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Cytosorbents Corporation (CTSO)

Q1 2017 Earnings Call· Mon, May 8, 2017

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Transcript

Operator

Operator

Good day everyone and welcome to the CytoSorbents First Quarter 2017 Operating and Financial Results Conference Call. [Operator Instructions] Today's call is being recorded. And at this time, I'd like to turn the conference over to our moderator, Amy Phillips, Please go ahead ma'am.

Amy Phillips

Analyst

Thank you and good afternoon. Welcome to CytoSorbents first quarter 2017 operating and financial results conference call. Joining me today from the Company are Dr. Phillip Chan, Chief Executive Officer and President; Vincent Capponi, Chief Operating Officer; Kathleen Bloch, Chief Financial Officer; Dr. Christian Steiner, VP of Sales and Marketing from Germany; and Chris Cramer, VP of Business Development. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the Company claims protection under Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today. And therefore, we refer you to a more detailed discussion of these risks and uncertainties in the Company's filings with the SEC. Any projections as to the Company's future performance represented by management include estimates as of today May 8, 2017, and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the financial and operating highlights for third quarter first quarter by Dr. Chan and Ms. Bloch. Following that presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. At this time, it's now my pleasure to turn the call over to Dr. Phillip Chan. Dr. Chan, go ahead please.

Phillip Chan

Analyst

Thank you very much Amy and thank you everyone for joining the call today. After going over a quick overview on the Company, Kathy will discuss financial highlights for the quarter after which I will cover exerted slides from the REFRESH 1 clinical trial presentation at the American Association for Thoracic Surgery Conference last Monday, and then will conclude with major initiatives for the remainder of 2017. On Slide 4, CytoSorbents is a leader in critical care immunotherapy leading the prevention or treatment of life threatening inflammation in the ICU in cardiac surgery using CytoSorb Blood Purification. Unfortunately, millions of people die every year of uncontrolled deadly inflammation from things like sepsis, trauma, burn injury, cytokine release syndrome from cancer immunotherapy, liver failure, surgical complications, pancreatitis, liver failure, influenza, and many other illnesses where inflammation plays a deadly role, for which there are no effective therapies that can control both these deadly inflammation while keeping the immune system intact. And that's where CytoSorb comes in. CytoSorb removes the fuel to the fire of inflammation, targeting a $20 billion opportunity in critical care in cardiac surgery. CytoSorb is approved in the European Union as the only specifically approved extracorporeal cytokine filter approved for any situation where cytokines are elevated. CytoSorb also removes many other different inflammatory mediators such as free hemoglobin, bacterial toxins, myoglobin, activated complement and many other inflammatory mediators in a typically 10 to 60 kilodalton molecular weight range. And CytoSorb works with standard dialysis in heart and lung machines as we will talk about later also works with standard extracorporeal membrane oxygenation or ECMO machines as well as now being patient well tolerated and now more than 23,000 human treatments up from 20,000 in the last quarter. And our goal of CytoSorb is to try to control this deadly inflammation in order to try to prevent or treat organ failure, which is a direct cause or result of this deadly inflammation that is the cause of nearly half of all deaths in the ICU today. In doing so, we hope to be able to improve patient outcomes and survival while decreasing the cost of ICU in patient care. With that, I'd like to turn it over to Kathy to talk about our financial highlights. Kathy?

