Milestone Scientific Inc. (MLSS) Earnings Call Transcript & Summary

May 5, 2020

NYSE American US Health Care Health Care Equipment and Supplies special 50 min

Earnings Call Speaker Segments

Operator

operator
#1

Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Milestone Scientific CathCheck Business Update Conference Call. [Operator Instructions] Please note the conference is being recorded. I will now turn the conference over to your host, David Waldman, with Crescendo Communications. Thank you, you may begin.

David Waldman

attendee
#2

Thank you, David, and good morning, to everyone, and thank you for joining Milestone Scientific's CathCheck Business Update Conference Call. On the call with us today are Len Osser, Interim Chief Executive Officer; and Dr. Hochman, Inventor and Director of Clinical Affairs of Milestone Scientific. If you have any questions after the call or would like any additional information about the company, please contact Crescendo Communications at (212) 671-1020. The company's management will now provide prepared remarks on recent developments related to the company's CathCheck system. Before we get started, we would like to remind everyone that during this conference call, we may make forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's report on Form 10-K for the year ended December 31, 2019. The forward-looking statements made during this call are based upon management's reasonable belief as of today's date, May 5, 2020. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. With that, we'll now turn the call over to Len Osser, Interim Chief Executive. Please go ahead, Len.

Leonard Osser

executive
#3

Thank you, David. Good morning, and thanks to everyone for joining us on the call. There have been many noteworthy developments surrounding our CompuFlo Epidural System, including new innovations in our technology, such as Quick Start and CathCheck as well as a successful economic study that was recently presented at the American Society of Regional Anesthesia and Pain Management, which validates the cost savings of our technology, which is quite significant. I realize it's unusual for us to host an investor call right after our year-end call and given our upcoming Q1 call. But I wanted to take this opportunity to have Dr. Hochman and myself discuss the importance of these milestones and answer questions from investors. First, I would like to recap some of the developments that transpired over the past year that helped us to get to where we are today. To begin with, we successfully trialed our CompuFlo Epidural System in multiple hospitals, placing the system with key opinion leaders while continuing important clinical studies and working closely with anesthesiologists in the U.S., Europe and in some cases, South America. We also completed and published 9 clinical studies, which further validated the CompuFlo Epidural System's ability to safely and effectively identify the epidural space. This month, we announced completion of an important economic study comparing the total cost of the CompuFlo Epidural System versus the standard of care, which is the loss of resistance technique. Due to the COVID-19 pandemic, the planned presentation at the 45th Annual Regional Anesthesiology and Acute Pain Medicine Meeting was canceled, but the scientific session and poster sessions were posted online so that the researchers could present their findings. The data was presented by Professor Rovnat Babazade, MD from the University of Texas Medical Branch at Galveston, Department of Anesthesiology. This is a nationally recognized university and the study results reflect over a year's effort compiling the data. Specifically, the study analyzed the cost of CompuFlo versus the present standard of care, conclusively demonstrating the economic benefit of our system, and why it is important for us, as investors, to understand, these were very significant findings. Professor Babazade concluded, and I quote, "To our knowledge, this is the first study in the literature, we report cost of the real-time pressure sensing technique and the traditional loss of resistance technique in patients requesting labor epidural anesthesia. Compared to the traditional loss of resistance technique, real-time pressure sensing technology cost about $504 less per patient in a hospital stay in the average hospital stay." Let me expand on the significance of this for a moment. If a hospital has 12,000 births per year and you assume $70 per disposable, which is ample margin for Milestone Scientific, and you apply a $500 savings per patient, assuming all patients use the CompuFlo, which would have to be the case because the doctors do not know in advance which patient will have morbidity. That institution alone would save over $6 million per year using our product. There is no question the economics favor our product versus the [ prior auth, ] which, by the way, was invented in the 1800s, and it's using a technique today that was developed in the early 1900s. This is the first major study to clearly validate the cost benefits of the CompuFlo Epidural System and was the final phase of our strategy, which we needed prior to commencing full-scale commercialization. We now have all the pieces in place, including support from leading key opinion leaders, global patents and broad regulatory approval, including the U.S., Canada, Europe and other markets. We have performed thousands of injections to date, and I am pleased to report all of these procedures performed as expected, no complications. As far as we're concerned, the product is now proven in terms of efficacy, and doctors are more than satisfied in terms of both safety and efficacy. We strongly believe our technology has the potential to transform the industry, and our goal is to become the new standard of care. Our technology is about providing the best possible care for the patients, which is why we continue to evolve and innovate our technology. Dr. Hochman will discuss our recent technology innovations in more details later on in the call. Turning now to our sales pipeline. We have a number of trials underway with hospitals. However, obviously, with the ongoing pandemic, the hospitals are in lockdown and no vendors are allowed to visit. Clearly, they have other high priorities at the moment, so some of our activities have slowed. But in the meantime, we're doing everything possible. Instead of in-person meetings, we're having phone calls, sending out marketing materials, including the economic study results and more. The interest has not waned and in fact, interest in certain applications of our technology has actually increased significantly in light of COVID-19, which I will discuss in a moment. But as you can imagine, it's been very difficult to get time from these institutions to do the planning, budgeting and get the necessary committee approvals at this time. That said, we are more encouraged than ever and expect to announce further developments in the near future. At this point, I'd like to turn the call over to Dr. Hochman, Clinical Director of Milestone Scientific, to go over the latest innovations in our technology. I will be back at the conclusion of Dr. Hochman's discussion. Please go ahead, Mark.

