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

Debt-free balance sheet with $13.3 million in cash as of today ($15.11 per share fully diluted) providing strategic flexibility for continued commercial growth

Nociscan scan volumes increase +89% year-over-year with third consecutive quarter of record utilization across U.S., U.K., and E.U. markets

CLARITY pivotal trial progressing on schedule and early 3-month readouts expected Q2 2026 as AI-driven disc pain biomarker validation continues

Webcast scheduled for October 20^th at 12:00 pm PT at the LD Micro Main Event

BROOMFIELD, Colo., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a commercial-stage healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today issued its Q3 2025 corporate update highlighting its strong financial position, accelerating market adoption, and continued progress in the pivotal CLARITY trial.

Market Adoption & Growth Momentum

• Nociscan scan volumes increased +89% year-over-year in Q3 – marking the third consecutive quarter of accelerating growth across U.S., U.K., and E.U. sites.
• Three straight quarters of record utilization underscore growing physician adoption and commercial traction.
• MR Spectroscopy and biomarker technology featured at the International Society of Pain and Neuroscience (ISPN) annual meeting in London validating the importance of disc chemistry as a key biomarker for chronic low back pain diagnosis.
• Aclarion named a finalist in the Rising Star – Clinical Diagnostic Device category at the 2025 Digital Health Awards (HLTH) – furthering industry validation of Nociscan’s innovation and clinical impact.
• Commercial expansion strategy on track to drive new revenue channels and strengthen global brand visibility in 2026.
  
  

Key Value Catalyst: CLARITY Trial Progress & AI Algorithm Validation

• CLARITY pivotal trial advancing on schedule – first patients enrolled at UHealth-University of Miami Health System and the Miller School of Medicine, advancing progression towards full enrollment of CLARITY patients by Q4 2026.
• Trial designed to quantify the clinical value of integrating Nociscan data into surgical planning, targeting outcomes that significantly exceed current ~54% industry benchmarks.
• Seven leading Phase I sites are now actively engaged:
  • Texas Back Institute
  • University of Miami Health
  • Advocate Health
  • Northwestern Medicine
  • Scripps Health
  • Keck Medicine of USC
  • Johns Hopkins University
• Early internal interim data readout expected Q2 2026, offering high-visibility catalyst as three-month patient data accumulates.
• Positive momentum reinforces Nociscan’s position as the first AI-enabled platform to objectively identify discogenic pain biomarkers.