Full Press Release Details
CytoSorbents Secures $20 Million Credit Facility
Credit facility provides timely non-dilutive
capital to support ongoing global commercialization of CytoSorb as well as regulatory submissions and potential commercialization
plans for DrugSorb -ATR in the U.S. and Canada
July 2, 2024 -- 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
Forward-Looking Statements
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.
U.S. Company Contact:
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LifeSci Advisors, LLC
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