Phillip P. Chan – President and Chief Executive Officer
Kathleen Bloch – Chief Financial Officer
Christian Steiner – Vice President-Sales and Marketing
Vincent Capponi – Chief Operating Officer
Christopher Cramer – Vice President-Business Development
Cytosorbents Corporation (OTCQB:CTSO) Q4 2013 Earnings Conference Call March 31, 2014 4:15 PM ET
Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Cytosorbents’ 2013 Shareholder Update Conference Call. During today’s presentation, all parties will be in listen-only mode. This conference is being recorded March 31, 2014.
I would now like to turn the conference over to our moderator, Donna Maricnas [ph].
Unidentified Company Representative
Thank you, operator and good afternoon. Welcome to Cytosorbent’s 2013 operating and financial results conference call. With us today 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 Kramer, 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 question 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 reproduce some more detailed discussions of these risks and uncertainties in the company’s filing for the SEC.
Any projections as to the company’s future performance represented by management include estimates today as of March 31, 2014. And the company assumes no obligation to update these projections in the future as market conditions change. During today’s conference call, we will first have an overview presentation covering the financial and operating highlights for the quarter by Dr. Chan and Ms. Bloch. We again, have done our best to take everyone submit the question that we’ll do our best to address them in the presentation, but also at the Q&A session with management follow-up. Thanks everyone again for participating. If we do not ask your question, we would ask you to contact the company directly after the call time.
At this time, I would like to turn the call over to Dr. Phillip Chan. Please go ahead, Dr. Chan.
Phillip P. Chan
Thanks very much Donna. And welcome everyone to our 2013 operating and financial results conference call. Thank you very much for taking the time to join the call today. Since our last earnings report there have been a lot of developments and we definitely have new shareholders online today and what I’d like to do is actually go over a brief summary of the company for the benefit of those new shareholders as well as for those who need an update of our story. Following that Kathy will give a brief overview of our financial and operating progress for the quarter as well as for 2013, and I will come back on the line with an overview of the catalysts for 2014 that will help us drive growth for this year.
So, Cytosorbents is an emerging leader in critical care immunotherapy. We are leading the prevention or treatment of life-threatening inflammation in the intensive care unit. When we talk about immunotherapy, broadly taken it is the ability to manipulate the immune response to help fight disease. Now this is $100 billion in revenue market. This is not a total addressable market. This is not a potential theoretical market. This is actually a market that has $100 billion in revenues for blockbuster products focused on manipulating the immune system.
Now we all know that’s the immune response in order to function normally has to be not too high and not too low, when the immune system is not functioning well, people are at high risk of developing infection, cancer, as well as poor healing . And on the other end of the spectrum, when the immune system is too high, patients are at high likelihood of developing things like allergy, asthma, anaphylaxis, autoimmune diseases, severe inflammation such as sepsis or SIRS and organ failure.
Companies have worked to try to encounter this by developing products on the low end that will activate the immune response, and vaccines are actually an excellent example of that. The five top companies in the vaccine space including Sanofi, Merck, GSK, Pfizer, and Novartis, together have $26 billion in vaccine revenue alone, it is a $30 billion plus category overall. And in the cancer immunotherapy space, it sells about $20 billion in product revenues every year with such blockbuster products such as Rituxan, Herceptin, Erbitux, and others, and even cancer vaccines such as Provenge and other immunotherapy such as Yervoy from Bristol-Myers Squibb.
On the high end, when we’re trying to suppress the immune response, all of us have no doubt taking antihistamines for seasonal allergies or a steroid for other complications of inflammation. Blockbuster products such as Zyrtec, Claritin, Allegra, and asthma medications such as Advair and Singulair produces more than $20 billion in revenues every single year. And in the treatment of autoimmune diseases, blockbuster products such as Enbrel from Amgen, Humira from AbbVie and Remicade from Johnson & Johnson, those three products alone have $26 billion in revenue worldwide revenue every year. And again, this is a $30 billion plus revenue market overall.
But where Cytosorbents fits is really in a space where we only spy ourselves. This is in the critical care immunotherapy space where we’re trying to reduce the deadly inflammation that is leading to death in patients with diseases like sepsis, burn and injury, trauma, and many others. CytoSorb is a product that is approved in the European Union, in fact in all 28 countries of the European Union. It is currently commercially available in nine countries that’s generating revenue with 30 plus post-market studies with support of more than 100 key opinion leaders and little-to-no competition. So what is the $20 billion critical care opportunity?
Unfortunately, many of us on the call today know someone who has been admitted into the intensive care unit for life-threatening illness, in fact millions of people are admitted to the intensive care units every year in the U.S. and in the European Union with deadly inflammation, inflammatory conditions such as sepsis, ARDS, burn injury, trauma, pancreatitis, influenza, and complications of surgery. In fact, in these conditions, little exist to reduce inflammation and then actively help patients to get better. Rather patients often need to be kept alive with machines called life support, things like mechanical ventilation and dialysis with the hope that their bodies heal on their own over time. So without active therapies, patients linger at cost of $2000 to $3000 a day in the United States.
With the risk of death despite having some of the best medical treatment in the world, here in the United States, still one in every three patients often die in these life threatening conditions. Because of this, and because of the inability to actively impact outcome, the U.S. alone spends almost 1% of our gross domestic product, a staggering $80 billion to $90 billion on critical care medicine every single year.
So what is driving this inflammation, well the inflammation is being driven by small proteins called cytokines that normally orchestrate the immune response and normally helps [genuinely] (ph) and regulate the immune system to control inflammation.
But cytokines are very much a dual-edged sword. They are required for proper immune system function, but when they are elevated they can actually cause or exacerbate diseases such as autoimmune diseases, but when they are in vast excess as they are often found in patients with life threatening conditions, it’s often called cytokine storm, and that cytokine storm reaches the massive uncontrolled inflammation that leads to the failure of vital organs such as the lungs, the brain, the heart, the kidney, the liver and many other vital organs in the body. In fact, organ failure causes nearly half of all deaths in the ICU today and little can be done to prevent or treat it.
So that where we come in, CytoSorb is specifically designed to remove the fuel to the fire of inflammation in the body. In fact, it represents one of the newest and most powerful immunotherapies to control inflammation. It’s approved in the European Union as the only specifically approved cytokine filter, and it is clinically proven to reduce key cytokines and cytokine storm by 30% to 50% in critically ill patients. It has a very broad indication for use approved in any situation where cytokines are elevated and it’s now been used safely in more than 1500 chemo treatments with no serious device related adverse events.
The heart of our technology is this what you see here in this slide, it is a highly porous polymer bead roughly the size of grain of salt that act like tiny sponges to remove harmful substances from blood and bodily fluids, and the beads are little things based on size as well as surface absorption . These beads are protected by 32 issued U.S. patents and multiple applications pending, and we manufacture these beads from raw chemicals out of our ISO 13485-certified facility in New Jersey, and in fact these are one highest grade medical absorbents on medical market today.
So the goal of CytoSorb is really to try to prevent or treat organ failure. When patients come into the ICU either from their emerging room or from the hospital wards, they are typically highly unstable, and the goal of therapy is to prevent them from spiraling down that rabbit hole of organ failure from which there is often no return. Our goal is to try to prevent them from getting so sick to prevent organ failure from happening or to treat it thereby hoping to improve patient outcome and survival, well thereby decreasing the costs of ICU and the Patient Care.
