Monogram Technologies Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
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| ITEM 7.01 | REGULATION FD DISCLOSURE |
On October 3, 2024, Monogram Technologies Inc. (the “Company”) issued a press release (the “Press Release”) to correct the press release issued on October 2, 2024 announcing that it received an Additional Information Request (“AIR”) from the U.S. Food and Drug Administration (“FDA”) related to the Company’s submission K242121 for marketing clearance for the Company’s mBôs (Monogram mBôs TKA System) (the “Application”). This Press Release clarifies that the Company has 180 days from the receipt of the AIR to produce additional information to the FDA. Other than that clarification, there are no other changes to the previous press release.
The foregoing disclosure is qualified in its entirety by the full text of the respective Press Release.
A copy of the Press Release is attached as Exhibit 99.1, respectively, and are hereby incorporated by reference into this Item 7.01. The information contained in this Current Report on Form 8-K, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose, including for the 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 and shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing, except to the extent expressly stated in such filing.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, including the Press Release, contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the Company’s lack of profitability and need for additional capital to grow its business; the Company’s dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections of the Company’s latest annual and quarterly reports and other filings with the SEC.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The Company undertakes no obligation to revise or update any forward-looking statements made in this Current Report on Form 8-K to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
| ITEM 9.01 | FINANCIAL STATEMENTS AND EXHIBITS |
| (d) | Exhibits: |
| Exhibit No. | Description | |
| 99.1 | Press Release dated October 3, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101). |
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SIGNATURE
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.
| MONOGRAM TECHNOLOGIES INC. | |
| Dated: October 3, 2024 | /s/ Benjamin Sexson |
| Benjamin Sexson | |
| Chief Executive Officer |
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