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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

Key Figures

CLARITY sample size: 300 patients Initial internal readout: End of Q3 2026 Interim public results: Q4 2026 +4 more
7 metrics
CLARITY sample size 300 patients Pivotal CLARITY trial design
Initial internal readout End of Q3 2026 Expected first internal CLARITY data
Interim public results Q4 2026 Planned early interim CLARITY disclosure
Cash runway Into 2028 Management reiterated funding through initial CLARITY readout
Shares outstanding (FD) 2,882,371 shares Fully diluted basis as stated in letter
ELOC expiry Dec 31, 2025 Equity line of credit expired at year-end 2025
ATM status Terminated in early 2025 Company states no ATM currently in place

Market Reality Check

Price: $2.70 Vol: Volume 254,505 is well be...
low vol
$2.70 Last Close
Volume Volume 254,505 is well below the 20-day average of 2,493,416, suggesting limited pre-news positioning. low
Technical Shares at $2.70 are trading below the 200-day MA of $6.82, reflecting a longer-term downtrend.

Peers on Argus

Two sector peers in the momentum scan moved down (median move about -14.8%), whi...
2 Down

Two sector peers in the momentum scan moved down (median move about -14.8%), while broader peers showed mixed single‑stock moves, indicating broader sector weakness but unclear direct alignment with ACON.

Historical Context

5 past events · Latest: Feb 03 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Feb 03 Commercial partnership Positive -2.1% Expanded Nociscan use via Source Healthcare to build real‑world evidence.
Jan 13 Financing / runway Positive -6.9% Closed $10.4M equity financing, lifting cash to $21.6M and runway into 2028.
Jan 08 Outlook & metrics Positive +42.1% Reported strong 2025 scan growth, higher cash, and extended runway into H1 2027.
Jan 06 Trial enrollment Positive +3.7% Additional CLARITY sites enrolling; outlined 300-patient design and interim timeline.
Dec 04 Clinical publication Positive +5.0% IJSS article showcased Nociscan-guided surgical decision leading to pain relief.
Pattern Detected

Recent news has often been clinically and financially positive, yet share reactions have been mixed, with balance sheet and financing updates sometimes met with weakness.

Recent Company History

Over the past few months, Aclarion has focused on Nociscan adoption, CLARITY trial progress, and balance sheet strengthening. A Dec 4, 2025 journal article and multiple CLARITY updates highlighted clinical validation efforts. In October 2025 and January 2026, the company raised capital through registered direct offerings, extending runway and remaining debt-free. A Jan 8, 2026 outlook and a Feb 3, 2026 partnership emphasized growth and real‑world evidence. Today’s shareholder letter reiterates these themes around runway into 2028 and trial milestones.

Market Pulse Summary

This announcement emphasizes Aclarion’s extended cash runway into 2028, the absence of an active ATM...
Analysis

This announcement emphasizes Aclarion’s extended cash runway into 2028, the absence of an active ATM or ELOC, and a fully diluted share count of 2,882,371, signaling a focus on limiting dilution ahead of CLARITY readouts. It reiterates the pivotal 300-patient trial with internal data expected by end of Q3 2026 and interim disclosure in Q4 2026. Investors may watch clinical timelines, execution of the investor-awareness strategy, and any future financing decisions once interim data are available.

Key Terms

biomarkers, mr spectroscopy
2 terms
biomarkers medical
"leveraging biomarkers and proprietary augmented intelligence (AI) algorithms"
Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.
mr spectroscopy medical
"payer/provider adoption for the non-invasive MR spectroscopy test"
MR spectroscopy is a scientific technique that uses magnetic fields and radio waves to analyze the chemical composition of materials, including biological tissues. It helps researchers identify and measure the presence of different molecules, providing insights into health, disease, or material properties. For investors, understanding MR spectroscopy can be important when evaluating innovations in medical technology or pharmaceutical developments that may impact healthcare markets.

AI-generated analysis. Not financial advice.

  • 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.
Aclarion Inc

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BROOMFIELD