CytoSorb truly has the potential to revolutionize critical care medicine, and yet it’s not only our belief, in fact, we now have more than $15 million of U.S. government to report from groups like DARPA that has awarded us $3.8 million of over five years as part of their Dialysis-Like Therapeutics program to treat sepsis. The U.S. Army which has awarded us $1.15 million in SBIR contracts for trauma and burn research. Where the U.S. Air Force that’s funding a 30 patients Human Pilot Study and trauma value at about $3 million or Phase I SBIR grant that we were originally awarded by the National Heart, Lung, and Blood Institute for our HemoDefend which tried to improve the quality and safety of blood transfusions.
So with that, that it covers the brief overview of the technology and the company, and what I’d like to do right now is, transition to operating and financial highlights for last year. Before I hand it over to Kathy I think, on this slide I think it’s very important to note that not only are we in that trying to address a major unmet medical need with what we believe is an exceptional product. CytoSorb in fact it has an excellent business model as well.
So none aware we’re addressing a huge $20 billion worldwide critical care opportunity, but this is really a need-to-have-type product, because we’re really dealing with the difference between life and death we’re not talking about temporary discomfort and someone who has an pain in and giving them a better drug to relieve the pain. This is really talking about life or death.
We also have little or no competition, critical care physicians understand the problem. So and we go and to sell to the physicians that we say that this is the product that is designed to control cytokines storm to reduce the deadly and inflammatory response in order to try to prevent or treat organ failure they already know that problem. This is in all the conferences, all the literature in that critical care, this is the exact problem that they faced and we have a therapy that can potentially help them solve their problem. So, very little education is needed to get themselves to utilize the product.
This is a plug-and-play, high margin disposable razor blade in someone else’s razor business model, we work with the standard chemo-dialysis machines that are found in hospitals today, so hospitals do not need to buy any new hardware or heart reduce our fits right into those machines that could be used with the existing technical staff as well as the existing heartware infrastructure. As by the next point, the patients already know how to use the device and this in fact we’ve been told that it’s easier to use then in even standard chemo-dialysis which is the most common blood purification technology in the world.
CytoSorb is also reimbursing Germany and Austria in more than $500 per heart treats and depending on the application and the number of devices used the revenue potential per patient is on the order of about $1,000 to $5,000 per patient. So when you talk about in the United States, there was about 1 million patients every year with the severe sepsis and septic shock, at $5,000 a patient which would involve multiple usage or multiple heart disease that’s a 5 billion total addressable markets in the United States alone.
This is an affordable and yet very profitable product with gross margins are greater than 60% and with volume are targeted to actually to get into gross margins greater than 80%. And because of that it has the ability to produce a cash flow very rapidly and we’re already using that cash flow to help offset our operating expenses. And last but not least, intensive care units are highly centralized and very easy for small sales force such as ours to be able to access effectively.
So with that, I’d like to turn it over to Kathy to cover our 2013 revenue results.
Thank you Phil and good afternoon everyone. And today we’re going to – right now we’re going to cover some of the company’s key financial results. And of course we encourage everyone listening to refer to our press release and our annual report on Form 10-K for a more detailed information regarding our operating results.
The first, look at revenue our total revenues for 2013 were approximately $2.4 million. 2013 was our first full year of product commercialization and our product sales we’re pleased to report we’re approximately $822,000 which is a dramatic increase over 2012 products revenues of approximately $152,000. We also know that brand revenue for 2013 was approximately $1.6 million as compared to approximately $1.2 million for 2012.
Next, we’ll look at the quarter-over-quarter sales results. This chart highlights the product sales of CytoSorb for each of the last six quarters since we began the commercialization of the product. First of all, note that product sales for the fourth quarter of 2013 touch the blue border [ph] of the far right are approximately $317,000, and this represent at the highest quarterly sales achieved by the company thus far.
They are in fact approximately 54% higher than product sales for the third quarter ended September 30, 2013. We actually completed orders worth and invoiced approximately $351,000 in the fourth quarter of 2014. That of this amount, approximately $37,000 could be not be recognized as revenue until 2014 due to common carrier delays in picking up the products which is where we sell slightly short of our guidance for the fourth quarter of 2013.
And now, our guidance for the first quarter of 2014. We’re expecting product sales of approximately $530,000, $570,000 which is an increase of approximately 75% over the fourth quarter of 2013. This is the new record once again for quarterly sales of CytoSorb. Note that the sales for the first quarter of 2013 were approximately $176,000, sales for the first quarter of 2014 are then more than tripled year-over-year same quarter sales. We are also seeing more stabilized sales growth trending towards the latter half of 2013 and continuing into 2014 as the engines of our commercialization process begin to bear results. These revenue multipliers include additional direct sales resources.
Our $100 plus key opinion leaders, orders from existing distributors, further international expansion with new distributors in new market the factors that the wise is being used for more invocations, repeat orders from existing customers and increased adoption within the critical care department. The majority of our orders are now repeat orders from existing customers, this is the result of our delivered strategy of moving our focus beyond the key opinion leaders to deep within the administering departments promoting the usage by the senior and junior doctors and the nurses and technicians who are actually treating the patients. We continue to establish new customers and distributors as well and this will also contribute to more reorders in the future.
So, I’ll just review our strategy for 2013. We were selling in Germany, Austria and Switzerland with our four person direct sales force. And this sales team has successfully garnered more than a 100 key opinion leaders and we are currently working with the largest and the most important university of public hospitals in most of the major cities of Germany. You see a list of those shown here. And these institutions are the equivalent of mass general Johns Hopkins Colombia, UCSF, which fills Germany for our direct sales efforts because it’s the third largest medical device market in the world.
In Germany, there are approximately 154,000 cases of sepsis and septic shock per year at an average cost per treatment of $5,000, the market opportunity for Germany alone is greater than $750 million if we were to become standard of care. Our CE Mark gives us broad commercialization potential just about everywhere except for United States and Japan. And so our strategy has been to complement our direct sales force with distributors in these other markets. In 2013, we signed distribution agreements with United Kingdom, Ireland, the Netherlands, Turkey and Russia and we entered into a strategic partnership in India. We are in active discussions with other potential distributors and/or strategic partners to expand to other parts of Europe and other countries that accept the CE Mark.
The sales momentum has been very positive. This slide summarizes our trailing 12 months of CytoSorb sales and we believe it demonstrates the successful path of our commercialization program. Note, that we have now surpassed the $1 million mark for annual sales. In fact, our trailing 12 months sales for the first quarter ending 2014 are expected to be approximately $1.2 million.
So while we’re very pleased with the growth and sales that we’ve experienced so far, we caution our investors the customer education does take time particularly in our environment where we’re just beginning to acquire clinical data to support the sales efforts. In addition, registration and reimbursement can be a lengthy process and it’s different in each new market that we enter. So there can be a delay between the time we identified the distributor and the distributor’s actual first sales of Cytosorbents.
Now, let’s take a look at our gross margin. Our gross profit margins of CytoSorb for 2013 exceeded 60%. There has not been any downward pressure on sales, in other words our sales prices have remained constant or driven. As the mix between direct sales and distributor sales changes our gross margins maybe impacted, but no matter what’s the mix, we do expect gross margins to remain strong as we move forward. Higher production scales should also result in lower product cost and we are working on this and this will also improve our gross margins. And finally, it’s important to note that as our product sales increased, the gross margin will provide a rich source of working capital for the company.
