroke risk is probably somewhere around 5%-6%. Now, when it comes to pressure-enabled thyroid artery embolization, we perform it a little bit different. We don't have to go into three out of the four vessels. We don't have to go into the arch and perform an angiogram on bilateral carotid circulations. What we do is that we advance the TriNav into the inferior thyroid artery, and we know that there are flow collaterals between the superior thyroid artery and the inferior thyroid artery. They're communicating inside the thyroid. So what we're able to do is just leverage those collaterals to allow for a complete embolization by accessing just one vessel.
And that's what makes the difference because you're accessing, theoretically speaking, the vessel that causes the less risk of non-target embolization in a high-stakes territory. So we utilize a five French catheter, the TriSalus TriNav microcatheter. And then we use very small spheres, 100- to 300-micron Embospheres that accommodate to the capillary of the thyroid. And we publish our results in the Journal of the Endocrine Society very recently, which is a very good journal in which not only endocrinologists and endocrine surgeons expose their research, but also endocrinology. So it's a very nice multidisciplinary journal. And we were able to show our very initial experience that we built over the course of a year back in 2023. We included 22 patients. We embolized 34 thyroid arteries depending if the patient had a unilateral or a bilateral goiter.
We were able to, in those patients that were hyperthyroid, obtain a 71% euthyroid conversion rate. The patients that we failed was a patient that had a very large toxic goiter that we, however, in that particular patient, were able to decrease the amount of medications that that patient was taking. There was another patient with Graves' disease that had the same outcome. However, she also decreased the amount of medication she was taking. In those patients that were performed with the intention of purely reducing the volume of the gland, we were able to reduce the volume in about 73%, which is, to this date, the largest volume reduction rate ever reported in the literature, which is about 23 points above the median reported in the literature for end-hole catheters. We only encountered grade one complications, which was mild pain and discomfort.
As a matter of fact, there were a few patients that underwent ablation prior to the embolization. We were able to demonstrate that those patients will actually recommend embolization rather than ablation because of the symptoms that they experience with the ablation, which is it was something kind of like interesting within our cohort. We didn't have any major complications or neurovascular events, meaning we didn't have any stroke and no patients developed hypothyroidism as a result of the procedure. This is kind of like how a procedure looks like. Here we have the TriNav in the descending portion of the inferior thyroid artery. You guys can appreciate how vascular this tissue is, which is why it's so advantageous to utilize the TriNav in such circulation.
You have the correlation here with the Cone Beam CT, which is a special form of CT that we do on the angiography table. We're able to demonstrate that the whole lobe of the thyroid, it's enhancing with a single injection from the inferior thyroid artery vasculature. When we go to the contralateral side, you can also appreciate how important is the hypervascularity of this tissue. You can see that this patient particularly had his trachea located essentially on the right side of his body instead of being in the midline. This patient was deemed for years as a patient with asthma induced by exercise. He had clear stridor with exertion.
And essentially, his stridor was secondary to the compression of the airway by this large goiter that, as you can see here below the clavicles, meaning in the superior mediastinum, is essentially compressing the airway in about 80%-90%. And again, we're showing here in this Cone Beam CT how with a single injection, you're able to opacify the whole lobe. In this particular case, there is contrast in the right side of the gland simply because that's the area that we embolize first. And you get retained particles and staining of the gland because of that. And this is on the top row. You have sequential images of how initially the patient presented. And if you focus on the top row in the middle picture, you can see that essentially the airway is pretty much, it looks like an inverted teardrop.
And there's pretty much an 80%-90% volume reduction of that airway. And following embolization below, these are the same cuts at the same level. And you can see an over 70% volume reduction with normalization of the size of this airway. And now this patient is completely off all of the medications that were prescribed for the so-called asthma. This is another example with a completely different application. This was a 27-year-old female that had a very large thyroid nodule that had a particular mutational profile that conferred her approximately a 70% risk of malignancy, which means this gland needs to come out. However, she was very petite. She's 27 years of age. Obviously, she was concerned about getting rid of the disease that she had, but also about the cosmetics of the surgery.
And she was concerned about losing her potential sensation in the anterior portion of her neck. And you can see here in the ultrasound at the bottom left of the screen that this particular nodule is very vascular in the periphery, which corresponds to the findings on the angiogram in the top left as well as the top right. And we went ahead and we embolized it. And this is the one on the bottom right. You can see the endoscopic view because this patient was able to undergo a transoral thyroidectomy because of her embolization. You can see a completely devascularized nodule. And she underwent successful surgery without needing to open. When I talked to the surgeon about this, he told me, like, "This is the best dissection that I've ever had." This is verbatim from him.