Kathleen Bloch

Analyst

Thank you, Phil, and good afternoon everyone. For today's call, I will be providing an update regarding CytoSorbents March 31, 2017 financial results including product sales progress and an update around our recent equity raise and cash runway. Turning to our quarterly financial results, CytoSorbents product sales for first quarter of 2017 were approximately $2.6 million, which is an increase of 63% over first quarter of 2016 product sales of approximately $1.6 million. Grant and other income grew a 143% from $212,000 in Q1 2016 to $517,000 million in Q1 2017, and total revenues which includes product sales and grant income increased by 72% to $3.1 million in Q1 2017 as compared to $1.8 million in Q1 of 2016. Now, let's take a look at our quarter-over-quarter product sales. Our first quarter product sales for 2017 were approximately $2.6 million which were just slightly and near $17,000 below our Q4 2016 product sales. This is coming off a very robust quarter of growth in Q4 2016. And one factor that impacted our Q1 2017 sales was that in Germany, hospitals have begun to receive notification about the reimbursement amount to which they were entitled under our new dedicated reimbursement code. Many hospitals have now received this information and a new reimbursement benefit is higher for hospitals because in most cases it now includes not only the cost of the device but also the other cost associated with the procedure. And now that the actual reimbursement rate it's being established at many hospitals, it is expected to benefit future sales growth. Most importantly, the underlying drivers of revenue growth remained unchanged and management continues to be optimistic about continuing sales growth particularly with regard to the second half of 2017. So, looking at our trailing 12 months product sales, you will…

Phillip Chan

Analyst

Thank you, Kathy. There have been many requests to review the REFRESH 1 data from both analyst as well as shareholders and so we thought that we would try to do that on today's call. So, this was a study that was presented by Dr. Tom Gleason, who is the Chair of Cardiac Surgery at the University of Pittsburgh Medical Center on behalf of the three fresh one investigators. This is entitled to use of novel hemoabsorption technology to reduce plasma free hemoglobin during complex cardiac surgery throughout results of the safety and feasibility REFRESH 1 study. Now, it's been known for a long time that cardiopulmonary bypass causes inflammation. What is cardiopulmonary bypass, it is when you are trying to operate on the heart so crack hope in the chest and you expose the heart, but the heart is beating. In order to operate on the heart, you usually need to stop the heart from beating and thereby then, in order to operate on the heart, but when you do so, you need to put someone cardiopulmonary bypass that oxygenates and pumps blood the rest of the body while you do your operation. Unfortunately, this cardiopulmonary bypass despite many advances in the past still continues to generate a high degree of inflammatory mediators to specifically free hemoglobin from the hemolysis of red blood cells caused by cardiotomy suction, blood share and blood transfusions. The activation of compliment particularly C3A and C5A, which are caused by blood contact with air and artificial surfaces, the last but not least cytokines which are caused by surgery -- the trauma of the surgery ischemia reperfusion injury as well as endotoxin generation. Now, one of these inflammatory mediators, plasma free hemoglobin has long been known as a direct contributor to cellular injury, tissue injury…

Operator

Operator

Thank you. [Operator Instructions] And our first question will come from Gabrielle Zhou with Maxim Group.

Gabrielle Zhou

Analyst

So, Phil, can you walk us through your clinical plan on the REFRESH 2s trial? What the size and timeline as well as the endpoint for the study? Thank you.

Phil Chan

Analyst

Thank you, Gabrielle. So, currently we are anticipating a 300-to 500-patient trial in a patient population that is enriched for those are undergoing valve replacement surgery or again the levels of positive plasma free hemoglobin are high and the risk of developing organ injury and acute kidney injury are high as well. This is pending discussions with the FDA, but we believe that the ultimate endpoint will be a clinical endpoint such as acute kidney injury or composite endpoint, and we will have more clarification on that soon, and we will back to you with more detail.

Operator

Operator

Next, we move to the [Indiscernible] with Aegis Capital.

Unidentified Analyst

Analyst

Phil, would you walk us through the IP strategy and what happens when the -- how the competitive landscape will evolve as some of the patents expire?

Phil Chan

Analyst

We recently announced the issuance of the 32 -- of our 32nd issued U.S. patent that is expected to -- it is a composition of matter patent that is expected to comp CytoSorb in the United States. It was also issued in Russia, in Japan, China as well as Australia and New Zealand and is pending in other countries around the world. This is key patent that extends the worldwide protection of Cytosorb through 2031 and then the United States maintains it as 2026. So, we have a very broad range of patents covering both compositions of matter, methods in manufacturing, device configurations as well as clinical applications. And we believe that, this is a very formidable patent portfolio that is intended to protect our technology in many countries going forward. I think the other thing that we announced last year was the development of CytoSorb-XL, which is the next generation product to Cytosorb. And this again is a new composition of matter, material that has patent pending worldwide. And this is a particular formulation that not only removes a broad range of cytokines and inflammatory mediators and bacterial toxins, but also removes bacterial endotoxin as well which is an important inflammatory mediator in sepsis particularly gram-negative sepsis, and this is anticipated to potentially add on up to 20 additional years of patent protection. So, the competitive landscape for sepsis therapies continues to be relatively limited in terms of dose targeting blood purification, we are one of the leaders in particularly the European Union and our goal is to continue to file key patterns, but also to run faster and innovate faster as well to be able to stay ahead.

