Dear Fellow Shareholders,
The first half of 2026 marked an important period of execution and momentum for Aclarion. We entered the year focused on three priorities: accelerating clinical adoption of Nociscan®, advancing reimbursement and evidence generation milestones, and maintaining the financial discipline required to deliver on our value creating catalysts. At midyear, we continue to demonstrate meaningful progress across each of these objectives.
First Half 2026 Highlights
- 141% year-over-year scan volume growth and 71% sequential scan volume growth in first half of 2026, reflecting accelerating clinical adoption and broader integration into physician workflows.
- Continued expansion of Nociscan utilization across commercial accounts in the U.S. and U.K.
- Reimbursement in the U.K., including reimbursement by Vitality, AXA, and Aviva, three of the four largest private insurers in the U.K., translating into scan volume growth
- Partnered with PRIA Healthcare to launch a U.S.-focused Market Access Program to establish payer coverage and expand patient access to Nociscan.
- Progress toward the CLARITY trial readout, a key evidence-generation milestone for the Company.
- Strengthened intellectual property position with a newly issued AI patent and 65 total issued and pending patents worldwide.
- $16.3 million in cash and no debt as of June 30, 2026, supporting continued execution through key milestones with cash runway into the second half of 2027.
We believe the first half of 2026 demonstrates that Aclarion is moving from early commercial validation toward a more scalable adoption phase. Scan volume growth in Q1 and Q2 reflected increasing physician engagement, strong execution by our commercial team, and growing confidence in Nociscan’s ability to provide objective biochemical insights that support spine-care decision-making.
While we remain early in the commercialization journey, the fundamentals of the business are strengthening. Our work in the first half has been focused on building repeatable pathways for adoption, reimbursement, clinical validation, and long-term shareholder value creation.
Commercial Adoption: Building Repeatable Growth
During the first half of 2026, our commercial focus remained clear: expand the number of physicians and sites using Nociscan while increasing utilization within active accounts.
The 141% year-over-year and 71% sequential scan volume growth reported in the first half of 2026 is an encouraging indication that our platform is gaining traction in clinical workflows. Growth was driven by both new account activation and deeper utilization at existing sites. Just as important, repeat usage trends continue to reinforce the value proposition of Nociscan and support our belief that objective, data-driven assessment of discogenic pain can become a meaningful part of spine care decision-making.
Reimbursement and Market Access: Reducing Adoption Friction
Reimbursement remains one of the most important drivers of long-term adoption. In the first half of 2026, we continued to make progress in establishing payer pathways that can support broader utilization of Nociscan.
- U.K. reimbursement traction: Nociscan has been reimbursed for several months by Vitality, AXA, and Aviva. This early payer adoption provides meaningful validation and a pathway for broader coverage expansion.
- U.S. reimbursement progress: We continue to engage with U.S. payers and support coverage pathways through the Nociscan Reimbursement Program. We also partnered with PRIA Healthcare to launch a Market Access Program in June. We have identified that some hospitals have negotiated reimbursement for our code set and have successfully adopted the technology from an economic perspective.
- Patient and physician awareness: We are supporting adoption with targeted market-development efforts, including direct-to-patient education in the U.K. and physician-led clinical engagement.
- Commercial execution: We remain focused on converting targeted accounts, improving onboarding velocity, and increasing utilization among physicians already engaged with the platform.
Together, these initiatives are designed to reduce adoption friction, broaden access, and strengthen the economic foundation for scalable growth.
Clinical Evidence and Product Development
Aclarion’s long-term opportunity depends on building the clinical and scientific evidence required to support physician confidence, payer coverage, and durable adoption. The CLARITY randomized trial remains central to that strategy. We added Lanman Spinal Neurosurgery, Endeavor Health, Texas Spine Care Center as new CLARITY sites as we continue to advance toward an anticipated readout.
We also engaged with Weill Cornell Medicine and the Institute of Neuro Innovation to continue to generate evidence in areas that will advance the field of spine care. Dr. Jaspal Ricky Singh of Weill Cornell Medicine will investigate whether the dose and quantity of bone marrow aspirate stem cell concentrate (BMAC) used for the treatment of osteoarthritis and/or Degenerative Disc Disease in the spine has an effect on patient-reported functional outcomes and pain. Dr. Roger Härtl of Weill Cornell Medicine plans to evaluate the long-term effects of lumbar microdiscectomy surgery with and without an intradiscal bone marrow aspirate concentrate (BMAC) injection on patient reported outcomes, intervertebral disc (IVD) health (tissue hydration & composition), and pain biomarkers. Dr. Amir Vokshoor of INI is leading a study comparing chemical biomarker data from Nociscan with bone metabolic information from SPECT-CT.
At the recent American Society of Pain & Neuroscience (ASPN) annual meeting, we were pleased to have two abstract presentations highlighting the clinical utility of Nociscan in clinical practice. Dr. Tim Davis of Source Healthcare shared insights from his real-world evidence study demonstrating immense utility and ability of Nociscan to be incorporated into clinical practice. Dr. Brian Durkin and Kristen Durkin presented a first-of-its kind case study reporting use of Nociscan to guide basivertebral nerve ablation, resulting in 95% relief of long-standing chronic low back pain for the patient.
In parallel, we continue to invest in the Nociscan platform and our broader intellectual property position. The newly issued AI patent further strengthens our proprietary foundation and supports our strategy of delivering a cloud-based, software-native solution with the potential for continuous improvement over time.
Financial Discipline and Shareholder Alignment
Aclarion entered the first half of 2026 with a strengthened balance sheet and a clear focus on disciplined capital allocation. As of March 31, 2026, the Company reported $19.0 million in cash and no debt, supporting continued investment in commercial execution, reimbursement, clinical evidence, and platform innovation. Ending the first half with $16.3 million in cash demonstrates management’s ability to advance key execution milestones while maintaining disciplined and efficient cash utilization.
Outlook for the Second Half of 2026
As we look ahead to the second half of 2026, our priorities are straightforward:
- Sustain scan volume growth and deepen utilization within active accounts
- Advance U.S. and U.K. reimbursement pathways
- Execute against CLARITY and related clinical evidence milestones
- Support payer engagement with clinical, economic, and real-world evidence
- Continue improving the platform through software and analytics innovation
“It is chemical before it is mechanical.” That’s how Dr. Roger Härtl framed Nociscan’s role at the State of Spine Surgery Summit, and it’s why this is a different kind of adoption conversation. We’re not upgrading a tool surgeons already trust; we’re asking them to let chemistry sit at the table next to mechanics in a decision that anatomical imaging alone has owned for decades.
The last few months show Nociscan moving from proving that case to scaling it: Dan Keefe now leads the Western US, joining Jason Brosniak, Eastern US, and Dan Isherwood, UK, giving all three major territories dedicated leadership. The PRIA Healthcare Market Access Program is clearing reimbursement friction. And with Weill Cornell running two trials and Lanman Spinal Neurosurgery, Endeavor Health and Texas Spine Care Center just added to CLARITY, the clinical evidence is deepening right alongside the commercial footprint.
We are encouraged by the progress made during the first half of the year, but we also recognize that execution remains the measure of our success. Our team is committed to building Aclarion with discipline, focus, and accountability. On behalf of everyone at Aclarion, thank you for your continued support as we work to expand access to objective spine-care insights and create long-term value for shareholders.
Sincerely,
Brent Ness
Chief Executive Officer
Aclarion, Inc.
