Cumulative CytoSorb treatments surpassed
195,000. Q4 2022 product sales rebounded from Q3 2022 low. Adjusted
for constant currency, Core non-COVID 2022 product sales were
within 5% of that achieved in 2021 and greater than 30% increased
from pre-pandemic 2019
PRINCETON, N.J., Jan. 31,
2023 /PRNewswire/ -- CytoSorbents
Corporation (NASDAQ: CTSO), a leader in the treatment of
life-threatening conditions in the intensive care unit and cardiac
surgery using blood purification via its proprietary polymer
adsorption technology, issues a stockholder letter from its Chief
Executive Officer, Dr. Phillip Chan,
and announces preliminary unaudited fourth quarter 2022 and full
year 2022 results ahead of filing its Form 10-K.
Preliminary Unaudited Full Year 2022 Results
- Cumulative CytoSorb treatments delivered exceeded 195,000 at
the end of 2022, up 20% from the end of 2021, and marking the
10th year of CytoSorb commercialization
- Preliminary unaudited 2022 Total Revenue, which includes
Product Sales and Grant Revenue, was approximately $34.7 million versus $43.2
million in 2021, and $24.9
million in pre-pandemic 2019
- Overall preliminary unaudited 2022 Product Sales were
approximately $29.4 million versus
$40.1 million in 2021, which included
$0.3 million and $6.3 million in COVID-19 related Product Sales,
respectively, and versus $22.8
million in pre-pandemic 2019
- 2022 Core (non-COVID-19) Product Sales were approximately
$29.1 million versus $33.8 million in 2021. This reflects an 11%
drop in the average Euro to dollar exchange rate from 1.18 in 2021
to 1.05 in 2022. On a constant currency basis, Core Product
Sales would have been approximately $32.2
million versus $33.8 million
in 2021, a decrease of 4.6%
- Solid cash balance at the end of 2022 of approximately
$23.8 million
Preliminary Unaudited Q4 2022 Results
- Q4 2022 Total Revenue was approximately $9.4 million versus $10.8
million in Q4 2021, and versus $7.4
million in pre-pandemic Q4 2019
- Q4 2022 Product Sales were approximately $7.6 million, which rose 18% sequentially from
$6.5 million in Q3 2022, but were
lower than the $9.7 million in Q4
2021, which benefitted from $1.7
million in COVID-related sales. Pre-pandemic Q4 2019
Product Sales were $6.6 million.
- Core (non-COVID-19) Product Sales in Q4 2022 were approximately
$7.6 million, compared to
approximately $8.0 million in Q4
2021. On a constant currency basis, core Q4 2022 product
sales would have been $8.5 million, a
6% increase over $8.0 million in Q4
2021
CytoSorbents targets pivotal STAR-T trial
completion this year, with massive U.S. & Canadian
markets in its sights
The Company expects to report fully-audited financial results
for Q4 2022 and full year 2022 on Thursday,
March 9, 2023, with a conference call held at 4:30PM ET. Further details for the earnings
call will be provided at a later date.
CytoSorbents 2023: Eyes on the
Prize
Dear Stockholders and Friends,
Before I begin, I thought it would be helpful to pause and take
stock of where CytoSorbents stands today. In short, we are a
NASDAQ-traded medical device company that generated total revenue
of approximately $34.7M in 2022,
primarily from international sales of our flagship product,
CytoSorb®, a unique therapy that is E.U. approved for many
life-saving applications in the multi-billion dollar markets of
critical care and cardiac surgery. CytoSorb has demonstrated
its clinical value through 10 years of commercialization and nearly
200,000 treatments administered across 75 countries around the
world. In addition, we are working to enter the U.S. and
Canadian markets for the first time with a second product,
DrugSorb™-ATR, intended to reduce serious bleeding complications
from cardiothoracic surgery associated with the blockbuster blood
thinning drug, Brilinta® (AstraZeneca). We anticipate
completing enrollment of our pivotal STAR-T registration trial this
summer and if positive, intend to file for FDA and Health Canada
marketing authorization of DrugSorb-ATR following study completion.
