Non-dilutive debt capital at market favorable
terms strengthens the balance sheet and provides additional working
capital to fund key clinical and commercial initiatives
PRINCETON, N.J., Dec. 29, 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 it has received
$5 million in non-dilutive debt
financing under the terms of the Fourth Amendment to its Amended
and Restated Loan and Security Agreement with Bridge Bank, which
provided for a term loan commitment of up to $15 million in aggregate, available for drawdown
in tranches of $5 million each at the
discretion of CytoSorbents and subject to certain financial
requirements. Separately, on December
29, 2022, the two parties entered into the Fifth Amendment
to the Amended and Restated Loan and Security Agreement, extending
the drawdown period on the remaining $10
million loan commitment from December
31, 2022 to March 1, 2023,
subject to certain requirements.
Non-dilutive debt at market favorable terms
strengthens balance sheet & helps fund key clinical &
commercial initiatives
The initial $5 million tranche of
the term loan has no associated financial or other covenants and
bears interest at the Index Rate (defined in the Loan Agreement as
the greater of 3.25% or the Prime Rate as published by the Wall
Street Journal on the last business date of the month immediately
preceding the month in which the interest will accrue) plus 1.25%,
subject to an interest rate cap of 8.00%. Subject to certain
financial requirements, interest-only payments are due until
January 1, 2024, followed by equal
monthly payments of principal and interest until the maturity of
the loan on December 1,
2025.
Kathleen P. Bloch, CPA, MBA,
Chief Financial Officer of CytoSorbents, stated, "We believe
that debt capital represents an attractive alternative to equity at
the current time and that this non-dilutive financing strengthens
our balance sheet at favorable terms, providing us with additional
capital that we anticipate using for three of our major goals as we
enter 2023. The first is to successfully complete our U.S.
STAR-T pivotal trial and to file for potential U.S. FDA and Health
Canada marketing approvals for DrugSorb-ATR™ in the second half of
2023. The second is to support a number of important
commercial initiatives and to steer our Company back to product
sales growth. The third goal is to ensure tight control of
expenses designed to make our cash go farther. Bridge Bank
has been an excellent partner for more than six years and we
greatly appreciate their continuing confidence and support of our
business."
Bill Wickline, Head of Life
Sciences at Bridge Bank, stated, "Over the years of working with
CytoSorbents, we have witnessed the significant revenue growth of
the Company and the validation of its scalable, high margin
business model. We are pleased to contribute to the capital
needs of CytoSorbents at this next stage of their evolution and to
support their important mission of working to save lives
worldwide."
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. As of September 30,
2022, more than 186,000 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.
About Bridge Bank
Bridge Bank, a division of Western Alliance Bank, Member FDIC,
delivers relationship banking that puts clients at the center of
everything. Founded in 2001 in Silicon Valley, Bridge Bank
offers a full spectrum of tailored business banking solutions
throughout the Bay Area and has specialized expertise, focused on
life sciences and technology and innovation companies, at every
stage in their life cycle, through its offices in major tech hubs
across the country. Bridge Bank also serves the private
equity and venture capital communities and provides business escrow
services. As part of $65
billion Western Alliance Bancorporation — ranked #1
top-performing large bank with assets greater than $50 billion in 2021 by both American Banker and
Bank Director — Bridge Bank has the reach, resources and deep
industry knowledge that make a difference for customers. For
more information, visit Bridge Bank.
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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CytoSorbents Contact:
Kathleen Bloch
(732) 398-5429
kbloch@cytosorbents.com
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SOURCE CytoSorbents Corporation