And let’s talk about working capital for a minute. Our cash balances have powered around $2 million for each of the last five quarters. Then in the first quarter of 2014, our working capital position has been dramatically enhanced by the financing we just successfully completed this month, which is added approximately $9.45 million to our working capital, that’s a big difference.
We’re very pleased with the successful capital raise, because it matures Cytosorbents’ future by providing the resources we need to execute on our strategic plan. First of all, it provides working capital to permit us to increase our direct sales and sales support in Germany to accelerate commercialization of CytoSorb. Additionally, we now have an estimated approximately $5 million of funding needed for our clinical trial CPA in the United States. And with continuing increases of sales, it will provide adequate working capital that is expected to carryout well beyond the first half of 2015.
We also expect to benefit from our other sources of working capital, which include product besides product sales, grand funding, and potential strategic partnership.
So at this, I would like to turn the call back to Phil, who will provide additional information related to our catalyst for 2014, Phil?
Phillip P. Chan
Thanks very much Candy. The financing that we just did, that added almost $10 million to our balance sheet, I will go a long way in terms of catalyzing our growth for 2014. Instead of doing what we need to do, we now have the capital of resources to do what we want to do and what is right for the business in order to build shareholder value, as well as grow our business more rapidly.
As we talked about in the first conference call, our earnings call, third quarter earnings call last year, one of the places where we are looking to spend new capital is to stimulate CytoSorb sales. Kathleen mentioned that we now have more than a 100 key opinion leaders in Germany and Austria, and our goal for this year is to leverage those key opinion leader contacts in order to be able to try usage deep within your department amongst the junior and senior physicians in those departments.
So rather than having key opinion leaders use the therapy once or twice a month, our goal is to actually have the permissions these clinicians, these junior and senior physicians utilize and think about the therapy on a daily basis when they admit patients with the variety of illnesses such as sepsis, burn injury, trauma, pancreatitis, and many other illnesses. In addition because of all the opportunity that we have, our goal is to really increase our sales team as well, as well as our clinical and distributor support material I will cover on the next slide.
In addition, what we are seeing right now is that not only our we have one intensive care unit in the hospital and many of our reference hospitals that we are working with today. We’ve expanded from one key opinion leader and one intensive care unit to now multiple intense of care units throughout the hospital, including, for example the medical ICU, the surgical ICU, the cardiac ICU, as well as the trauma ICU, and in many cases in the cardiac surgery departments.
A further demand for the product, we believe will be generated by the 30 plus post-market study that will hopefully help to generate clinical data in many applications. Christian in his remarks will – Christian, our Vice President of Sales and Marketing will discuss some of our activity in this area.
And accordingly as Kathleen had mentioned, our distributors represent a significant source of potential growth for the company as we expand internationally and add geographically to our business. We expect that orders from existing distributors will increase particularly as number of them get the product registered in their countries. And as Kathy mentioned, we’re looking to actively add on additional distributors for different geographic territories around the world where CE Mark approval is recognized.
In this next slide, I’d like to talk about our sales infrastructure targets for 2014. As it demonstrates, where the whole world in 2013 and how we’re looking to fill those in 2014. In 2013, we had revenue coming from a broad network of direct sales distributors as well as our partner Biocon in India.
Direct sales, we are selling in Germany, also in Switzerland. We have five distributors and Biocon was our partner that we signed on in September of last year. We did this all with four sales reps and we added a clinical support person at the end of the year and from the manufacturing standpoint, we began ramping manufacturing as the demand for the product increased towards the second half of 2013. And from a reimbursement standpoint, we’re really focused on the direct sales territories, where we have reimbursement to determine actually today.
In 2014, our goal within cash available to us now as investing our business is to now continue to expand upon the strategy, specifically with the focus on Germany where we are looking to add a total 10 sales reps. We currently have seven as of the end of the first quarter as well as continue to push sales in Austria and Switzerland.
On the distributor side, we are looking to add at least five more distributors and on the partner side, we are looking to add at least one more partner to help broaden the reach of CytoSorb both in the European Union as well as outside the European Union.
In order to support our distributors and partners, we will be adding a distributor partner support representative, who will be helping to communicate the advances and treatments that are we are seeing in our direct sales territories and in other places in the world and to be able to bring that research to treating physician that’s all over the world.
We are also are looking to expand our clinical support staff to two people and in doing so in order to meet the need, we are also increasing our manufacturing and all the insurance all the control staff appropriately.
In addition, we will be spending a significant number of resources in order to obtain reimbursement in other countries through not only the establishment of more clinical data, but also by having appropriate effort on reimbursement in those countries.
So what we are seeing right now is market pull from two key applications of all the different applications that have been that CytoSorb has been used for, the two that are rising to the top are sepsis and cardiac surgery. As I mentioned before sepsis, it is over resulted in response towards the life-threatening infection. It effect $2.5 million people in the United States and the Europe annually, about $25 million people worldwide every year and it represents in these two territories of $6 million to $8 million market.
And although many of you know that you are get many failures in the sepsis space, we believe that CytoSorb represents really one of the most comprehensive treatments for sepsis, because it has the ability to do many different things, not only connect control side of consortium, both for inflammatory as well as anti-inflammatory Cytokine, but because of our work with DARPA, we know that CytoSorb can remove many different bacterial toxins such as totally resistance agonist, alpha chymotrypsin that is a cause of major morbidity and tissue damage in staph aureus infection, but that through work with Dr. John Kellum, we now know that we can also direct the instances, the activated immune system, to co-work supposed to going by the infection and away from innocent by standard organics where these activated cells can often cause more harm they could.
No other single therapy have demonstrated this broad range of activity, which is why many key opinion leaders believe that CytoSorb 50 to be answer for the treatment of certain key Sepsis. In cardiac surgery another application this is an area where patients are undergoing coronary artery bypass graft surgery or CABG surgery Bill Clinton, President, Bill Clinton and David Letterman underwent CABG surgery for blocked heart arteries for valve surgery for a left ventricular assist device implantation made by manufactures like Zyrtec and Heartrun [ph] for the treatment of heart failure for valve replacement surgery in general effect repair as well heart and lung transplant.
There are 0.5 million procedures done every year in the United States, 0.5 million in the European Union alone and the problem with cardiac surgery is that it can cause severe inflammation that can lead to post operative complication such lungs failure and kidney failure. And because of this it represents addressable market for us about $500 million to $1 billion in the U.S and Europe alone.
So, what we expect to see is a revenue multiplying effect of all these activities that we’re undertaking to try to do sales from what – with almost 857,000 sales this year, 2013 to really multiples of that in 2014 and I just would point out that the number of heart disease here are only – is the graphically demonstrated the multiplier effect on that and this not reflect revenue guidance for 2014.
So just to give you a little bit of color in terms of the clinical activity that we’re seeing in Europe. This is the picture of the first ever CytoSorb’s Users Meeting at the DIVI Conference for the intensive care conference in Leipzig, Germany in December last year. What we saw with that these key opinion leaders, these pioneers of CytoSorb research that come together to share their clinical experiences with each other in this day session that we conducted in a Leipzig. In fact, on YouTube then in the press release that we put out today in our annual report was actually a link to a summary of the DIVI Conference and I in fact would urge you to take a look at that video that is presently on YouTube.
But, not only that we see a lot of different examples of CytoSorb is used in sepsis and in trauma and in cardiovascular surgery and other things, but I think what was remarkable that this meeting with levels of excitement of the people at the meeting, and the feeling that we were really on to something very special. In addition as Christian will talk to you about later we also established CytoSorb registry, that will hopefully categorize and catalog that many different treatments that bring all over the world for CytoSorb able to help clinicians all over the world to better treatment their patients from many different illnesses.