Unidentified Analyst

Analyst

Yes, thank you for the additional color. So, I am changing subject to the immuno-oncology, so mostly the CAR-T and one of the known side effects is the cytokine storm. So, would you walk us through how you think about potentially to from partnership with these drug companies? Or how do you think about these things? How do you insert CytoSorb into the process of immuno-oncology?

Phillip Chan

Analyst

Thank you. So, this despite directly to one of our major announcements for in the last quarter of the joining of the Dr. Carl June, who is the pioneer of CAR T-cell immunotherapy at the University of Pennsylvania Medical Center, and they were one of the first to demonstrate that taking someone's T-cells out of the body, putting a chimeric antigen receptor into them that makes them cancer homing killer cells, hunter killer cells and putting them back into the body can actually lead to potential cures in refractory leukemia and lymphoma patients. It's one of the -- as we've discussed previously, one of the major innovations in cancer immunotherapy in the past. And it's not just CAR-T-cell immunotherapy that causes cytokine release syndrome, which is a subset of the cytokine storm that CytoSorb is intended to treat, but there are many other cancer immunotherapies that can lead to this unwanted excessive inflammatory response. I think the joining of Dr. Carl June to our Scientific Advisory Board is tremendous validation of our technology in the cancer field. The goal of his involvement is to really help us really reach out into many different areas of cancer immunotherapy where CytoSorb has the potential ability to modify the immune system to fight cancer in a number of different ways, not just control cytokine release syndrome, but potentially actually help tune the immune system to fight cancer. So, I think that it is a part of an ongoing strategy that is underdevelopment and there are many potential strategic partners in this space. I think one of the major goals of our what we're trying to do is to get CytoSorb approved in the United States so that they can be used on label for the treatment of things like cytokine-released syndrome, and one of the other press releases that we put out last quarter was the similarity of the successful treatment cases of CytoSorb in hemophagocytic lymphohistiocytosis or HLH. It has similarities to Cytokine release syndrome and why we believe that Cytosorb could potentially help patient with Cytokine released syndrome and trick that complication of cancer immunotherapy. So, I think that this is developing story and Dr. Carl June's involvement has just been very recent and we would look to update everyone in the near future.

Unidentified Analyst

Analyst

Thanks Phil. If I could flip you one last question on the U.S. commercial strategy. So do you -- how do you think about partnership? Or do you plan to go alone in the case of partnership? What would be an ideal profile for the partner for CytoSorbents? Thanks.

Phillip Chan

Analyst

Sure, well, in the United States, we are not yet approved, but we are on the path of potentially U.S. approval by 2020 with this REFRESH trials, refresh key trial in complex cardiac surgery should everything go well. So, if we do achieve U.S. approval in cardiac surgery, our goal would be potentially to go to this market ourselves with our own direct sales force. We certainly have a lot of experience in building new markets such as what we have done in Europe and the rest of worlds. And the next thing about the cardiac surgery market is that, it is very easily targeted by relatively small sales force since most of the major cardiac surgery centers are in the major universities or public hospitals within the major cities. So that being said, it is also a market that could potentially be partnered with the major strategic player in the area of cardiac surgery. We're already working with one of the largest cardiac surgery companies in the world Terumo Cardiovascular, and we also have a lot of interest from the other major players as well. So, there is a lot of options opened, I think we are focused on trying to assure a successful REFRESH 2 trial first, but we will certainly have more detail in the future should we be able to achieve U.S. approval in cardiac surgery.

