Core Insights - Aclarion, Inc. is advancing towards an expected initial internal readout of its 300-patient CLARITY trial by the end of Q3 2026, with public disclosure of early interim results anticipated in Q4 2026 [1][2] Financial Position - The company has a strengthened balance sheet with a cash runway extending into 2028, allowing it to complete the CLARITY trial without the need for additional capital raises [2][7] - Aclarion has terminated its ATM and its ELOC expired at the end of 2025, reinforcing its commitment to shareholder alignment [2] Business Model and Technology - Aclarion operates as a software-native MedTech innovator, delivering solutions entirely through the cloud, which allows for software-level gross margins and rapid scalability [3] - The company's Nociscan platform utilizes Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to help physicians identify the source of chronic low back pain noninvasively [5] Strategic Initiatives - In 2026, Aclarion will implement a structured investor-awareness strategy targeting institutional healthcare investors and enhancing visibility in financial and medical media [4]

Core Viewpoint - Aclarion, Inc. has established an agreement with Source Healthcare to enhance the application of its Nociscan technology in addressing chronic low back pain, aiming to fill a significant gap in pain management solutions [1][2]. Group 1: Agreement and Strategic Expansion - The agreement with Source Healthcare aligns with Aclarion's strategy to expand the use of Nociscan, a non-invasive diagnostic tool for chronic low back pain [2]. - Source Healthcare, led by Dr. Timothy T. Davis, will integrate Nociscan into its multidisciplinary approach, generating real-world evidence to compare Nociscan with traditional anesthetic discography [2][3]. Group 2: Nociscan Technology and Benefits - Nociscan is a non-invasive alternative that objectively measures pain and structural integrity biomarkers in spinal discs, providing insights that traditional methods like MRI and discography do not offer [3][4]. - The technology has shown improved outcomes and lower costs in spinal fusion studies, and this collaboration aims to establish its efficacy in the broader pain management field [3][5]. - Approximately 266 million people globally suffer from chronic low back pain, highlighting the significant market potential for Nociscan [3]. Group 3: Clinical Validation and Growth Strategy - The partnership supports Aclarion's scalable growth strategy while building critical data assets necessary for payer and provider adoption of Nociscan [5]. - Nociscan's ability to provide clarity in diagnosing painful versus non-painful discs is expected to optimize treatment strategies for physicians [6].

Core Insights - Aclarion has successfully strengthened its balance sheet and extended its cash runway into 2028 through a $10.4 million financing, enhancing its operational flexibility and supporting its commercialization efforts for Nociscan [2][3][5] Financial Performance - For the three months ended May 31, 2024, Aclarion reported total revenues of $5.031 million, a 40% increase from $3.603 million in the same period of 2023 [1] - The revenue breakdown includes: - Fluxing Systems: $134,000 (2% of total), down 43% from $236,000 (6% of total) - Integrated Coating Systems: $747,000 (15% of total), up 142% from $309,000 (9% of total) - Multi-Axis Coating Systems: $2.664 million (53% of total), up 51% from $1.763 million (49% of total) - OEM Systems: $332,000 (7% of total), up 21% from $274,000 (8% of total) - Spare Parts, Services, and Other: $1.154 million (23% of total), up 13% from $1.021 million (28% of total) [1] Capital Structure - Aclarion's balance sheet is now debt-free with $21.6 million in cash as of January 12, 2026, allowing for a significant extension of its cash runway [6] - The financing has preserved the integrity of the capital structure and supports ongoing commercialization and strategic partnerships [3][4] Strategic Focus - The company aims to enhance the adoption of Nociscan, deepen clinical evidence, and build strategic relationships to drive growth for patients, providers, payers, and shareholders [5] - Upcoming milestones include accelerating enrollment in the CLARITY trial, expanding access to major MRI manufacturers, and collaborating with commercial payers for reimbursement coverage of Nociscan [11]

Core Insights - Aclarion, Inc. has successfully closed a $10.4 million financing round at $5.18 per share, resulting in a debt-free balance sheet and $21.6 million in cash as of January 12, 2026 [1][7] - The financing enhances Aclarion's capital structure, extends its operational runway into 2028, and supports ongoing commercialization and strategic partnerships for its Nociscan technology [2][4] Financial Highlights - The company has transformed its balance sheet over the past year, positioning itself for long-term value creation with a strong capital structure [3] - Aclarion's cash reserves and extended cash runway allow for focused execution on key objectives, including expanding adoption of Nociscan and deepening clinical evidence [4][7] Upcoming Milestones and Objectives - Aclarion aims to accelerate enrollment in the CLARITY trial, targeting approximately 25% of patients by the end of Q2 2026, with initial readouts expected after the first cohort's follow-up [8] - The company plans to complete and publish multiple real-world evidence trials and expand access to major MRI manufacturers, increasing the global market size by over 30% [8] - Aclarion will support clinician education through participation in CME events and refine workflow integration with the launch of Nociscan software version 2.8 in Q1 [8] - Collaboration with commercial payers in the US market is ongoing to evaluate broad reimbursement coverage for Nociscan [8]

