PRINCETON, N.J., Aug. 17,
2022 /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, announced that the Israeli Ministry of Health (MoH) has
approved national reimbursement for CytoSorb® in certain cardiac
surgery indications that is expected to take effect in 2023.
Israeli Ministry of Health Adds CytoSorb
Blood Purification Cartridge to Healthcare Basket with National
Reimbursement
Specifically, the Hospital Technologies Committee of the Israeli
MoH has approved national CytoSorb reimbursement, also known as
"addition to the Healthcare Basket," for the following
indications:
- Intraoperative treatment for urgent or emergency cardiac
surgery in patients treated with ticagrelor or rivaroxaban
- Intraoperative treatment during cardiac surgery in patients
with acute infective endocarditis
- Intraoperative treatment during surgery for correction of
aortic dissection
With its decision, the Committee recognizes the importance and
value of CytoSorb to remove a variety of antithrombotic drugs and
inflammatory mediators intraoperatively during cardiac
surgery. Once the policy revision is completed, public
hospitals are expected to receive reimbursement for CytoSorb for
these applications.
Christian Steiner, M.D.,
Executive Vice President, Sales and Marketing of CytoSorbents,
stated, "Israel has one of the
highest quality and advanced healthcare systems in the world,
strengthened by its leadership in adopting innovative medical
technologies. We are pleased that the Ministry of Health
recognizes the benefits of intraoperative CytoSorb use in cardiac
surgery and has approved national reimbursement."
Israel has a population of
approximately 9 million people, all of whom are covered by
universal health insurance. Annually, the country spends about 7.5%
of its gross domestic product (GDP) on healthcare.
Israel spends an estimated
$2.4 billion annually on medical
devices, with imports accounting for approximately 65% of the
medical device market. According to the Israel Heart Society,
heart disease is the second leading cause of death in the
country. More than 4,000 heart surgeries are performed in
Israel each year.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of
life-threatening conditions in critical care and cardiac surgery
through blood purification. Its lead product, CytoSorb®, is
approved in the European Union and marketed in more than 70
countries worldwide. It is an extracorporeal cytokine adsorber
designed to reduce the "cytokine storm" or "cytokine release
syndrome" that occurs in common critical illnesses and 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 inflammatory
mediators that can lead to postoperative complications, including
multiple organ failure. As of June 30,
2022, more than 179,000 CytoSorb devices have been used
cumulatively worldwide. CytoSorb was originally launched in
the European Union under the CE Mark as the first extracorporeal
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 during cardiothoracic surgery. CytoSorb
has also received FDA emergency approval 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 FDA
Breakthrough Device Designation to remove ticagrelor and FDA
Breakthrough Device Designation to remove the direct oral
anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary
bypass circuit during urgent cardiothoracic procedures. The
company has initiated two FDA-approved pivotal studies to support
marketing approval of DrugSorb-ATR in the United States. The
first is the randomized, controlled STAR-T (Safe and Timely
Antithrombotic Removal-Ticagrelor) study of 120 patients at 30
centers to evaluate whether intraoperative use of DrugSorb-ATR can
reduce perioperative bleeding risk in ticagrelor patients
undergoing cardiothoracic surgery. The second study is the
STAR‑ D (Safe and Timely Antithrombotic Removal-Direct Oral
Anticoagulants) randomized controlled trial of 120 patients at 30
centers evaluating the intraoperative use of DrugSorb-ATR to reduce
perioperative bleeding risk in patients undergoing cardiothoracic
surgery who are taking direct oral anticoagulants, including
apixaban and rivaroxaban.
CytoSorbents' purification technologies are based on
biocompatible, highly porous polymer beads that can actively remove
toxic substances from blood and other body fluids through pore
entrapment and surface adsorption. The Company's technologies
have received more than $39.5 million
in non-dilutive grants, contracts and other funding from DARPA, the
U.S. Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), the 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 and
in-development products based on this unique blood purification
technology protected by numerous issued U.S. and international
patents and registered trademarks, as well as several pending
patent applications, 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 contains forward-looking statements that fall
within the safe harbor of the Private Securities Litigation Reform
Act of 1995. These forward-looking statements include, but are not
limited to, statements regarding our plans, objectives, future
goals and prospects for our business, expectations regarding the
future impact of COVID-19 or the ongoing conflict between
Russia and Ukraine, representations and assertions, and
are not historical facts and are generally identified by the use of
words such as "may," "should," "could," "expect," "plan,"
"anticipate," "believe," "estimate," "predict," "potential,"
"continue" and similar terms, although some forward-looking
statements are worded differently. You should be aware that the
forward-looking statements in this press release reflect
management's current beliefs and expectations, but that our actual
results, events and performance may differ materially from those in
the forward-looking statements. Factors that could cause or
contribute to such differences include, but are not limited to, the
risks disclosed in our Annual Report on Form 10-K filed with the
SEC on March 10, 2022, our Quarterly
Reports on Form 10-Q and the press releases and other
communications to stockholders that we issue from time to time
seeking to inform interested parties of the risks and factors that
may affect our business. We caution you not to place undue reliance
on such forward-looking statements. We are under no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise, except
as required by federal securities laws.
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U.S. Company Contact:
Amy
Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
avogel@cytosorbents.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com
U.S. Public Relations:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
European Public Relations:
Marcus Schult
commponists
+49 69 13823 ext. 960
+49 172 4238938
marcus.schult@die-kommponisten.com
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SOURCE CytoSorbents Corporation