Operator

Operator

And we will move next to Andrew D'Silva with B. Riley.

Andrew D'Silva

Analyst

Just got a few quick ones here also with a couple of bookkeeping ones. First of were there any unusual stocking orders or lack of stocking orders during the last quarter may because of the dedicated reimbursement code or otherwise? And then maybe also provide small update how things are going in Belgium and Luxembourg?

Phillip Chan

Analyst

Kathy, if you want to take that?

Kathleen Bloch

Analyst

Yes, Andrew, you've always asked that question about whether there were any unusual reorders or no orders, and I would say that the answer is no. We did have a very minor decline in direct sales in Germany, which we believe is directly correlated to that reimbursement code just sort of revealing itself during the quarter. So, we expect that should resolve going forward.

Andrew D'Silva

Analyst

And maybe Christian, if you could comment on sales in Belgium and Luxembourg?

Christian Steiner

Analyst

As you know, the directive process covering not just in Germany, but also Australia and Switzerland, and we have started in Belgium and Luxembourg, and we will very soon start in Singapore. And for the most of them of the markets outside of Germany is Australia and Switzerland, I think we see a similar development as we have seen in Germany. This is a number of months delay, but as the markets also close together and many doctors are also visiting the congresses inside enter Germany and there is miles to miles growth spreading, we think that the development and also in Switzerland that it goes same way as in Germany. In Belgium and in Luxembourg, we have started much later so we need some more time to prepare the market and then I think it could go to same way.

Andrew D'Silva

Analyst

Great. Thank you very much. And then, Kathy, just a quick follow-up question, R&D was substantially lower sequentially and year-over-year for the first quarter, should we expect that to be the run rate until our REFRESH 2 starts?

Kathleen Bloch

Analyst

Yes, I think you can we are in fact seeing increased activity from the government grant program and that should continue through the remainder of this year.

Andrew D'Silva

Analyst

But below the line as just OpEx not cost of goods the actual R&D spend decline substantially, so that…

Kathleen Bloch

Analyst

So, there are actually two reasons for that. Part of it is the increased grand activity does absorb R&D cost, but the second factor that we won't see during fluid as we start REFRESH 2 is the fact that we had pretty much completed REFRESH 1 and so there were not significant cost related to our REFRESH trail activities in Q1 in 2017.

Andrew D'Silva

Analyst

Do you have an anticipation when that should ramp back up for REFRESH 2?

Kathleen Bloch

Analyst

I think we would starting to ramp although it will be gradual in Q3 and then into Q4 it will build?

Andrew D'Silva

Analyst

Okay, perfect. And then just touching on the co-marketing relationship that you established with Fresenius, it's obviously you've highlighted that is the second half of the year catalyst or event that we should we looking for? Maybe give me some inferential data point as to how the distributor base that you have in place currently is welcoming or looking at this co-marketing deal with Fresenius is obviously many several different hands in the pods when you start looking at your footprint globally?

Phillip Chan

Analyst

Yes, I'll turn it over to Chris for some more commentary, but I think that it is very important part of about the co-marketing agreement is that we meaning either CytoSorbents and its direct territories or our strategic partners as well as distributors in other countries will be the sole seller of CytoSorb in these countries. Fresenius sales force will ring in the sales for ancillary products like blood sets that are in fluids and other dialysis hemofilters that are often used with our therapy, but there is definitely a very sharp division between who sell CytoSorb which is us and who sells the other things which is them. So, the feedback that we've gotten from many of our distributors has been that this can only help drive sales of CytoSorb in their territories and I think that is actually positive. So, Chris maybe if you wanted to have a little bit more color commentary.