Mark Hochman

executive
#4

Thank you, Leonard. Last week, we successfully validated and integrated the new CathCheck feature into the CompuFlo Epidural System. This was an important milestone as CathCheck marked a technological leap forward in both the capabilities and intellectual property surrounding the CompuFlo Epidural System, adding another 20 years to our patent protection. This capability makes CompuFlo the first and only known commercially available instrument that can identify the presence of a pressure waveform signal and that can be used to confirm proper placement of a catheter, and this can be accomplished in an objective way in seconds as opposed to using the conventional subjective method taking up to 20 to 40 minutes. Using CathCheck, physicians and nurses cannot only determine what is the objective pressure at the tip of the needle, but now can monitor the presence or the absence of a pulsatile waveform to determine the presence and the proper placement of a catheter. The pulsatile waveform correlates to being in the epidural space, thereby providing important new information that can be used to determine if the catheter is in place or has become dislodged from the epidural space. Importantly, this capability saves time and money and provide better patient care. Traditionally, the only way to verify placement of a catheter was through the injection of a bolus of medication and then waiting an extended period of time to subjectively monitor a patient's response. With this new feature, physicians and nurses can verify in real-time that the catheter is placed correctly. This enables them to more easily verify the catheter. The confidence gained with CathCheck and its ability to check catheter placement crosses over to the epidural procedure itself, where physicians and anesthesiologists can now use the CompuFlo to further verify catheter placement during and after the epidural procedure as well as providing supporting documentation throughout the procedure. From the standpoint of the hospital, we've discovered during clinical evaluations that checking catheters throughout the day not only takes a lot of time, but is costly to the institution. Epidural catheter dysfunction is something that needs to be assessed on a regular basis for patients. For example, obstetric patients who had an epidural procedure during childbirth may typically have an ongoing catheter that will need to be reassessed. The average hospital has anywhere between 6 to 10 patients per day and larger hospitals have as many as 20 to 30 patients per day or more with catheters that are remaining post birth. It is estimated that 1/4 to 1/2 of these patients will need catheter reevaluation during their stay. During the reevaluation, the patient is typically in pain and demanding additional medications. With a dysfunctional catheter, physicians have to determine quickly if it is an issue of drug dosage, catheter migration or a catheter blockage. As I said before, the conventional technique currently takes anywhere from 20 to 40 minutes with an endpoint that is not always clear. CathCheck provides objective monitoring and that clear endpoint, as it provides the presence or the absence of the pulsatile pressure waveform in just seconds, providing critical and important information for the physician to use when determining proper catheter function. If proper function of the catheter is not found, then the patient may have to undergo either further epidural procedures for the placement of a new catheter. That decision can be the difference between immediate comfort or additional procedures to be performed. Given the number of patients with catheters, we believe the CathCheck feature will help and make a significant difference in the reduction of time, cost as well as the benefits to the patient I've described before. More importantly, we believe CathCheck will help improve the overall patient experience by ensuring that patients get the necessary medications when they need it and without further delay. This is our first application of this technology and our current CompuFlo Epidural System, we believe there are many other applications for this technology in the assessment of catheters and other medical procedures. As you can see, this represents an exciting new market opportunity. The most recent development, which Len will expand upon, is that we are now being approached by hospitals interested in CathCheck to help protect both patients and physicians during COVID-19 pandemic. We are now piloting the use of the CathCheck in a major hospital in the United States. This trial is ongoing, and we are receiving encouraging feedback from the doctors. While we are still in the early phase of this pilot, we are optimistic by what we are seeing. We also recently announced the successful implementation of the Quick Start pathway into the CompuFlo Epidural System. The Quick Start pathway simplifies and provides an alternative means to reduce the procedural time to the CompuFlo instrument prior to the procedure. In addition, we're exploring ways to make the use of disposables even more efficient, and we will be providing an update on this as we reach these new milestones. At this point, I would like to turn my talk over to Len. Thank you, Len.

