UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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ITEM 8.01 OTHER INFORMATION.
As previously reported, in March 2024, KORU Medical Systems, Inc. (the “Company”) received an assessment report from its notified body in the European Union, BSI, stating that, following BSI’s review of technical documentation submitted by the Company in connection with a prior audit nonconformance, a recommendation for continued certification cannot be made. The Company filed an appeal to that determination. On April 8, 2024, the Company’s appeal was upheld. The Company intends to address the identified nonconformance through the routine BSI assessment process.
Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking” statements regarding the nonconformance and BSI assessment process and that are based on the Company’s beliefs and assumptions and on information currently available to the Company on the date of this Current Report on Form 8-K. These forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause the Company’s actual results to differ materially from the results anticipated by the Company’s forward-looking statements is included in the reports the Company has filed with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
Exhibits.
| Exhibit No. | Description |
| 99.1 | Press Release dated April 11, 2024 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
| KORU Medical Systems, Inc. (Registrant) | ||
| Date: April 11, 2024 | By: | /s/ Linda Tharby |
| Linda Tharby President and Chief Executive Officer | ||
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