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]

[Form 10-Q Filing Information](index=1&type=section&id=Form%2010-Q%20Filing%20Information) This section details ACLARION, INC.'s Quarterly Report on Form 10-Q filing for the period ended June 30, 2025, including registrant specifics and filing status [Registrant Details and Filing Status](index=1&type=section&id=Registrant%20Details%20and%20Filing%20Status) ACLARION, INC. filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025. The company is incorporated in Delaware and is classified as a Non-accelerated Filer, Smaller reporting company, and Emerging growth company - Registrant: ACLARION, INC.[2](index=2&type=chunk) - Filing Period: Quarterly period ended June 30, 2025[2](index=2&type=chunk) Registrant Filing Status | Status | Indication | | :------------------------ | :--------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated Filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☒ | - As of August 14, 2025, there were **582,371 shares** of common stock outstanding[4](index=4&type=chunk) [Special Note Regarding Forward-Looking Statements](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions about forward-looking statements, highlighting inherent risks and potential material differences in actual results [Nature and Risks of Forward-Looking Statements](index=3&type=section&id=Nature%20and%20Risks%20of%20Forward-Looking%20Statements) This section serves as a cautionary note regarding forward-looking statements within the report, indicating that such statements involve substantial risks and uncertainties and actual results may differ materially from expectations. It advises against undue reliance and refers readers to the Risk Factors section of the Company's Annual Report on Form 10-K - All statements, other than statements of historical facts, regarding strategy, future financial condition, operations, projected costs, prospects, plans, objectives, and expected market growth are forward-looking statements[6](index=6&type=chunk) - Forward-looking statements are subject to risks and uncertainties that could cause actual results to be materially different, as described in the Risk Factors section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024[7](index=7&type=chunk) - The Company undertakes no obligation to publicly update any forward-looking statements, except as required by law[7](index=7&type=chunk) [PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents ACLARION, INC.'s unaudited condensed financial statements and management's analysis of financial condition and results of operations [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents Aclarion, Inc.'s unaudited condensed financial statements, including the Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, along with comprehensive notes detailing the company's accounting policies, financial instruments, equity activities, and other relevant financial disclosures for the periods ended June 30, 2025, and December 31, 2024 [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Balance Sheet Highlights (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :--------------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $12,825,657 | $453,661 | | Total current assets | $13,440,755 | $824,279 | | Total assets | $14,754,520 | $2,123,483 | | Total current liabilities | $564,422 | $1,153,426 | | Total liabilities | $564,422 | $1,153,426 | | Total stockholders' equity | $14,190,098 | $970,057 | - Cash and cash equivalents increased significantly from **$453,661** at December 31, 2024, to **$12,825,657** at June 30, 2025[14](index=14&type=chunk) - Total assets grew from **$2,123,483** to **$14,754,520**, while total liabilities decreased from **$1,153,426** to **$564,422**[14](index=14&type=chunk) [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) This section outlines the company's financial performance, presenting revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024 Condensed Statements of Operations Highlights (Three Months Ended June 30) | Metric | 2025 | 2024 | | :-------------------------- | :---------- | :---------- | | Revenue | $19,319 | $10,971 | | Cost of revenue | $14,179 | $23,294 | | Gross profit (loss) | $5,140 | $(12,323) | | Total operating expenses | $1,741,648 | $1,123,238 | | Net Loss | $(1,600,757)| $(1,238,077)| | Net loss per share (basic & diluted) | $(2.75) | $(1,362.83) | Condensed Statements of Operations Highlights (Six Months Ended June 30) | Metric | 2025 | 2024 | | :-------------------------- | :---------- | :---------- | | Revenue | $38,309 | $21,085 | | Cost of revenue | $37,658 | $42,770 | | Gross profit (loss) | $651 | $(21,685) | | Total operating expenses | $3,229,084 | $2,389,184 | | Net Loss | $(3,638,193)| $(3,637,180)| | Net loss per share (basic & diluted) | $(9.09) | $(4,816.86) | - Revenue increased by **76%** for the three months ended June 30, 2025, and by **82%** for the six months ended June 30, 2025, compared to the prior year periods[16](index=16&type=chunk) - Gross profit turned positive for the three-month period in 2025 (**$5,140**) from a loss in 2024 (**$(12,323)**), and significantly improved for the six-month period[16](index=16&type=chunk) [Condensed Statements of Changes in Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This section details the company's equity changes, including common stock, additional paid-in capital, and accumulated deficit, for the six months ended June 30, 2025 Changes in Stockholders' Equity (Six Months Ended June 30, 2025) | Item | December 31, 2024 | June 30, 2025 | | :------------------------------------ | :------------------ | :-------------- | | Common Stock (Value) | $ * | $6 | | Additional Paid-In Capital | $52,232,368 | $69,090,597 | | Accumulated Deficit | $(51,262,311) | $(54,900,505) | | Total Stockholders' Equity | $970,057 | $14,190,098 | - Total stockholders' equity increased substantially from **$970,057** at December 31, 2024, to **$14,190,098** at June 30, 2025, primarily due to significant capital raises[21](index=21&type=chunk) - Additional paid-in capital increased by over **$16.8 million**, reflecting proceeds from registered direct offerings and a public offering of common stock and warrants[21](index=21&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024 Condensed Statements of Cash Flows Highlights (Six Months Ended June 30) | Activity | 2025 | 2024 | | :------------------------------ | :------------ | :------------ | | Net cash used in operating activities | $(4,376,394) | $(3,293,096) | | Net cash used in investing activities | $(122,290) | $(157,523) | | Net cash provided by financing activities | $16,885,680 | $3,602,237 | | Net increase in cash and cash equivalents | $12,386,996 | $151,618 | | Cash, cash equivalents and restricted

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 Points - Aclarion, Inc. has adjourned its Annual Meeting of Stockholders originally scheduled for July 7, 2025, to July 21, 2025, to solicit additional votes on proposals [1][2] - The record date for stockholders entitled to vote remains May 9, 2025, and stockholders are encouraged to vote as soon as possible [2] - Proxies submitted for the Annual Meeting will be voted at the adjourned meeting unless revoked, and stockholders can change their votes before the meeting [3] Company Overview - Aclarion is a healthcare technology company utilizing Magnetic Resonance Spectroscopy (MRS) and a proprietary biomarker to enhance clinical treatments for low back and neck pain [5] - The company addresses a significant market, valued at $134.5 billion in the U.S. for low back and neck pain [5] - Aclarion is incorporating Artificial Intelligence (AI) to improve quality control in spectroscopy data and is researching AI applications to better associate MRS data with clinical outcomes [5]

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 Insights - Aclarion, Inc. is participating in the State of Spine Surgery Think Tank to showcase its NOCISCAN platform, which utilizes biomarkers and AI to identify chronic low back pain [1][2] - Dr. Kris Radcliff will present the NOCISCAN platform, emphasizing its innovative approach to objectively identify discogenic pain [2] - The conference highlights the increasing interest in NOCISCAN's clinical and commercial value, as noted by Aclarion's Chief Strategy Officer [3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, leveraging Magnetic Resonance Spectroscopy (MRS) and AI algorithms [6] - NOCISCAN is the first evidence-supported SaaS platform designed to noninvasively distinguish between painful and nonpainful lumbar discs [4][6] - The platform quantifies chemical biomarkers associated with disc pain, providing critical insights when used alongside other diagnostic tools [4][6] Market Context - Chronic low back pain affects approximately 266 million people globally, representing a significant healthcare challenge [4] - The integration of NOCISCAN into clinical practice aims to develop personalized and effective surgical strategies for patients [2][3]