All right, hello everyone, and thank you for joining us throughout the day here at the Lytham Partners Fall 2024 Investor Conference. My name is Robert Blum, Managing Partner of Lytham Partners. Up next here, we welcome Milestone Scientific, ticker symbol of MLSS on the New York Stock Exchange, and joining us today from the company is the company's CEO, Arjan Haverhals. Before I turn it over, I just want to remind everyone that management is available for one-on-one meetings throughout the conference. If you've not already signed up and would like to schedule a one-on-one, please send me an email. That's blum, B-L-U-M, @lythampartners.com, or you can visit the landing page for the conference there. That's lythampartners.com/fall2024. From there, you can click on the Investor Registration button to make your one-on-one selection.
So, Arjan, thank you very much for your presentation today, and the floor is all yours.
Thank you, Robert. Good morning, everybody, and thank you for giving me the opportunity to present our company, Milestone Scientific, at the Lytham Conference. Milestone is traded at the New York Stock Exchange on the ticker symbol MLSS. You see the shares outstanding, about 77 million. Our market cap is currently $76.5 million. Very happy to present as well that the company is financially very healthy and solid and sound. Cash and cash equivalents at hand at the end of the second quarter this year was $5.8 million, and we have zero debt, and enjoy revenues that I will allude to in the next slides. The safe harbor statement, I think you're all familiar with it.
I will just leave that for a couple of seconds, but please be aware that some of the statements that I'm making could be regarded as forward-looking statements. But we want to make sure that we obey the rules and the regulations also of the SEC. In summary, our company was a typical research and development company, and we are very proud always to position ourselves that we are the leaders in computer-controlled injection technology. And what that means is that we apply a proprietary technology called Dynamic Pressure Sensing technology, where we measure real-time pressure at the tip of the needle. It sounds very detailed, but what it allows us to do is to make injections in dental and in medical precise, safe, predictable, efficient, and very comfortable.
So in other words, the Dynamic Pressure Sensing technology, the patent technology, is, so to say, our base, for all our businesses that we enter in with our medical devices, current business segments and future business segments. The company has a legacy business, and it's fair to say that in more than the last two decades, we've been very successful in the dental, market segment, where we are actually able to inject a local anesthetic below the patient pain threshold. In other words, no pain during the injections, but more importantly, no facial numbness or lip numbness, and an immediate single-tooth anesthesia within as little as sixty seconds. Today, we have done more than eighty million injections, with our technology in the dental business. Again, I'm talking about the legacy business, the Single Tooth Anesthesia System.
Over the last couple of years, we're trailing at a revenue at about $10 million. It's patented, protected, and more importantly, we're very proud also that we recently, throughout the last two years, continue to increase our gross margins, which is currently trailing for above 70%. Now, being successful in the dental business, we made the decision to enter the medical market segment. And most recently, we have made some active inroads in entering the high-growth pain management epidural market segment for the injection of epidural steroid injections. That is a total addressable market with our technology that we believe of a value of $2 billion. It's a growing market as well.
And more recently, we have been able to receive a payment rate assignment that was granted in the jurisdictions in New Jersey, Florida, and Texas, which allows clinicians to get reimbursed after using our technology and after submitting the necessary documentation to the Medicare insurance providers. And from a business perspective, of course, we are now in the early stages of the introduction of our technology in this pain market segment, and we are looking not only domestically as well as internationally, to expand our distribution network. I will revert to all these points made in this initial executive summary.
The problem with epidural analgesia today can be regarded as very challenging, and I want to bear in mind that today, the procedures are performed by a very subjective manual, technology called the loss of resistance technique, which is nothing more or less than a hypodermic needle out of eighteen hundred and sixty-... that was later positioned in the marketplace at the loss of resistance technique in the early 1900s. I will briefly explain to you how that works. It's nothing more than a six-inch needle with a syringe filled with saline, and the clinician is placing the needle in the back of the patient, and while advancing the needle, he feels at his thumb if there is any loss of resistance against his thumb.
