Core Insights - Aclarion, Inc. is participating in the 2025 Spine Summit to showcase its innovative NOCISCAN technology aimed at addressing chronic low back pain [1][3] Company Overview - Aclarion is a healthcare technology company that utilizes biomarkers and proprietary augmented intelligence algorithms to assist physicians in identifying chronic low back pain [1][7] - The company’s NOCISCAN platform is the first evidence-supported SaaS solution designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4][7] Technology and Innovation - NOCISCAN combines Magnetic Resonance Spectroscopy (MRS) with augmented intelligence to provide critical insights into the location of low back pain, enabling tailored treatment plans for patients [2][4][8] - The platform quantifies chemical biomarkers associated with disc pain, enhancing diagnostic accuracy when used alongside other tools [4][10] Event Participation - Dr. Nicholas Theodore, a prominent orthopedic surgeon, will present at the Spine Summit, discussing the transformative impact of NOCISCAN on spine surgery [2][9] - The presentation is scheduled for February 21, 2025, at the JW Marriott Tampa Water Street [9]

Core Insights - Aclarion, Inc. has received a Notice of Allowance for its 24th US patent, expanding its ability to use Magnetic Resonance Spectroscopy (MRS) to identify propionic acid (PA) throughout the body, which may indicate potential sources of infection and pain [1][6][2] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing MRS, proprietary signal processing techniques, and augmented intelligence algorithms to optimize clinical treatments [4] - The company's Nociscan platform is the first evidence-supported SaaS solution designed to help physicians differentiate between painful and non-painful discs in the lumbar spine [4] Patent and Technology Development - The new patent allows Aclarion to measure propionic acid as a biomarker for identifying potential infections and pain beyond just discogenic low back pain [6][2] - MRS is a capability of MRI scanners that provides spectral data on various chemical biomarkers, but traditional MRS post-processing can be challenging; Aclarion's patents address these challenges, enhancing the reliability and quality of spectral data [2][6] Implications of the Patent - The patent's implications are significant, as it positions Aclarion to commercialize MRS applications more broadly, potentially impacting the diagnosis and treatment of various conditions associated with propionic acid [2][6]

Core Insights - Aclarion, Inc. is conducting the pivotal CLARITY trial to evaluate the clinical and economic value of its Nociscan technology for chronic low back pain surgery [1][2] - Nociscan aims to become the gold standard in identifying sources of low back pain using MR Spectroscopy and AI [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][5] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful lumbar discs [3][6] Clinical Trial Details - The CLARITY trial is a randomized, multi-center study involving 300 patients scheduled for surgical treatment of discogenic low back pain [2][3] - The trial will compare surgical outcomes based on Nociscan results, with a primary endpoint of back pain change measured on a 100mm VAS scale at 12 months [2][3] Market Context - Approximately 266 million people globally suffer from degenerative spine disease and low back pain, highlighting the significance of Aclarion's Nociscan solution [3][6] - The trial is fully funded and led by Dr. Nicholas Theodore from Johns Hopkins, indicating strong institutional support [2][3]

Core Insights - Aclarion, Inc. has secured nearly $20 million in gross proceeds to fully fund its pivotal CLARITY trial, which aims to validate the effectiveness of Nociscan in improving surgical outcomes for chronic low back pain patients [1][2] - The CLARITY trial is a prospective, randomized, multicenter study enrolling 300 patients, led by Dr. Nicholas Theodore from Johns Hopkins, and builds on existing peer-reviewed data supporting Nociscan's potential [2][3] - Nociscan is positioned as a groundbreaking solution in the chronic low back pain market, utilizing Magnetic Resonance Spectroscopy (MRS) and augmented intelligence to differentiate between painful and nonpainful discs [3][5] Funding and Trial Details - The funding secured since January 1, 2025, ensures the completion of the CLARITY trial, which is critical for potentially unlocking broader payer coverage for Nociscan [2] - The trial aims to demonstrate Nociscan's clinical and economic value in spine surgery, with a focus on matching surgical interventions to specific discs identified as pain sources [2][3] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting the significant healthcare challenge and the potential market for Aclarion's Nociscan solution [3] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively assist physicians in identifying the source of low back pain, achieving a reported 97% surgical success rate at one year follow-up when treating identified pain-positive discs [3][5]

