Cytosorbents Corporation filed SEC Form 8-K: Results of Operations and Financial Condition, Other Events, Financial Statements and Exhibits
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| Item 2.02 | Results of Operation and Financial Condition |
On October 1, 2024, CytoSorbents Corporation (the “Company”) issued a press release announcing certain preliminary financial results for the quarter ended September 30, 2024, including estimated ranges for quarterly product sales and product gross margins. A copy of the press release is furnished herewith as Exhibit 99.1.*
| Item 8.01 | Other Events |
The Company has submitted its DrugSorb™-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (the “FDA”) to reduce the severity of perioperative bleeding in patients on ticagrelor undergoing coronary artery bypass graft surgery. The FDA has previously granted Breakthrough Device Designation to DrugSorb-ATR to address this major unmet medical need, making it eligible for priority review. The Company has also completed its DrugSorb-ATR Health Canada Medical Device License application, which will be submitted with the expected near-term receipt of Medical Device Single Audit Program certification.
| Item 9.01 | Exhibits |
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Press Release of the Company, dated October 1, 2024 |
| 104 |
Cover Page Interactive Data File (embedded with the Inline XBRL document) |
* The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: October 1, 2024 |
CYTOSORBENTS CORPORATION | |
| By: | /s/ Dr. Phillip P. Chan | |
| Name: | Dr. Phillip P. Chan | |
| Title: | Chief Executive Officer | |