We closed 2022 with a strong cash balance of $23.8M, and a grant contract backlog of
approximately $11.5M, primarily to
fund the development of HemoDefend-BGA for Universal Plasma,
another potentially major product in the queue.
We believe our value proposition is unique and compelling,
particularly in light of the major unmet medical needs that our
products address globally, our high margin "razorblade" business
model, the validation of our technology by our customers, strategic
partners, and government funding agencies, and the potential
proximity of opening and driving sales in the U.S., the largest
medical device market in the world, with the potential to
significantly accelerate our sales growth and profitability.
1. Opening the U.S. and Canadian Markets with
DrugSorb-ATR
Antithrombotic, or "blood thinning," medications are among the
most widely prescribed drugs in the world, with millions of people
on these agents to reduce the risk of heart attack and
stroke. However, patients taking these medications have a
higher tendency to bleed, sometimes fatally, particularly when
undergoing urgent surgery, suffering an acute injury, or developing
a spontaneous bleeding event such as a hemorrhagic stroke or
gastrointestinal bleed.
We are in the midst of the pivotal U.S. and Canadian STAR-T
(Safe and Timely Antithrombotic Removal
of Ticagrelor) randomized, controlled trial, designed to
support FDA and Health Canada marketing approval for DrugSorb®-ATR
to reduce the risk of perioperative bleeding in patients undergoing
cardiothoracic surgery potentially caused by Brilinta®
(ticagrelor). DrugSorb-ATR has already received two FDA
Breakthrough Device Designations, one to remove Brilinta, and the
other to remove direct oral anticoagulants such as Xarelto® (Bayer,
Janssen) and Eliquis® (Pfizer, BMS), highlighting the lack of
effective approved or cleared therapies in the U.S. to deal with
the bleeding risk in surgical patients. Based on actual data
on numbers of U.S. and Canadian patients on Brilinta® needing
urgent cardiothoracic surgery each year, we estimate the immediate
combined total addressable market for DrugSorb-ATR in these two
countries is approximately $300-350M
currently, and expected to potentially double as Brilinta® becomes
generic in 2024. We are already working with many of the
leading cardiac surgery centers and surgeons in both the U.S. and
Canada that have historically been
instrumental in driving innovation in the cardiac surgery
field.
In 2023, our goal is to successfully complete the STAR-T
trial, finalize our data analysis, and file for U.S. FDA and Health
Canada regulatory approval. We believe this would be a
game changing win for our company and have been working to put the
pieces in place to achieve this. Most recently, we
have:
- Enrolled the first third of a total of 120 patients in the
STAR-T trial in November 2022,
achieving the first of three major milestones in the study
- Received the recommendation by the independent Data and Safety
Monitoring Board (DSMB) to continue the trial without modification
in December 2022, following an
unblinded data review of the first 40 patients
- Obtained Health Canada approval of our STAR-T protocol this
month, clearing the way for us to initiate new high volume
Brilinta-using centers in the country, which is expected to speed
enrollment and completion of the study, while also supporting a
Health Canada regulatory submission
- Welcomed Dr. Irina Kulinets, PhD
as Senior Vice President of Global Regulatory Affairs and the
newest member of the executive management team, to lead the
regulatory approval of DrugSorb-ATR for anti-thrombotic
removal. Previously, she was the SVP of Regulatory Affairs,
Clinical Research, and Quality at Microvention, a global leader in
advanced neuroendovascular surgical products. Irina is highly
experienced in all aspects of U.S. and international medical device
regulatory affairs and has an outstanding track record of
successful device approvals across the gamut of low to high-risk
medical devices.
