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CytoSorbents 2021: Leadership and Growth in the "New Normal"

Key Takeaway: CytoSorbents 2021: Leadership and Growth MONMOUTH JUNCTION, NJ - February 18, 2021 - CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and card

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CytoSorbents 2021: Leadership and Growth
MONMOUTH JUNCTION, NJ - February
18, 2021 - CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb
blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around
the world, issues a stockholder letter from Chief Executive Officer, Dr. Phillip Chan. Additional detail will be forthcoming in
the Company's Q4 and Full Year 2020 earnings press release and Form 10-K, expected March 9, 2021.
Future Growth in 2021 and Beyond
1. Achieve solid growth in product revenue, while replacing COVID-19 sales
2. Prioritize path to U.S. regulatory approval of CytoSorb based on ticagrelor removal in cardiothoracic surgery
3. Build-out the U.S. commercialization team
4. Execute on our new clinical trial strategy in the U.S. and Europe
5. Expand manufacturing facility to accommodate a peak capacity of $350-400M in sales
6. Roll out a new company look and perspective
Dear Stockholders and Friends,
were pleased to pre-announce preliminary, unaudited 2020 total revenue of $40.8 million and product sales of nearly $40
million, representing 73% growth from 2019, and a healthy year-end cash balance of approximately $71 million, despite the COVID-19
pandemic - one of the most serious debacles the world has faced in recent history.
was a force majeure that ground global economic growth to a halt. Companies everywhere and in every industry faced a host of unknowns,
including the potential for a precipitous drop in revenue, the risk of major losses and even bankruptcy, the prospect of mass workforce
lay-offs, and the risk of true personal harm to their employees - especially those that could not work remotely. Certainly
for CytoSorbents, COVID-19 led to many unprecedented and complex challenges that had
a profound impact on nearly every part our company, from sales to manufacturing to clinical trials. That said, we believe
the experience and resourcefulness of our leadership team, including management and the Board of Directors, and the tenacity, hard
work, and dedication of our employees, enabled us to both navigate safely through most of these obstacles and to have our best
With so much uncertainty
caused by the COVID-19 crisis, we moved decisively in 2020 to embrace our opportunities, protect our business, drive innovation,
and importantly, lay the building blocks for future growth.
has disrupted many aspects of our business, it has also been a catalyst, helping to bring the dangers of hyperinflammation, and
specifically the term "cytokine storm," into the collective consciousness, while shining a spotlight on CytoSorb. This
in turn, led us to pivot quickly to maximize our sales of CytoSorb for both COVID-19 and our non-COVID-19 core businesses in critical
care and cardiac surgery. Because of this, in a down year for many companies, we continued to extend our scientific and commercial
leadership in these existing markets, and also in new applications we helped to create. But our success did not happen by chance.
It was due to the dedicated effort and hard work from our entire company to take advantage of every opportunity. Even the increase
in sales related to COVID-19 was only possible because of the extensive prior use of CytoSorb to treat cytokine storm. For example:
financial crisis of 2007-2008 have we seen such a pervasive and devastating threat to the global economy and our personal lives.
The COVID-19 pandemic didn't just create fear and uncertainty, it wreaked universal havoc on governments, entire industry
sectors, companies, families, and individuals. To protect our company:
We believe innovation
is the lifeblood of our company, fueled by our own investment as well as more than $38 million in government contracts, grants,
and other non-dilutive funding towards our technology over the past many years. In 2020, we made excellent progress in advancing
our pipeline of potential products. For example, we:
Foundation for Future Growth
2021 will be a transition year as COVID-19 hopefully fades from dominance, and business returns to "the new normal."
