8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 26, 2024 (June 26, 2024)

Aclarion, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-41358	47-3324725
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

8181 Arista Place, Suite 100
Broomfield, Colorado	80021
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (833) 275-2266

Not Applicable

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

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

	Trading
Title of each class	Symbol(s)	Name of each exchange on which registered
Common Stock	ACON	Nasdaq Stock Market
Common Stock Warrants	ACONW	Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 1.01 Entry into a Material Definitive Agreement.

On June 26, 2024, Aclarion, Inc. (the “Company”) issued a press release announcing an initial payer coverage of the Company’s Nociscan product by AXA, a private medical insurance provider in the U.K., for the greater London, U.K. area. A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d)	Exhibits
	Exhibit Number	Description
	99.1	Press Release dated June 26, 2024
	104	Cover Page Interactive Data File - the cover page iXBRL tags are 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.

	ACLARION, INC.
June 26, 2024		/s/ John Lorbiecki
	Name:	John Lorbiecki
	Title:	Chief Financial Officer

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EX-99.1

Exhibit 99.1

Aclarion Announces Initial Payer Coverage

of Nociscan by AXA throughout Greater London, UK

AXA is the 2^nd largest provider of private medical insurance in the UK.

Payer coverage is the most important catalyst Aclarion can achieve to drive volume and revenue.

AXA represents the first insurance company to approve payment for Nociscan.

June 26, 2024, Broomfield, CO – Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today their initial payer coverage of Nociscan by AXA in London, UK in conjunction with The London Clinic, one of the UK’s largest and most renowned independent hospitals. AXA is a leading provider of private medical insurance in the UK.

“Securing first payer coverage is the most significant milestone Aclarion has achieved to date,” said Brent Ness, CEO Aclarion. “This is a monumental step in launching widescale commercialization efforts at Aclarion. Nothing becomes standard of care in healthcare without reimbursement and we have now validated our strategy in one of the largest most sophisticated healthcare markets in the world.  We anticipate additional coverage decisions in the weeks to come and will be filling reimbursed markets with sales teams trained to drive adoption.  We are very committed to serving the needs of the patients covered by this AXA payer decision.  Evidence to date demonstrates that when Nociscan is incorporated into the treatment plan, outcomes significantly improve.  This evidence and our physician support is why other payers will be following AXA's example."

In the UK, self-pay and private medical insurance are estimated to represent nearly 70% of private hospital revenues, with private medical insurance becoming increasingly popular. AXA is one of the four leading private medical insurers in the UK with an estimated 30% of the private medical insurance market and an estimated 3 million insured customers.

The London Clinic and their expert spine physicians have adopted Nociscan as an important decision support tool to be used when diagnosing and treating their chronic low back pain patients. The AXA coverage decision expands access to Nociscan for insured patients for the first time.

For more information about The London Clinic, please visit: www.thelondonclinic.co.uk

For more information about the London Spine Clinic, please visit: www.londonspineclinic.com

For more information about AXA, please visit: AXA - Global Healthcare: global health insurance (axaglobalhealthcare.com)

About Aclarion, Inc.

Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit www.aclarion.com.

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Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes" and "expects" or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company's current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclosure

The information stated above was prepared by Aclarion and reflects solely the opinion of Aclarion. Nothing in this statement shall be construed to imply any support or endorsement of Aclarion or any of its products by The London Clinic.

Investor Contacts:

Kirin M. Smith

PCG Advisory, Inc.

646.823.8656

ksmith@pcgadvisory.com

Media Contacts:

Jodi Lamberti

SPRIG Consulting

612.812.7477

jodi@sprigconsulting.com

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Cover	Jun. 26, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jun. 26, 2024
Entity File Number	001-41358
Entity Registrant Name	Aclarion, Inc.
Entity Central Index Key	0001635077
Entity Tax Identification Number	47-3324725
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	8181 Arista Place
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Broomfield
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80021
City Area Code	(833)
Local Phone Number	275-2266
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Common Stock Par Value 0. 00001 Per Share [Member]
Title of 12(b) Security	Common Stock
Trading Symbol	ACON
Security Exchange Name	NASDAQ
Warrants Each Exercisable For One Share Of Common Stock [Member]
Title of 12(b) Security	Common Stock Warrants
Trading Symbol	ACONW
Security Exchange Name	NASDAQ