That means, if there would be a loss of resistance that he senses, he or she might think he is in the epidural space. Now, your and my sensitivity is definitely different, and the challenges with the current technology, the loss of resistance technique, is rather cumbersome, because first of all, it's a very subjective methodology. Secondly, it takes about up to 60 placements for a resident to be familiar, to be profound, to be comfortable with it, with placing the needle in the epidural space. That's one thing. What we have been doing with our technology, we have reduced those 60 placements to two placements. The claims that I'm making are supported by clinical documentation in national and international journals, very knowledgeable and acknowledged journals, both national and international, where we have done 12 of these publications.
So all the claims I'm making are supported by clinical, evidence-based, publications. Second challenge that we are seeing is that 17% of these placements are false positive. That means that even if the clinicians feels that loss of resistance against his thumb, he is not in the epidural space. In other words, the drug is administered at a place where it should not be. In other words, again, the drug is not effective, so you have to repeat that procedure. Those 17, quote, unquote, "failure rates" calls are also called as false positive results. Again, with our technology, we have been able to reduce that 17% to 0%.
Now, if the clinician would advance the needle too far in the epidural space, he or she would reach a membrane, breach that membrane, resulting in leakage of cerebrospinal fluid in the epidural space, and that causes terrible side effects like headache, severe headache, worse than a migraine, paralysis, or mortality, and these cases have been seen. These side effects, called morbidity rates, are 5%, according to medical literature, in the lumbar spine, which is the lower part of the back. Seventeen percent in the thoracic spine, the middle section of the back. And up to 30% in the cervical spine, so the region in our neck. So that actually means that one out of three injections or placements in the cervical spine have the potential risk of damaging the spinal cord.
So as a summary of this slide, high risk, difficult, uncomfortable for the patients, and non-predictable. So the solution that we bring is actually the CompuFlo Epidural System, which is a computer-controlled injection technology for needle placement and verification of the needle in the epidural space during epidural anesthesia. What you see on this slide, it comes with an instrument, and it comes with consumables, and the consumables to be used for each individual patient case, so it is a sterile component. So the business model that we apply is nothing more or less than the razor-blade business model, where the razor is the instrument and where the razor blade is then the consumable that you see on the arrow on the slide.
It's a set of consumables with an adapter that is steering the software, the computer part of this instrument, and also where we have an inline pressure sensor to measure any pressure feedback once the needle is placed and once the fluid has been dispersed in the epidural space. An instrument, a device, where we will see the pressure build-up and the pressure release and the loss of resistance once the needle is placed in the epidural space, and a set of consumables called the CompuFlo Epidural consumables. The instrument has a list price of $14,995, and the CompuFlo disposables are priced on an average selling price to the marketplace, dependent in the range of $200-$250 per patient procedure, dependent on the volume that the clinicians are using.
So high-margin business, and a unique technology that we are proud to introduce into the medical space of epidural anesthesia. A little bit of repetition of what I already alluded on is that the technology has been cleared by the FDA, most recently in February 2023. We got an indication expansion, an indication widening, apart from the lumbar, also including the thoracic and the cervical thoracic junction of the spine, which means that we are increasing the accessibility of the total addressable market of these nine million epidural steroid injection procedures that are performed in the United States on an annual basis alone. The technology is patent-protected.
In particular, I would like to highlight this display, which is nothing more or less than an ECG or a pulsatile waveform that you can detect when the needle is placed in the right way in the epidural space. So in other words, what you would see if you inject and placing the needle with our instrumentation, you will see on the screen the pressure build-up. So you'll have a visual increase of pressure, and then later on, a loss of resistance, so a reduction of the pressure, as well as a change in audio change in sounds, and thirdly, the presence of this pulsatile waveform, three confirmations that the needle is placed in the right way in the epidural space.
