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PRINCIPAL BUSINESS ACTIVITY
12 Months Ended
Dec. 31, 2025
PRINCIPAL BUSINESS ACTIVITY  
PRINCIPAL BUSINESS ACTIVITY

1. PRINCIPAL BUSINESS ACTIVITY

Nature of Business

The Company is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. The Company, through its subsidiary CytoSorbents Medical, Inc. based in New Jersey, is engaged in the research, development and commercialization of medical devices with its blood purification technology platform which incorporates a proprietary adsorbent, porous polymer technology. The Company, through its wholly-owned European subsidiary, CytoSorbents Europe GmbH, based in Berlin, Germany, its wholly-owned Indian subsidiary, CytoSorbents India Private Limited, based in Kasavanahalli, India, and its wholly-owned Dubai entity, CytoSorbents MEA FZCO, based in CommerCity, Dubai, conducts sales and marketing related operations for the CytoSorb device outside of the United States.

Going Concern

As of December 31, 2025, the Company’s total cash and cash equivalents and restricted cash was approximately $7.8 million, with $1.5 million classified as restricted, and $6.3 million as unrestricted and available to fund operations. These cash and restricted cash balances considered with the Company’s historical cash used in operations, notwithstanding the Company’s Strategic Workforce and Cost Reduction Plan (see Note 12, “Restructuring”) and the impact of the Amended Loan and Security Agreement (see Note 5, “Long - Term Debt”) raises substantial doubt about the Company’s ability to continue as a going concern within twelve months after the date that the accompanying consolidated financial statements are issued.

The Company’s expected future capital requirements may depend on many factors including expanding the Company’s customer base and sales force, the timing and extent of spending in obtaining regulatory approval and introduction of new products, including the potential regulatory approval and introduction of DrugSorb-ATR in the U.S. which would allow for the opportunity to receive Tranche 2b of the Amended Avenue Capital Commitment by December 31, 2026, and receive an additional 6-month extension of the interest-only period on the credit facility. Additional sources of liquidity available to the Company include the 2024 Shelf (see Note 9, Stockholders’ Equity), other public or private equity offerings, debt financings, or from other sources. The sale of additional equity may result in dilution to shareholders. There is no assurance that the Company will be able to secure funding on terms acceptable, or at all. Although the Company has taken actions to achieve cash flow breakeven, if it does not achieve this goal, the potential need for capital could also make it more difficult to obtain funding through either equity or debt. Should additional capital not become available as needed, the Company may be required to take certain actions, such as slowing sales and marketing expansion, delaying further regulatory approvals, or reducing headcount. The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company routinely evaluates other financing sources, including less or non-dilutive debt financing, additional grant funding, royalty financing, strategic or direct investments, equity financing, and/or combinations thereof. There can be no assurance that management will be successful in these endeavors.