We also sponsored the symposium at this DIVI Conference this was an early morning conference that competed with a number the academic conferences and this was specifically focused on CytoSorb and our therapy and yet weren’t able to compact the room with 120 people from Germany and Austria who were interested to learn more about this technology.
More recently at the International Society of Intensive Care Medicine and Emergency Medicine Conference in Brussels, Belgium we held another symposium where we had really some of the major key opinion leaders in sepsis research and critical care research this include Dr. John Kellum on the left there from the university of Pittsburgh Medical Center, who is the Chair of our success advisory report and who has done most preclinical animal work on our technology, Professor [indiscernible], who is the President of the German Sepsis Society. Professor Michael Quintel, who is the Principal Investigator of our Sepsis doses study that is currently ongoing in Germany as well as Professor Träger, who is a critical care intensivist in the cardiothoracic ICU at the University of Ulm.
And what we heard here in a session that attracting more than a 100 participants from international countries was really a very fascinating set of lectures on thesis of immune response from sepsis the preclinical and clinical work that has been done to date with CytoSorb as well as clinical application including cardiac surgery.
So, second major catalyst for the Company is the expansion of our clinical trial capability and data. As a small company with unmet resources we have not had previous to this the ability to develop our clinical trials the way that we have wanted to in the past. But we have now have so much clinical activity now both in Europe as well as in the United States and with the financing that we just did we have the ability we have now to really augment our capabilities to keen clinical data to hopefully help makes CytoSorb standard of care medicine in a number of different application.
Because of this we are looking we are actually in the process of hiring a Chief Scientific Officer, who will help manage both the U.S. as well as the European studies. Last year we announced the hiring of our Director of European Scientific Affairs, Dr. Rainer Kosanke, and we will be hiring comparable position in the United States, Clinical Trial Manager to help manage a pivotal trial in cardiac surgery as well as a U.S. Air Force Funded Trauma Pilot.
In addition, in the next month or so we will be announcing the recruitment of the Cardiac Surgery Advisory Board, which will augment our capabilities with our Sepsis Advisory Board and our Trauma Advisory Board as well. You can see that just the tremendous amount of clinical activity here and this is something that Christian will discuss in his prepared comments.
So, what I wanted to do right now is basically talk to you about the U.S. cardiac surgery pivotal trial. Now many of you who have followed our company in the past know that we have been pursuing sepsis as a pivotal study in the United States. But because of the market pull that we are seeing and the market interest in cardiac surgery, there are a lot of reasons why doing a cardiac surgery trial in the United States makes a lot of sense. We believe that the past approval in the United States is potentially faster, less expensive and most importantly less risky in seeking approval for critical care applications such as sepsis.
Again we are seeing significant marketable from this application we have more than 20 heart centers in Germany and Austria for either using or evaluating this technology. And we will see data coming in the second quarter and third quarter this year from cardiac surgery trials in Germany and in Austria.
These are very large markets. They are again half a million cardiac surgeries in the U.S. every year, half a million in Europe and more than 1.5 million in the world, with India and China representing major areas of growth in terms of cardiac surgery. This is the potential total addressable market just in the U.S. and Europe of about $1 billion or more.
CytoSorb importantly is the only cytokine reduction technology capable direct installment and a bypass circuit into a heart-lung machine without the need for another machine like a valve system machine because of this we have a very competitively strong position if we were to become proved as a standard of care for cardiac surgery.
In addition, there is already a market for a product called leukoreduction filter in cardiac surgery. Companies like [indiscernible] Pall Medical, Assaki excelled leukoreduction filters to try to reduce the inflammatory molecules that are often generated during cardiac surgery that we talked about before. Unfortunately if they cannot remove cytokines and free hemoglobin and other inflammatory substances directly, you are trying to remove it by removing cells and definitely it does not work, but they’ve created a multi-million dollar market for this product, for these, leukoreduction filters today with CytoSorb finally delivering on the promise of active cytokine reduction and free hemoglobin reduction during cardiac surgery. We did take over this market while significantly expanding the market as well.
Another reason to do this cardiac surgery trial is that the trial is expected to be much more straightforward, less expensive and less risky because, first of all, patients are much more homogenous that in a critical care application and they can be enrolled quickly in treatment and follow up can be relatively short. We’re not looking for 60-day mortality and that’s another major point here. The endpoint for cardiac surgery trial will not be mortality, which is really the highest bar there is for clinical study today.
But a clinical endpoint such as the incidents of respiratory failure or kidney injury is much easier to achieve. And I apologize for this, the formatting in this presentation. Sometime that couples a little bit. But once approved in the United States, CytoSorb, we can expand the applications in the United States through our label extension strategy, while driving ECG and cardiac surgery outside the U.S. where CytoSorb is already approved and being used in cardiac surgery today. These are just some of reasons why a U.S. cardiac surgery trial makes a lot of sense.
And what we’re thinking of right now, and this will do determine later on this year. But we are looking to use the product either intra-operatively, where it’s used in bypass circuit in a heart-lung machine to prevent post-operative complications by actively removing these inflammatory mediators during a surgery itself, or the second alternative is that in fact three path of the surgery is done and treat patients who developed inflammation and instability following these cardiac surgeries, which is actually relatively common.
So this is something that will be giving more guidance to investors later this year. So from a success trial, however, we actually believe that sepsis is one of the largest markets, one of the most important markets for CytoSorb and we are looking rather than to duplicate efforts in the United States and in Germany, have focused our efforts in sepsis in Germany and the European markets.
What is remarkable about sepsis is that it’s a very difficult disease to treat and in fact the treatment alternatives continue to shrink. At the conference, the ISICEM Conference in Brussels what we learned is that two major trials, the early goal-directed therapy trial and the ended toxin removal trial with [indiscernible] have both showed no benefit. Early goal-directed therapy was trying to use early optimization of blood pressure and other sort of dynamics and oxygenation in septic patient. But unfortunately it was not successful and showed no benefit in mortality and this reverses the findings of a landmark 2001 study.
There was another study called the ABDO-MIX trial done in France, where unfortunately they also showed no benefit of endotoxin removal in septic shock patients due to organ proliferation in a large scale clinical study. CytoSorb remains one of the few promising therapies in sepsis and other application.
So the goal for success in our mind is that because of the lack of competitors forgetting down our next so to speak we have an opportunity to continue to advance the understanding and knowledge of how to treat patients with receptors with Cytosorb and increase our odd to success.
CytoSorb is one of the only therapies again being used to treat us today in Europe and elsewhere and hope promise in early studies. Our European success trial in dosing study demonstrate that up to 24 hours of treatment is safe. And that they are certain patients that seem to benefit from the therapy including those with very high satisfying levels, and those who are older than age 6 to 5 to make up about two-thirds of the patients possible receptors today. And in actual clinical practice there have been many remarkable treatment success in patients with either severe status for septic shock, particularly when it’s been used early.
Our goal is to ensure our particular success study design as the best chance of success. And the many success study with Cytosorb that are being conducted today including our dosing study will hopefully help us get there. And when we are ready we plan to conduct a study in Germany led by our major collaborators who are already part of the Sepsis Trials Network, the SepNet network in Germany which is was a government funded a trials consortium that is government funded Sepsis Trials in Germany.