Patient enrollment in STAR-T continues to meet
expectations. We expect to reach the second milestone of 80
patients enrolled this spring, which will trigger the next
unblinded data review by the DSMB, and to complete enrollment of
all 120 patients this summer, with database lock and topline data
expected shortly thereafter. If positive, FDA and Health
Canada regulatory submissions are planned upon the completion of
the trial.
Preparing for Commercialization of
DrugSorb-ATR
Meanwhile, we have developed a detailed launch and
commercialization strategy for DrugSorb-ATR and are pursuing our
pre-commercial development in parallel to the clinical study.
A key area of focus is how DrugSorb-ATR will be funded. Based
upon a number of health economic analyses done in the U.K.,
Germany, and here in the U.S., the
value proposition of DrugSorb-ATR to reduce bleeding complications
and their associated costs is dominant, even in the absence of
dedicated reimbursement. With approval, we expect rapid
adoption under current cardiac surgery payment bundles. That
said, the STAR-T randomized, controlled trial is designed to
provide valuable health economics data to support market pricing
and standard reimbursement of DrugSorb-ATR from both private and
government insurers such as Centers for Medicare and Medicaid
Services (CMS), where we believe the cost-benefit message is very
compelling.
Although we feel very comfortable with the conventional path to
obtain reimbursement for DrugSorb-ATR, interestingly, there may
soon be another alternative avenue to obtain CMS reimbursement that
will only be available to a select group of FDA-approved
Breakthrough Devices. We have previously discussed how in
January 2021, CMS announced the
"Medicare Coverage for Innovative Technologies (MCIT)" rule, that
was designed to spur innovation in the medical device industry by
offering up to four years of automatic reimbursement for approved
or cleared FDA Breakthrough Devices. This would have been
very relevant to DrugSorb-ATR as a Breakthrough Device, as many
patients on blood thinners who require cardiothoracic surgery are
in the targeted Medicare population. Unfortunately, CMS
rescinded the rule in late 2021, citing needed improvements to
ensure safety, efficacy, and relevance in Medicare patients.
In the wake of this disappointing news, leading researchers at
Stanford University, including Dr.
Joshua Makower, published a paper
entitled "The Need for Accelerated Medicare Coverage of Innovative
Technologies: Impact on Patient Access and the Innovation
Ecosystem." In the paper, CytoSorbents and DrugSorb-ATR were
selected as one of four highlighted Breakthrough technologies,
among all other FDA Breakthrough Devices, that exemplified the
importance of the MCIT rule to the Medicare population.
Thankfully, there is broad bipartisan support of the MCIT rule,
and a modified version of it is included in the proposed CURES 2.0
Act legislation. In addition, in early 2022, CMS announced a
new initiative called "Transitional Coverage for Emerging
Technologies (TCET)" as a potential replacement for MCIT.
TCET is supported by AdvaMed (Advanced Medical Technology
Association) – the world's largest medical technology association
representing device, diagnostics, and digital technology
manufacturers who issued a similar letter supporting a proposed
TCET rule in August 2022.
In an article entitled, "A Vision of Medicare Coverage for New
and Emerging Technologies – A Consistent Process to Foster
Innovation and Promote Value" published in the October 13, 2022 edition of the Journal of the
American Medical Association (JAMA), Dr. Lee Fleisher and Jonathan Blum, Centers for Medicare &
Medicaid Services (CMS), said that CMS is "committed to making sure
Medicare beneficiaries are able to access emerging technologies"
and announced plans to develop a new expedited Medicare
reimbursement coverage pathway for new and innovative medical
devices that are relevant to the Medicare population.
At a Medtech Conference panel in October
2022, Tamara Syrek Jensen,
director of the CMS Coverage and Analysis Group, stated that CMS
plans to issue a proposed TCET policy by April 2023 and stated "We will have a proposed
[rule] out by April of 2023, that is a big priority for my
crew." This was reiterated at the November 9-10, 2022 Medical Device Manufacturers
Association (MDMA) meeting featuring CMS officials where in a
meeting synopsis, a key takeaway was that "TCET is still a CMS
priority and policy development is ongoing, expected timeline for
the proposed rule is early 2023."