Chris Cramer

Analyst

Sure, thanks Phil. Hi, Andy, this is Chris. I think it still describes that it hits a nail in the head here is that the way we set this up is that FMC is really providing the introduction to their customer base and generating leads. So, the really the door open or I would for this new customer base that either our direct sale team or the distributors will continue to own. So, in terms of the control of the product and therapy and the strategic decisions about how to market and sale it that hasn’t change really what's happening is that they are getting this kind of lead generation support coming from FMC. So far we haven’t heard anything negative about that, hoping we can continue that. But just while you've asked the question I just wanted to answer and give a little bit more color commentary about where we are at with this. Right now, as we've talked about this is a second half 2017 expected launch and right now the program development is underway and they are making their progress. I would estimate that we are around 75% to the way through the design set up, and we have been very actively involved with FMC and the design of this, we're typically on a weekly call just in working through a lot of the detail things like clarifying the sales and marketing profits to make sure as Phil had mentioned, there is no confusion about who owns what coming up with joint marketing material and planning out the training and rollout strategy. So, I think it's moving in the right direction again we are still targeting a second half of 2017 rollout to the market but overall it's moving in the right direction I would say.

Andrew D'Silva

Analyst

Chris thanks that was very helpful. Phil, you have a lot of great detail about this highly trial in you prepared remarks. Now, we are just wondering, if you could refresh my memory, activated complements were not actually an endpoint that you are looking at in the REFRESH 1 trial. This wasn’t additional data point that was positive above and beyond the endpoint that you are looking for, is that correct?

Phillip Chan

Analyst

That’s correct. It was one of the exploratory endpoint but compliment has been long known as a contributor to mortality. In fact in the dialysis field, there was a cellulosic dialyzing membrane called cuprophane that actually increased activated complement that was associated with increased risk of death, and so it was actually taken off the market for that region. And activated complement is normal part of your immune system, but when it's activated unintentionally as it often in cardiac surgery, it can cause whole host of problem such as causing server tissue damage and basically compromise of your immune system and a wide variety of other complications.

Operator

Operator

[Operator Instructions] We will move to Brian Marckx with Zacks Investment Research.

Brian Marckx

Analyst

On the reimbursement in Germany, can you just kind of talk about when the new reimbursement rate became effective? I understand that it's most likely somewhat region-to-region specific, but maybe you can kind of then lighten us a little bit when it became effective? And then when you think it may be effective throughout in Germany?

Phillip Chan

Analyst

Yes, so the reimbursement, the new reimbursement code and the negotiated rates around that code, all go back to January 1, 2017. So even though that these hospitals are negotiating with your operating budgets, which includes the CytoSorb procedures like the CytoSorb therapy during the first quarter any decisions made on reimbursement rates across the Board are typically go back to January 1. And so, I think that it's just one of those things where there is a is that a little bit of uncertainty causes people just to wait a little bit in terms of ordering. But I think that what we're seeing now is that having gone through the first quarter that many hospitals have established those reimbursement rates, and as Kathy mentioned that those will be contributing now to what we believe will be accelerated orders going forward. Just to remind you in the past what we had seen is that hospital administrators have been really urging their clinicians to be very selective of CytoSorb use because the reimbursement that they are getting at that time typically only was 60% to 100% of the cost of the cartridge, but did not cover the cost of the procedure. And without looking at any of the cost benefit issues related to CytoSorb treatment and potential decreases in hospitals stay and decreased ICU stay and other things and just looking at it as a in cost and then out cost, what they have to pay for their therapy versus what they are getting reimbursed for, it was in some cases in hospitals were not achieving full reimbursements that is the value of this new reimbursement code is that now it is a much more robust reimbursement for the hospital. And we've heard from many hospital administrators that this is what they need it to be able to open up the gates to more CytoSorb usage, and I think what a lot of clinicians in hospitals around Germany have been waiting for. So, I think that it on one hand it's when we look back at it we do see an impact a little bit of an impact on waiting for this rates to be finalized and orders, but on the whole it's a very good thing because it is really removing one of the major bottlenecks, I think in economic bottlenecks in terms of more robust usage, and this is one of the major reasons why we think that particularly in the second half of the year we are going to see significant increases in direct sales and that continuation of our direct sales growth.

