MONMOUTH JUNCTION, N.J.,
April 24, 2015 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical care
immunotherapy company commercializing its European Union approved
CytoSorb® blood filter to treat deadly inflammation in
critically-ill and cardiac surgery patients, issued a letter to its
shareholders as part of its annual report, from its Chief Executive
Officer, Dr. Phillip Chan, which
reads as follows:
Dear Fellow Shareholders and Friends,
By all measures, 2014 was an outstanding year for CytoSorbents,
highlighted by many significant achievements. We exceeded our
internal forecasts for CytoSorb® sales growth, fueled by broadening
physician interest and usage in a growing number of
countries. We established or strengthened key strategic
partnerships with Fresenius Medical Care, Biocon, and a major
global cardiac surgery company, and expanded distribution of
CytoSorb® to 29 countries worldwide. These initiatives have
the potential to catalyze significant future growth. We also
began the clinical trial process needed to bring CytoSorb® home to
the U.S., initially for the application of cardiac surgery, and
possibly later for other applications. Finally, with the
support of our shareholders, we became a NASDAQ-listed company,
giving CytoSorbents much broader visibility in the investment
community and significantly increasing liquidity for
shareholders.
With that said, the most exciting part of this journey has been
the growing number of stories of how CytoSorb® has helped, in some
way, save the lives of ordinary people like you and me. These
patients find themselves in the intensive care unit because of
common life-threatening conditions such as sepsis and infection,
lung injury, trauma, burn injury, pancreatitis, liver failure, and
many others where inflammation plays a potentially deadly
role. Left untreated, severe uncontrolled inflammation can
lead to multiple organ failure, where patients spiral out of
control and become unresponsive to therapy, leaving families and
physicians with the difficult prospect of having to potentially
withdraw life-support. The fact that CytoSorb® therapy has
been used to reduce the "fuel to the fire" of this inflammation and
help bring many of these people back from the brink of death is, to
me as a physician, nothing short of remarkable.
To be clear, the diseases we treat are some of the most complex
life-threatening conditions in medicine for which no effective
therapies exist, and where the risk of death is still one in every
three patients despite the best medical treatment. We have no
expectation that CytoSorb® will work every time. But with the
collaboration and experience of a growing number of physicians who
have collectively performed more than 5,500 human treatments to
date, we have made significant progress toward identifying which
diseases and patients best respond to CytoSorb® therapy.
Centralized data from our recently launched International CytoSorb®
Registry and from the more than 50 planned investigator-initiated
and company-sponsored studies (a dozen of which are already
enrolling patients), will also be invaluable to understanding the
full potential of CytoSorb®. We now have the funding and
clinical development team to advance our trial agenda more
aggressively, particularly in the areas of sepsis and cardiac
surgery – our two largest markets.
A significant new opportunity has emerged that may accelerate
U.S. approval of CytoSorb® for critical illnesses such as
sepsis. The FDA has recently issued new guidance on two
related topics: the Expedited Access Pathway (EAP) program
and the Balancing of Pre-market and Post-market Data Collection for
Devices Subject to Premarket Approval. Together, the EAP and
Data Collection programs are designed to facilitate and expedite
the U.S. approval of medical devices that treat life-threatening or
irreversibly debilitating conditions that have no approved
alternative treatments. Similar to "Breakthrough Therapy
Designation" for drugs and biologics, devices that achieve EAP
Designation would be eligible for more intensive FDA guidance and
collaboration with senior managers, and priority review.
Meanwhile, the FDA and Device Sponsor would work together to
specify the clinical trial design and "least burdensome" efficacy
and safety data needed for early marketing approval, leaving the
proof of more stringent efficacy to the post-market period.
The end result is that devices that are safe and achieve EAP
Designation have an opportunity to get to U.S. approval and
commercialization much faster, and with less regulatory risk.
We believe this new program could benefit CytoSorbents as CytoSorb®
currently targets the treatment of many life-threatening conditions
such as sepsis, acute respiratory distress syndrome, severe acute
pancreatitis, trauma, and many others that do not have effective
treatments. As we move forward with our REFRESH cardiac
surgery trial in the U.S., we plan to aggressively pursue this EAP
opportunity for critical care applications in parallel, and foster
open collaboration with the FDA.
We have started 2015 in the strongest financial and commercial
position in our history, well-capitalized with a healthy cash
position, no debt, and the highest international awareness and
interest in our CytoSorb® therapy that we have ever seen.
Although we face some potential challenges such as the weakness in
the Euro, the need to strengthen our direct sales force, and the
unpredictability of timely country-specific product registrations,
we continue to believe that the many potential opportunities for
significant future growth greatly outweigh these near-term
concerns. As detailed in our April 7,
2015 press release responding to Frequently Asked
Questions, we have a clear strategy and plan on how to drive
long-term, sustainable growth of our business.
