Company anticipates no capital raises prior to expected value enhancing catalysts Cash runway into 2028ATM terminated in early 2025 and ELOC expired December 31, 2025 BROOMFIELD, Colo., Feb. 05, 2026 (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 announced the re ...

Expands availability of Nociscan in the greater Los Angeles areaReinforces Nociscan’s non-invasive advantage with real-world clinical validation compared to anesthetic discography, a spinal injection procedureSupports scalable growth strategy while building data assets critical to payer and provider adoption BROOMFIELD, Colo., Feb. 03, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a commercial-stage healthcare technology company that is leveraging biomarkers a ...

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]

Revenue Performance - Total revenues for the three months ended September 30, 2025, were $18,942, an increase of $4,535 or 31.5% compared to $14,407 for the same period in 2024, driven by the growing volume of NOCISCAN® reports sold in the UK market [133]. - Total revenues for the nine months ended September 30, 2025, were $57,251, an increase of $21,759 or 61.3% from $35,492 in 2024, driven by increased NOCISCAN® report sales in the UK [142]. Cost of Revenue - Total cost of revenue for the three months ended September 30, 2025, was $14,556, a decrease of $6,776 or 31.8% from $21,332 in 2024, primarily due to reduced hosting fees allocation and a change in revenue mix [134]. - Total cost of revenue for the nine months ended September 30, 2025, was $52,214, a decrease of $11,888 or 18.5% from $64,102 in 2024, due to reduced hosting fees allocation [143]. Expenses - Sales and marketing expenses for the three months ended September 30, 2025, were $632,409, an increase of $399,634 or 171.7% compared to $232,775 in 2024, largely due to the initiation of the Clarity trial [135]. - Research and development expenses for the three months ended September 30, 2025, were $302,037, an increase of $106,240 or 54.3% from $195,797 in 2024, driven by patent maintenance fees and expanded regulatory compliance activities [136]. - General and administrative expenses for the three months ended September 30, 2025, were $900,904, an increase of $40,443 or 4.7% compared to $860,461 in 2024, influenced by bonus accruals and higher D&O insurance costs [137]. - Sales and marketing expenses for the nine months ended September 30, 2025, totaled $1,278,759, an increase of $639,890 or 100.2% compared to $638,869 in 2024, primarily due to higher post-market clinical expenses [144]. - Research and development expenses increased by $133,719 or 21.0% to $770,659 for the nine months ended September 30, 2025, compared to $636,940 for the same period in 2024 [145]. - General and administrative expenses rose by $612,608 or 25.5% to $3,015,016 for the nine months ended September 30, 2025, driven by higher accruals under the 2025 incentive bonus program [146]. Net Loss - The net loss for the three months ended September 30, 2025, was $1,706,294, compared to a net loss of $1,366,176 for the same period in 2024, reflecting an increase of $340,118 [131]. - The net loss for the nine months ended September 30, 2025, was $5,344,487, compared to a net loss of $5,003,355 for the same period in 2024, an increase of $341,132 [141]. Cash Flow and Financing - Cash used in operating activities was $5,536,766 for the nine months ended September 30, 2025, an increase of $1,188,019 compared to $4,348,747 used in the same period in 2024 [164]. - The company raised an aggregate of $20,058,913 in gross proceeds through various offerings during the nine months ended September 30, 2025 [160]. - The public offering price for each Unit was $0.10, with net proceeds to the Company of $13.4 million from the offering [176]. - The Company may need to obtain substantial additional funds to achieve its business objectives, as developing medical technology products is expensive and uncertain [184]. Other Financial Information - Interest expense decreased to $0 for the nine months ended September 30, 2025, from $535,199 for the same period in 2024 due to the retirement of all unsecured non-convertible notes [147]. - The company recognized a gain of $73,272 during the nine months ended September 30, 2025, related to the retirement of an obligation associated with commitment shares [149]. - Cash used in investing activities decreased to $162,441 for the nine months ended September 30, 2025, from $261,220 in the same period in 2024 [167]. - The Company does not have any contractual obligations or off-balance sheet arrangements as of September 30, 2025 [187][188]. - The Company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million [191]. Shareholder Activities - As of March 31, 2025, all Pre-Funded Warrants have been exercised, with Series A and Series B Common Warrants having an exercise price of $0.20 [177]. - Approximately 14.7 million common shares were issued from Series B warrant exercises following the approval on March 5, 2025 [178]. - The Company redeemed all Series B Preferred Stock for a cash payment of $1,213,590 on January 22, 2025 [179]. - During the nine months ended September 30, 2025, holders converted 874 shares of C Preferred Stock into 6,211,618 shares of common stock [181]. - The Company received payments of $336,411 from the exercise of 5,685,049 Series C warrants during the nine months ended September 30, 2025 [182]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $4,900,996, including gross proceeds of $2,691,391 from a public offering [183].

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]