Aclarion Provides Corporate Update Highlighting Market Expansion as CLARITY Trial Advances Toward Key Data Catalyst

Core Insights - Aclarion, Inc. has a debt-free balance sheet with $13.3 million in cash, equating to $15.11 per share fully diluted, providing strategic flexibility for growth [1][9] - Nociscan scan volumes have increased by 89% year-over-year, marking the third consecutive quarter of record utilization across U.S., U.K., and E.U. markets [1][4] - The CLARITY pivotal trial is progressing on schedule, with early three-month readouts expected in Q2 2026 as AI-driven disc pain biomarker validation continues [1][3] Market Adoption & Growth Momentum - Nociscan scan volumes increased by 89% year-over-year in Q3, indicating strong physician adoption and commercial traction [4] - The technology was featured at the International Society of Pain and Neuroscience annual meeting, validating its importance in chronic low back pain diagnosis [4] - Aclarion was named a finalist in the Rising Star – Clinical Diagnostic Device category at the 2025 Digital Health Awards, further validating Nociscan's innovation [4] Key Value Catalyst: CLARITY Trial Progress & AI Algorithm Validation - The CLARITY trial is on track, with the first patients enrolled at UHealth-University of Miami Health System, aiming for full enrollment by Q4 2026 [4] - The trial is designed to quantify the clinical value of integrating Nociscan data into surgical planning, targeting outcomes that exceed the current industry benchmark of approximately 54% [4] - Early internal interim data readout is expected in Q2 2026, providing a high-visibility catalyst as patient data accumulates [4] Leadership & Financial Strength Catalyst - The appointment of Greg Gould as CFO strengthens the leadership team at a pivotal inflection point for the company [6][9] - Aclarion's financial discipline remains a core priority, with capital allocation aligned to high-return milestones across commercial and clinical initiatives [9] - The company is focused on operational leverage, strategic partnerships, and scalable revenue models to unlock long-term shareholder value [9]