Don't take it from me," and that's how I know that we really had something that we can help with to patients, and this is a final example of a patient that presented to our hospital with a new onset atrial fibrillation. Atrial fibrillation can develop in the setting of hyperthyroidism, so basic tests were done, and we noticed that this patient had hyperthyroidism, and on an ultrasound, we were able to detect multinodular goiter. Subsequently to that, we did a thyroid uptake scan that demonstrated that this large right-sided nodule was the culprit and the responsible for the autonomous function, and therefore, we went ahead and we embolized it completely to stasis, as you can see in this particular picture, and then you can see here on the left of the screen the pre and on the right of the screen the post.
We get complete necrosis of that nodule with associated volume reduction. Now this patient, his atrial fibrillation is resolved. He doesn't have to be on a blood thinner for life. He doesn't have to wear a pacemaker. He had a clearly correctable source of his pathology. He didn't have to go surgery in order to get cured. In summary, I think that what do we know? I think that pressure-enabled thyroid artery embolization is definitely an emergent treatment for large goiters. It provides a very good option for patients that have a large gland, that there are symptomatics, or that they have a substernal component. It's especially useful when surgery is a high risk and is not desired by the patient or in those patients that will require a sternotomy or thyroidectomy. It does have value in hyperthyroidism.
We know from the literature that it has benefits in patients for Graves' disease that don't have poor response or they have contraindications to conventional therapy. There's a fairly significant amount of patients that will achieve that euthyroid conversion rate. And we also know that by utilizing pressure-enabled delivery, we're actually using less embolics with increased penetration into the tissue. It can be useful as a surgical adjunct. I showed you a case in which we were able to bridge this patient to a transaxillary thyroidectomy so she can have the aesthetic result that she wanted. And we could decrease the risk of converting to an open surgery. We know that it can play a palliative role in malignancy. I'm in the process of not only publishing a case report that demonstrated that after thyroid artery embolization, we're able to achieve complete pathologic necrosis.
That will come into the future. But also by treating those patients that don't have any options with embolization, we can potentially control their symptoms because those patients that don't have any options, many times their main complaint is because of bulk symptoms, meaning compression and pain. We do know that head and neck embolization also can be associated with a potential risk of stroke. And we know that by utilizing the device, we can potentially decrease that possibility because we do not have to access the carotid circulation. And at the same time, the major complications that have been reported usually can be managed. So it's a risk that in a way is worthwhile taking. So what are our future directions? We're trying to build more and robust data because we need it. The only experience published in the United States is. It's my paper.
Most of the papers that are in the literature with end-hole catheters are from Europe and Asia, so we need to build our experience here, and we're making a big effort to do that. We have to discuss guidelines about who can be the best candidate for this particular procedure. We want to increase awareness of the technique through patient advocacy groups, as well as we want to make sure that people are able to access training because that's the most important thing. I think that this procedure carries some degree of risk, absolutely. However, when it's done well, when it's done in the proper hands with good training and good education, those risks are probably very minimal, in my opinion, and we definitely have to do more work in optimizing and standardizing the technique, and we clearly have an opportunity here because we're leading the way.
We want everybody to perform the procedure in a very standardized way. This is our first step. I'm showing this slide directly from the ClinicalTrials.gov website. This is a study that we are leading. It's called the PROTECT Registry. It's called PROTECT because we want to protect our population against bad outcomes. We want to protect our population against the potential of stroke. It's a multi-center registry. We are currently about 12 sites interested. We have acquired 25% of our sample right now. So we are very hopeful that in the next six to eight months, we can have at least an interim analysis to demonstrate that this is something that our population will benefit from.
We will continue to make efforts based on the results to try to define even further what are the best populations and potentially challenge the standards here as we think we are challenging right now. So thank you very much for your attention. And I'm very happy to answer any questions that you may have.
Great. Thank you, Dr. Camacho. So at this time, we'll be conducting a question-and-answer session with our speakers. Please hold for a brief moment while we poll for questions. So our first question comes from Nelson Cox at Lake Street Capital Markets. Please go ahead, Nelson.
Hey, thanks for taking the questions, and I appreciate the presentation and time today. It was very comprehensive. Dr. Camacho, just maybe to start, how many thyroid embolization procedures are you currently completing approximately per month? And then how many of these in your practice make sense? Would it make sense to use a TriNav versus kind of just a standard end-hole catheter?
So, right now, it's variable, but usually more than three a month. The months that I've performed the most, it's probably around six or seven. I use a TriNav 100% of the times. And I'm a firm believer in the technology. And when I first started doing thyroid artery embolization, I actually started with an end-hole. And I always felt that I was not only under-embolizing, but that I was unprotected when it comes to reflux and non-target embolization. So when I started using the TriNav, and I was able to figure out that I no longer had to go into the brain circulation, meaning into the carotid arteries. And I could do everything from a vascular territory that is slightly safer. That was the one that essentially just converted me. And I was like, "This is the way to go." And I use it 100% of the times.
If I cannot use the catheter, I pretty much don't perform the procedure.