Core Insights - Aclarion, Inc. is participating in the Selby Spine Conference to showcase its NOCISCAN platform, which utilizes biomarkers and AI algorithms to assist in identifying chronic low back pain locations [1][2] - Dr. Sigurd Berven will present on how NOCISCAN can help physicians detect biomarkers that are not visible through traditional imaging methods, enabling personalized treatment plans for patients [2][4] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, leveraging Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to optimize clinical treatments [6] - NOCISCAN is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine, providing critical insights for treatment strategies [4][6] Presentation Details - The presentation titled "MR Spectroscopy, Augmented Intelligence, and Low Back Pain – A New Gold Standard" will highlight the innovative capabilities of NOCISCAN [2][3] - NOCISCAN combines MR Spectroscopy with augmented intelligence to set a new standard for noninvasive diagnostics in spine surgery and chronic pain management [3] Market Context - Chronic low back pain affects approximately 266 million people globally, indicating a significant healthcare challenge that Aclarion aims to address with its technology [4]

Core Viewpoint - Aclarion, Inc. (ACON) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - Aclarion's rising earnings estimates and the subsequent rating upgrade suggest an improvement in the company's underlying business, likely leading to increased stock prices [5][11]. Earnings Estimate Revisions - For the fiscal year ending December 2024, Aclarion is expected to earn -$0.79 per share, representing a 91% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Aclarion has increased by 20.2%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [7]. - Aclarion's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10][11].

Core Insights - Aclarion's Nociscan product is featured in the RSNA Edition of Siemens Healthineers magazine, MAGNETOM Flash, highlighting its role in addressing chronic low back pain [1][2] - The article emphasizes the significance of MR spectroscopy (MRS) as a decision support tool for physicians in diagnosing chronic low back pain [1][3] Company Overview - Aclarion, Inc. is a healthcare technology company that utilizes biomarkers and proprietary AI algorithms to assist physicians in identifying the source of 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 [3][6] Product Details - Nociscan quantifies chemical biomarkers associated with disc pain and provides critical insights when used alongside other diagnostic tools [3][6] - The platform operates through a cloud connection, receiving MRS data from MRI machines to analyze lumbar discs [6] Market Context - Chronic low back pain affects approximately 266 million people globally, representing a significant healthcare challenge [3]

