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Aclarion Publishes 2026 Shareholder Letter from the Chairman

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Aclarion (Nasdaq: ACON) published its 2026 shareholder letter outlining clinical, financial, and operational priorities. The company expects an initial internal readout of its 300-patient CLARITY trial at the end of Q3 2026 and plans a public disclosure of early interim results in Q4 2026.

Key facts: cash runway into 2028, ATM terminated in early 2025, ELOC expired December 31, 2025, and 2,882,371 fully diluted shares outstanding. The company emphasizes a cloud-delivered, software-native MedTech model and will pursue an investor-awareness program focused on institutional healthcare investors and physician education.

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Positive

  • Cash runway into 2028 provides funding through the CLARITY initial readout
  • Software-native, cloud-delivered model enables software-level gross margins and scalability
  • 300-patient CLARITY trial on track with internal readout expected end of Q3 2026

Negative

  • No remaining ATM or ELOC
  • Public disclosure of only early interim results in Q4 2026 leaves commercial milestones dependent on trial data

News Market Reaction – ACONW

+3.14%
+3.14% Session close to close

In the Feb 5 session, ACONW gained 3.14%, reflecting a moderate positive market reaction.

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  • Company anticipates no capital raises prior to expected value enhancing catalysts 
  • Cash runway into 2028
  • ATM terminated in early 2025 and ELOC expired December 31, 2025

BROOMFIELD, Colo., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a commercial-stage healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today announced the release of its 2026 Shareholder Letter from the Chairman. The letter outlines significant clinical, financial, and operational priorities as the company advances toward an expected initial internal readout of its 300-patient CLARITY trial at the end of Q3 and an expected public disclosure of early interim results in Q4 of 2026.

“Aclarion enters 2026 with a strengthened balance sheet, a scalable software-native business model, and a clear path to an initial readout on our CLARITY trial,” said Jeff Thramann, Executive Chairman of Aclarion. “With cash runway into 2028 and a clean capital structure, we are fully funded to deliver this important clinical milestone. Our focus is on ensuring that the value created by our early data accrues directly to our existing shareholders as we continue advancing a technology that provides physicians with objective biochemical insights to support better decision-making for patients suffering from chronic low back pain.”

The company highlighted its strengthened financial position. Following recent financings, the company reiterated it now has a cash runway into 2028, providing the resources needed to complete the CLARITY trial and operate through the initial data readout without raising additional capital. To reinforce this commitment to shareholder alignment, Aclarion no longer has an ATM in place and its ELOC expired at the end of 2025. The Company currently has 2,882,371 shares outstanding on a fully diluted basis and will not be putting a new ATM or ELOC in place until after it reports on the initial interim CLARITY results.

Aclarion also emphasized its position as part of a new generation of software-native MedTech innovators that, unlike traditional device companies, deliver its solution entirely through the cloud. This enables software-level gross margins, rapid scalability, and continuous algorithmic improvement without manufacturing or inventory constraints.

In 2026, the company will be executing a structured investor-awareness strategy focused on institutional healthcare investors, physician-led clinical education, and increased visibility in financial and medical media.

The full 2026 Shareholder Letter is available on the company’s website at: https://investors.aclarion.com/news

For more News from Aclarion, please visit: Latest News

To find a Nociscan center, view our site map here.

For more information on Nociscan, please email: info@aclarion.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.

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. Forward-looking statements in this release include, among others, statements regarding the enrollment of patients in our ongoing clinical trials, the expected initial internal readout of its 300-patient CLARITY trial at the end of Q3 2026 and an expected public disclosure of early interim results in Q4 of 2026, having a cash runway into 2028, providing the resources needed to complete the CLARITY trial and operate through the initial data readout without raising additional capital, the Company will not be putting a new ATM or ELOC in place until after it reports on the initial interim CLARITY results, the potential benefits of our Nociscan technology, and the Company’s plans for future regulatory and commercialization activities. 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, 2024, 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. 

Investor Contacts:

Kirin M. Smith
PCG Advisory, Inc.
ksmith@pcgadvisory.com

Media Contacts:

Jessica Starman
media@elev8newmedia.com


FAQ

When will Aclarion (ACON) report the initial CLARITY trial readout in 2026?

The initial internal readout is expected at the end of Q3 2026. According to the company, the 300-patient CLARITY trial targets an internal readout end of Q3 with early interim results expected for public disclosure in Q4 2026.

Does Aclarion (ACON) have enough cash to reach its CLARITY milestone?

Yes, Aclarion says it has cash runway into 2028 to fund operations through the initial readout. According to the company, recent financings strengthened the balance sheet and allow completion of CLARITY without raising capital before the announced catalysts.

What capital markets tools does Aclarion (ACON) currently have in place?

Aclarion currently has no active ATM and its ELOC expired December 31, 2025. According to the company, it terminated the ATM in early 2025 and will not re-establish an ATM or ELOC until after initial interim CLARITY results.

How many fully diluted shares does Aclarion (ACON) report?

The company reports 2,882,371 fully diluted shares outstanding. According to the company, that is the current fully diluted share count and it intends to align early data value with existing shareholders.

What is Aclarion's (ACON) business model and operational advantage?

Aclarion delivers a cloud-based, software-native MedTech solution designed for scalability and continuous algorithm improvement. According to the company, this model avoids manufacturing constraints and targets software-level gross margins and rapid commercial scaling.