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Aclarion, Inc. Adopts Limited Duration Stockholder Rights Plan
Globenewswire· 2026-03-19 13:25
Core Viewpoint - Aclarion, Inc. has adopted a limited duration stockholder rights plan to protect stockholders' long-term value and prevent any person or group from gaining control without appropriate compensation [1][2]. Summary by Sections Rights Plan Overview - The Rights Plan is effective immediately and will expire in one year, specifically on March 18, 2027 [1][10]. - It aims to ensure that the Board has adequate time to make informed decisions in the best interest of Aclarion and its stockholders [2]. Applicability and Intent - The Rights Plan applies equally to all current and future stockholders and was not adopted in response to any specific acquisition proposal [3]. - It is designed to deter unauthorized control attempts while allowing the Board to consider fair offers [3]. Rights Distribution - Aclarion declared a dividend distribution of one preferred stock purchase right for each share of common stock and each Rights-Eligible Warrant outstanding as of March 30, 2026 [4]. - Each right will attach to shares of common stock and Rights-Eligible Warrants, initially not being exercisable [5]. Rights Exercise Conditions - Rights become exercisable if an entity or person acquires 10% or more of the common stock without Board approval [7]. - Existing ownership above the threshold prior to the Rights Plan announcement is grandfathered, but any increase in ownership will trigger the rights [7][9]. Rights Value and Exchange - If exercisable, each right allows the holder to purchase shares of Series D Junior Participating Preferred Stock at a cash price of $14.00 per right [6]. - In the event of a triggering ownership threshold, rights holders (excluding the triggering party) can receive shares of common stock valued at twice the exercise price [8]. Legal and Company Information - Goodwin Procter LLP is serving as legal counsel for Aclarion [11]. - Aclarion is a healthcare technology company focused on optimizing clinical treatments using Magnetic Resonance Spectroscopy and other advanced techniques [12].
Aclarion Publishes CEO Shareholder Letter Highlighting Strategic Progress and 2026 Catalysts
Prism Media Wire· 2026-03-19 10:00
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]
Aclarion to Participate in the 38th Annual ROTH Conference, Highlighting Key 2026 Catalysts and Strong Balance Sheet
Globenewswire· 2026-03-17 10:00
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]
Aclarion Publishes 2026 Shareholder Letter from the Chairman
Globenewswire· 2026-02-05 11:00
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]
Aclarion Adds High-Volume Practice, Source Healthcare, to Support Nociscan Growth and Real-World Evidence Generation
Globenewswire· 2026-02-03 11:00
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].
Aclarion Strengthens Balance Sheet and Extends Cash Runway Into 2028
Prism Media Wire· 2026-01-13 11:00
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]
Aclarion Strengthens Balance Sheet and Extends Cash Runway Into 2028
Globenewswire· 2026-01-13 11:00
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]
Aclarion Provides 2025 Update and 2026 Corporate Outlook
Globenewswire· 2026-01-08 11:00
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]
Aclarion Announces First Patient Enrollments at Two Additional CLARITY Trial Sites and Provides Guidance on Expected Availability of Initial Data
Globenewswire· 2026-01-06 11:00
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]
Aclarion Announces Publication of Nociscan Article in Special Pain Issue of the International Journal of Spine Surgery (IJSS)
Globenewswire· 2025-12-04 13:00
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]