In a press release and open letter to CMS Administrator
Chiquita Brooks-LaSure on
December 16, 2022, members of
Congress urged CMS to issue a proposed rule to streamline Medicare
beneficiaries' access to innovative medical devices" and stated,
"We firmly believe a successful implementation of a TCET rule
should include an independent transitional coverage pathway for
breakthrough devices that have been proved safe and effective by
the FDA."
Again, we believe DrugSorb-ATR, as an FDA Breakthrough Device
whose target population comprises many patients 65 years of age and
older in the Medicare population, could be well-suited to a
proposed CMS TCET policy. We are encouraged by the continued
prioritization of this program by CMS and will continue to follow
the progress closely. If it becomes a reality, we will
investigate this as an alternate path for CMS coverage.
Meanwhile, we continue to be laser-focused on driving DrugSorb-ATR
to the finish line.
2. Return to Sales Growth
CytoSorb is a European Union-approved blood purification
technology used primarily to treat deadly inflammation that is the
key common factor that drives illness severity and risk of death in
a wide range of life-threatening conditions in the intensive care
unit and cardiothoracic surgery. These are major unmet
medical needs that include, for example, sepsis, trauma, shock,
lung injury, liver failure, and complications of cardiothoracic
surgery, where outside of antibiotics, there is little more than
supportive care therapy (e.g. mechanical ventilation, dialysis,
vasopressors) to treat them. The number of afflicted patients
is being driven by many key trends in healthcare, particularly the
aging demographic. Collectively, these conditions afflict
tens of millions of people each year, typically killing 20-40% of
patients despite the best medical treatment, and often severely
debilitating survivors such that many are not alive or back in the
ICU in the next year. Sepsis alone is estimated to be
responsible for 1 in every 5 deaths worldwide. CytoSorb
celebrated its 10th year of commercialization last year,
accumulating nearly 200,000 human treatments and hundreds of
publications to date, and helping to save many, many lives across
75 countries.
CytoSorb targets a global multi-billion dollar total addressable
market each year. To date, among dozens of different
applications, nearly half of all CytoSorb treatments were related
to sepsis and septic shock. But other applications are
expected to gain momentum, particularly:
- Treatment of severe ARDS (acute respiratory distress syndrome)
with new exciting survival data in 100 patients from 5 major U.S.
ECMO centers, combining CytoSorb with ECMO (extracorporeal membrane
oxygenation) in the setting of COVID-19 to achieve "enhanced lung
rest" under FDA Emergency Use Authorization
- Treatment of acute liver disease where CytoSorb demonstrated
superiority to the leading liver dialysis platform in terms of
liver toxin and cytokine removal, and importantly, ease-of-use
- Antithrombotic drug removal with strong adoption by
cardiothoracic surgeons in Europe
and the pending completion of the STAR-T randomized controlled
trial
- Staph aureus endocarditis, driven by the risk of infection of
aging implanted prosthetic heart valves as well as the opiate
crisis and use of dirty needles
CytoSorbents sells CytoSorb with a direct sales force in 15
countries, and through distributors and partners in 60 other
countries. We leverage an attractive "razorblade" disposables
business model, where we believe the historic blended product gross
margins (mixing higher direct sales margins with lower distributor
margins) for CytoSorb are in the top tier for the medical device
industry and are more comparable to those seen in the biotechnology
and pharmaceutical industries. We are also partnered with some of
the leading providers of the blood pump machine "razors", that
include industry leaders Fresenius Medical Care (FMC), B Braun,
Terumo Cardiovascular, Biocon, and Nikkiso. Late last year,
CytoSorb became the "featured solution for cytokine, bilirubin, and
myoglobin removal" on FMC's blood pump platforms, helping to
"expand the dimension of blood purification" beyond the
approximately 10% of ICU patients who require kidney replacement
therapy, to the estimated 30-40% of patients in the ICU who suffer
from severe, damaging
inflammation.
