Aclarion to Present at the LD Micro Main Event XIXPresentation on Monday, October 20, 2025 at 12:00 PM PTOctober 09, 2025 6:00 AM EDT | Source: LD MicroBroomfield, Colorado--(Newsfile Corp. - October 9, 2025) - Aclarion, Inc. (NASDAQ: ACON) (NASDAQ: ACONW) ("Aclarion" or the "Company"), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, announced today that it wi ...

BROOMFIELD, Colo., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a 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 its selection as a finalist in the Rising Star - Clinical Diagnostic Device category for the prestigious 2025 Digital Health Hub Foundation: Digital Health Awards at HLTH. This recognition ...

Core Insights - Aclarion, Inc. is leveraging biomarkers and proprietary augmented intelligence algorithms to assist physicians in identifying chronic low back pain locations through its platform, Nociscan [1][3] - The company recently presented at LSI Europe '25, highlighting Nociscan's potential to transform the chronic low back pain market and enhance shareholder value [2] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques [3] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [3] Technology and Clinical Evidence - Nociscan converts MR spectroscopy signals into objective biomarker data, aiding physicians in creating personalized treatment plans [5] - The ongoing 300-patient CLARITY randomized clinical trial aims to demonstrate that Nociscan-guided surgical decision-making can improve surgical outcomes beyond the current 54% industry success rate, with interim results expected in Q2 2026 [5] Financial Position - Aclarion has recently strengthened its balance sheet, providing the necessary capital to achieve commercial and clinical milestones [5]

Core Insights - Aclarion, Inc. has initiated the CLARITY trial to evaluate the clinical and economic value of its Nociscan technology in spine surgery for chronic low back pain [1][3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing biomarkers and proprietary AI algorithms to assist physicians in identifying pain sources [1][4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful lumbar discs [3][4] CLARITY Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving 300 patients scheduled for surgical treatment of discogenic back pain [2][5] - The trial will randomize patients in a 1:1 ratio between surgeons blinded and unblinded to Nociscan results, with the primary endpoint being the change in back pain measured on a 100mm VAS scale at 12 months [2][5] - Initial patient enrollment has begun at the University of Miami Health System, with additional sites including Northwestern Medicine and Texas Back Institute [2][3] Market Context - Chronic low back pain affects an estimated 266 million people globally, representing a significant health challenge [3] - Aclarion aims for Nociscan to become the gold standard in identifying sources of low back pain through advanced diagnostic techniques [5][6]

Core Viewpoint - Aclarion, Inc. has appointed Greg Gould as the new Chief Financial Officer, bringing over 30 years of experience in public and private companies to drive growth and profitability [1][2][3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing biomarkers and proprietary AI algorithms to assist physicians in identifying pain sources [1][4] - The company's flagship product, Nociscan, is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [3][4] Leadership Transition - Greg Gould succeeds John Lorbiecki, who is retiring after establishing a strong financial foundation for Aclarion [1][2] - Gould has a proven track record, having raised over $450 million in public company debt and equity offerings and led multiple acquisitions [2][3] Market Opportunity - Chronic low back pain affects approximately 266 million people globally, presenting a significant market opportunity for Aclarion's innovative solutions [3] - Nociscan aims to improve surgical outcomes by objectively quantifying chemical biomarkers associated with disc pain [3][4] Technology and Innovation - Aclarion leverages Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments [4][5] - The Nociscan platform integrates with MRI machines to provide critical insights into the location of low back pain, enhancing treatment strategies for physicians [5]

Core Viewpoint - Aclarion, Inc. has reported a significant year-over-year growth in scan volume of 132% from Q2 2024 to Q2 2025, marking two consecutive quarters of growth for the first time, driven by new physician adoption and insurance coverage in the UK [1][6]. Group 1: Scan Volume Growth - The company has achieved a scan volume growth of 132% year-over-year from Q2 2024 to Q2 2025, indicating strong commercial traction [6]. - Aclarion expects continued quarter-over-quarter growth in scan volume through the remainder of 2025 and beyond, supported by new physician adoption and activation of commercial sites in the U.S. [2][6]. - Over 5.2 million people in the UK now have access to Nociscan through their insurance providers, which is expected to drive further volume increases [4][6]. Group 2: Key Catalysts - The first key catalyst for Aclarion is the growth of scan volume in the UK, where insurance approval for Nociscan has been secured, facilitating broader physician adoption [4][5]. - The second key catalyst is the CLARITY trial, which aims to demonstrate that using Nociscan in surgical planning can lead to better outcomes for patients with chronic low back pain, potentially securing widespread insurance coverage in the U.S. [5][6]. - The CLARITY trial is designed to validate Nociscan's ability to improve surgical outcomes, with internal interim results expected in Q2 2026 [6][8]. Group 3: Clinical Evidence and Publications - Aclarion's Nociscan has been shown to be more effective and less costly than provocative discography, saving $1,712 per patient and improving surgical success rates by 10% [9]. - The company is focused on building clinical evidence to support payment coverage for Nociscan, with a cost-effectiveness analysis published in a peer-reviewed journal [9]. - Aclarion continues to invest in real-world evidence development with customers in both the UK and U.S. [9]. Group 4: Customer and Market Strategy - The company remains selective in adding new customers outside the UK, focusing on strategic U.S. customers that prioritize real-world evidence development [9]. - Aclarion participated in six important industry conferences in the first half of 2025 to establish relevance and credibility among surgeons and spine societies [9]. Group 5: Intellectual Property and Funding - Aclarion holds 24 U.S. patents and is auditing its intellectual property portfolio to explore potential partnerships for optimizing shareholder value [9]. - The company raised nearly $15 million in net cash and eliminated all debt, ensuring it is adequately funded through Q3 2026 to execute its strategic objectives [9].