Core Insights - Aclarion, Inc. is advancing its proprietary Nociscan platform to transform the diagnosis of chronic low back pain, reporting significant growth in scan volumes and a strong financial position as it enters 2026 [1][5][9] Market Adoption & Growth Momentum - In 2025, Aclarion achieved a 69% year-over-year increase in annual Nociscan scan volumes, with Q4 2025 scan volumes growing by 114% year-over-year [2][5][6] Strategic and Operational Highlights - The company added 9 new imaging centers and 22 new physician users in 2025, expanding its commercial presence in key UK and U.S. healthcare markets [6] - Aclarion is focused on enrolling approximately 25% of patients in the CLARITY trial by the end of Q2 2026, with the first internal readout of interim data expected in Q3 2026 [5][6] Clinical and Product Developments - The Nociscan platform has shown to be more effective and less costly than traditional methods, saving $1,712 per patient and improving surgical success rates by 10% [6] - Aclarion published significant clinical evidence in 2025, including a cost-effectiveness analysis and a case study in the International Journal of Spine Surgery [6] Financial Highlights - As of December 31, 2025, Aclarion had $12.0 million in cash and no debt, having raised over $22.0 million in equity financing during fiscal 2025 [7][8] - The company believes its existing cash resources are sufficient to fund operations into the first half of 2027 [8] Management Commentary - The CEO of Aclarion expressed satisfaction with the company's progress in strengthening its financial position and expanding clinical traction, emphasizing the importance of evidence generation and strategic partnerships for long-term value [9][10] Future Plans - Aclarion aims to expand access to major MRI manufacturers, support clinician education initiatives, and refine workflow integration with the launch of version 2.8 of the Nociscan software in Q1 [12]

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]

Core Insights - Aclarion, Inc. has announced the publication of a featured article in the Special Pain Issue of the International Journal of Spine Surgery, highlighting the importance of understanding pain as a complex condition and showcasing their Nociscan solution for chronic low back pain [1][2][4] Company Overview - Aclarion is a healthcare technology company focused on leveraging biomarkers and proprietary AI algorithms to assist physicians in identifying chronic low back pain locations [1][6] - The company’s Nociscan solution is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [2][7] Product Details - Nociscan utilizes Magnetic Resonance Spectroscopy (MRS) data to extract and quantify chemical biomarkers associated with disc pain, providing critical insights for treatment optimization [6][7] - A case study featured in the publication demonstrated Nociscan's effectiveness in identifying the source of pain, leading to successful surgical intervention for a patient [3][4] Industry Context - The Special Pain Issue of IJSS emphasizes the evolving understanding of pain, integrating objective biomarkers with clinical judgment to enhance diagnosis and treatment [2][4] - IJSS is recognized for advancing scientific and clinical excellence in spine care, publishing over 150 articles annually from over 40 nations [4][6]

Core Insights - Aclarion, Inc. has appointed Jason Brosniak as Commercial Director for the Eastern U.S. to enhance the adoption of its Nociscan technology [1][3] - Brosniak brings over 20 years of experience in MedTech, having previously worked with companies like Relievant Medsystems and Kyphon, which positions him well to drive growth in the spine and pain management sectors [2][3] - The demand for Nociscan is increasing due to real-world evidence trials and the national CLARITY randomized controlled trial, highlighting the need for additional commercial resources in the Eastern U.S. [3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to help physicians differentiate between painful and nonpainful discs [4] - Nociscan is the first evidence-supported SaaS platform that noninvasively quantifies chemical biomarkers associated with disc pain, providing critical insights for treatment optimization [4] - The company aims to expand access to its technology for the estimated 266 million people globally suffering from chronic low back pain [3]

Core Insights - Aclarion, Inc. has appointed Dan Isherwood as UK Commercial Director, marking a significant commercial milestone for the company [2][3] - The UK market is the first where physicians can order Nociscan without payment concerns, potentially benefiting over 5 million patients [2][6] - Nociscan has gained traction in the UK, being covered by three of the four top private insurers, reaching over 5.2 million covered lives [2][6] Company Overview - Aclarion is a healthcare technology company utilizing biomarkers and proprietary AI algorithms to assist in identifying chronic low back pain [1][5] - The company's Nociscan solution is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4][5] - Nociscan employs Magnetic Resonance Spectroscopy (MRS) to analyze data and quantify chemical biomarkers associated with disc pain [5][6] Market Potential - An estimated 266 million people globally suffer from chronic low back pain, highlighting a significant health challenge [4] - The appointment of Dan Isherwood is expected to accelerate the adoption of Nociscan in the UK, leveraging his extensive experience in advanced imaging and spine technologies [3][6] - Aclarion aims to strengthen relationships with physicians and imaging centers as part of its UK commercial expansion strategy [2][3]

Core Insights - Aclarion, Inc. has been recognized as a Rising Star in the Clinical Diagnostic Device category at the 2025 Digital Health Awards, highlighting its innovative Nociscan solution for chronic low back pain [1][3][4] Company Overview - Aclarion is a healthcare technology company that utilizes biomarkers and proprietary augmented intelligence algorithms to assist physicians in identifying the sources of chronic low back pain [1][6] - The company's Nociscan solution is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [4][6] Product Details - Nociscan transforms magnetic resonance spectroscopy (MRS) signals into objective biomarkers associated with disc pain, providing actionable insights for personalized treatment plans [5][6] - An estimated 266 million people globally suffer from chronic low back pain, indicating a significant market opportunity for Aclarion's technology [5] Industry Recognition - The Digital Health Awards celebrate advancements in the digital health sector, with Aclarion's recognition from over 1,800 submissions underscoring its commitment to improving healthcare efficiency and equity [3][6]