CytoSorb, DrugSorb-ATR, ECOS-300CY® and VetResQ® are now being
manufactured at our new, certified, state-of-the-art production
facility and headquarters in Princeton, New Jersey. With capacity to
support up to $400M in global product
sales, the new plant was designed to streamline production, drive
manufacturing efficiencies, and ultimately drive down costs of
goods sold, and conversely help to expand product gross
margins.
We believe the fundamentals of our business and sales model are
sound. However, in 2022, we experienced a perfect storm of
many geopolitical, economic, post-pandemic, and company-specific
factors that contributed to lower-than-expected sales and product
gross margins, and higher capital expenditures and operating costs,
that made it a challenging year. Some of these factors
included:
- Significant weakness in the acute care hospital segment
worldwide. As widely reported, the toll of the protracted
pandemic led to an exodus of healthcare professionals, particularly
nurses, and a shortfall in revenues due to fewer hospital beds,
patients, and procedures, coupled with the additional financial
strain from inflation and energy costs. Many hospitals in
many countries are experiencing major deficits and are facing
significant financial hardship
- The 11% drop of the Euro against the U.S. dollar resulting in
major currency exchange headwinds as a majority of our sales are
based in Euros and converted into dollars
- The impact of high inflation and rapidly rising interest rates
that threatened global recession, cascading down into all aspects
of our business
- The Russia-Ukraine war that drove both political and
economic instability, and fueled skyrocketing energy costs
throughout Europe
- The plunge of the stock market that triggered a bear market in
many sectors, impacted our stock, and iced new investments and
funding
- "Pandemic inflation" resulting in higher-than-expected
construction costs to open our new manufacturing facility
- A temporary decline in product gross margin due to the
transition to our new Princeton, New
Jersey manufacturing facility
- The unusually competitive labor market, resulting in higher
labor costs and employee turnover, and
- The simultaneous launch of the two pivotal STAR-T and STAR-D
trials that increased our clinical spend
Given these challenges, we still managed to achieve
approximately $29.2 million in core
product sales last year, that when adjusted for the 11% drop in the
Euro, would have been at approximately $32.2M, within 5% of 2021 core sales of
$33.8M, and greater than 30% higher
than pre-pandemic product sales of $22.8M in 2019.
As we look ahead to 2023, many of the factors that we faced last
year still remain, but importantly, we believe a number of these
have abated, and we believe our own situation has improved
significantly. This year, we expect:
- Increased Visibility on the Likelihood of DrugSorb-ATR
Contributing to Future Sales
As we discussed above, every
month that goes by, we get closer to the completion of the STAR-T
randomized controlled trial, expected this year. High quality
clinical efficacy and health economics data from this study, if
positive, are expected to support FDA and Health Canada regulatory
approval, demonstrate cost savings to the healthcare system to
justify reimbursement, and support consideration for inclusion into
patient care guidelines. Should these come to pass, we
believe DrugSorb-ATR adoption could be swift with it becoming a
significant contributor to overall product sales, capturing a
portion of the estimated initial total addressable U.S. and
Canadian markets of $300-350M annually
- Rebound of International Product Sales Growth
Core
product sales for the year, when adjusted for currency exchange
differences, were within 5% of that achieved in 2021. In
addition, Q4 2022 core product sales were 18% sequentially higher
than Q3 2022, and actually 6% higher than core product sales in Q4
2021 on a constant currency basis. We believe this was
primarily related to our efforts and ability as a company to get
back to selling and marketing our products in person, rather than
any significant improvement of the hospital markets. Although
too early to draw broad conclusions, we are encouraged by the
continued market enthusiasm for our therapy and are projecting
stronger product sales this year based upon numerous growth
opportunities and initiatives. We expect gains from key programs
such as our standalone blood pump initiative, our global marketing
agreement with Fresenius Medical Care, our therapy area focus in
critical care, cardiac surgery, and liver & kidney diseases,
and our preferred supplier agreements with the top two largest