Leonard Osser

executive
#5

Thank you, Mark. I'd like to take a moment to expand on the benefits of CathCheck being that many investors have called, not quite sure of what it would mean. And that's why we have decided to have this call. I'd like to take a moment to explain how it came about that we are now being approached by hospitals interested in CathCheck to help protect both patients and physicians during the pandemic. CathCheck, as most of you may know, was originally developed by Dr. Hochman, who is the world's authority on computerized injections. It started with the fact that our 510(k) for the CompuFlo deals with location. When a patient has an epidural for labor and delivery, there is a catheter placed in the epidural space that is used to relieve the pain, both during and after delivery. The catheter is left in the patient and taped to the patient's back. The patient is then placed on a gurney, moved to recovery. Then on another gurney, moved yet to the final room. As you can see, there is a lot of movement. That catheter is connected to a pump and the pump is pumping pain relief medication into the supposed epidural space. If the procedure -- if after the procedure, the patient is experiencing pain, the anesthesiologist doing the rounds has to determine why the patient is experiencing pain. As Dr. Hochman mentioned, there are only 2 possibilities: Either the patient is not getting enough pain medication or given all the movement, there is a good possibility that the catheter has been dislodged from the epidural space. So the medication is no longer going into the epidural space. To determine which of the 2 events may have occurred, anesthesiologists will pump a large amount of medication into the patient through the catheter and typically wait for 20 to 40 minutes. This is a great deal of time and money lost to the institution while the patient remains in pain. If the patient is no longer in pain, after that procedure the anesthesiologist determines that there was not enough medication initially, so they can increase the dosage. But if the patient is still experiencing pain, the anesthesiologist will come to the determination that the catheter has, in fact, been dislodged. At that point, you've wasted an average of 30 to 40 minutes to make the determination. This represents a great deal of time to the patient, but secondly, a great deal of cost to the institution. We can accomplish this with our device in under 10 seconds, and we can determine definitively whether the epidural catheter is in the right space or has been dislodged. This is a substantial savings of time and money and an obvious substantial benefit to the patient. In terms of COVID-19, this all started when we received a call from a major university hospital in the United States that was already familiar with CompuFlo. Previously, they had expressed interest due to the cost savings and the benefits for patients. However, they called us this time specifically because their doctors and nurses have been handling patients with the virus, and they immediately recognized that the less you handle the patients, the less you are subjected to the possibility of contracting the virus or transmitting the virus. They pushed for us to get them the instrument and disposables as quickly as possible. And within a short period of time, we were able to get them started. We are now in a pilot program and they are actively using it on patients. The feedback thus far has been positive. It's worth noting that the extended use of CathCheck post epidural procedures means potentially more disposables used by the hospital during the course of the patient's stay. It is also important to point out that the market for CathCheck goes way beyond the epidural market. As long as the catheter is going somewhere with a pulsatile waveform, meaning that we can read the heartbeat, we can apply this technology to a very broad array of uses within the hospital setting. We have also explored other opportunities that will allow us to further leapfrog our own technology. So to summarize, the use of our technology demonstrates the versatility of our platform. In this case, it minimized the contact between the patient and the provider. In addition to less contact with the patient, it provides the healthcare provider, for the first time, a definitive tool to ensure the catheter is in the right place and has not been dislodged. In a period of time, that is -- takes 30 to 40 minutes to under 10 seconds. Beyond COVID and beyond epidural procedures, as I have always said, there are countless other applications for our technology. And we have barely scratched the surface. That said, as a small-cap company with limited resources, we've been very focused on the epidural market, where we know there is immediate demand, an unmet need and limited options for patients and providers. We believe this is a very exciting time in our company, and we continue to make technological advancements and move forward on the commercial rollout of the CompuFlo Epidural System. One final note. We received a number of questions in terms of the dental business in light of COVID-19 as well as the rationale behind doing the recent financing when we did. As I'm sure everyone on the call understands, these are unprecedented times in terms of a major global pandemic. Obviously, most dental offices around the country and perhaps around the world are closed, given they are among the most susceptible doctors, as they are working in patients' mouths. During the turbulence in the market, we completed the financing on what we believe were very favorable terms relative to the market price at that time. Importantly, we believe this financing gives us runway for over a year. Nevertheless, we are encouraged by the gradual reopening of dental practices, which are happening now actually. At the same time, we're pushing forward with other high-priority initiatives, like the use of CathCheck to minimize patient and physician exposure during the pandemic. We believe CathCheck could become an important door opener in this market. I'd like to thank you for joining the call today. At this point, we would like to open the call to questions. Operator?

