MONMOUTH JUNCTION, N.J.,
April 19, 2021 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a critical
care leader whose flagship E.U. approved CytoSorb® blood
purification technology is intended to treat deadly conditions in
critically-ill and cardiac surgery patients, announces that
the U.S. Food and Drug Administration (FDA) has granted conditional
approval of its investigational device exemption (IDE) application
for the U.S. Safe and Timely Antithrombotic
Removal - Ticagrelor (STAR-T) randomized,
controlled trial. Based on this conditional approval, study
initiation activities, including clinical trial agreement
negotiations and institutional review board (IRB) submissions, can
now commence, putting the study ahead of the Company's
internal schedule. The Company has already identified and
pre-screened many high-quality U.S. clinical centers that have
indicated strong interest to participate in the STAR-T trial.
The Company believes conditions for full IDE approval can be
appropriately addressed within the 45-day timeframe outlined by the
FDA, and once accepted, the Company expects to provide additional
detail on the trial.
FDA gives green light to CytoSorbents to begin U.S. STAR-T Trial
designed to support U.S. FDA marketing submission
Dr. David Cox, Vice President of
Global Regulatory of CytoSorbents stated, "We are pleased that the
FDA has approved our randomized, controlled clinical trial for the
removal of ticagrelor (Brilinta®,AstraZeneca) during cardiothoracic
surgery to reduce perioperative bleeding complications. We
will promptly address FDA's conditions of approval and finalize the
IDE protocol to best support a U.S. marketing submission of our FDA
Breakthrough Device technology for this application."
Mr. Vincent Capponi, President
and Chief Operating Officer of CytoSorbents added, "We are very
excited to have received the go ahead from the FDA to begin the
STAR-T trial, that if successful, is expected to support our first
U.S. FDA marketing submission. In the future, we plan to
leverage the alignment with FDA and the STAR-T study
infrastructure, including the academic leadership, operational
framework, and participating clinical trial sites to seek label
expansions in antithrombotic removal beyond ticagrelor. This
IDE approval marks a key first step forward in our long-term U.S.
commercialization strategy to become the de facto standard
of care therapy to remove antithrombotic drugs, generically called
blood thinners, during cardiothoracic surgery, with an estimated
total addressable U.S. market of $1
billion."
In April 2020, the FDA granted
CytoSorbents Breakthrough Device Designation to remove ticagrelor
during cardiothoracic surgery, recognizing this major unmet medical
need. Each year, ticagrelor is prescribed to millions of
cardiovascular patients worldwide to reduce the risk of recurrent
hearts attack, stroke or cardiovascular death. Ticagrelor is
frequently preferred as first line therapy in patients presenting
to hospitals with an acute coronary syndrome in preparation of
percutaneous coronary intervention (PCI) and stent placement.
However, up to 10% of these patients will require coronary artery
bypass graft (CABG) open heart surgery and as several clinical
studies, such as the PLATO trial, have shown, they face a very high
risk of severe or life-threatening bleeding during
surgery.
Mr. Capponi continued, "CytoSorbents' blood purification
technology offers a simple solution to mitigate bleeding risk by
being placed in the cardiopulmonary bypass machine blood circuit to
directly remove ticagrelor during cardiothoracic surgery. We
are working collaboratively with FDA under Breakthrough Device
Designation to aggressively pursue this opportunity and address
this major unmet clinical need. This approval accelerates our
internal timeline, and with the identification of clinical sites
already completed, we are now in a position to move agressively
forward with the execution of the STAR-T trial."
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 outside of the US, as an
extracorporeal cytokine adsorber designed to reduce the "cytokine
storm" or "cytokine release syndrome" that may result in massive
inflammation, organ failure and death in common critical illnesses.
These are conditions where the risk of death may be 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), and both ticagrelor and
rivaroxaban during cardiothoracic surgery. CytoSorb has
also received FDA Emergency Use Authorization in the United States for use in critically ill
COVID-19 patients with imminent or confirmed respiratory failure,
in defined circumstances. CytoSorb has also been granted FDA
Breakthrough Designation for the removal of ticagrelor in a
cardiopulmonary bypass circuit during emergent and urgent
cardiothoracic surgery.
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 more than $38 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 products under development based upon this unique blood
purification technology protected by many issued U.S. and
international patents and multiple applications pending, including
ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™,
VetResQ™, K+ontrol™, DrugSorb™, 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, 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 9, 2021, 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.
Please Click to Follow Us on Facebook and Twitter
Investor Relations Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com
Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
View original content to download
multimedia:http://www.prnewswire.com/news-releases/us-fda-approves-cytosorbents-to-initiate-us-star-t-trial-for-ticagrelor-removal-during-cardiothoracic-surgery-301271177.html
SOURCE CytoSorbents Corporation