Aclarion Announces First Patient Enrollments at Two Additional CLARITY Trial Sites and Provides Guidance on Expected Availability of Initial Data

Core Insights - Aclarion, Inc. has initiated patient enrollment in its pivotal CLARITY trial, which aims to evaluate the effectiveness of its Nociscan technology for chronic low back pain [1][2] Group 1: Trial Progress and Enrollment - Northwestern Medicine and Scripps Health have enrolled their first patients, contributing to the overall progress of the CLARITY trial [1][2] - Four clinical sites have enrolled patients, with seven sites having completed necessary regulatory approvals and preparations for patient enrollment [2] - The company aims to enroll approximately 25% of the total 300 patients by the end of Q2 2026, with an initial readout of results expected 90 days after the last patient completes their 3-month follow-up [5][8] Group 2: Clinical Objectives and Methodology - The CLARITY trial is designed to assess whether the integration of Nociscan into surgical planning can improve patient outcomes beyond the current industry benchmark of approximately 54% for chronic low back pain surgeries [4] - The trial will randomize patients between those who are blinded and unblinded to Nociscan results, focusing on surgical planning for Fusion/TDR procedures [4] Group 3: Company Strategy and Leadership - Aclarion has appointed Jason Brosniak as Commercial Director for the Eastern U.S. and Andy Murillo as Director of Market Access to enhance trial enrollment and site expansion [3] - The company views the CLARITY trial as a foundational initiative for value creation, aiming to generate high-quality clinical evidence and support long-term shareholder value [6] Group 4: Market Context and Technology - Chronic low back pain affects an estimated 266 million people globally, highlighting the significance of Aclarion's Nociscan solution, which is the first evidence-supported SaaS platform to help differentiate between painful and nonpainful discs [7] - Nociscan utilizes Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to quantify biomarkers associated with disc pain, potentially improving surgical outcomes for patients with degenerative spine disease [9]