We expect the same, but unlike our contemporaries in the medical device industry that suffered revenue shortfalls from sharp declines
in elective surgeries, we were fortunate to actually see a surge in sales, both from COVID-19 and its halo effect on our underlying
business. As such, our focus for 2021 is not on recovery, but on progress and growth. Our overall projected goals for this year
April, we achieved FDA Breakthrough Designation of CytoSorb to remove ticagrelor during urgent or emergent cardiothoracic
surgery. However, expectedly, the Agency focused on the pandemic which significantly delayed the FDA's availability to advance
non-COVID-19 applications. That said, we recently just met again with the Agency and believe that we are now aligned on the positive
benefit-risk profile of the therapy and the additional clinical data needed to support approval. Furthermore, we recently strengthened
our team by hiring David Cox as Vice President of Global Regulatory Affairs, formerly VP of Regulatory Affairs at Integra
LifeSciences. David is a seasoned regulatory executive with a long track record of regulatory successes at Integra, Terumo BCT,
and Medtronic, who will add the needed firepower and focus to our regulatory efforts. There is another point that makes U.S. FDA
Breakthrough Designation even more meaningful. Last month, the Centers for Medicare & Medicaid Services (CMS) announced the
Medicare Coverage of Innovative Technology pathway that will provide national Medicare coverage as early as the same day
as FDA market authorization for breakthrough medical devices, where coverage would last 4 years. This program is expected to speed
adoption of CytoSorb, if approved, across the U.S. for this application. Finally, the United Kingdom's internationally renowned
National Institute for Health and Care Excellence (NICE), viewed by most as the world's leading authority in evaluating
the cost-effectiveness of novel therapies, just recently issued a Medtech Innovation Briefing on CytoSorb for reducing
risk of bleeding during cardiac surgery, highlighting the unique potential of CytoSorb to improve clinical outcomes and efficiency
that can lead to substantial cost savings to hospital systems.
still working to manage the challenges of the COVID-19 pandemic, though fortunately rates of new infection have been falling worldwide.
With the rollout of COVID-19 vaccinations, we are optimistic that the COVID-19 pandemic will abate significantly, but not completely
disappear, by mid-summer. According to Bloomberg, more than 186 million vaccinations have been given across 82 countries,
with 57 million doses already administered among 40 million people in the U.S. Although an encouraging start, there are 7.8 billion
people worldwide, and in the U.S., only 20% have either been infected or received a vaccine. At current reported vaccination rates,
it will take an estimated 9 months to vaccinate 75% of the U.S. population alone.
And even as the world races to vaccinate
the masses, the virus has not been standing still. Potentially more deadly variants of the virus are now circulating with
the highly contagious B.1.1.7 variant, first isolated in the United Kingdom, now in more than 40 U.S. states and doubling in
new U.S. infections every 10 days. The U.S. Centers of Disease Control and Prevention (CDC) expect B.1.1.7 to become the
dominant strain in the U.S. by March. Fortunately, the vaccines from Pfizer and Moderna appear to protect against this strain.
However, there are even more worrisome strains, such as the B.1.351 variant that originated in South Africa, and now the
B.1.525 variant, found in 11 countries including here in the U.S., with multiple mutations that may confer a degree of
resistance to some vaccines. For example, early in vitro studies indicate that the Moderna and Pfizer vaccines may
be less effective, and the AstraZeneca vaccine is not efficacious enough, against the B.1.351 variant. Time will tell if
these mutant viruses become major problems, but what is clear is that the coronavirus, in some shape or form, will continue to
be with us for some time.
Regardless of what will happen, know
that the same leadership team that has successfully and responsibly led the Company through a tremendous multi-year expansion with
strong and consistent growth, and through numerous complicated challenges such as the COVID-19 pandemic, has only gotten stronger
with our recent additions, and remains committed to the future success of CytoSorbents.
A Sincere Word of Thanks
In a time of crisis, true heroes see the
need and heed the call, without thought for themselves. Our appreciation and gratitude to all of the unsung heroes on the front
lines of the pandemic - from the myriad of healthcare workers and support staff, the first responders, and researchers, to all
of those in the background who kept the economy running and kept our families fed and supplied, our houses warm and connected,
our children educated, and made it possible for the rest of us to shelter in place. And on behalf of the Board of Directors and
the management team, a sincere word of thanks to all of you in our extended CytoSorbents family - patients and their families,
physicians, nurses, perfusionists and other healthcare workers, scientific and clinical researchers, hospital administrators, distributors,
strategic partners, service providers, shareholders, and our amazing employees and their families - for your tremendous dedication
and effort in a challenging year, and for your support, trust, and faith in CytoSorb and our Company. Without you, this past year
would not have been possible. Wishing everyone a safe, healthy, and prosperous 2021!
Dr. Phillip Chan, MD, PhD
Chief Executive Officer
CytoSorbents Corporation
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader
in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb is approved in
the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce
the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ
failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective
treatments exist. CytoSorb is also being used during and after cardiac surgery to remove inflammatory mediators that
can lead to post-operative complications, including multiple organ failure. CytoSorb has been used in more than 121,000 human
treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma),
Last updated: Feb 18, 2021