Proven commercial leader with 20+ years of experience driving revenue growth and market adoption for early-stage and high-growth MedTech companiesStrong track record of launching breakthrough technologies across spine, neurosurgery and pain managementStrengthens Aclarion’s commercial execution as the Company expands adoption and payer engagement across the Eastern U.S. BROOMFIELD, Colo., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare techn ...

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]

Core Insights - Aclarion, Inc. has a debt-free balance sheet with $13.3 million in cash, equating to $15.11 per share fully diluted, providing strategic flexibility for growth [1][9] - Nociscan scan volumes have increased by 89% year-over-year, marking the third consecutive quarter of record utilization across U.S., U.K., and E.U. markets [1][4] - The CLARITY pivotal trial is progressing on schedule, with early three-month readouts expected in Q2 2026 as AI-driven disc pain biomarker validation continues [1][3] Market Adoption & Growth Momentum - Nociscan scan volumes increased by 89% year-over-year in Q3, indicating strong physician adoption and commercial traction [4] - The technology was featured at the International Society of Pain and Neuroscience annual meeting, validating its importance in chronic low back pain diagnosis [4] - Aclarion was named a finalist in the Rising Star – Clinical Diagnostic Device category at the 2025 Digital Health Awards, further validating Nociscan's innovation [4] Key Value Catalyst: CLARITY Trial Progress & AI Algorithm Validation - The CLARITY trial is on track, with the first patients enrolled at UHealth-University of Miami Health System, aiming for full enrollment by Q4 2026 [4] - The trial is designed to quantify the clinical value of integrating Nociscan data into surgical planning, targeting outcomes that exceed the current industry benchmark of approximately 54% [4] - Early internal interim data readout is expected in Q2 2026, providing a high-visibility catalyst as patient data accumulates [4] Leadership & Financial Strength Catalyst - The appointment of Greg Gould as CFO strengthens the leadership team at a pivotal inflection point for the company [6][9] - Aclarion's financial discipline remains a core priority, with capital allocation aligned to high-return milestones across commercial and clinical initiatives [9] - The company is focused on operational leverage, strategic partnerships, and scalable revenue models to unlock long-term shareholder value [9]

Core Insights - Aclarion, Inc. will present at the 19th Annual LD Micro Main Event on October 20, 2025, at 12:00 PM PT, focusing on its healthcare technology solutions for chronic low back pain [2][3] Company Overview - Aclarion is a healthcare technology company utilizing Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to enhance clinical treatments [6] - The company is targeting the chronic low back pain market with its product Nociscan, which is the first evidence-supported SaaS platform designed to noninvasively help physicians differentiate between painful and non-painful discs in the lumbar spine [6] - Nociscan operates by receiving MRS data from MRI machines, processing it in the cloud to extract and quantify chemical biomarkers associated with disc pain, and providing insights to optimize treatment strategies [6] Event Details - The LD Micro Main Event XIX will take place from October 19 to 21, 2025, at the Hotel del Coronado in San Diego, California, featuring around 120 companies presenting in half-hour increments [4][5] - The event will include registration, keynote speakers, company presentations, one-on-one investor meetings, and a closing reception [4]

Core Insights - Aclarion, Inc. has been selected as a finalist in the Rising Star - Clinical Diagnostic Device category for the 2025 Digital Health Hub Foundation: Digital Health Awards at HLTH, highlighting its innovative contributions to healthcare technology [1][4]. Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary AI algorithms to enhance clinical treatments [7]. - The company's flagship product, Nociscan, is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [3][7]. Product Details - Nociscan transforms MR spectroscopy signals into objective biomarkers associated with disc pain, providing actionable insights for personalized treatment plans [3][7]. - An estimated 266 million people globally suffer from chronic low back pain, indicating a significant market opportunity for Aclarion's solutions [3]. Recognition and Impact - The recognition as a finalist from over 1,800 submissions underscores Aclarion's commitment to improving healthcare efficiency and equity through digital innovations [4][6]. - CEO Brent Ness emphasized that this acknowledgment reflects the company's vision and determination to make Nociscan widely available to those affected by chronic low back pain [4].

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].