Aclarion, Inc.

(Former name or former address, if changed since last report)

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Item 1.01 Entry into a Material Definitive Agreement.

On October 13, 2025, Aclarion, Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the purchasers named therein. Pursuant to the terms of the Purchase Agreement, the Company agreed to sell, in a registered direct offering (the “Offering”), an aggregate of (i) 64,000 shares (the “Shares”) of its common stock, par value $0.00001 per share (“Common Stock”), at a price per share of $8.36; and (ii) pre-funded warrants (the “Pre-funded Warrants”) to purchase up to 236,000 shares of Common Stock. The Offering is expected to close on or about October 14, 2025, subject to the satisfaction of customary closing conditions.

The Pre-funded Warrants are immediately exercisable, have an exercise price of $0.00001 and may be exercised at any time after the date of issuance until such Pre-funded Warrants are exercised in full. A holder of Pre-funded Warrants may not exercise the warrant if the holder, together with its affiliates, would beneficially own more than either 4.99% or 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to such exercise. A holder of Pre-funded Warrants may increase or decrease this percentage not in excess of 9.99% by providing at least 61 days’ prior notice to the Company.

The aggregate gross proceeds to the Company from the Offering are expected to be approximately $2.5 million, before deducting the placement agent fees and other estimated offering expenses payable by the Company. The Company also may receive nominal proceeds, if any, from the cash exercise of the Pre-funded Warrants. The Company intends to use the net proceeds from the Offering to fund market development and clinical evidence, The Clarity Trial, product development and quality, and general and administration support, and other general corporate purposes.

The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, other obligations of the parties and termination provisions.

The Offering is being made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-286761), as previously filed with the Securities and Exchange Commission (the “SEC”) on April 25, 2025 and declared effective by the SEC on May 5, 2025 (the “Registration Statement”). A prospectus supplement to the Registration Statement was filed with the SEC on October 14, 2025. The Offering is expected to close on or about October 14, 2025, subject to the satisfaction of customary closing conditions.

Pursuant to an engagement letter, Dawson James Securities, Inc. (the “Placement Agent”), has agreed to serve as the exclusive placement agent for the Offering. As compensation to the Placement Agent, the Company has agreed to pay the Placement Agent a cash fee of 7.0% of the aggregate gross proceeds raised in the Offering and reimburse certain expenses of the Placement Agent.

The foregoing summaries of the Purchase Agreement and form of Pre-funded Warrant do not purport to be complete and are qualified in their entirety by reference to the full text of such documents attached as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.

The legal opinion of Carroll Legal LLC relating to the Shares, the Pre-funded Warrants and shares of Common Stock issuable upon exercise of the Pre-funded Warrants is filed as Exhibit 5.1 to this Current Report on Form 8-K.