Okay. That's helpful, and then we walked through some of the benefits and risks of TAE versus surgery, which looks very supportive of embolization, but can you walk through kind of what you think is most needed for this to become a standard of care and practice? What do you hear out there in the field with your peers, and I know you talked a little bit about guidelines and more clinical data, but just any other color there would be helpful.
I think there's several things. I think that the way I would answer this is what needs to happen clinically. And I'll go into that. And also the struggles that we have as interventional radiologists. And it's the fact one of the problems that we have is that we are called interventional radiologists. So if you ask yourself, "When would you go to an interventional radiologist?" The fact that we're talking about thyroid artery embolization right now, probably the answer is like, "I don't know," because I don't know what they do. And I think it's a problem of the way how the public perceives us and how we relate with the public itself.
So I think that one of the things that needs to happen is that we need to take the driver's seat when it comes to informing the public, relating to the public, advertising directly to the patient, and speaking more with patient advocacy groups. I think that part of the problem is just ignorance about that these options actually exist. And they're good options. So that's one part of the problem. The other component of this is that I truly believe that in order for this to work, it has to be performed in a multidisciplinary environment in which everybody is sitting at the table and is able to individualize patient care. So I think that those discussions do not necessarily happen in routine clinical practice. And that's what we're trying to actually change from the private sector.
I'm part of a society that is called the North American Society of Interventional Thyroidology. And it's a society that is a small society. But right now, we have about 400 members throughout the United States. And it's a society that is comprised of endocrine surgeons, head and neck surgeons, endocrinologists, interventional radiologists. And we're trying to have these discussions. And this is what I think is going to be more successful. Within these discussions and presenting these data, we're going to be able to change the guidelines soon. And we're going to be able to offer this technology more. So I think that that's part of how I would solve and what I think that needs to happen.
Yeah. And Nelson, this is Richard Marshall, Chief Commercial Officer. And I just wanted to add on very briefly that we're very actively exploring how to help Dr. Camacho and his colleagues who are working in these multidisciplinary environments and providing the best care for patients to make sure that we can make patients aware of this very important option for them other than surgery.
All right. Very helpful. Thank you for the time today.
Thanks for the questions, Nelson. Our next question comes from William Plovanic at Canaccord Genuity. Please go ahead, Bill.
Great. Thanks. Good afternoon. And Dr. Camacho, thanks for the overview. It's very helpful. I think you answered my first question, which was on referral. So it's creating awareness in the endocrinologist community to get them to you as part of the challenge. And then as I think about this, you gave us a lot of kind of subsegments of that, the potential market opportunity here as we think about it in terms of numbers. But of those 100,000 procedures today, based on the criteria outlined, what percentage or what number of those 100,000 would be applicable to TAE? That's my first question. And then just the second is more geared towards kind of insurance coverage. What does that look like without clinical data? How hard is it for you to get the approval to do these types of procedures for these patients?
In terms of your first question, we know that 65% of the thyroidectomies that I mentioned, over the 100,000 thyroidectomies that occur in the country on a yearly basis, 50% are because multinodular goiters. About 15% are because of autonomously functioning nodules. That is a market on its own. Now, out of the remaining 35%, those are for malignancies. I will say that probably around 10%-20% of the malignancies, and this is just an estimation, will benefit from this procedure in the presurgical setting. There's a significant amount of those thyroidectomies that could potentially benefit from this procedure. I think that that's probably about a good estimation. Now, regarding the other question, which is, oh, remind me again. I'm sorry. I just lost my train of thought.
Yeah, just the insurance companies need to be pre-authing the payment for it.
So in interventional radiology, we're kind of blessed in the way that we have a unique code for embolization. So you can embolize the thyroid or the uterus or the liver or the joints or hemorrhoids or all of the things that we can embolize throughout the body. And we use exactly the same code. That's one part of the reason why I feel that things are actually moving along. And even though there is no data, or I wouldn't call it no data, there is very limited data in the United States. There's pretty much fairly compelling data from other latitudes. And when you have a patient that has a lot of comorbidities or is ineligible for surgery or is ineligible to other potential alternatives, and this is kind of like the only thing that you have left, I so far, I haven't encountered any resistance from insurances.
I mean, I do my case, and I explain to them why I feel that thyroidectomy wouldn't be cost-effective, and the other things that we have will generate essentially a little bit more morbidity, and I have been able to get the approvals that I need, so I think that probably that will become a challenge down the road, but what I'm anticipating with the multi-institutional registry is that we're going to have some degree of compelling data to say that this is a technique that is reproducible, that we can help patients with this, and that patients will benefit from having an alternative.
Dr. Camacho, I'd like to add a little bit too because my experiences have been that I haven't had any problems from insurance companies authorizing this just because there is such a need, and this is such a routine type of treatment that interventional radiologists do. It's coded, and so there hasn't been any pushback, but I do think it's important that we don't take that for granted and we continue to build, so the PROTECT Registry, I think, will be very helpful in showing the quality of life improvement, the safety, and efficacy of the procedure.
