Aclarion Inc.

03/19/2026 | Press release | Distributed by Public on 03/19/2026 03:48

Shareholder Letter from Chief Executive Officer Brent Ness

Letter to Shareholders

Dear Fellow Shareholders,

Aclarion entered 2026 with strong operational momentum and a clear set of strategic priorities. Our mission is to provide physicians with objective, personalized biochemical insights, not available through conventional imaging. With Nociscan, our proprietary scan technology that identifies the source of pain in lumbar spine discs in a simple, non-invasive way, we can get to the source of chronic low back pain. Our peer-reviewed, published evidence suggests that treatment of chronic low back pain improves with Nociscan, further supporting our mission of building a scalable healthcare technology platform capable of delivering long-term value for patients and shareholders.

Low back pain remains one of the largest and most costly healthcare conditions in the United States, with an estimated annual burden exceeding $134 billion.

Despite decades of progress in medical imaging, physicians still lack reliable, noninvasive tools to identify spinal discs that may appear normal on traditional imaging but are actually generating a patient's pain. Aclarion's Nociscan platform was developed to address this gap by combining Magnetic Resonance Spectroscopy (MRS), proprietary biomarkers, and advanced data processing to provide physicians with new biochemical information that complements traditional MRI imaging.

Evidence suggests Nociscan represents a meaningful advancement in evaluating how chronic low back pain is identified and understood by treating physicians. By helping physicians better differentiate painful discs from non-painful discs at a biochemical level, our technology has the potential to improve treatment planning and patient outcomes. Early clinical studies have demonstrated significantly improved outcomes when discs identified as painful by Nociscan are included in surgical treatment plans.

These results reinforce our belief that objective biochemical evaluation that correlates to provocative discography, the current invasive gold standard, can play an important role in improving care for patients suffering from discogenic low back pain.

Key Company Highlights

During the past year, our team remained focused on expanding physician awareness and increasing scan utilization across our commercial markets. In Q4 2025, Nociscan scan volumes increased +114% year-over-year - marking the third consecutive quarter of year-over-year growth. While adoption of new decision support technologies requires time and clinical validation, we believe the continued engagement we are seeing from spine surgeons, pain management physicians, imaging centers, and clinical researchers reflects growing recognition of the value our technology can provide.

The United Kingdom continues to serve as an important validation market for our commercialization strategy. Today, three of the four largest private insurers in the U.K. provide reimbursement coverage for Nociscan, representing 5.2 million out of 69 million people in the U.K. The private insurer coverage allows us to grow scan volume and gain valuable clinical experience under reimbursed conditions. Given that spine fusion and total disc replacement (TDR) procedures occur at significantly lower rates in the U.K. than in the U.S, we view the U.K. as a conservative proxy market. We believe this progress demonstrates payer recognition of the potential economic value of our technology and provides a meaningful model for how reimbursement adoption may evolve in the U.S.

In 2026, our operational priorities are focused on executing against several key value-creating catalysts. First, we intend to continue growing overall scan volume across our current markets as physician awareness and utilization increase. Second, we are beginning to build a targeted U.S. commercial sales organization to support physician engagement and expand adoption at imaging centers and spine practices. Third, we are pursuing reimbursement coverage from one or more regional insurance providers in the United States as an important step toward broader payer adoption.

Clinical evidence development remains central to our strategy. Our ongoing CLARITY trial is a 300-patient randomized clinical study designed to further validate the clinical utility of Nociscan in guiding treatment decisions for patients suffering from chronic low back pain. We anticipate an initial internal data readout in Q3 2026 and an expected public disclosure of early interim results in Q4 2026. In addition, we have seven ongoing clinical trials and multiple investigator-initiated real world evidence trials. Together, these data are expected to support reimbursement discussions and the potential issuance of local coverage decisions by commercial insurance carriers as well as conversion of our current Category III CPT codes to permanent Category I codes.

Importantly, we are executing this strategy from a position of financial strength. Aclarion maintains a clean balance sheet with no outstanding debt, a clean capital structure with 2,882,371 shares outstanding on a fully diluted basis, providing a cash runway extending into 2028. This financial foundation allows us to focus on advancing our clinical programs, expanding commercial adoption, and achieving the milestones that we believe can drive long-term shareholder value.

Focused on Execution and Value Creation

As we move through 2026, our focus remains on disciplined execution against the key catalysts that can expand adoption of Nociscan and strengthen the clinical and reimbursement foundation of our business. We believe continued progress in scan volume growth, reimbursement expansion, and clinical evidence development will position Aclarion to accelerate adoption and unlock the long-term value of our platform.

On behalf of the entire Aclarion team, thank you for your continued support and confidence in our mission.

Sincerely,

Brent Ness
Chief Executive Officer
Aclarion, Inc.

Aclarion Inc. published this content on March 19, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on March 19, 2026 at 09:48 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]