Operator

operator
#6

[Operator Instructions]

David Waldman

attendee
#7

As we wait for questions, we've also received some questions via e-mail, which I'll read some of them aloud. The first question is, given that there are close to 6,000 hospitals in the U.S., how does the company plan to reach out and provide product demonstrations to all of them in a timely manner? And along that same line, how large is the U.S. sales team? And how many hospitals are they able or planning to cover in a month or quarter?

Leonard Osser

executive
#8

Thank you, David. In fact, there are 17,490 hospitals in the U.S. in '19/'20, according to the American Hospital Association. Not all of them do labor and delivery, but most, if not all, will need to check catheters. We currently have a plan to hire 10 territory managers. We have 2 that have been hired, that work under our Executive Vice President, in charge of sales. We also plan to have 4 clinical specialists in key markets that we'll be training. Given the simplicity of the instrument, it does not require a great deal of training. Training can be done on Skype or Zoom, but we will have people in the hospital to do the original training, especially while we're still doing trials. In addition to that, in areas where it won't pay to have a sales manager, we will have distribution partners in those areas as we have in some areas of Europe. The key strategy is managed growth, which means don't expand faster than we can support. Keep in mind, though we have a good margin on our instrument, we're in the disposable business. So the placement of instruments is to sell disposables. Next question?

David Waldman

attendee
#9

How many GPOs are you currently negotiating with, and how many hospitals do they represent from low to high? And any other color you might be able to add on where you are in having one of them cross the finish line?

Leonard Osser

executive
#10

GPOs are -- basically GPOs come about when you are in a hospital, and they want to buy and they go to the GPO. Having said that, we are now speaking with 3 different -- hospitals, one has over 400 hospitals. So they're considerably large. The process at the moment is we have been accepted by one as a new technology. So we believe that we will be accepted by that very large GPO by the end of the year, being that we have no competition as to where we are. Vizient, for example, has 5,400 hospitals. Kaiser Permanente has 400 hospitals. Premier, 3,250 hospitals. It's Premier that we have been accepted as a technology breakthrough. So we are in that process right now. It's very hard to give an indication, especially given COVID-19 and people working from home, but it is our best guess that we will have that this year. David?

Operator

operator
#11

[Operator Instructions]

David Waldman

attendee
#12

Our next question. Does CathCheck catheter locating provide the opportunity outside the epidural space? And if so, how ubiquitous could it become in catheter placement across the body?

Mark Hochman

executive
#13

David, if you'll allow me, I'll answer that question. As Leonard alluded to during the presentation, we believe that the catheter technology that we've developed here can be outside of the epidural space. Specifically for the CompuFlo, as you know right now, we're using it for checking catheters after epidurals are performed, and we're quite excited about that. But if you think about the physiologic parameters that are used for this, what we are sensing is the heart rate and that pulse wave that's generated through the cardiovascular system. So therefore, we believe that if a catheter is placed elsewhere in the body in one of those locations where you're trying to detect the cardiovascular system, you should be able to detect that. Right now, we've optimized it for the epidural procedure, but we believe that there will be other applications and other catheters that we should be able to apply this to in the future.

