CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® now
cleared for manufacturing from this site
PRINCETON, N.J., Sept. 27,
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 today that it has received ISO
13485 Certification of its new manufacturing facility in
Princeton, New Jersey from its
European Union (E.U.) notified body, clearing the way for full
manufacturing of CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® from
this site, with capacity to add additional product lines as they
are developed.
CytoSorb®, DrugSorb®-ATR, and ECOS-300CY®
now cleared for manufacturing from Princeton, NJ site
Mr. Vincent Capponi, President
and Chief Operating Officer of CytoSorbents stated, "We are very
excited to receive this certification, which represents another key
milestone in our company development and commercialization story.
Our manufacturing, engineering, quality, and regulatory teams
deserve the credit for this significant accomplishment. This
state-of-the-art facility expands our manufacturing capacity to
support up to $350-400 million in
sales of our commercialized products, and will be a key component
in the regulatory application and expected commercial launch of
DrugSorb-ATR in the United
States."
CytoSorb is an advanced blood purification cartridge approved in
the E.U. and distributed in 75 countries worldwide to remove
cytokines (inflammation), bilirubin (liver failure), and myoglobin
(trauma), from blood. CytoSorb is also E.U. approved to
remove the antithrombotic "blood thinning" drugs, Brilinta®
(ticagrelor, Astra Zeneca) and Xarelto® (rivaroxaban, Janssen,
Bayer) during cardiothoracic surgery to reduce the risk of
perioperative bleeding.
DrugSorb-ATR is an investigational blood purification cartridge
that uses an equivalent polymer technology to CytoSorb, and is in
two pivotal U.S. randomized, controlled clinical trials under dual
FDA Breakthrough Device Designations, to remove Brilinta® (STAR-T;
Safe and Timely Antithrombotic Removal – Ticagrelor) and the direct
oral anticoagulants (DOACs), Eliquis® (apixaban, Pfizer, BMS) and
Xarelto® (STAR-D, - DOAC), intraoperatively during cardiothoracic
surgery to reduce the risk of perioperative bleeding with the goal
of achieving FDA marketing approval. The STAR-T trial is
enrolling well and is expected to reach the first milestone with 40
patients enrolled within the next couple of months that will
trigger the first Data and Safety Monitoring Board (DSMB)
meeting.
ECOS-300CY® is approved in the E.U. as a cytokine adsorber for
ex vivo organ perfusion machines used in solid organ
transplant to reduce circulating cytokines and other inflammatory
mediators. The goal of the therapy is to improve the
functioning of substandard organs, potentially increasing the pool
of donated organs and reduce the waiting list for
transplant.
ISO 13485 was written to support medical device manufacturers in
designing a quality management system (QMS) that establishes and
maintains the effectiveness of their processes. It ensures the
consistent design, development, production, installation, and
delivery through to disposal of medical devices that are safe for
their intended purpose.
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
more than 70 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 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. 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 has initiated
two FDA-approved pivotal studies to support FDA 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 the
perioperative risk of bleeding in patients receiving ticagrelor and
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 and 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 $41.5 million
in non-dilutive grants, contracts and other non-dilutive 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 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, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and the Ukraine, 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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Investor Relations Contact:
Amy
Vogel
(732) 398-5394
avogel@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation