Aclarion (ACON) investor relations material

Market need and opportunity

• Chronic low back pain affects 266M people; 330,000 spinal fusion procedures are performed, with average success near 54%.

• U.S. revision surgeries cost $6B annually; fusion procedures cost $58,000 for one level and $71,000 for two levels.

• Nociscan targets a stated $32B global market; identified beachhead opportunity totals roughly $7B, including $6.7B in pain management and $478M in surgical decision support.

Nociscan platform and evidence

• Nociscan uses MRI spectroscopy and cloud-based algorithms to assess disc chemistry, translating complex spectral data into a clinically actionable physician report.

• The report identifies chemical indicators associated with painful discs and includes a structural integrity score to inform treatment decisions at adjacent levels.

• Gornet trial results showed 97% success when Noci-positive discs were treated versus 54% when missed; evidence was durable at two years.

• The platform is positioned as a non-invasive, objective alternative to provocative discography; nine peer-reviewed publications were cited, including a recent European Spine Journal paper.

• Intellectual property portfolio includes 62 active patents covering spectroscopy, AI and spectral-data assessment.

Commercial progress and clinical trial

• Private payers in three of the U.K.'s top four health insurers reimburse Nociscan; engagement with Bupa was underway, with outreach planned in the coming months.

• U.S. commercialization uses Category III CPT codes; strategy is to grow scan volume, secure individual private-payer coverage decisions and pursue a Category I coverage decision over time.

• The national CLARITY randomized trial plans to evaluate 300 patients at 11 active sites, measuring outcomes at 3, 6 and 12 months, including missed/matched and blinded/unblinded cases.

• Inclusion criteria were expanded in the prior month; the change was adopted at nine sites and was already associated with increased adoption, though it may make results statistically messier.

• Trial end date remains three years after the first patient, who entered in mid-2025; interim information may be used as it becomes available because the study is not an FDA trial.