Financial Performance - Total revenues for Q3 2024 were $14,407, a decrease of $4,658 or 24% from $19,065 in Q3 2023, primarily due to the conclusion of certain clinical activities [126]. - Net loss for Q3 2024 was $1,366,176, compared to a net loss of $998,010 in Q3 2023, reflecting an increase of $368,166 [125]. - Total revenues for the nine months ended September 30, 2024 were $35,492, a decrease of $26,115 or 42% from $61,607 in the same period of 2023 [135]. - The Company incurred losses for the nine months ended September 30, 2024, totaling $1,066,732 from the first debt reduction transaction and $111,928 from the second transaction [142][143]. Expenses - Cost of revenue increased by 9% to $21,332 in Q3 2024 from $19,558 in Q3 2023, driven by a change in revenue mix that increased partner fees [127]. - Sales and marketing expenses rose by 21% to $232,775 in Q3 2024 from $192,896 in Q3 2023, attributed to increased post-market clinical expenses related to the Clarity trial [128]. - General and administrative expenses increased by 12% to $860,461 in Q3 2024 from $770,534 in Q3 2023, due to higher investments in investor relations [130]. - Cost of revenue for the nine months ended September 30, 2024 increased by 14% to $64,102 from $56,312 in the same period of 2023, driven by a price increase related to hosting costs [136]. - Sales and marketing expenses for the nine months ended September 30, 2024 were $638,869, an increase of $60,900 or 11% from $577,969 in the same period of 2023 [138]. - General and administrative expenses for the nine months ended September 30, 2024 decreased by 5% to $2,402,408 from $2,524,308 in the same period of 2023 [140]. Cash Flow and Financing - Cash used in operating activities for the nine months ended September 30, 2024, was $4,348,748, compared to $2,913,165 for the same period in 2023 [159]. - As of September 30, 2024, the Company had cash of $1,322,098, which is expected to fund operations into December 2024 [157]. - The Company raised approximately $1.4 million from an equity line in January 2024 and $0.3 million in April 2024 [155]. - The Company completed a public offering of 5,175,000 units at a price of $0.58 per unit, generating gross proceeds of approximately $3.0 million [155][163]. - The Company issued 930 shares of Series B convertible preferred stock in exchange for $930,052 of principal and accrued interest on the notes [166]. - The Company has raised $1,000,000 in gross proceeds from a securities purchase agreement for convertible preferred stock and warrants financing [167]. - The Company anticipates needing additional funds to continue technology development and maintain liquidity [152][153]. Internal Controls and Compliance - The Company’s disclosure controls and procedures are currently not effective due to limited resources, impacting timely reporting of material information required for SEC filings [182]. - As of December 31, 2023, the internal control over financial reporting was deemed ineffective due to material weaknesses, including limited segregation of duties and inadequate accounting resources [184]. - The Company engaged an outside firm in Q3 2023 to enhance accounting support and segregation of duties, continuing efforts to improve internal controls through best practices [185]. - No material changes to internal control over financial reporting occurred during the quarter ended September 30, 2024, that would materially affect the internal controls [186]. Legal Proceedings - The Company is not currently involved in any material legal proceedings that could adversely affect its operations or financial position [188].

Company Overview - Aclarion, Inc. is a healthcare technology company focused on leveraging Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to enhance clinical treatments [2] - The company is primarily 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 [2] Product Details - Nociscan operates by receiving MRS data from MRI machines for each lumbar disc being evaluated, utilizing cloud-based proprietary signal processing techniques to extract and quantify chemical biomarkers associated with disc pain [2] - The platform integrates biomarker data into proprietary algorithms to indicate potential sources of pain, providing critical insights that assist physicians in optimizing treatment strategies [2] Upcoming Events - Aclarion's CEO, Brent Ness, is scheduled to present at the 2024 Maxim Healthcare Virtual Summit on October 15, 2024, at 2:00 PM ET, where he will engage in discussions with senior analysts and other healthcare technology companies [1]

Core Insights - Aclarion, Inc. presented findings on Modic changes (MC) and chronic low back pain (cLBP) at the 50th International Society for the Study of the Lumbar Spine Annual Meeting 2024, highlighting the use of their Nociscan solution to better understand MC in cLBP patients [1][2][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 identify painful versus nonpainful discs in the lumbar spine [5][6] - The Nociscan platform is the first evidence-supported SaaS solution that noninvasively quantifies chemical biomarkers associated with disc pain, providing critical insights for treatment optimization [2][5][6] Research Findings - A prospective study involving 88 patients with low back pain for over three months was conducted, measuring intradiscal propionic acid (PA) levels to understand the etiology of MC and its association with treatment responses [1][2] - The study challenges the notion of a sterile disc environment and suggests that PA levels could help stratify patients for personalized treatment approaches [2][3] Industry Context - Globally, 266 million people suffer from spinal degeneration and low back pain, with Modic changes and vertebral endplate irregularities being significant areas of research [3] - Current diagnostic methods lack noninvasive techniques for identifying disc infections, making the measurement of PA via Nociscan a potential breakthrough for personalized treatment strategies [3]