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CytoSorbents 2012 End of Year Shareholder Letter Monmouth Junction, NJ - (

Key Takeaway: CytoSorbents 2012 End of Year Shareholder Letter Monmouth Junction, NJ - (January 9, 2013) - CytoSorbents Corporation (OTCBB:CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, issued the following letter to shareholders. Dear

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CytoSorbents 2012 End of Year Shareholder Letter
Monmouth Junction, NJ - (January
9, 2013) - CytoSorbents Corporation (OTCBB:CTSO), a critical care focused company using blood purification to treat life-threatening
illnesses, issued the following letter to shareholders.
Dear Shareholders and Friends,
As we welcome 2013, it marks an opportune
time to reflect upon our many important accomplishments in the past year and to further elaborate on our vision for the future.
Our mission is to improve and save lives,
reduce spiraling healthcare costs, and increase shareholder value by driving the success of CytoSorbents. To this end, we are building
the Company upon three pillars of value.
This represents our overarching strategy
for the Company. With trailing revenues expected to be approximately in the range of $1.2-1.4 million in 2012 (unaudited results)
- a combination of primarily grant income and early product revenue - we hope that we are just at the beginning of creating
a valuable growth company.
Commercialization of
We officially launched direct sales of
CytoSorb in Germany, Austria and Switzerland in the second half of 2012. CytoSorb is approved in the E.U. as a first-in-class
extracorporeal cytokine filter to be used in any situation where cytokines are elevated. We are positioning the device as a safe
and powerful new tool to control cytokine storm, reduce uncontrolled inflammation, and potentially prevent or treat organ failure.
The launch was the culmination of a significant effort to position CytoSorbents as a commercialization focused company.
Since the first commercial availability
of the CytoSorb cytokine filter in Q4 2011, through the end of 2012, we have generated product revenues in the range of $190-$200K.
CytoSorb sales in Q4 2012 (unaudited results) are expected to be nearly half this total figure, reflecting primarily the first
full quarter that our direct sales team was active.
Going forward, we are implementing a multi-pronged
strategy for CytoSorb sales expansion. The first part focuses on direct sales in Germany, Austria and Switzerland, using our
direct sales force. The advantage of direct sales is that we intimately control the sales process, have direct contact with the
KOLs and end-users that facilitates feedback and planning, and can sell with higher gross margins. We are currently in the key
opinion leader adoption phase, where there is naturally a lag between when a KOL first agrees to use or trial the CytoSorb
filter, to when we achieve first sales, to when we can achieve broader departmental usage with reorders. That said, as we have
described before, KOL approval is one of the most important steps to driving adoption and greater usage. CytoSorb has been
generally met with enthusiasm by physicians, as little can be done today to help critically ill patients, and CytoSorb attacks
the well-known underlying causes of organ failure. This seeding of the market will hopefully help generate ongoing data and clinical
usage in many different applications.
The second phase of the strategy is to
work with distributors or strategic partners to expand the commercial footprint of CytoSorb to the rest of Europe and to other
countries that accept European regulatory approval. This will allow us to leverage their pre-established sales force and distribution
capabilities, including important KOL contacts, enabling broader CytoSorb filter sales.
By layering these two sources of revenue
with grant income from government R&D contracts, we hope to accelerate our revenue growth and time to cash flow breakeven.
If our European strategy is successful, it would provide an abundance of opportunities for the Company. We estimate that Germany
alone represents a total addressable market of at least $500 million to $1 billion for critical care applications. However, to
further drive success of the Company, we plan to pursue U.S. regulatory approval for CytoSorb . We intend to leverage our existing
FDA approved IDE application (to run a small sepsis trial), to run a larger pivotal trial in the U.S. The timing of a trial in
the U.S. is subject to many variables, and we are working through those now with the intent of conducting detailed discussions
with the FDA regarding trial design later this year. Should a pivotal trial be successful in the U.S., it could lead to U.S. FDA
approval and be yet another major catalyst to CytoSorb adoption and usage worldwide.