Brian Marckx

Analyst

Okay, that's helpful. Phil. If you can talk about REFRESH 1 and then how it can relates to REFRESH 2? What are your thoughts in terms of valve replacement surgery? And how that affects plasma free hemoglobin? Is it specifically related to the time relation how long the actual procedure is? Or is there something else regarding that increases free hemoglobin?

Phillip Chan

Analyst

Yes, valve replacement surgery is one of the most common complex cardiac surgeries that are performed in United States, roughly counting for more than half of all complex cardiac surgery cases. And so, valve replacement surgery is more or less a surrogate for those surgery that require a long cardiopulmonary bypass times, but more importantly a lot of cardiotomy suction because when they go into these surgical procedures, there is a lot of blood in the field. And in order to cut out a heart valve and repair the ring that holds the valve in place and make sure there are no leaks et cetera, you are constantly sucking blood away from the field so that you can visualize the heart valves and see where there any leaks happening. And so, this is a -- because of that high amount of cardiotomy suction, we actually see that even though the cardiopulmonary bypass times are relatively shorter than non-valve procedures, it produced much higher levels of free hemoglobin because this negative pressure suction is causing the red blood cells to explode and release the free hemoglobin inside into the blood stream. And so on one hand, what it says is that in terms of our market, it really is much larger than valve replacement surgery. It really involved those complex cardiac surgery procedures where you are sucking blood from the field a lot and where you are expected to be on bypass more than three hours or more. But it's very convenient to have identified the subpopulation for our trial because again we in the inclusion criteria of our study, we can specifically say patients under -- included patients are those undergoing multiple valve replacement or valve replacement in conjunction with another procedure. And again in the REFRESH 1 trial, it predicts those that have the highest levels of free hemoglobin and therefore are at higher highest risk of developing organ injury particularly kidney injury.

Brian Marckx

Analyst

So, it is so unclear in REFRESH 2, it would or would not -- the inclusion criteria would or would not include specifically valve replacement surgery?

Phillip Chan

Analyst

It will include specifically valve replacement surgery.

Brian Marckx

Analyst

So in terms of REFRESH 1 and acute kidney injury, do you have that or expect to have the data or where there be data on specifically on acute kidney injury?

Phillip Chan

Analyst

So, these data are included in the paper that was submitted for publication because data of data embargoes, I can't really discuss these data here today publically. But the thing of that is that, that is the goal of the REFRESH 2 study. The REFRESH 1 study was powered to look at safety and feasibility of CytoSorb therapy, but the goal of REFRESH 2 is really to look at the efficacy on reduction in acute kidney injury and other things like stroke, respiratory failure, need for vasopressor support, days in the intensive care unit and other types of clinical and cost economic and economic outcomes in a much larger study, powered specifically to look at these points. So, I think that moving forward, we feel comfortable that looking at organ injury is something that is very doable.

Brian Marckx

Analyst

Okay and as a primary end point acute kidney injury?

Phillip Chan

Analyst

Yes, so as we've said before that right now the discussion has been around the acute kidney injury versus a composite endpoint. There is some debate amongst our advisors that, if single endpoint like acute kidney injury would be the cleanest endpoint in terms of being able to say that, it reduces the risk of acute kidney injury for example. Others on our other investigators and advisors have said that a composite end point maybe the better endpoint because it enables you to power study with fewer patients, but still yet achieve statistical significance in a composite endpoint that includes many different adverse events including acute kidney injury, stroke and other endpoints. And that composite endpoint is in fact what is most meaningful to patients because when you -- when a doctor goes to a payment form consent for this therapy, I think what we've heard from a number of physicians is that the patients want to know well, does this reduce my risk of bad thing happening to me, and that's where the composite endpoint would tell you. So, I think that this is a matter of active debate right now and something that we look to finalize before very shortly.

Operator

Operator

And gentlemen, we have time one more question that will be from Swayampakula Ramakanth with H.C. Wainwright.

Swayampakula Ramakanth

Analyst

This is RK from HCW. Most of my questions have been answered, but however I was just wondering regarding some of these collaborations unfold core distributorships that you have the term and for seniors. Once, they get going, how do we think about our current, is this going to be at quarter in earlier so how does that work? Are they accounted part in the same quarter that we shift product out?