So, a third catalyst is that are B technology and able to diverse the valuable pipeline and Chris Cramer, our Vice President of Business Development will give you a little bit more color on this in just a little bit. But Cytosorb is CE Mark approved and is now generating revenue for critical care illnesses.
We’ve another product called HemoDefend, which is designed to help improve the quality and safety of blood supply. And we’ve another product called ContrastSorb that we are developing to remove IV contrast that it’s given during imaging procedures and interventional radiology procedures such as cardiac catheterization that can lead to kidney failure at high risk individuals.
We have another product called DrugSorb, for drug detox and drug overdose and an another product called BetaSorb. But we actually have another actually four to five different products that are underdevelopment that we have not yet publicly disclosed that also are very exciting products that address very large markets as well.
Very importantly the reason why this pipeline is important, it’s because of this slide. These are companies that are focused in our key markets that we are addressing with our pipeline companies in the renal dialysis space, in the critical care space, in cardiac surgery space and the blood transfusion space as well as in the biotech and immunotherapy space.
And I’d note here, the company will full secure or use simply as examples of companies in these respective verticals, I mean we make no other representations to our relationship with any of these companies. But I would say that in fact the majority of these companies know who we are and know our technology.
And as you can see there are companies like Haemonetics that cross over from blood transfusion to cardiac surgery. McKay crosses over from cardiac surgery to critical care. Companies like Fresenius on the dialysis side as well as on the blood transfusion side. You can see how Cytosorbents technology could be very synergistic to these, just for example these companies of larger businesses.
We addressed such a major markets that have billion dollar revenue potential that we can actually, if successful impact both our top and bottom line growth, which is something that you cannot normally say for technologies from the small companies such as ours.
So one of the partnerships that I just wanted to touch on that the Chris will actually describe it much more detailed in our Biocon partnership. Again Biocon is the largest biotechnology company in India often called the Amgen of India and we are seeing the sense of bringing together the most comprehensive treatment for sepsis where they are bringing critical care antibiotics that treat the primary infection and we’re treating the massive inflammatory response and we are securing Shaw as the Chairman in Managing Director of Biocon who has been sited as one of the I think four top 100 must influential people in the world, Time Magazine’s 100 most influential women in the world, she mentioned us directly in their January 2014 third quarter earning reports where she said our recent launches of CytoSorb have done extremely well with strong uptick by both doctors and patients and they have actually continued to reorder product after launching the product in September of last year.
Now another opportunity for us on the business development side is a HemoDefend. We expect there to be two major trials in 2014 that maybe very important to HemoDefend platform. These are the research trial and the APO trial where in the research trial they are giving old versus new blood to cardiac surgery patient, it will recognize cardiac surgery as a major market that we’re trying to address with CytoSorb as well as the APO trial which is giving new versus old blood state of issued blood to critically no patients another one of our major target market.
So again HemoDefend is designed to keep new blood fresh and we’re actually supported by a Phase I SBIR alternate from the NHLBI, the National Heart, Lung, and Blood Institute that will use contaminants from transude blood products that accumulates during blood storage as blood gets old the things accumulate that can cause transfusion reactions in adverse events such as organ failure and death and we continue to advance development of a HemoDefend platform towards commercialization increasing at the value while de-risking the assets with the goal of utilizing the technology to major strategic partner.
Another major catalyst is our uplifting that we have talked about for sometime, but we’re still targeting this for the second half of 2014 certainly a fund raiser that we just did goes a long way to getting up there, but what we’re to looking to do is uplift to either the New York stock exchange or NASDAQ. We’re targeting major operational momentum in the second half of 2014 that should help to support our uplifting and closed market performing after up listing during that time. We’ve already met with New York exchange and NASDAQ that we’re now preparing the company for uplifting and our cultivating relationships with analysts as well as the institutional investors.
And last, but not least the final catalyst for 2014 is that CytoSorb is being used successfully in a broad range of applications. We’ve been asked by many investors as well what are some examples of how CytoSorb is being used today and what I thought I do is, take a few moments to talk to you about a handful of different applications across the Board where we have been seeing positive benefit and you will note at the bottom of every one of the slides of the University that has been doing, that has done that study over that patient.
This is a 57 year old patient that was diagnosed with gangrenous dermatitis at University of Groningen in Germany, he had a severe deterioration of his clinical course with severe respiratory failure requiring mechanical ventilation and he was transferred to the ICU with multiple organ failure requiring heavy light support.
But what was remarkable about this was really the timing of this patients improvement, because they did – according to the investigator here, they did nothing else, but start our CytoSorb therapy within minutes, saw an immediate rapid improvement in hemodynamics stability, he was weaned off all ways of pressures by day two, he has weaned off all mechanical ventilation by day five, you did not require to have therapies that did not spiral into kidney failure and he was transferred out of the ICU to the step-down unity by day nine.
The investigator who treated this patient said, I have no other explanation except for the CytoSorb therapy have helped stabilize this patient, and of course, paraphrasing, but that was essentially what he had told them, which was quite remarkable. But this is something that septic shock subsequent to receptors is what we are seeing in many different institutions across Germany, Austria, in India, in Turkey and many other countries.
We’ve been hearing very similar type remarkable stories about how this therapy has been able to help patients. At the University of Ulm, Professor Träger has used this therapy many times interoperability, but during cardiac surgery, he relayed a case whether it’s a 49-year old man who developed a graft infection and sepsis he is after aortic heart valve replacement cardiac surgery. And he went to do redo operation with CytoSorb with CytoSorb installed and a bypass circuit in the heart-lung machine.
And in fact, when they opened [indiscernible] saw a lot of plus [indiscernible] of this patient very sick, they expected him to be highly unstable. But was in fact, completely stable during the operation, which was accredited to the use of CytoSorb therapy. He went on to a full recovery and left the hospital after a total of 12 days without complication.
But there was another study at the University of Ulm, it was post op cardiac surgery usage an 83 year old man underwent quadruple bypass, and on day eight, he’s developed pneumonia with septic shock respiratory and renal failure, so multiple organ failure. The infection was probably microbial with bacteria in his blood, which was treated with Cytosorbents antibiotics.
And you can see in the graph below, how he responded to the therapy, that he rapidly –were able to rapidly reduce his Basal-Plus requirement in adrenalin network that used to keep his blood pressure up. They were able to remove those and he became much more hemodynamically stable. And again, a reduction in cytokine interleukin-8 that we already knew that we could use. He covered and was discharged from the ICU by day seven to respiratory weaning unit.
And another patient had a debridement graft [indiscernible] Germany. This is a severe burn injury patient. He was in his mid-20s. He suffered severe burn injury more than 60% of the total body secondary burn, but also severe smoke inflation injury. His particular mortality was 45% to 50%. The overall mortality today in burn injury is typically under 4% or 5%, but because of his severe injury, his mortality was very high.
He was admitted to the ICU with multiple organ failure, CytoSorb with continuously renal support over eight days, changing the cartridge each day, and he was weaned of basal pressures within four days. He has significant improvement in kidney and lung function. And what he noted was that his wound killing was much faster than they had anticipated and that he currently is kind of a good prognosis for recovery. This is a just a recent case.
Another case was a case of trauma in Rhabdomyolysis, 25-year old man who was involved in a high speed motor vehicle accident suffering severe polytrauma, including internal bleeding requiring massive transfusion at trauma, broken leg, chest wall injuries and others, he was admitted to the ICU for a decompression of his brain because of high intracranial pressure, but he developed massive tissue injury that resulted in rhabdomyolysis which is the release of myoglobin from crushed muscles that can be lead to kidney failure.
