Quarterly Nociscan scan volumes increased 114% year-over-year in Q4 2025Annual Nociscan scan volumes increased 69% year-over-year in 2025Debt-free balance sheet with $12.0 million in cash as of December 31, 2025, extending cash runway into 2027 and providing strategic flexibility for continued commercial growthCompany aims to enroll approximately 25% of patients in CLARITY trial by the end of Q2 2026, with the first internal readout on interim data anticipated in Q3 2026 BROOMFIELD, Colo., Jan. 08, 2026 (GL ...

Northwestern and Scripps Health join two previously announced sites in achieving this critical patient enrollment milestone Seven leading U.S. spine centers have now completed the regulatory and operational requirements to screen and enroll patients in CLARITY First readout on interim data expected after initial cohort of patients achieves 3-month follow up visit in 3Q 2026 BROOMFIELD, Colo., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare ...

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]

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]

Aclarion Conference Call Summary Company Overview - Aclarion (NasdaqCM:ACON) is a healthcare technology company focused on non-invasive diagnostic solutions for chronic low back pain, specifically through its product, NOSI scan [1][2] Industry Context - Chronic low back pain affects approximately 266 million people globally, contributing significantly to opioid addiction and leading to costly surgical interventions [3][4] - The lumbar fusion market in the United States is valued at $10 billion, with a broader market encompassing various invasive procedures estimated at $40 billion [5][6] Key Points and Arguments - **Financial Position**: Aclarion has zero debt, no preferred shares, and is fully compliant with Nasdaq requirements. The company has a cash burn rate of $2 million and a runway through 2027 [1][34] - **Scan Volume Growth**: The company has experienced consistent double-digit growth in scan volume over three consecutive quarters, supported by expanding physician referrals [1][2] - **Clinical Evidence**: Aclarion has funded a national randomized control trial (CLARITY trial) to validate the effectiveness of NOSI scan, with initial results from a previous trial showing a 97% positive outcome when surgery matched NOSI scan recommendations [2][19][20] - **Market Opportunity**: The company targets the largest single expenditure in healthcare, with a significant revenue opportunity in the lumbar fusion market alone estimated at $603 million [5][6][35] - **Innovative Technology**: NOSI scan utilizes MR spectroscopy to identify biomarkers in discs that cause pain, offering a non-invasive alternative to traditional, painful diagnostic methods [8][10][16] - **Regulatory and Reimbursement Landscape**: Aclarion has secured reimbursement from three of the top four payers in London, which is expected to drive adoption and growth in the U.S. market as well [26][27] Additional Important Insights - **Intellectual Property**: Aclarion holds 24 issued US patents and 17 international patents related to its technology, enhancing its competitive edge [14] - **Management Team**: The management team includes experienced professionals from the healthcare and technology sectors, which is expected to drive the company's strategic initiatives [32][33] - **Future Catalysts**: Key catalysts for growth include the results from the CLARITY trial, increased physician adoption, and ongoing marketing initiatives in both the U.S. and London [36] Conclusion - Aclarion is positioned to capitalize on a significant market opportunity in chronic low back pain diagnostics through its innovative NOSI scan technology, backed by strong clinical evidence and a solid financial foundation [35][36]

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 - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Powell Max Limited (PMAX) increased by 115% to $5.59 - Solidion Technology, Inc. (STI) rose by 102% to $11.14 - ESS Tech, Inc. (GWH) saw a 44% increase to $6.11 - Aclarion, Inc. (ACON) gained 27% reaching $10.98 - Mannatech, Incorporated (MTEX) was up 20% at $10.80 - USA Rare Earth, Inc. (USAR) increased by 19% to $38.80 - Critical Metals Corp. (CRML) rose by 18% to $17.73 - United States Antimony Corporation (UAMY) gained 13% to $13.86 - Compass Diversified (CODI) increased by 12% to $9.46 - Forward Industries, Inc. (FORD) was up 11% at $22.69 [3] Premarket Losers - Yunhong Green CTI Ltd. (YHGJ) decreased by 24% to $7.00 - Kentucky First Federal Bancorp (KFFB) fell by 22% to $2.85 - One and One Green Technologies, Inc. (YDDL) dropped 20% to $5.23 - Safe & Green Holdings Corp. (SGBX) declined by 15% to $5.25 - Lazydays Holdings, Inc. (GORV) was down 14% at $2.12 - Acurx Pharmaceuticals, Inc. (ACXP) decreased by 10% to $6.69 - Top KingWin Ltd (WAI) fell by 10% to $3.82 - Super League Enterprise, Inc. (SLE) dropped 10% to $3.75 - Chanson International Holding (CHSN) decreased by 10% to $2.28 - Alaunos Therapeutics, Inc. (TCRT) was down 5% at $3.28 [4]