Change in Certifying Accountants (Form 8-K)

Item 4.01 Changes in Registrant's Certifying Accountant.

(a) Dismissal of Independent Registered Public Accounting Firm

On September 3, 2025, INVO Fertility, Inc. (the "Company") notified M&K CPAS, PLLC ("M&K") of its dismissal, effective September 5, 2025, as the Company's independent registered accounting firm. The decision to change the independent registered public accounting firm was approved by the audit committee (the "Audit Committee") of the board of directors of the Company.

M&K's audit reports on the Company's consolidated financial statements for the fiscal years ended December 31, 2023 and December 31, 2024 did not contain an adverse opinion or disclaimer of opinion and were not qualified as to uncertainty, audit scope, or accounting principles. M&K's audit reports for the fiscal years ended December 31, 2023 and December 31, 2024 do, however, contain an expression of substantial doubt regarding the Company's ability to continue as a going concern.

During the Company's two most recent fiscal years and the subsequent interim period through September 5, 2025, there were no: (i) disagreements, as defined in Item 304(a)(1)(iv) of Regulation S-K under the Exchange Act of 1934, as amended (the "Exchange Act") and the related instruction thereto, between the Company and M&K on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of M&K, would have caused M&K to make reference to the subject matter of the disagreements in connection with its audit report on the Company's financial statements, or (ii) reportable events (as defined in Item 304(a)(1)(v) of Regulation S-K under the Exchange Act).

The Company has provided M&K with a copy of the disclosures made by the Company in response to this Item 4.01 and has requested that M&K furnish the Company with a letter addressed to the SEC stating whether it agrees with the statements made by the Company in response to this Item 4.01 and, if not, stating the respects in which it does not agree. A letter from M&K is attached hereto as Exhibit 16.1.

(b) Engagement of Independent Registered Public Accounting Firm

On September 5, 2025, the Audit Committee approved the engagement of WithumSmith+Brown, PC ("Withum") effective immediately as the Company's independent registered public accounting firm to audit the Company's consolidated financial statements for the year ending December 31, 2025.

During the Company's two most recent fiscal years and the subsequent interim period through September 5, 2025, neither the Company, nor anyone on its behalf, consulted Withum regarding (A) the application of accounting principles to a specific transaction, either completed or proposed, or the type of audit opinion that might be rendered on the Company's financial statements, and neither a written report nor oral advice was provided to the Company by Withum that Withum concluded was an important factor considered by the Company in reaching a decision as to any accounting, auditing, or financial reporting issue, or (B) any matter that was either (i) the subject of a disagreement (as defined in Item 304(a)(1)(iv) of Regulation S-K under the Exchange Act), or (ii) a reportable event (as defined in Item 304(a)(1)(v) of Regulation S-K).