In treating with CytoSorb plus dialysis they were actually able to reduce myoglobin very rapidly you can feature on this is the picture of how the device was been used in the hemodialysis machine and then here how with the institution of our therapy were able to drop myoglobin leveled relative very quickly this is subject our U.S trauma trial in the United States.
It is well known that – hemofiltration does not effectively remove myoglobin. And so now this could only be really explained by our CytoSorb therapy. Yet an another example was that the University Hamburg, Eppendorf, a major hospitals – biggest hospitals in Germany, this was the patient who overdosed on 30 gm of Tylenol more than 12 gms is often considered highly fatal because of liver failure, if this patient despite developing multi-organ failure he was treated with CytoSorb and he survived, which was quite remarkable.
And then, last but not least, this was a case that was reported by Mr. Frank Brunkhorst [ph] who is the [indiscernible] is that University of Munich [indiscernible] and he reported on a case where you can see CytoSorb in the upper right-hand picture being used with an ECMO machine, Extracorporeal Membrane Oxygenation Machine this is often used to help stabilize patients when the respiratory failure are so severe that their lungs no longer function despite pumping an highly oxygenated – highly oxygenated air to their lungs.
And so this is was actually used to transport to stabilize the 50 year old man by a massive heart attack in Kuwait and transfer him 7 hours to Berwyn and then ultimately it’s Berwyn and this was a dramatic success where they – he was so unstable before transport that but they started him on the therapy for 2 hours, he became much more stable and then they transported him without for 7 hours on a plane without incident and then they actually used a therapy during cardiac surgery effectively and this patient actually did well.
So, these are just examples of how CytoSorb is being used in the market today, hope which just gives you just a sampling of how dramatic some of these cases could be in why we have so much key opinion leader support and why our sales are have rapidly expanding. So in summary, Cytosorbents is leading the way to prevent or treat life from an information in the ITU.
It is approved in the ETU and generating international revenue we are just touching that surface of a massive $20 billion market opportunity addressing critical unmet medical need of organ failure, with validation of the company and technology on many fronts including the U.S government, acute and laborers which partners which they make highly comfortable product growth-to-no competition.
We have a very substantial accomplishment team and there are many catalysts that we expect to see over the next 6 to 9 months including revenue growths, strategic partnerships, clinical data, uplifting, new product development and institutional ownership that can hopefully help catalyze that this company to even greater heights.
So, with that I’d like to turn it back over to the moderator and open up session for questions and answers with prepared remarks from our management team. Moderator?
Unidentified Company Representative
Thank you Dr. Ken. Over the past several week, we’ve been receiving a number of questions from investors. I think one of the most common questions relates to sale of CytoSorb. Christian , , sales seem to be trending upward, can you comment on your progress with direct sales?
Yes, thank you Donna and good evening to everybody. So, first of all, because of the high level of interest that we have seen in cardiac surgery for the past 12 months, we have intentionally modified our sales efforts to dedicate more resources towards this [clean] (ph) application. Cardiac surgery has a number of very attractive characteristics as it relates to CytoSorb therapy.
In addition to what Phil mentioned in his presentation, relatively to critically ill patients, cardiac surgery patients are much more homogenous, and are needing currently more predictable and repeated outcomes. Doctors know exactly what in going to happen and when it happens. We have also seen the clinical data can be generated much faster and are more predictive compared to data generated in [critical] (ph) premises.
Furthermore, the group of current customers is relatively small and they are defined including approximately 100 cardiac surgery centers in the German speaking countries. In addition, the events of cardiovascular diseases and related surgery in public is much higher compared to sepsis.
Given that cardiac surgery generates significant profits for hospitals, allocation of resources and purchases by the hospitals also (inaudible). There are approximately 0.5 million cardiac surgeries performed in the European Union per year. Based on statistics from the German Society of Thoracic and Cardiovascular Surgery, in 2012 there were approximately 100,000 cardiac surgeries in Germany alone.
This represents the German market opportunity of about 100 million, and CystoSorb became standard of care. In addition to being a very profitable modest cost, it will help to build a bridge to many other possible indications of our technology.
Our existing sales staff will spend a significant amount of sales time on this in the near term. Just to give you an example, in 2013 we had eight to 10 cardiac surgery centers interested, Already in this year 2014, we are now working with 22 cardiac surgery sites .
The first cardiac surgery congress we attended, the annual meeting of the cardiac -- of the German Society of CardioThoracic Surgery has brought us remarkable attention from this community.
I have invested a great deal of time and carefullyt expanding on our direct sales force in Germany. As we have communicated during previous conference call, we have increased the number of target sales reps from four to seven, and (inaudible) the beginning of March.
This was essential to adequately cover most of the major German speaking territories. Two out of the three sales reps that we added have an excellent network in cardiac surgery, which will be helpful to the entire team. The third person is an outstanding sales person I have worked with in the past.
We can already see some effects of the hires , but the full effect through the visible within the next three to six months. So, we are targeting a total of 10 sales reps at the end of this year, and we will also strengthen our international distributor business with adequate personnel over the coming two quarters.
During the last investor call, I also announced that we will (inaudible) U.S. meeting during the National Intensive Care Conference DB in December.
As we touched upon earlier, we had very exciting data from clinical cases and studies from about 15 different sites. This was the first time that key opinion leaders have publicly presented their experiences to their colleagues outside of their own hospitals both during the user meeting and also during the National DB Conference itself. What was exciting for us was the energy and enthusiasm during these sessions .
We heard many influential people talk about how positively they view the CytoSorb therapy and how it may possibly change medicine. We have prepared a short video of some of the testimonials that will be available on our website shortly.
In February, the other important national symposium on critical care medicine had (inaudible) in Germany. Several key speakers highlighted CytoSorb therapy as the only promising adjunctive therapy for sepsis at the moment. Competitive methods have been rated as not working. So that then Germany evolved, our CytoSorb therapy is significantly rising, and interestingly users are spreading word about their positive experiences.
My team and also myself experienced several occasions including telephone calls late in the night that are treating the patient, what is this amazing cartridge, we just rescued a patient, we never thought he would survive.
Obviously we also have patients who do not respond to therapy. These are the patients where the therapy was used too late, but these other positive situations that doctors could really turnaround patients and rescue them are really astonishing and give us additional determination to continue our work.
First, I want to give you just a handful of the many examples of how CytoSorb has been used recently to help doctors regain control of the patients and help them to survive. Back to you, Donna.
Unidentified Company Representative
That’s very helpful, Christian. As Kathy mentioned, distributors in international expansion are another major source of revenue growth. How are distributors contributing to sales results and what is your overall outlook for 2014?
Yes, thank you. The growth of our international business outside Germany is going to be a major topic for this year. As Kathy mentioned, CE Mark approval is (inaudible) to be sold in all 28 countries of the European Union and we’ll also have to expand our distribution way beyond Europe. We have been pleased with the reception of the technology in general, but particularly in many countries outside of Western Europe.
Physicians in these other countries are very progressive and eager to use new technologies, particularly blood purification. The challenges in these markets are similar everywhere; product registration, adoption, and reimbursement.
It is one of the reasons we will be adding a specific distributor support person this year. In 2013, the majority of players that come on direct to us (inaudible) especially Germany and Austria. However, as we sign more distributors and existing distributors gain product illustrations in the countries, I expect that distributor revenue will become a very significant proportion of overall revenues in the future.