Phillip Chan

Analyst

So, we book to sell of our product when it leaves our dock, right. And so when they take the possession of the devices which is typically during transit from our facilities to theirs, that is when we book to sell. Now, we knew we are selling two different products, so the CytoSorb is the core of both products. But in for cardiac surgery, we are selling the cardiopulmonary bypass kit which includes both the cartridges the CytoSorb cartridge as well as a number of other accessory products within the kit that allows easy hook up to a cardiopulmonary bypass machine in the operating room. In the ICU, we are selling pretty much the CytoSorb cartridge itself as a second SKU and that fits right into the blood set that typically the dialysis that Fresenius sells in the intensive care unit. The third product that we have is our ECMO kit and that is yet a third product that we feel -- we will have actually a -- will be a significant driver of growth going forward given the 1,000 plus usages that we have already had.

Swayampakula Ramakanth

Analyst

My last question is in that, if we start thinking about the German situation now. How does -- how should we think about of their -- how they can have a growth of revenue especially now as you know [Indiscernible] can certainly cross the $10 million in revenue for this year. What could be the contribution of Germany assets? You did state that you just see an increased revenue rate from the constitution from third quarter, but if there is anything that's been talked about [Indiscernible] with respect to those are produced?

Vincent Capponi

Analyst

Sure, last year we disclosed Germany accounted for roughly 60% of our overall product sales for 2016. But even at these levels, it really scratches the surface of the really massive opportunity in Germany alone. We have stated previously that each of the major 400 hospitals in Germany could be a 1 million to 3 million account and we disclosed last year that actually one of our customers have now exceeded that $1 million in sales in 2016. So, we estimate that the German market is $1 billion to billion and $1.5 market alone. Right, there is about 154,000 cases of severe sepsis and septic shock in Germany alone, 10s of 1,000s of cases open heart surgery and many, many case of other critical analysis like trauma and other things. So, these are very large markets that we are just scratching a surface of. If shareholders think that we have plateaued here in what we believe is breath that refreshes no pun intended, but if they think that this is a plateauing of our sales, I would be very pressed argue that point because we believe that we are just getting started and this reimbursement is really the key to much broader usage in job to of sales through Germany moving forward.

Swayampakula Ramakanth

Analyst

Thank you Philip, I may have one last question. On the PR, you had introduction of VetResQ products for the animal health industry. Could you kindly elaborate a little bit more about this product?

Phillip Chan

Analyst

So, that rescue is a product that has similar underlying technology to our CytoSorb technology. It is designed to actively remove a wide range of inflammatory mediators that are present in animals particularly domesticated animals like cats and dogs, but also for high value animals like horses and foals to reduce these inflammatory mediators and toxins that our present in a wide variety of illnesses such as sepsis, pancreatitis, trauma and other things just like humans in fact. And so, it was because of demand from or request really and from existing veterinarians that we bring this product to the market for that market in the United States. This is not the core market for us -- this is the core market that we're focusing on. Clearly, it is the human clinical market for CytoSorb, but I think that it is a very important market to many people particularly to those who have pets, and we have made the products now available in those centers that provide dialysis and blood purification services.

Operator

Operator

That concludes our question-and-answer session at this time everyone. For those of you having questions that we weren’t able to address today, we apologize and we ask that you please contact amyvogel@investorrelations with these questions. And at this time, I would like to turn the call back to management for any additional or closing remarks.

Phillip Chan

Analyst

Thank you very much. And thank you everyone for taking the time today to participate on the call. We certainly appreciate your continued interest and support, and if you do have any other questions as the moderator mentioned, please contact Amy Vogel at avogel@cytosorbents.com and we'll try to get you to answers to your questions where if possible. In the mean time hopefully will have an opportunity to meet with many of you at our Annual Meeting June 6, 2017 in New York City and look forward to the next update in the quarterly call. Thank you very much.

Operator

Operator

Everyone that concludes our conference for today, I'd like to thank everyone for their participation. You may now disconnect your line.