The way that we position it, it is actually, quote-unquote, "a GPS system," a navigation system of placing an epidural needle in the epidural space on the trajectory for an epidural anesthesia. I think that's one of the main highlights of the technology or the technical aspects of our offering. It offers real-time needle location and verification, and it definitely supports the increase of the physician's confidence in terms of resulting in fewer attempts. It accelerates the learning curve, so we also have been able to position this instrument and this technology in teaching hospitals, teaching institutes, for residents on their way to become an anesthesiologist.
More importantly, we have reported no dural punctures in our clinical research and in our clinical studies, and that is important because not only the benefits of being predictable, higher efficiency, more comfort, safety aspects, the cost of litigation can be avoided. Now, in the United States, in our market, the cost of litigation is remarkably high. There are cases reported all in the range from $500,000 to $15 million dollars for cases where these procedures have not been performed in the most optimal medical professional way. And for institutions and care physicians, the cost of litigation is reduced to zero by simply using a technology like ours. From a financial and a business perspective, the chronic back pain relief market is gigantic.
Not only millions seeking chronic back pain relief, it's also one of the fastest-growing market segments or procedures in this medical environment that we are behaving in as we speak today. As I alluded on earlier, there are about nine million epidural steroid injections performed annually in the United States, which is representing a $2 billion market. Now, what is important always in healthcare where we are acting in as a company, we always have to respect, and are respecting, of course, the healthcare system, and it is of utmost importance that there is coverage by reimbursement.
So this slide is actually showing you what is the split between what we call the commercial payers, or the private payers, or the private insurance, which is representing about 60% of all the patients in the United States, of these nine million epidural steroid injections, and the 40%, which is covered by Medicare insurance. And what is important for the company is at least that you make inroads and that you get payment rates granted by Medicare in those jurisdictions, because then there is a sort of a general policy by Medicare for allowing clinicians using the technology as we have that CPT code, allowing the clinicians using this technology, and at the same time, also get reimbursed for that.
Most recently, in the month of July, we received a positive payment assignment by Medicare in three jurisdictions in the amount of $325 for the clinicians once they are using our procedures, in addition to a primary code for the epidural steroid injections. So in other words, Medicare accounts for 40% of these total procedures, with a total ESI volume then valued versus and times our ASP, which is then giving you a valued market segment of $800 million immediately. So doing the same math, 40% is the equivalent of $800 million; 60% is then the equivalent of $1.2 billion.
What happens, of course, is that private payers and commercial payers, it's a little bit of different markets for companies to act in, because every individual has different payers in his own private insurance plan, his own deductible. So there is not always a general statement that you can make other than that the private payers will, of course, follow the payment rate that has been granted by the jurisdictions, by Medicare. Like I said, we recently received patient payments granted by the Medicare insurance providers in three jurisdictions as of July 23rd, 2024. That gives us, as a company, the fantastic opportunity that we are covering about 30% of the Medicare ESI procedures as of today in these jurisdictions.
So in other words, these three jurisdictions is covering 30% of the Medicare ESI procedures in the United States, so roughly one-third of the U.S. market. In particular, the jurisdictions in New Jersey, in Florida, in Texas, so not only in those states, but also surrounding states around Florida, New Jersey, and Texas. That equates to initial target market for us of $250 million. Now, in other words, if you do the math again, and we look at the pie, so the initial target market that we are targeting is 12% of the overall market in the United States, so that is what we call a near-term market. But more importantly, these three jurisdictions, we also have a presence in an additional four. In the United States, there are 12 jurisdictions.
We have actively been working in seven, we have coverage in three, and as we speak, we also want to enhance further in these other jurisdictions. Now, the additional four jurisdictions would mean for us that there is an expanding in this jurisdiction, which is then representing an additional 30% of the Medicare procedures. So in other words, initial market segment, 12%, we add in an additional 30%, so we're trying to increase our market penetration in these additional jurisdictions in the United States. What are the benefits of the Medicare reimbursement? Well, there are numerous benefits. Apart from the increased accessibility, what it brings is that patients can benefit from safer, more comfortable, more predictable, higher efficient procedures, taking the fear and the anxiety away of these procedures.