With each new CytoSorb treatment,
we learn more about how best to use it. In our ongoing dosing study, CytoSorb has been successfully used with continuous treatment
(each cartridge used for 24 hours) for 7 days with no serious device related events. The trial is ongoing, with additional patients
being enrolled, samples collected and data being analyzed. We are currently expanding the study to include a total of seven hospitals
in Germany, all of which are leading university hospitals that expressed an interest to join our trial. We are also using the trial
as an opportunity to answer some important questions related to treatment, which will be helpful to further guide clinical usage.
Outside of the trial, in every day clinical
practice, physicians have had generally encouraging results with CytoSorb . For example, there have been a number of cases
of septic shock and multiple organ failure where CytoSorb was used in patients with extremely high cytokine levels (e.g. IL-6
greater than 20,000 pg/ml). These patients were extremely sick with a variety of infections ranging from a Streptococcal limb infection
to suspected gram negative sepsis following complications from a gynecologic procedure. In each of these cases, the prognosis was
reportedly grim by the treating physicians. With Cytosorb treatment, IL-6 levels dropped dramatically over the course of several
days, with an eventual resolution of organ failure, and patient recovery. Based upon feedback from these physicians, they are interested
in documenting these surprising results for potential publication.
There have also been a handful of cases,
unfortunately, where CytoSorb has not been able to rescue the patient. A common theme in these treatment failures appears
to be either suboptimal usage of Cytosorb or treatment that was too late in the disease process. We cannot expect CytoSorb
to save all patients, particularly when patient's illnesses are so advanced that recovery is unlikely. That said, the more
clinical experience we gain with the technology, the better the odds of treating these patients optimally and having a better clinical
Overall, we continue to make significant
progress in our commercialization efforts and are pleased with the initial physician response and clinical experience.
Research and Development update
We continue to advance our technologies
and grow our product pipeline through investments in research and development. We have recently been awarded approximately $5M
in government contracts that help to fund these efforts.
DARPA $3.8M Contract
As part of DARPA's "Dialysis-like
Therapeutics" program to treat sepsis, we were awarded a $3.8M five-year contract in August to develop advanced polymers that
can remove not only cytokines but also a variety of bacterial and biowarfare toxins. Our technology is ideally suited for this
broad spectrum capability. In fact, we have already demonstrated the ability of CytoSorb to remove a number of these toxins
in vitro such as Staphylococcus aureus alpha toxin, a potent toxin that is responsible for cell destruction and widespread
tissue damage in Staph. aureus and methicillin resistant Staph. aureus, or MRSA, infection. MRSA is one of the leading and most
deadly hospital acquired infections. Outside of this DARPA contract, Dr. John Kellum at University of Pittsburgh has demonstrated
in an animal model of sepsis, that a reduction of cytokines by CytoSorb hemoadsorption appears to redirect the immune response
to the area of infection, helping to control it even in the absence of antibiotics, while preventing unwanted immune-mediated injury
to uninvolved, healthy organs. These new and exciting findings highlight the multi-factorial and synergistic benefit that CytoSorb
may have in these critical illnesses (i.e. reduction of cytokine storm, removal of damaging bacterial toxins, redirection of the
immune response, and others) and why we believe our technology is the best-in-class solution.
United States Army $1M Phase 2 SBIR
We are nearing the completion of our negotiations
of our $1 million Phase 2 SBIR award with the U.S. Army. Ahead of this, we have been continuing our work from the Phase I SBIR
award, and should be in a good position to make rapid progress with funding. We remain excited by the prospect of continuing to
work with the Army and obtaining efficacy data in animal models of both burn injury and trauma which, if positive, will help advance
these applications in human treatment. We are also encouraged by interest from other branches of the military in our technologies,
which may lead to other opportunities.
Business Development
One of the key goals of the Company is
to establish strategic partnerships for various products in our pipeline. We cannot commercialize all of them by ourselves, so
leveraging the expertise, financial resources, and infrastructure of dedicated partners remains a logical option. The majority
of our products under development have achieved proof-of-concept, at a bare minimum.
One of our most advanced development candidates
is our HemoDefend blood purification technology. HemoDefend is designed to remove contaminants in blood transfusion products that
can cause transfusion reactions, effectively "washing blood" without the cost, time and trouble of actually doing so.
Last updated: Jan 9, 2013