In terms of outlook for 2014, we just had another strong quarter of revenue growth benefiting from strong market demand. We will of course continue to work to expand usage and adoption in all direct and distributor territories. Back to you, Donna.
Unidentified Company Representative
Christian, during the week of March 19, CytoSorb participated in the 34th International Symposium on Intensive Care and Emergency Medicine Congress at Brussels and hosted a scientific symposium entitled SIRS and SEPSIS – New Therapy with CytoSorb. Please tell us about that.
Thank you, Donna. So Phil mentioned this already. The CytoSorbents scientific deposing at the Brussels ISICEM Conference, the biggest in terms of Care Medicine Congress in the world was really great success, especially the lineup of all speakers was remarkable. Professor Herwig Gerlach is the President of the Germany Sepsis Society and member of the International Surviving Sepsis Guideline Committee.
Professor John Kellum is the one of the top five few intensive gynecologists in the world and has done most of the preclinical up to this time up. Professor Michael Quintel one of the leading in terms with Germany, he is the past President of DV, the German anti-disciplinary society for intensive care and emerging medicine and leads the department of anesthesiology and intensive care medicine of the University of Cuttington [ph] which has the most experience of using final [indiscernible] in patients suffering from septic shock.
And last but not least, Professor Karl Träger is one of the most experienced user of CytoSorb in cardiac surgery patients. Not many companies can easily have such excellent speaker to present. This ICA reflects our excellent materials and also the belief this will be hardly seven or product and now, the presentation covered the wide range of material from the basis of the new response and fitness to pre-clinical and clinical data and then to different application in sepsis and cardiac surgery. And yet approximately 100 people at this symposium and obtained a lot of feedback. We are currently working on the summary of these tasks for the new future.
Unidentified Company Representative
Okay Christian, can you bring us up to-date regarding the investor initiative studies underway.
Yes, of course. I only can repeat myself by saying that a talent body of clinical and published evidence is essential for the next phases of commercialization of all CytoSorb therapy, they still outline in this presentation additional funding that we have received, we will continue to be focused on five key levels to generate the necessary data that we need to make CytoSorb done at out of KN hospital. Number one is published cases and case reports and case serious. Number two, international CytoSorb.
Number three, the more than 30 of investigated and initiative clinical project and trial, and number four, which is in the trials including pivotal studies. And additionally, of course, studies to investigate an important high topics such as ill children, antibiotic removal and other studies are planned. These levels are not necessarily sequential but will be brought on unparalleled. Case reports are low level grade of evidence but helped tremendously because they are real world examples of how this helped people used successfully by others, along as the parameters of treatment.
They removed inertia and encouraged others to try the therapy in similar situations. Along these lines, there will be two datasets published on theory and post operative styles of applications and cardiac surgery, patient later in the year. The cause is expected in April. The next evident layer, the international time observatory should be online by the end of the Q2 of this year.
We took massive effort to set up the high quality medical registry, which also fulfills FDA requirements and is led by the world renowned sepsis researcher Professor Brunkhorst and his study sent at the University of Jena, Germany. This will give us the opportunity to quickly – very quickly collect data from nearly all treated patients on an international base. Also we will have the ability to embed randomized controlled study onto this – into this registry. We are also spending significant results to have coordinated support to more than 30 investigator initiated studies, so that either being planned on currently enrolling patients in the wide range of our patients for CytoSorb.
This includes 11 studies in the pre-operative application of CytoSorb in cardiac surgery of which two controlled randomized studies will be finished by Q2 or Q3 of this year. There are first off evaluating the therapy in the post-operative treatment of wave encountered surgery patients and there are two studies in connections with ECMO, Extracorporeal Membrane Oxygenation.
In the case of severe sepsis and septic shock and lung injury, we are currently working on six studies. one is expected to be finished by Q3, Q4 of this year and there are another five studies in liver disease, the three studies in trauma or burn injuries and one study in to be acute pancreatitis. We already discussed our plans to conduct pivotal trials and chronic surgery in the United States, as well as sepsis studies in Germany. These are two areas where we have the more significant experience to-date.
Finally, we continue to invest the recourse to improve technical support to our customer and are evaluating many aspects of treatment including length and timing of treatment, removal of additional drugs, as well as the potential treatment of children. Again, just to keep expectations in the appropriate range, this is a huge amount of block that’s exposed currently underway and needing to be done. for some studies, it took over a year to prepare the protocol, obtain funding, complete the FX application and finally to receive FX approval for corporate tax recruitment.
On the patient recruitment itself, it’s dependent on many factors, such as availability of patients, investigators of studying that as being available when the patient comes in and getting informed content by the patient or relative and so on and so on. So we are sowing seeds to get all the things we need, but as it everything that needs the adequate time for the studies to develop before we can bring in the crop.
At the end of the day, we are seeking at least one clinical publication coming on every month. This is the kind of life awareness and the development of the therapy introduction tremendously. thank you, Donna..
Unidentified Company Representative
Thanks very much Chris, and another topic on many people’s mind is the Air Force rhabdomyolysis trial and various programs such as DARPA. Dr. Chan discussed it briefly but Vinc could you please elaborate a little more regarding the progress of these programs.
Thanks Donna. As Phillip mentioned the Air Force Rhabdomyolysis trial has begun. We were approved last year July but we experienced delays in the clinic as a result of the sequestration that occurred in 2013, with these governmental delays behind us we are up and running. In addition, we decided to add a second site to increase the rate of enrollment and we are in the process of doing this now. We will bring this site on in the coming months as soon as the contract requirements and the IRB approvals have been completed.
Regarding grants, I’m happy to say we’ve recently returned from the annul DARPA principal investigator meeting where we represented on our progress for year two. We’ve made good progress against our milestones taking down nearly $1.1 billion in DARPA grant funding and approximately $0.5 billion in other grant funding for 2013. Our progress in the program continues and we have supplied a small quantity of devices for testing by Battelle Memorial Institute, a systems integrator. We are encouraged by DARPAs continued interest in the CytoSorb technology and we looked forward to providing second and third generation bead technology to address toxins in addition to cytokines.
Beyond DARPA, we’ve completed the Phase I SBIR for burn and trauma and received an additional Phase I grant from NHLBI or the HemoDefend inline filter and beads in the back. We continue to look toward new brand opportunities as a way of securing non-dilutive funding to advance research for Cytosorbents platform. Donna?
Unidentified Company Representative
Have the increases in sales impacted production and do we have sufficient capacity for the near future at our existing facility?
Okay, great question. Our quarter-over-quarter growth continues to gain momentum and with an average increase in excess of 50%, but this increased growth comes in need to increase production to assure product availability for our customers. As such we are adding additional production staff to increase our output to address the growing demand for CytoSorb. Regarding plant capacity, we believe we have sufficient capacity to meet our needs into 2015, however from a manufacturing perspective our need to consider new facility is not far off given the lead time to bring on a new plant online.
We have begun engineering layouts to model various plant capacities and cost scenarios to better prepare for future growth, the question that often comes up is why not outsource? This is a good question, and simply it revolves around the need to maximize production flexibility, control quality and know-how. Regarding flexibility by controlling production we control the schedule, if we outsource we are at the mercy of lead times and production scheduling associated with the contract manufacturer. In other words, we are not the only customers that contract manufacturer has, we have to get into queue.