private hospital networks in Germany, Asklepios and Helios. We also
expect to launch several new sales and marketing initiatives in
2023 that we believe have the potential to drive increased sales of
CytoSorb throughout the world. We will have more detail on
these programs as the year progresses. Our goal is to more
than double our annual ex-U.S. product sales to at least
$80M in the next three years
- Restoration of Product Gross Margins – In 2022, product
gross margins were lower due to scheduled pauses in device
production, the combined overhead of two manufacturing facilities,
one-time manufacturing issues, and decreased production due to
inventory and lower than expected product sales. As most of
these issues were non-recurring, we believe product gross margins
will return to historic ranges between 75-80% in 2023
- Full CytoSorb Production from Princeton Facility
In
December 2022, we consolidated all of
our U.S. operations to our Princeton, New
Jersey headquarters. The transition was smooth and we are
currently beginning full production of CytoSorb out of the new
manufacturing facility
- More Normalized Year-over-Year Comparisons
In
the past several years, our results have been skewed by two major
items: large COVID-19 related product revenue from the first two
years of the pandemic, and currency exchange volatility.
Going forward, we expect more normalized year-over-year
comparisons, with nominal COVID-19 related revenue to compare to
last year, and what was a likely bottoming of the Euro in
2022
- Reduced Cash Burn with Tight Control Over Expenses, and No
Major Capital Expenditures
In December, we strengthened our cash balance to $23.8M with a non-dilutive $5M term-loan from Bridge Bank. Meanwhile in Q4
2022, we reduced our cash burn significantly and expect our
quarterly cash burn to be even lower in 2023 with achievement of
budgeted sales. Many of the cost cutting efforts that we took
in 2022 will become more apparent. For example, consolidation
of our U.S. facilities, where we exited our prior lease at the end
of 2022, will save approximately $0.8M this year. The postponement of STAR-D
is expected to save $4M in
2023. And annualized savings from the 10% headcount reduction
made last year will begin to be realized, particularly in
Europe now that mandatory
employment notice periods have expired. In addition, we do
not expect any major capital expenditures this year, after
completing the build out of our manufacturing facility last
year
- Finally, We Expect More Economic Relief for Hospitals
Throughout Europe
Healthcare is often cited as
recession resistant, as there are always people getting sick.
However, the pandemic initiated a global healthcare crisis, and
eroded the infrastructure and buffer that protected hospitals as
the backbone of the healthcare industry. This will likely
result in a wave of hospital consolidations with weaker ones being
assimilated or closed. But overall, we believe hospitals are
such a core part of the economy and provide such a fundamental,
basic human right that governments cannot afford, both economically
and politically, to let them fail despite occasional rhetoric to
the contrary. This is particularly true in most European
countries where governments regulate and fund, or heavily
subsidize, universal healthcare. For example, Germany pledged financial support for
German hospitals to offset the cost of energy in October
2022. In the same month, France announced a 150M Euro relief fund for pediatric
services, and earlier this month announced an overhaul
to the French health system. At the same time, the
U.K. Prime Minister called an emergency meeting
in early January 2023 on how to
shore up the struggling National Health System
(NHS). Although not enough, it highlights the
motivation of governments to address this crisis, which ultimately
we believe would be good for us
Eyes on the Prize
With everything going on in the world today, it is easy to get
distracted by short-term events and uninformed speculation, and to
lose sight of the significant value that we have created in this
Company, the expected proximity of some potentially game-changing
events such as the completion of the STAR-T trial and submission
for FDA and Health Canada marketing approval for DrugSorb-ATR, and
the long game goal of becoming a highly profitable leader in acute
care blood purification.
Despite the significant challenges that we have faced this past
year and their impact on our business, we believe we have
successfully navigated through some of the most challenging times
in our Company's history and believe we are in excellent shape and
well-positioned to take the next step in our evolution. We
believe we have been able to do so because of our strong
fundamentals.