Definitely, the predictability, the enhanced patient outcome is key because there's a reduction of the complications. There's no dural punctures. It leads to better patient outcomes, and it increases the satisfaction rates. Now, in other words, what we are trying to do here is taking drug delivery from the nineteen hundreds to the twenty-first century, increasing healthcare outcome at a reduction of cost, right? And the support of the healthcare providers is, is, yeah, pretty impressive because now with the technology that we are offering, there is an advanced pain management solution available without necessarily high financial barriers for the healthcare providers. And again, it increases the quality, and it improves the quality of care that we, together with the clinicians, are able to provide.
The question is always then, okay, now we have all these tools in the toolbox, and how are you going to commercialize a technology like ours? So on purpose, we have taken the decision not to invest heavily in our own direct sales team. In other words, having a heavily loaded number of people on our balance sheet. First, we are not in the position of doing that, but I've been in that market in past experiences and in past roles and responsibilities, and building up a sales team of 40 people, it's very costly, it's not necessarily a guarantee of success, therefore, we took another route. And the way that we approach it is that we want to have a laser-focused, very disciplined commercial rollout by partnering with partners that know the market better than we do.
It sounds perhaps a little bit weird, me saying that they know the market better than we do, but at the end of the day, it's the essence of what we are doing, because we did have a long experience in the dental business. We are new in the medical market, in the anesthesia market, and in the pain segment market, and there are numerous companies that bring that expertise that we are not having. So therefore, we are very proud and happy that we have a strategic partnership with Axial Biologics to distribute the CompuFlo in the New Jersey, Texas, and Florida jurisdictions. They know the key players in the marketplace. They have a vast network of the right clinicians, the right private clinicians that can benefit also from the reimbursement and from our technology.
And, as of the middle of the month of August, towards the end of August, we really started by reaching out to these pain institutions, these private pain institutions, thereby getting them access and getting the feedback of using our technology, not only from a reimbursement perspective, but more importantly, of course, still that we have to follow the clinical benefits, the clinical efficiencies, and all the advantages that we provide for them by using our technology. Axial Biologics has about 30 people on the ground. They have expansion plans to reach more than 40-45 in the first quarter of 2025. So we are very pleased with that partnership that we have been able to release and to announce also a couple of weeks ago.
At the same time, in addition to that, we have, of course, our own people. We have currently four sales people, including myself, for rolling out and helping training Axial Biologics, but also doing demos and trials in the OR in the private pain clinics, thereby further increasing the penetration and the adoption of our technology. For those jurisdictions and markets or states where we currently are not present, we continue to coordinate and work closely together with so-called advisory sites that are helping us in sending in the reimbursement and the documentation needed to get payments granted, hopefully by these other jurisdictions. What I did in the first part of this presentation is that it's specifically refocusing on the epidural steroid injection.
We have the legacy business, the dental business, but now it's time to move forward. So of course, what you should always bear in mind is that wherever the hypodermic syringe is used, our technology could apply, and this accounts for the cosmetic market segments for the injection of botulinum toxin. But I think closer by where we already have made inroads is, of course, the epidural analgesia during labor and delivery, which accounts for 2.4 million procedures out of 4 million births per year. So in other words, more than 50% of the women giving birth, they choose for an epidural analgesia during labor and delivery.
And it also gives us another opportunity to introduce another product, which gives a lot of benefits and advantages for the management, the pain management after the woman giving birth to a child. Because there's a risk that catheters can be dislodged and can be displaced. So in other words, the drug is not delivered continuously to the woman. And by just adding a new set of tubing to the catheter, which is still in the placement, and you would see the pulsatile waveform that I alluded on in the first part of the presentation. Within a minute, you have the confirmation that your catheter is still in place. Instead of what is happening today, giving a bolus injection, wait for 45 minutes, thereby causing unnecessarily pain for the woman.
So for us, very importantly, we do whatever we can to also increase and improve women healthcare outcomes, in particular in this market segment. Then another area that we would open up for discussion with in strategic partners is in the field of peripheral nerve block. In the U.S., it's estimated another eight million procedures performed annually. And we have been granted a patent for peripheral nerve block in the U.S. and in Europe. And as we speak, we are open for any strategic partnerships of companies that have a better presence in this segment that can help together with us a joint development of making this technology also tailor-made for peripheral nerve block.