Core Insights - Aclarion, Inc. has initiated the first patient enrollment in the CLARITY trial, which aims to evaluate the clinical and economic value of its Nociscan platform in spine surgery for chronic low back pain [1][6] Company Overview - Aclarion is a healthcare technology company that utilizes Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to enhance clinical treatments [5] - The company is focusing on the chronic low back pain market with Nociscan, the first evidence-supported SaaS platform designed to help physicians differentiate between painful and nonpainful discs in the lumbar spine [5] Trial Details - The CLARITY trial is a prospective, randomized multi-center study that will enroll 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain across multiple high-volume sites in the US [2] - The trial will randomize patients in a 1:1 ratio between surgeons who are blinded and unblinded to the Nociscan results, with the primary endpoint being the change in back pain measured on a 100mm VAS scale at 12 months compared to baseline [2][6] - The first patient was enrolled at the Texas Back Institute, which has a strong history in advancing spine care through clinical trial research [2][6] Market Context - Chronic low back pain is a significant global healthcare issue, affecting approximately 266 million people worldwide with degenerative spine disease and low back pain [3] - Aclarion's Nociscan solution aims to objectively quantify chemical biomarkers associated with disc pain, potentially leading to improved surgical outcomes [3][6]

Core Viewpoint - Aclarion, Inc. announced the addition of UHealth — University of Miami Health System as a trial site for the CLARITY study, which aims to demonstrate the clinical and economic value of its Nociscan technology in spine surgery [1][2]. Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing biomarkers and proprietary AI algorithms to assist physicians in identifying pain sources [1][6]. - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4][6]. CLARITY Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain [3]. - The trial will randomize patients in a 1:1 ratio between surgeons blinded to Nociscan results and those unblinded, with the primary endpoint being the change in back pain measured on a 100mm VAS at 12 months [3]. - UHealth joins other prestigious institutions like Johns Hopkins Medicine and Northwestern Medicine as a trial site [2][3]. Clinical Significance - Chronic low back pain affects approximately 266 million people globally, highlighting the need for effective diagnostic and treatment solutions [4]. - Nociscan aims to improve surgical outcomes by providing critical insights into the location of low back pain through the analysis of chemical biomarkers [4][8]. Research and Development - The CLARITY trial represents a unique opportunity to advance the spine industry and showcase the research capabilities of the University of Miami [2][7]. - Aclarion's technology leverages Magnetic Resonance Spectroscopy (MRS) to optimize clinical treatments for chronic low back pain [6][7].

Core Insights - Aclarion, Inc. announced the addition of Keck Medical Center of USC as a site for the CLARITY trial, aimed at demonstrating the clinical and economic value of Nociscan in spine surgery [1][2] - The CLARITY trial will evaluate 300 patients undergoing surgical treatment for discogenic low back pain, with a primary endpoint of measuring changes in back pain at 12 months [3][4] Company Overview - Aclarion is a healthcare technology company utilizing biomarkers and AI algorithms to assist physicians in identifying chronic low back pain [1][6] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4][6] Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving multiple high-volume sites across the US, including notable institutions like Johns Hopkins Medicine and Northwestern Medicine [2][3] - The trial will randomize patients in a 1:1 ratio between surgeons who are blinded and unblinded to Nociscan results [3] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting a significant healthcare challenge [4] - Aclarion's Nociscan aims to improve surgical outcomes by providing insights into the sources of low back pain through advanced diagnostic techniques [4][7]

MR Spectroscopy, Augmented Intelligence, and Low Back Pain - a New Gold Standard. Spine Summit 2025 Presenter: Nick Theodore, MD Aclarion 2023 3 THE PROBLEM & THE SOLUTION Aclarion 2023 5 Problem Disclosure Aclarion (NASDAQ: ACON) Forward Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's curr ...