Aclarion Inc.

02/05/2026 | Press release | Distributed by Public on 02/05/2026 04:57

2026 Annual Shareholder Letter from the Chairman

Fellow Shareholders,

As we begin 2026, I want to share a clear view of where Aclarion stands today, the progress we have made, and the path ahead as we work to transform the way physicians evaluate and treat discogenic low back pain.

Aclarion was founded on a simple but powerful premise that patients deserve better clarity before undergoing spine surgery. For decades, physicians have lacked reliable, objective tools to understand which intervertebral discs may be contributing to a patient's pain. This uncertainty has led to inconsistent outcomes and avoidable suffering for millions of people.

Our technology was built to change this paradigm.

Advancing Objective and Non-Invasive Decision Support for Discogenic Pain

Early clinical studies demonstrated that our Nociscan platform can provide surgeons and pain physicians with objective data about the biochemical properties of intervertebral discs. Using our augmented intelligence (AI) algorithm Nociscan helps identify which discs are painful, giving physicians new insight as they evaluate the likely source of a patient's pain.

Nociscan is designed to support clinical decision-making, not replace it. Physicians integrate our results with MRI findings, clinical examination, patient history, and their own expertise to diagnose the patient and determine the appropriate treatment plan.

To establish the highest level of clinical evidence, we are executing a 300-patient, prospective, randomized clinical trial - our largest and most rigorous study undertaken to evaluate whether providing Nociscan data to physicians leads to improved surgical decision-making and better patient outcomes. We remain on track for an initial interim data readout on CLARITY to be available internally at the end of Q3 and are planning to report on these early results externally in Q4.

A New Breed of MedTech Company

Aclarion is part of a new generation of MedTech innovators whose core products are cloud-delivered algorithms, not physical devices.

This model offers several compelling advantages:

  • Software-level gross margins

  • Global scalability without manufacturing or inventory constraints

  • Rapid deployment across health systems and imaging centers

  • Continuous algorithmic improvement without hardware replacement cycles

  • Capital-efficient commercial expansion

As algorithms become central to clinical decision-making, companies like Aclarion are defining a new category of MedTech: software-native, cloud-delivered, and built for scale at industry leading margins.

A Strengthened Balance Sheet Aligned With Shareholder Interests

Over the past year, we have taken deliberate steps to strengthen our balance sheet and position Aclarion for success as we approach our pivotal CLARITY data readout. Following our recent financings, we now have a cash runway that extends into 2028, giving us the financial stability to execute our clinical and operational plans without the need to raise additional capital before reporting initial interim CLARITY data expected in Q4 of this year.

These financings were structured with a clear objective: to ensure that value created by our early CLARITY readout accrues to our existing shareholders without the overhang of intermittent dilution.

To reinforce this commitment:

  • We cancelled our ATM last year and let our ELOC expire on December 31, 2025

  • We will not utilize a new ATM or ELOC prior to reporting initial CLARITY data

  • We are maintaining a clean, stable capital structure heading into our initial readout

This disciplined approach ensures that shareholders are positioned to benefit directly from the value we aim to create.

Expanding Our Exposure in the Capital Markets

As an early commercial stage company pursuing a large clinical and economic opportunity, we recognize the importance of expanding awareness among investors who understand the value of high-quality clinical evidence in MedTech. In 2026, we are executing a structured investor-awareness strategy focused on:

  • Engaging institutional healthcare investors

  • Elevating our clinical story through physician-led education

  • Strengthening our presence in financial and medical media

  • Building long-term relationships ahead of our CLARITY results

Looking Ahead

The year ahead will be one of the most important in our company's history. We are approaching a pivotal moment, supported by a strong scientific foundation, a disciplined clinical program, and a business model built for scale.

Thank you for your continued trust and support. Your belief in our mission fuels our work every day. We look forward to sharing our progress with you as we advance toward our Q3 2026 internal readout and subsequent Q4 disclosure as well as to the opportunities that follow.

Sincerely,

Jeffrey J. Thramann, M.D.

Executive Chairman

Aclarion, Inc. (NASDAQ: ACON)

Aclarion Inc. published this content on February 05, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on February 05, 2026 at 10:57 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]