And if I could add on just procedure time as I think of doing a procedure with the PETAE versus any other type of procedure that maybe you could do, even a thermal ablation or some other types of procedures, just a quick compare and contrast on the time to do that relative to others, longer, shorter, if so, by how much? And thanks for taking my questions.
100%. So an average ablation session, which is about 10,000-20,000 watts, it's probably 30-45 minutes. It's a pretty long procedure. And it's a procedure that you do with no sedation whatsoever with just local anesthesia. And in some instances, it could be very traumatic because we're talking about a large volume gland, right? We're not talking about the smaller nodules that you can knock out in 10-20 minutes. Now, for an embolization, from starting the procedure to conclusion of the procedure, and I'm not talking about how much the patient needs, how much time you need for the patient to come in ahead of time and get some labs and get an IV and get prepped and get positioned on the table and all of this stuff.
I'm just saying from puncture time to embolization per side, it takes me about 10 minutes, 10, 15 minutes. It's not a complicated procedure to do. It's a procedure about paying attention, being on your guard all the time, watching under fluoroscopy, and essentially exercising your expertise as an interventional radiologist.
Thank you.
Thanks for the questions, Bill. Our next question comes from Carl Byrnes at Northland Capital Markets. Please go ahead, Carl.
Thanks. Thanks for the question. I hope you can hear me. In real-world practice, do you see adoption of TAE being driven more from endocrinologists' referrals or through interventional radiologists?
It's interesting that you asked that. I can tell you that 70% of my patients are actually self-referred because I've done a very good effort about trying to educate people through social media, through YouTube videos, through patient advocacy groups, etc. I do complete the workup, and I make sure that they meet with an endocrinologist and with a head and neck surgeon because it's very important for them to have their options. I don't hide anything at all. I always tell them, "Hey, listen, you can go this way. You can go this way. You can go this way," but it's very important for me to be upfront about their options. Now, I'm very fortunate that I am in a healthcare system in which my main head and neck surgeon, he's a leader in ablation, and he's a leader in minimally invasive thyroid therapies.
He does a lot of transoral thyroidectomies and whatnot. So he understands very well the application of this. And I feel that we have been able to convey and relay a message that has been more compelling and easily adopted by surgeons than endocrinologists. Usually, the endocrinologist goes, "I have a nodule. I biopsied it. It's either cancer or benign. It's causing issues. It goes to the surgeon." And then the surgeon decides what to do. So I think that the main stream of how my referrals occur are either directly to the patient or because the surgeon thought that this was a patient that they will benefit from the intervention.
Excellent. That's great. Thanks so much.
Dr. Camacho, can you do a quick follow-up on that regarding preservation of thyroid function and how you think endocrinologists are going to view this in the future as they learn more about it compared to surgery where there is a risk for lobectomy and certainly for total thyroidectomy of hypothyroidism and hormone replacement that's lifelong?
Yeah. I think that that's a great question because all of these patients that thyroid disease in general, it's a disease stage that opens you up to have cardiovascular and, yeah, in general, cardiovascular diseases, whether you call it an arrhythmia or heart failure or stroke. That's what you open up with when you have problems with your thyroid, and you really need your thyroid, especially when you're very sick, when you're in the intensive care unit and you don't have your thyroid working for you. That's when all of the metabolic derangements happen, and those patients have really poor outcomes, so from the physician's standpoint of view, there has been a significant trend in the past few years to de-escalate the management of thyroid diseases via surgery. In other words, the paradigm in the 1990s was to do a total thyroidectomy.
Right now, the paradigm is if we can avoid a total thyroidectomy, we should do that, and it's because people have realized that saving thyroid tissue and preserving thyroid tissue is something that is very important for everything, so I think that the most remarkable thing about this intervention, compared, for example, to a radioactive iodine, which is just a pill and it's purely non-invasive, is that we do not damage the normal thyroid. And we have shown that we have been able to achieve complete pathologic necrosis of the nodules of the abnormal tissue, but the normal thyroid doesn't get damaged, and that's something that is remarkable. We've seen it in other organs like the liver or the prostate that we only affect with embolization the hyperplastic tissue, and I think that that's how we are able to protect our patients.
Great. So this concludes our question and answer session. I'll now turn it over to Mary for closing remarks.
Thank you, team. That's all the time that we have today. Dr. Camacho, thank you so much for sharing your expertise and for advancing the conversation around minimally invasive options for thyroid disease. We appreciate everyone who joined us today and hope this discussion provided practical insight into thyroid artery embolization as well as Pressure-Enabled Thyroid Artery Embolization, PETAE. Thank you for your time and continued engagement. Have a great day.