Aclarion (ACON) Investor Update summary

Business and clinical progress

• Focused on providing non-invasive, AI-driven diagnostics to identify painful spinal discs, improving surgical decision-making and patient outcomes.

• Clinical studies, including the Gornet and EVAL studies, demonstrated significant improvement in patient outcomes and potential healthcare cost savings of $1,700 per patient.

• Ongoing and upcoming studies, such as the CLARITY trial and NIH-funded BEST study, aim to further validate technology and support payer coverage decisions.

• Revenue is primarily driven by research collaborations, with major organizations like NIH and regenerative medicine companies paying for inclusion in studies.

• Expansion in the UK has led to successful payer coverage at major clinics, with plans to replicate this model in the US.

Technology and competitive landscape

• Utilizes MRI spectroscopy and proprietary algorithms to objectively identify pain biomarkers in spinal discs.

• Only non-invasive alternative to the traditional, invasive discogram procedure, offering improved safety, objectivity, and cost-effectiveness.

• Holds a broad patent portfolio and has regulatory clearance in the US, EU, and UK.

• Market opportunity is substantial, targeting a $10 billion surgical market initially, with potential to expand to $135 billion in population management.

Commercialization and reimbursement strategy

• Achieved Category III CPT codes in 2021; focus is now on increasing scan volume and transitioning to Category I codes for broader reimbursement.

• Key opinion leaders (KOLs) are central to driving adoption, scan volume, and payer coverage decisions.

• Successful UK case study with The London Clinic resulted in coverage from three of the top four private payers, with plans to expand further.

• US strategy mirrors the UK model, leveraging KOLs and clinical data to secure payer coverage and scale adoption.