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]

Core Insights - Aclarion, Inc. is a healthcare technology company focused on chronic low back pain, developing noninvasive tools to identify pain sources in spinal discs, potentially transforming care standards in a $134 billion market [1][5] Group 1: Nociscan Technology - The Nociscan platform utilizes augmented intelligence algorithms and biomarkers, representing a significant advancement in chronic pain treatment [1] - Nociscan has been selected for the LIFEHAB Trial in Norway, which aims to evaluate its MRS biomarkers for determining optimal treatment options for chronic low back pain [2] - Aclarion's technology is protected by 40 issued patents and 12 pending applications, indicating strong intellectual property backing [1] Group 2: Clinical Trials and Research - Aclarion is awaiting results from a completed trial in Rome and two NIH-funded studies in the U.S. that examine Nociscan's role in treating low back pain [2] - The CLARITY trial will enroll up to 300 patients across eight sites to validate Nociscan's ability to improve surgical outcomes [2] Group 3: Payer Coverage and Partnerships - Key Opinion Leader (KOL) surgeons are instrumental in advocating for Nociscan and influencing insurance coverage decisions, with Aclarion collaborating with 10 top spine surgeons globally [3] - The company is expanding partnerships in the U.S., particularly targeting personal injury and worker compensation sectors with its Nociscan technology [3]

Core Insights - Aclarion, Inc. has completed the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway, which compares lumbar interbody fusion surgery with multidisciplinary rehabilitation for chronic low back pain [1][2] - The LIFEHAB Trial involves 202 patients with low back pain lasting over one year and aims to evaluate the effectiveness of Nociscan technology in identifying treatment responses through magnetic resonance spectroscopy (MRS) biomarkers [1][2] - Aclarion anticipates that the results from the LIFEHAB trial will contribute to achieving successful reimbursement in national health insurance systems, such as Norway'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 identify painful discs in the lumbar spine [4] - Nociscan is described as the first evidence-supported SaaS platform that noninvasively distinguishes between painful and nonpainful discs, providing critical insights for optimizing treatment strategies [4] Market Position and Future Outlook - The company is experiencing accelerated adoption of Nociscan in the research market and is looking to establish more partnerships to enhance its presence [3] - Aclarion is awaiting results from a completed trial in Rome and two NIH studies that also evaluate the role of Nociscan in treating chronic low back pain [2][3]

Core Insights - Aclarion has been added to the PRISM Emerging Medical Devices Index, highlighting its innovative position in the medtech sector with its AI-driven diagnostic solutions for chronic low back pain [1][3] - The U.S. medical devices market is projected to grow to nearly $315 billion by 2032, driven by increased R&D investments and innovations like Aclarion's NOCISCAN technology [1][2] Company Highlights - Aclarion's NOCISCAN technology is the first noninvasive diagnostic tool for identifying painful discs in patients with chronic low back pain, improving surgical outcomes [3][4] - The company addresses a significant healthcare expenditure, with the lumbar spine diagnostics and treatment market estimated at $40 billion annually, contributing to overall costs of up to $134.5 billion [2][3] - Aclarion has secured its first commercial agreement with Sheridan Community Hospital in Michigan and extended its agreement with The London Clinic, increasing access to its technology [3][4] - The company has obtained private payer coverage from major UK insurers, covering 60% of private health insurance patients in greater London [3] - Aclarion's technology is supported by strong clinical data, showing an 85% improvement in patients treated based on NOCISCAN diagnostics, with ongoing clinical trials to further validate its efficacy [3][4] Industry Context - The medical devices market is experiencing significant growth, with a robust pipeline of innovations and increasing investments in research and development [1][2] - Chronic low back pain is a major health challenge affecting 266 million patients globally, highlighting the demand for effective diagnostic and treatment solutions [3]

Core Insights - Aclarion, Inc. is launching a program to develop a statewide network of providers in New Jersey to utilize Nociscan for chronic low back pain evaluation [1][2][3] - The average settlement for personal injury claims involving neck and back injuries in New Jersey is $918,967, while the national average for work-related accidents causing similar injuries is $148,750 [1] Company Overview - Aclarion is a healthcare technology company that uses Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to help physicians identify chronic low back pain sources [5] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively distinguish between painful and nonpainful discs in the lumbar spine [5] Market Strategy - The initiative in New Jersey aims to improve the objective evaluation of chronic low back pain patients within the personal injury and workers compensation systems [2][3] - Following the establishment in New Jersey, Aclarion plans to target other U.S. markets to replicate its success [4]

Core Insights - Aclarion, Inc. is expanding its multi-center CLUE Trial to New Jersey, aiming to assess how often Nociscan's AI data alters initial treatment plans for chronic low back pain patients [1][2] - The trial is expected to attract more spine surgeons, enhancing the data supporting the effectiveness of Nociscan in treatment decision-making [2][4] Company Overview - Aclarion is a healthcare technology company utilizing biomarkers and augmented intelligence algorithms to assist physicians in identifying chronic low back pain sources [1][5] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine, leveraging Magnetic Resonance Spectroscopy (MRS) [5] Clinical Significance - Approximately 266 million people globally suffer from degenerative spine disease and low back pain, highlighting the need for effective diagnostic tools [3] - Nociscan quantifies chemical biomarkers associated with disc pain, providing critical insights when combined with other diagnostic methods [3][5] Trial Participation - Dr. Justin Kubeck is the second surgeon to join the CLUE Trial, following Dr. John Keller, with expectations for more surgeons to participate in the coming months [2] - The trial aims to generate real-world evidence to support payer coverage decisions for Nociscan [4]

Surgeons Will Determine Their Surgical Treatment Plan Before Nociscan and Report on How Often the Surgical Plan Changes After Receiving Nociscan Data Multiple Physicians and Sites Will Enroll in CLUE in the Coming Months Adding Practical Real-world Data to Aclarion’s Expanding Body of Clinical Evidence BROOMFIELD, CO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented i ...

Aclarion (ACON) Update / Briefing August 20, 2024 04:00 AM ET Speaker0 Good afternoon, and welcome, everyone, to the Summer twenty twenty four Investor Summit. We have here joining us today, Geoff Trayman, Executive Director and Chairman of Aclarian Incorporated, and we are thrilled to host them. We will hold a Q and A session towards the end of the webcast. You can ask a question at any point during the presentation. Your mics are muted, so it is necessary to type your question into the ask question box on ...