David Waldman

attendee
#14

Our next question, the product is 3 years post FDA approval without a big name winner. As an investor, could you provide in a few short sentences why it's taken so long, and why it's different this time around?

Mark Hochman

executive
#15

Leonard, if you would permit me to just start the answer to the question, then I'll turn it over to you. But from a technological standpoint, the way that I see it is that you can understand and appreciate that in order to get all of the different components to the program together for the commercial sale, we needed to go through several different phases of this. And this is not unlike other products that are out there in the anesthesia sector. One in particular that many people have brought to my attention that's very analogous to this is a product called video laryngoscope, which is now the standard of care in anesthesia for intubating patients. When you intubate a patient, they previously used or conventionally used what they called a laryngoscope, which was just a blade that was placed down the patient's throat so that you could place the tube then, which was actually the intubation tube. About 8 years ago or 10 years ago, actually somebody came up with a clever idea of just putting a little video camera on the tip of the -- that scope that allowed you then to see where you were going. And the reason I bring this up to you and use it as an analogy is that initially the whole profession of anesthesiologists, there was a tremendous pushback of integrating this into clinical use because they felt that they already had a very proven technique of providing this care. But then what happened is people realize for those really challenging patients, the ability to see actually the larynx when you're placing the tube in, even though in certain situations, they were able to do it with the conventional technique, this was a far simpler, much more predictable and much easier, as you can imagine, to train residents with. And after 5 or 6 years now, this has now become the total standard of care in anesthesia. So going back to the original question, we're only 3 years post the FDA approval, it's an analogous concept. Many times when something comes in that's so innovative, it takes a while for the profession itself to realize those improvements. And I think that's kind of an analogous situation that we're in with the CompuFlo, but I'm very excited about the future. And particularly now that we've pretty much released our own technology with CathCheck, I think that the perception of what this instrument and the technology offers is becoming much more clear to individuals. Leonard, would you like to add to that, please?

Leonard Osser

executive
#16

Yes. As we move ahead with the product and move into the market, irrespective of focus groups, we've had to make a number of changes. We originally made the product, for example, with a number of screens in the computer, which the doctor would have to go through. They don't want to spend the time on that. They want to go right to Quick Start. So we had to advance and change the software, which has already occurred. We had a disposable, which requires less than 2 minutes to put together. The doctors felt that took too long. So we are redoing the disposable -- not redoing it, we're putting it together ourselves and sterilizing. So there are a number of things that we have had to accomplish. We had a setback. Most unfortunately, one of our team members passed away from the virus. That team member was with us for 15 years and headed up regulatory approval. We have someone else coming into the company now, on the 11th of this month. So a number of things have transpired. We're trying to reach out to the market and accommodate what their needs are, and we feel that we have done that in a number of cases already. There's one more case with the disposable that we are working on, that will happen. It's not a technological advancement. It's very, very simple, but unfortunately, everything requires a number of weeks to get to that point. David?

Operator

operator
#17

[Operator Instructions] Our first question is from [ Richard Durando ].

Unknown Analyst

analyst
#18

Yes. Leonard, could you talk about IP relationship in regards to China? Do they have access to IP rights? And if so, what are they? And then if not, how concerned are you with reverse engineering and things like that, that sometimes the Chinese are accused of doing?

Leonard Osser

executive
#19

Well, there's always a concern with that. We don't manufacture our computers anywhere other than in the United States, and we have worked with this company for over 20 years in the United States. We don't share that IP with any other country or any other company. We have a joint venture in China in the dental area, but they do not have access to the IP. They are a distribution company. So Mike, I don't have any specific concerns regarding what we are doing with our IP other than one would normally have in any other country, whether it's South Korea, China, or anywhere else. I don't think we're affected any more than any other company would be.

Unknown Analyst

analyst
#20

That's great. And then can you comment on your sourcing for the VA. You said maybe a couple of months ago that you needed to get secured sourcing before the VA would use your products? Is that -- how far along is that process?