Before I conclude, I should comment on the potential use of
CytoSorb® as a rescue therapy for "cytokine release syndrome", or
CRS, that can lead to cytokine storm in activated T-cell
immunotherapy cancer treatments. This is one of the most
promising and exciting areas of cancer research where a patient's
own white blood cells (T-cells) are engineered to recognize and
kill cancer cells. This is a strategy being pursued by major
corporate and university alliances such as Novartis/University of Pennsylvania, Juno
Therapeutics/Memorial Sloan Kettering/Fred Hutchinson Cancer
Center/Seattle Children's Research Institute, Celgene/Bluebird Bio,
Kite Pharma/National Cancer Institute, GlaxoSmithKline/Adaptimmune,
Merck KGaA/Intrexon/MD Anderson, and Pfizer/Cellectis. In a
number of studies, the use of activated T-cells has led to the
"cure" or remission of many refractory leukemias and other
cancers. Common to all of these activated T-cell therapies is
the potent stimulation of the inflammatory response, leading to an
expected extended "flu-like" syndrome in patients, characterized by
high levels of cytokines. However, CRS can spiral out of
control, despite the use of tocilizumab and other prophylactic
measures, leading rapidly to multiple organ failure and often
death. CRS is exactly what CytoSorb® was designed
to control and we believe that CytoSorb® represents a
potentially unique rescue therapy to treat immune overstimulation
in T-cell immunotherapy. While we are still in the beginning
phases of exploring this new opportunity, CytoSorbents already has
several initiatives underway.
After a fantastic 2014, we are tremendously excited about the
opportunities this year and beyond. We are deeply grateful
for the continued faith and effort of our extended CytoSorbents
family: our patients and their families, the physicians and
nurses on the front lines using our therapy, our shareholders,
advisors, Board of Directors, distributors, strategic partners,
research collaborators, and importantly, our more than 50 dedicated
employees and consultants both here and in Berlin, Germany. Together, we can help
revolutionize the treatment of deadly inflammation, and help give
patients a fighting chance.
Finally, we fondly remember Joseph
Rubin (1938-2014), our co-founder and Board Director, whose
unwavering faith in the potential of our CytoSorb® technology to
help people remains an inspiration to us all.
Sincerely,
Dr. Phillip Chan, MD,
PhD
Chief Executive Officer
CytoSorbents Corporation
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused
immunotherapy company using blood purification to control severe
inflammation -- with the goal of preventing or treating multiple
organ failure in life-threatening illnesses. Organ failure is
the cause of nearly half of all deaths in the intensive care unit,
with little to improve clinical outcome. CytoSorb®, the Company's
flagship product, is approved in the European Union with
distribution established in 29 countries around the world, as a
safe and effective extracorporeal cytokine adsorber, designed to
reduce the "cytokine storm" that could otherwise cause massive
inflammation, organ failure and death in common critical illnesses
such as sepsis, burn injury, trauma, lung injury, and pancreatitis.
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,
such as cytokines and free hemoglobin, which can lead to
post-operative complications, including multiple organ
failure.
CytoSorbents' purification technologies are based on
biocompatible, highly porous polymer beads that can actively remove
toxic substances from blood and other bodily fluids by pore capture
and surface adsorption. CytoSorbents has numerous products
under development based upon this unique blood purification
technology, protected by 32 issued US patents and multiple
applications pending, including HemoDefend™, ContrastSorb,
DrugSorb, and others. Additional information is available for
download on the Company's website:
http://www.cytosorbents.com/.
Forward-Looking Statements
This press release includes forward-looking statements intended
to qualify for the safe harbor from liability established by the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to,
statements about our plans, objectives, representations and
contentions and are not historical facts and typically are
identified by use of terms such as "may," "should," "could,"
"expect," "plan," "anticipate," "believe," "estimate," "predict,"
"potential," "continue" and similar words, although some
forward-looking statements are expressed differently. You should be
aware that the forward-looking statements in this press release
represent management's current judgment and expectations, but our
actual results, events and performance could differ materially from
those in the forward-looking statements. Factors which could cause
or contribute to such differences include, but are not limited to,
the risks discussed in our Annual Report on Form 10-K, filed with
the SEC on March 31, 2015, as updated
by the risks reported in our Quarterly Reports on Form 10-Q, and in
the press releases and other communications to shareholders issued
by us from time to time which attempt to advise interested parties
of the risks and factors which may affect our business. We caution
you not to place undue reliance upon any such forward-looking
statements. We undertake no obligation to publicly update or revise
any forward-looking statements, whether as a result of new
information, future events, or otherwise, other than as required
under the Federal securities laws.
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SOURCE CytoSorbents Corporation