So all in all, what we do then is adding a specific addressable market of an additional $1 billion in the U.S. alone. In summary, we are a leading developer of computer-controlled injection technology, drug delivery devices in the dental market and needle placement and verification in the epidural anesthesia market. We have proven success. This is not just a new technology without the support of clinical documentation. In the dental market, we have 70-plus clinical publications. We have done our homework in the medical market in a shorter period of time, of course. Like I said earlier, 12 peer-reviewed clinical trials in well-known national and international clinical journals.
And from a business perspective, there is a unique opportunity for our company in a $2 billion high margin recurring revenue opportunity. Margins that we estimate are in the range of 80% or more, depending on the pricing that I alluded on earlier. It's FDA approved. It's also approved in European markets, where we have an international distribution network that we are setting up. And more importantly, there's another 20-plus year patent coverage for this technology. So, a very solid and sound new technology that we bring to the market, in particular, also in the medical market segment. Our main short-term focus is to expand reimbursement, not only Medicare, but also looking more into and getting a foot in that market for commercial payers and private insurance payers, as well as growing in our distribution.
Because we are a small entity, a small-size organization, and I've always said we cannot do it alone. Thereby, you know, we're having then the partnership with Axial Biologics. And as we speak, also outside of these jurisdictions, we foresee to add more distribution partners, creating more feet on the ground, thereby increasing penetration and adoption of our technology in the marketplace. High incremental margins of 80%, that I already mentioned. And what you need to know is that our dental business is cash positive as a standalone business. We have been able to have a net profit of the dental business in the fiscal year 2023 of $2.2 million. But of course, we have investments to make in the medical business segment as well.
But according to our estimation and our calculations, only 40,000 ESI procedures run rate is needed to result in a break-even result for our company. And that is exactly the game plan, to accelerate the adoption and the penetration in the marketplace so that we can enjoy, you know, a cash neutral quarter, hopefully, in the year 2025. The team, apart from myself, it's more important that I highlight the team. I'm very pleased with the management team we have.
Mark Hochman, he is definitely the champion and a world-class authority in the computer-controlled injection technology, a periodontist by education, who has invented the technology, has also hold the patent, and we have the rights to all the patents that he submitted and have been approved. James Hibbert, that joined our company in the beginning of this year with a good background in sales and business development in a variety of market segments. Keisha Harcum, which is a VP of Finance, based on her education and her you know tenure with our company, this is a classical example of a person, an individual, you know, that have worked up the ranks in our company, starting many years ago, and is now heading our finances team as a vice president.
All people having a solid background in the area of expertise that they are presenting and what the company is needing. Apart from these people, I'm very happy with the other team members that we are having in building this company and driving this company and growing this company moving forward. I'm always available for any questions you might have. You see my email. If you have any questions, please send me an email. I'm always accessible. I always like to tell the story of our company and to make people more enthusiastic, so please do not hesitate to send me an email at j.haverhals@milestonescientific.com, and you will get an answer within a couple of hours, perhaps even minutes.
That is always my, my goal, to be very responsive to anybody that seeks information about our company. Thank you for your time. Enjoy the conference, and I might see you during my one-on-one meetings during this conference. Thank you again, and have a great day.
Yeah, thank you very much for that presentation. Very thorough and appreciate your participation in the event here as well. I will remind everyone, as you just said, if you'd like to schedule a one-on-one meeting with management here, you can shoot me an email. Again, that's Blum, B-L-U-M, @lythampartners.com. Or again, visit the website lythampartners.com/fall2024, and click on that Investor Registration button. Even if it's not today at the event and we can help to schedule something afterwards as well, we'd be happy to help coordinate there. So, Arjan, appreciate your presentation. I hope you enjoy the conference, and I'll talk to you soon.
Thank you so much.
Thank you.