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 on June 28, 2024, the
Company entered into a new $20 million credit facility with Avenue
Capital Group, including its Avenue Venture Opportunities Fund,
L.P. and Avenue Venture Opportunities Fund II, L.P. Armentum
Partners, LLC served as financial advisor to the Company on the
transaction. Proceeds from the facility are intended to provide
non-dilutive working capital to support the Company’s ongoing
global CytoSorb® franchise in critical care and cardiac surgery
that generated $32.2 million in trailing 12-month sales as of March
31, 2024, planned marketing applications to U.S. Food and Drug
Administration (FDA) and Health Canada for DrugSorb™-ATR and
initial launch and commercialization preparations if approved, and
refinancing of existing Bridge Bank debt.
The credit agreement, which has an initial term
of three years, provides up to $20 million in total term loan
capital including an initial tranche of $15 million, with immediate
availability of $10 million and an additional $5 million with the
timely acceptance by U.S. FDA of the Company’s planned De Novo
application for DrugSorb-ATR and certain liquidity
requirements. A second tranche of $5 million would be
available in the second half of 2025 with FDA marketing clearance
for DrugSorb-ATM to help support an anticipated launch of the
therapy in the United States.
Ms. Kathleen Bloch, Chief Financial Officer of
CytoSorbents stated, “We are pleased to enter into this
relationship with Avenue Capital Group to strengthen our financial
position, expand our working capital, and to enable us to
confidently pursue our regulatory and commercialization objectives.
We believe the planned marketing applications of DrugSorb-ATR to
U.S. FDA and Health Canada this summer and the prospects of opening
an estimated total addressable market in the U.S. and Canada in
excess of $0.5 billion if approved, represents a potential
watershed event for the Company. As an FDA Breakthrough
Device, DrugSorb-ATR aims to reduce serious bleeding complications
in patients undergoing coronary artery bypass graft (CABG) surgery
on the blockbuster blood-thinning drug Brilinta® (ticagrelor,
AstraZeneca) – a major unmet medical need. The full $20 million is
expected to help fund the Company through both Health Canada and
U.S. FDA regulatory decisions.”
Mr. Chad Norman, Senior Portfolio Manager at
Avenue Capital Group stated, “We have followed the CytoSorbents
story for many years and all of the exciting work the company is
doing to help save lives in critical care and cardiac surgery. We
are pleased to now partner with CytoSorbents to support the
international growth of CytoSorb® and other products, and
importantly help fund the U.S. and Canadian initiatives with
DrugSorb-ATR. Many of us unfortunately know family, friends, and
colleagues on blood thinners and the high bleeding risk they have,
should they need surgery. We see a great opportunity to be part of
a solution to address this major problem.”
About Avenue Capital Group
Avenue Capital Group is a global investment
firm, founded in 1995, that is primarily focused on specialty
lending, opportunistic credit, and other special situations in the
United States, Europe, and Asia. The Senior Principals and the
Senior Portfolio Managers have spent virtually their entire careers
investing in the private and public debt markets. Headquartered in
New York, with three offices across Europe, four offices throughout
Asia, an office in Silicon Valley, and an office in Abu Dhabi, the
firm manages assets estimated to be approximately $12.5 billion.
Avenue draws on the skills and experience of over 185 employees
worldwide and maintains a well-developed infrastructure with
experienced accounting, tax, compliance, risk management, legal,
investor relations, and information technology professionals.
Avenue’s team of over 60 investment professionals has deployed
approximately $100 billion in investments across a variety of
industries, regions, and market cycles with an eye toward value
creation and capital conservation. Through rigorous due diligence
and a robust network of relationships, the Firm proactively
identifies public and private opportunities in fragmented,
capital-constrained markets.
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 March 31, 2024, more than 237,000
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,
an investigational device based on the same polymer technology as
CytoSorb, has 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 completed the FDA-approved, randomized,
controlled STAR-T (Safe and Timely Antithrombotic
Removal-Ticagrelor) study of 140 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 U.S. FDA 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 $50 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™,
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 X.
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, statements about potential exposures
resulting from our cash positions, 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 14, 2024, 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
X
U.S. Company Contact:Kathleen
Bloch, CFO305 College Road EastPrinceton, NJ 08540+1 (732)
398-5429kbloch@cytosorbents.com
Investor Relations Contact:Eric RibnerLifeSci
Advisors, LLC250 W 55th St, #3401New York, NY 10019+1 (646)
751-4363ir@cytosorbents.com
CytoSorbents (NASDAQ:CTSO)
Historical Stock Chart
From Jul 2024 to Aug 2024
CytoSorbents (NASDAQ:CTSO)
Historical Stock Chart
From Aug 2023 to Aug 2024