Aclarion (ACON) investor relations material

Strategic and financial highlights

• Biomarker-based technology with AI algorithms aims to improve accuracy in identifying painful discs for chronic low back pain cases.

• Early studies indicate potential to increase correct first surgical interventions from 54% to 97%.

• Achieved 196% year-over-year Q1 growth, driven by initial payer coverage and adoption in the U.K.

• U.K. market used as a test bed for U.S. commercialization and payer approval strategies.

• Financial strength supports execution of key catalysts, notably the CLARITY trial.

Market opportunity and clinical need

• Chronic low back pain represents a $10 billion initial market, expanding to $40 billion with broader adoption, and up to $135 billion in the triage space.

• Technology targets cases where MRI shows only degenerative changes, addressing a major decision-making challenge for surgeons.

• Nociscan technology provides objective biomarkers to guide surgical decisions, reducing reliance on subjective and invasive discography.

• Surgeons in the U.K. rapidly adopted the technology after initial trials, shifting away from discography.

• High gross margins due to software-based model and minimal cost of goods.

Clinical evidence and trials

• Retrospective study showed 97% clinical improvement when surgical decisions matched Nociscan results, compared to 54% otherwise.

• CLARITY trial is a multi-center, prospective, randomized study with interim results expected in Q4, focusing on validating the 97% outcome.

• Eight peer-reviewed publications covering 250 patients support the technology's efficacy.

• Key opinion leaders from major U.S. institutions are involved in ongoing studies and adoption efforts.