Leonard Osser

executive
#21

It's -- well, it's very -- it's not very far along. It's far off. The problem is it's not solely the VA. It's any government purchase, whether it's for the VA, Bureau of Indian Affairs, the military, you cannot have a Chinese part in that product. We have Chinese parts in some of our products. So to go through resourcing and changing all of that would take a considerable effort on our part. So what we've decided to do is put that aside for the moment, concentrate on Europe and the United States for sales and put all of our effort in that. As soon as we move along on that, then we will work on sourcing other parts. We've already looked into certain other parts, which we can exchange for the Chinese parts, but it is not in the near future for that to happen. We're not putting our energy into that at the moment.

Unknown Analyst

analyst
#22

So don't look for anything until the end of the year, I guess, is what you're saying?

Leonard Osser

executive
#23

Yes. I think that between the fact that, that would take a lot of energy, a lot more cost and being that we're in the pandemic at the moment, that certainly exacerbates what we were trying to do with that. So I would not look for anything for that to happen for the next 6 months or so.

Operator

operator
#24

Our next question is from [ John Bronza ], a Private Investor.

Unknown Attendee

attendee
#25

I had a question for you as far as the cost savings. I did read that article that was put out by you, where the cost savings was $504 per case involving the labor and delivery. So not having seen much more than that, and I don't recall all the details, so this cost savings did not include the cost savings that you alluded to with the CathCheck?

Mark Hochman

executive
#26

Well, the CathCheck is -- that is correct. It has nothing to do with that. The CathCheck is -- it's a different -- it's a change in the software in the same instrument, but it's a different disposable and that's used for a different purpose.

Unknown Attendee

attendee
#27

So -- but you mentioned that during the labor and delivery procedure that the CathCheck may have to be checked 1 or 2 times, and there was a cost savings because the anesthesiologist wouldn't have to spend an hour. That was -- that -- those cost savings are not included in the $504, is that correct?

Mark Hochman

executive
#28

That's correct. It's certainly apart from that. Yes.

Unknown Attendee

attendee
#29

Okay. Okay. And then the -- one other question, the $504 cost savings, I didn't maybe quite catch what you had said earlier. But you said that there was about a $70 cost in disposables that the hospital had to pay through a labor and delivery procedure with the Milestone disposables?

Unknown Executive

executive
#30

Yes. We have a list price of $125 on our disposable. We're looking now at discounting and selling to the hospital, to the end user, at $70. So if you look at -- if you -- the study done in Galveston took into account a $70 cost to the institution. Taking that into account, the savings would be $504 per patient.

Operator

operator
#31

Our next question is from [ Ricky Salman ], a Private Investor.

Unknown Attendee

attendee
#32

I'm just looking at your balance sheet after the last financing. Are you comfortable with your cash position through the year and through, like, wide-scale launch?

Leonard Osser

executive
#33

I'm comfortable with our cash position over the next 12 months. We raised, obviously, we try not to dilute our shareholders. We raised the least that's necessary, but we don't ever want to wait till the last minute to raise capital. We're...

Unknown Attendee

attendee
#34

Right. But presumably -- presumably you'll be in a much better position to raise capital at a much more reasonable price than when you're launching at hospitals and the like. Is that your feeling?

Leonard Osser

executive
#35

Absolutely. Yes. Yes. But for now, with our present program, we're comfortable that we have a year.

Unknown Attendee

attendee
#36

Great. And just to piggyback on the last question. So the additional savings -- additional cost savings to the hospitals from the other -- the other gentleman was just referring to. Is that likely to be a bigger number than the $500 per procedure average? Or is it similar?