- An outstanding and passionate team of nearly 200 employees
worldwide
- A strong network of dedicated users and healthcare
professionals in 75 countries globally
- A portfolio of compelling products, including CytoSorb,
DrugSorb-ATR, ECOS-300CY, VetResQ, HemoDefend-BGA, and others under
commercialization and development that address pressing unmet
medical needs, massive markets, and are driven by major trends in
healthcare
- An attractive high margin "razorblade" business model
- World-class industry partners
- A solid balance sheet to fund our initiatives
- A new manufacturing facility that is expected to drive further
product gross margin expansion while supplying product for years to
come, and finally,
- The expected successful completion of the STAR-T trial this
year, and if positive, submission for FDA and Health Canada
marketing approval, potentially opening up the massive U.S. and
Canadian markets – a potential watershed event for our Company
We are grateful to all of you who continue to support
CytoSorbents, see the tremendous value we have created, and share
our vision of success in the future. Best wishes to you and
your families for a happy, healthy, and prosperous New Year!
Dr. Phillip Chan, MD,
PhD
Chief Executive Officer
CytoSorbents Corporation
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in the intensive care unit and in
cardiac surgery through blood purification. Its lead product,
CytoSorb®, is approved in the European Union and distributed in 75
countries worldwide. It is an extracorporeal cytokine adsorber that
reduces "cytokine storm" or "cytokine release syndrome" in common
critical illnesses that can lead to massive inflammation, organ
failure and patient death. In these diseases, the risk of
death can be extremely high, and there are few, if any, effective
treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove antithrombotic drugs and
inflammatory mediators that can lead to postoperative
complications, including severe bleeding and multiple organ
failure. At the end of 2022, more than 195,000 CytoSorb
devices have been used cumulatively. CytoSorb was originally
launched in the European Union under CE mark as the first cytokine
adsorber. Additional CE mark extensions were granted for
bilirubin and myoglobin removal in clinical conditions such as
liver disease and trauma, respectively, and for ticagrelor and
rivaroxaban removal in cardiothoracic surgery
procedures. CytoSorb has also received FDA Emergency Use
Authorization in the United
States for use in adult critically ill COVID-19 patients
with impending or confirmed respiratory failure. The
DrugSorb™-ATR antithrombotic removal system, based on the same
polymer technology as CytoSorb, also received two FDA Breakthrough
Device Designations, one for the removal of ticagrelor and
another for the removal of the direct oral anticoagulants (DOAC)
apixaban and rivaroxaban in a cardiopulmonary bypass circuit
during urgent cardiothoracic procedures. The Company is
currently conducting the FDA-approved, randomized, controlled
STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of
120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use
of DrugSorb-ATR can reduce the perioperative risk of bleeding in
patients receiving ticagrelor and undergoing cardiothoracic
surgery. This pivotal study is intended to support FDA
marketing approval in the United
States and Health Canada marketing approval for DrugSorb-ATR
in this application.
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. Its technologies have received
non-dilutive grant, contract, and other funding of approximately
$48 million from DARPA, the U.S.
Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special
Operations Command (SOCOM), Air Force Material Command (USAF/AFMC),
and others. The Company has numerous marketed products and
products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and registered trademarks, and multiple
patent applications pending, including ECOS-300CY®, CytoSorb-XL™,
HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more
information, please visit the Company's websites
at www.cytosorbents.com and www.cytosorb.com or
follow us on Facebook and Twitter.
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, future targets and outlooks
for our business, including our future sales goals and targets,
expectations regarding the future impacts of COVID-19 or the
ongoing conflict between Russia
and the Ukraine, statements about
our growth opportunities, statements regarding the expected impacts
of our cost cutting measures, statements about the anticipated
timing for completion of our STAR-T clinical trial and regulatory
submissions, 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 10, 2022, 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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CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
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SOURCE CytoSorbents Corporation