Aclarion (ACON) Investor Update summary

Technology and clinical validation

• Utilizes MR spectroscopy and augmented intelligence to identify pain biomarkers in lumbar discs, enabling personalized surgical decisions.

• Clinical studies show patients whose surgeries matched Nociscan results had 97% significant improvement at one year, with durable results at two years.

• Technology demonstrated $1,700 per patient savings and 10% better outcomes, factoring in technology costs.

• Involved in NIH-funded studies targeting opioid addiction and early patient triage, with over 500 patients across two major studies.

• Completed a 204-scan study on biologic disc treatments, awaiting outcome data.

Market opportunity and competitive landscape

• Addresses the $135 billion annual U.S. market for low back pain, the highest-cost diagnosis in the country.

• Main competitor, invasive discogram, is falling out of favor due to subjectivity, higher cost, and long-term risks.

• Holds significant intellectual property covering biomarkers, algorithms, and AI correlations.

• Regulatory approvals secured in the U.S. and overseas, with a pathway to expand from surgical decisioning to population management.

Commercialization and reimbursement strategy

• Follows a proven model from cardiology AI companies, aiming to move from CPT Category III to Category I codes for reimbursement.

• Key strategy involves partnering with surgeons, building local payer coverage, and expanding to national coverage.

• Achieved first major payer coverage win in the U.K., now covered by three of the top four private insurers.

• U.S. strategy leverages key opinion leaders at major institutions to drive adoption and payer decisions.