Aclarion (ACON) Planet MicroCap Showcase VEGAS 2025 summary

Strategic and financial highlights

• Nearly $14.6 million in cash provides runway into Q3 2026, with zero debt and a clean cap table.

• Fully NASDAQ compliant, meeting bid price and shareholder equity requirements.

• Strong patent portfolio with over 40 patents worldwide, covering biomarkers, post-processing, and AI algorithms.

• FDA cleared, CE marked, and planning expansion into Australia.

• Category III CPT codes issued in the U.S., with a clear regulatory and reimbursement path.

Market opportunity and clinical need

• Chronic low back pain is the top healthcare cost in the U.S., affecting 266 million globally.

• 635,000 spinal fusion surgeries annually in the U.S., with a $603 million initial addressable market for the product.

• Revision surgeries cost the U.S. healthcare system over $2.2 billion annually.

• Current surgical success rates are only 48%-54%, with high rates of persistent pain and opioid addiction.

• Market expands further with pain management and chiropractic procedures, exceeding $2 billion.

Technology and clinical evidence

• Product uses MRI spectroscopy to quantify pain and structural biomarkers in spinal discs.

• Provides actionable, cloud-based reports for physicians, translating complex data into clear treatment guidance.

• Non-invasive, less costly, and safer than traditional discogram procedures.

• Foundational study showed 97% improvement when treatment matched product findings, compared to 54% average surgical success.

• National CLARITY trial is fully funded, led by Johns Hopkins, with interim results expected in about a year.