Leonard Osser

executive
#37

Yes. It's likely to be considerably bigger because what that -- what this study looked at primarily were the migraine headaches and a 2-day stay for the mother and the offspring. Looking at that, it did not take into account litigation. And litigation will be getting obviously much larger in this sector because there's now an alternative. I mean litigation prior to this, as far as we've been able to discover, they're not our numbers, was approaching a settlement of $400,000 per occurrence in the United States. However, when you look at, for example, this is about 2 months ago. I won't mention the hospital, but a woman was in labor. They weren't in the epidural space. She was in pain and they kept putting in more and more boluses, large amounts of the drug, and it was not going in the epidural space. And they put in so much that they paralyzed the woman. The woman was not even able to hold her baby. She -- I think she spent about -- I'm not certain with the timing, but about 3 months -- 3 weeks in the hospital, and then she was moved to a nursing care facility. So obviously, we live in a litigious society. And if a doctor, an anesthesiologist, has a wet tap when the needle goes beyond the epidural space and -- such as the membrane that surrounds the spinal column, there will be morbidity. So if the doctor is on the stand, I would think the lawyer would ask, is there anything you could have used other than the device from the 1800s. And the procedure from the early 1900s. Why didn't you use it? What's the difference in success? So I would think that, that added cost to the $504 would be significant.

Unknown Attendee

attendee
#38

Right. I think so too. And what about the anesthesiologist's time, like needing so much time? That's got to be worth a lot of money for each procedure, not just the ones that are having an issue, correct?

Leonard Osser

executive
#39

Oh, absolutely. That's very, very significant for CathCheck. One of the issues that we had, as I mentioned earlier, where it took 2 minutes or less to put the disposable together. That was a gate. The doctors were very encouraged by our technology. They wanted to use it, but felt the woman's in labor, the husband's in the room. Things are chaotic. We don't have the 2 minutes. We work in seconds, not minutes. These are quotes that we've heard from them. So certainly, when you start dealing with 20 minutes, 40 minutes. This is a major savings to the anesthesiologist and the institution.

Operator

operator
#40

Ladies and gentlemen, we have reached the end of the question-and-answer session. I would like to turn the call back to management for closing remarks.

Leonard Osser

executive
#41

Well, I'd like to thank everybody for your support and your patience with us. Unfortunately, we're in this pandemic, but we're continuing as a company to do whatever we can possibly do to move things ahead. I just wanted to mention that our IP, which is very extensive and -- in all the important countries throughout the world and as Dr. Hochman mentioned, we have -- because of his latest invention, we have 20 more years. In the first instance, keep in mind that we've always leapfrogged ourselves, and there's every reason to believe we will do so again with technology. But also, please keep in mind, we are not an epidural company. We've chosen the epidural as the first product in medical to bring out because of the very long teaching curve, which is very expensive. Perhaps 90 different in vivo injections in patients by residents, 2 years, very expensive and very uncontrolled because the attending sitting next to the student with the woman in labor doesn't really -- doesn't know where the needle is, unless they use our equipment. But also the morbidity is a major factor. But the technology we have can be used in many, many different areas. We have an instrument that we brought to a certain level with Botox, an intraarticular instrument, but there are numerous areas that we could go into. The high morbidity factor for epidurals is one of the other reasons we went into it, but we could be in ophthalmic, rhinoplasty. Any area where you're using a needle, we can play a role in that and make it far better than the hypodermic syringe. So keep in mind that we have a very broad platform of IP, we keep adding to it and that the reason we're in epidurals is because it's the lowest barrier that we believe we should have entered with the lowest cost at this point. But we will be entering many other areas of medicine, including perhaps making certain products perform much better. There are products that have cost considerable money to pharma companies that -- drugs that work well, but can't be delivered because of the high pain or a problem with location. Well, that's exactly what we do. We eliminate the pain or bring it down substantially. So you can do the injection. We can also take drugs that are off-patent. You might have a $3 billion drug that's gone off-patent, and from 100%, you now have 5% market share when the biosimilars come in. However, we could take that drug, make a patented vessel and an instrument that can only be used for that drug because we have technology where we can use a military-grade chip in our disposable, which we do for epidurals. So that if you do not use our disposable, the instrument will not activate. So we can control all of this, and we could get that pharma company another 20 years of patent life using our instrument. Now certainly, they won't recapture 100%, but if it's a multibillion-dollar drug and they recapture a few points, that could be meaningful. So please keep in mind that we are not an epidural company. We will be in many other areas, and epidural is our first children into the era of medicine. So I'd like to thank you all very much for your support and your patience, and we hope to inform you shortly of some successes that we anticipate in the future. Thank you very much.

Operator

operator
#42

Thank you. This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.

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