BROOMFIELD, Colo., March 19, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc. (Nasdaq: ACON, ACONW) (“Aclarion” or the “Company”) today announced that its Board of Directors (the “Board”) has unanimously adopted a limited duration stockholder rights plan (the “Rights Plan”). The Rights Plan is effective immediately and expires in one year. The Rights Plan is intended to enable all stockholders to realize the long-term value of their investment in Aclarion. The Rights Plan is also intended to reduce the likelihood th ...

Core Insights - Aclarion, Inc. has published a CEO Shareholder Letter outlining strategic progress and upcoming catalysts for 2026, emphasizing the company's focus on expanding the adoption of its Nociscan platform and enhancing clinical evidence and reimbursement initiatives [2][3][4] Financial Performance - For the three months ended May 31, 2024, Aclarion reported total revenue of $5,031,000, a 40% increase from $3,603,000 in the same period of 2023 [1] - Revenue breakdown includes: - Fluxing Systems: $134,000 (2% of total), down 43% from $236,000 (6% of total) in 2023 - Integrated Coating Systems: $747,000 (15% of total), up 142% from $309,000 (9% of total) in 2023 - Multi-Axis Coating Systems: $2,664,000 (53% of total), up 51% from $1,763,000 (49% of total) in 2023 - OEM Systems: $332,000 (7% of total), up 21% from $274,000 (8% of total) in 2023 - Spare Parts, Services, and Other: $1,154,000 (23% of total), up 13% from $1,021,000 (28% of total) in 2023 [1] Strategic Initiatives - The company is pursuing reimbursement coverage from regional insurance providers in the U.S. as a critical step towards broader payer adoption [2] - Aclarion is advancing its ongoing CLARITY clinical trial, with initial readout expected in Q4 2026, and is expanding commercial engagement with physicians and imaging centers [3][4] - The company maintains a strong balance sheet with a cash runway extending into 2028, supporting its strategic initiatives [2][3]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ | Delaware | 47-3324725 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer Identification No.) | | incorporation or organization) | | 8181 Arista Place, Suite 100 Broomfield, Colorado 80021 FORM 10-K _________________ (Address of principal executive offices) (Zip Code) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended Dec ...

Core Insights - Aclarion, Inc. is participating in the 38th Annual ROTH Conference from March 22-24, 2026, to discuss its proprietary MR spectroscopy platform, Nociscan, aimed at identifying chronic low back pain [1][2] Company Overview - Aclarion is a commercial-stage healthcare technology company utilizing biomarkers and augmented intelligence algorithms to assist physicians in diagnosing chronic low back pain [1][4] - The company’s Nociscan platform is the first evidence-supported SaaS solution designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [4] Financial Position - Aclarion has a strong balance sheet with no debt, positioning the company well for future growth and expansion of Nociscan in both the UK and US markets [3] Conference Engagement - CEO Brent Ness will hold one-on-one meetings with institutional investors and analysts during the ROTH Conference to discuss the company's advancements and future catalysts [2][3]

Core Insights - Aclarion, Inc. is participating in LSI USA 2026 to discuss advancements in its proprietary MR spectroscopy platform, NOCISCAN, aimed at addressing chronic low back pain [1][2]. Company Overview - Aclarion is a commercial-stage healthcare technology company utilizing biomarkers and augmented intelligence algorithms to assist physicians in identifying chronic low back pain [1]. - The company’s NOCISCAN platform is the first evidence-supported SaaS solution designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [3]. Product Details - NOCISCAN employs Magnetic Resonance Spectroscopy (MRS) to analyze data from MRI machines, extracting chemical biomarkers associated with disc pain [3]. - The platform integrates proprietary signal processing techniques and algorithms to provide insights into the source of a patient's low back pain, aiding in treatment optimization [3]. Event Participation - Brent Ness, CEO of Aclarion, will attend LSI USA 2026 from March 16-20, 2026, in Dana Point, CA, to engage with investors and industry partners [2][3]. - The event focuses on accelerating innovation in MedTech and HealthTech, bringing together key stakeholders in the industry [3].

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]