Product quality is critical to our success, production in our direct control allows us to focus on quality and ensure the expectations of our customers are already being met. Know-how in a highly technique business such as this is a critical part of our success. If we begin outsourcing our products, we must also outsource our know-how making it difficult to control trade secrets, for these reasons we have decided to keep manufacturing in CytoSorb in-house but we will continue to consider outsourcing as an option to meet additional capacity requirement as the business grows.
Unidentified Company Representative
Has the company made any progress in advancing the development of the HemoDefend product?
Hey, HemoDefend will fit nicely with; we will fit nicely in additional product line to be sold by our direct sales force in the ICU along the CytoSorb. Chris will speak to the partnering opportunities in a moment, but I believe likely, we will likely see the strategic partner for larger rollout of this product outside of Germany.
Regarding development efforts for EBIT event, we’ve included resources for development in our 2014 budget and began more rigorous engineering efforts. Our intend is to develop a first generation western class three hemoglobin both are produced with high risk patient required in blood transfusion.
At this point, we have develop prototypes and I’ve shown proof-of-concept with the technology. We can’t predicate to final end date and having an improved product, but we have made good progress and identifying to keep project milestones for critical path items for us to begin refining our development timeline. Donna.
Unidentified Company Representative
Thank you very much Vince. Let’s move to business development, Chris on the last call you talk about the Biocon product partnership and described how it will work? With the partnership now up and running, can you describe how things are going so far and what we might expect for the remainder of 2014?
Thanks Donna. Our partnership with Biocon is going very well, in fact many of our investors have noticed the positive remarks issued in the recent quarterly report. Early in the year, Phil and I met with Kiran Shaw, Biocon’s Chairman and Managing Director. After speaking with her, it’s clear to us that Biocon understand the CytoSorb value proposition and it’s putting the necessary resources into making our partnership successful. While Biocon is still in the beginning stages launching CytoSorb market demand has been favorable.
Initial field marketing and sales efforts have commenced several major cities through the surviving assisted with campaign, Biocon has been able to highlight the team of prevention of sepsis and saving patients lives.
Interest levels continue arise among the key opinion leader physicians and the success story so far have been instrumental for other insensitive to initiate treatment. More recently user meanings it helps per usage of the device and have raised interest levels to create a protocol in sepsis management and the roll of CytoSorb.
In addition for reasons of proactively reaching out to Biocon telling more about CytoSorb and many of expressed interest and trying it in their hospital. As a result I am pleased to report the Biocon’s already excited it’s first sales projections within the first six months.
The remainder of 2014 is shaping up to be very busy with several Biocon let’s formal targeted marketing and outreach programs and the developing key opinion leader support for CytoSorb, increasing product awareness, collecting usage in case study data and driving physician adoption.
Biocon have announced they will create a separate dedicated sales and marketing team to ensure adequate attention is given to creating awareness of CytoSorb and educating physicians on the usage of CytoSorb. In addition, Biocon is developing a patient registry and evaluating different case studies for developing manuscripts.
We will continue to swap Biocon by sharing data from our various studies in conducting fresher training throughout the year. Overall, we are very pleased with the Biocon partnership and look forward to continued success. We believe this partnership as potentially to change for treatment of critical care illnesses such as Sepsis and are confident that our work related ground work with expanded partnership in the future.
Unidentified Company Representative
Can you please comment on the progress towards establishing new strategic partnership for CytoSorb and describe where things stand relative to the partnership discussion you described on our last earnings call?
Sure. As I mentioned on our last earnings call, we’ve identified a key group of potential industry partners where we believe CytoSorb is a strong step from both the commercial and strategic perspectives. These partners have been prioritized for their ability to globally develop the market and maximize the potential opportunity for CytoSorb.
Over the last quarter and throughout the remainder of the year, our BD efforts have and was focused on developing relationships with these key players. In short, we continued to see strong interest in CytoSorb from major strategic players. Conferences such as the German Cardiovascular Surgery Society, European Association with Cardiothoracic surgery, International Symposium on Intensive Care and Emergency Medicine, The JPMorgan Healthcare Conference and others have given us an opportunity to showcase CytoSorb and meet with virtually all of our target partners.
I’m pleased to report that we continue to make good progress in establishing relationships with senior business leaders and advancing partnership discussions in both critical care and cardiac surgery organizations.
While deals with large corporate partners can take some time to develop for many reasons, some outside of our control it’s most important that they recognized is the value proportion of our products and potential role in their future strategy, I’m pleased to say that partners are indeed responding very favorably to our message and our partnership discussions are definitely moving in the right direction. I'm encouraged by our progress to-date and I remain confident about the strategic partnership potential for CytoSorb and to other products.
The business development team will be very active throughout the reminder 2014 and participating in industry conferences and advancing our strategic partnership objectives we hope to more positive news to discuss on future earnings calls.
Unidentified Company Representative
How about progress on strategic partnerships for Cytosorbents’ development program like HemoDefend?
Phillip P. Chan
Turned on to everyone HemoDefend is our advanced development program for improving the safety and quality of transfused blood. As Phil mentioned earlier, HemoDefend has the potential to reduce a broad range of transfusion reactions by moving various substances such as free hemoglobin, bioactive lipids, antibodies and other contaminants commonly found in stored blood. HemoDefend is a multi-faceted platform technology with multiple potential opportunities in purifying blood components such as packed red blood cells, platelets and plasma in various clinical studies including blood collection, processing, storage and point of care transfusion settings.
The first generation HemoDefend inline filter will target hospital-based customers for using high risk transfusion patients. Our goal with HemoDefend is to identify our partner to help fund and commercialize the platform. To that end we’ve been very activate in conferences like the American Association for Blood Banking, International Society of Blood Transfusions and many others, much like CytoSorb the value proportion for HemoDefend has been very positively received by potential strategic partners in the blood management space.
In addition to BD efforts, we are taking steps to de-risk HemoDefend as Vincent talked about thereby making it easier and more attractive for a large partner to potentially enter into an agreement. For example, we made strides in advancing the product design based on expert user input, we continue to expand the data on a removable capabilities to research collaborations with groups such as NHLBI and we’ve confirmed the likely regulatory path for the first generation HemoDefend inline filter in both U.S. and EU. All these are significant accomplishments which further helped to increase the value of the HemoDefend platform and improve our ability to establish the strategic partnership.
Finally, as Phil had mentioned in his presentation, we’re monitoring several important clinical studies which we believe to provide an additional positive tailwind to our partnering efforts. Most notably the RECESS and ABLE trials that Donna talked about, those studies are exploring the hypothesis that old blood is bad blood if they’re positive we could accelerate the need for blood verification solution such as HemoDefend.
In summary, we continue to make good progress on developing and de-risking HemoDefend while investments like this take time, we’re confident that they will ultimately help increase the value of the platform and advanced discussions with strategic, potential strategic partners. Overall I’m very optimistic. Overall, I’m very optimistic about the opportunities that lie ahead for us for HemoDefend.
Unidentified Company Representative
Thank you, Chris. Well, we seem to cover what were the major questions, Dr. Chan any closing remarks.
Phillip P. Chan
Yes, Donna. thank you very much everyone for submitting questions and participating in the call. if you have any additional questions, feel free to forward them to the company at www.cytosorbents.com and we’ll try to address them in our next update. with that, thank you everyone and have a great evening.
Ladies and gentlemen, this concludes Cytosorbents’ 2013 shareholder update conference call. If you would like to listen to a replay of today’s conference call, please dial 877-870-5176 and international dialers can call 858-384-5517. thank you for your participation. You may know disconnect.
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