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]

Core Insights - Aclarion, Inc. has launched the multi-center CLUE Trial to assess how often surgeons alter their treatment plans after receiving Nociscan data, aiming to provide real-world evidence of its value in treating chronic low back pain [1][2] - The CLUE Trial is designed to complement the earlier launched CLARITY trial, which aims to demonstrate improved surgical outcomes when Nociscan data is included in decision-making [2][3] - The company emphasizes the importance of evidence-based approaches in advocating for insurance coverage of Nociscan, drawing parallels to successful strategies used in other medical fields [3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to differentiate between painful and non-painful discs [4] - Nociscan is the first evidence-supported SaaS platform that aids physicians in identifying the source of low back pain through non-invasive methods [4] - The company aims to optimize treatment strategies by providing critical insights into the location of pain, thereby addressing a significant healthcare challenge [4]

Aclarion (ACON) Update Summary Company Overview - **Company**: Aclarion Incorporated - **Industry**: Medical Technology, specifically focused on low back pain diagnostics and treatment Core Points and Arguments 1. **Technology and Innovation**: Aclarion has developed an augmented intelligence algorithm that analyzes MRI data to identify biomarkers indicating whether a disc is likely to be painful, aiding surgeons in making informed treatment decisions [4][5][6] 2. **Clinical Study Results**: A clinical study conducted in 2019 showed that 97% of patients whose surgical decisions aligned with Aclarion's technology experienced significant clinical improvement at one year, compared to only 55% in the mismatch group [9][10] 3. **Economic Impact**: The technology could save approximately $1,700 per patient in the U.S. healthcare system while improving clinical success rates [11] 4. **Upcoming Trials**: Aclarion is initiating a prospective, randomized, multicenter trial called CLARITY, expected to enroll its first patient in Q4 2024, to further validate its technology [12] 5. **Revenue Generation**: Most of Aclarion's revenue comes from research studies where organizations pay to utilize their technology, highlighting its unique capability in identifying painful discs [13][14] 6. **Market Opportunity**: The U.S. market for low back pain and neck pain is valued at $135 billion annually, with Aclarion targeting the $10 billion lumbar fusion and disc replacement surgery market initially [24][25] 7. **Regulatory Progress**: Aclarion has received category three CPT codes for billing and aims to transition these to category one codes to facilitate reimbursement [27][28] 8. **Key Opinion Leaders (KOLs)**: The company is working with leading surgeons and institutions to drive adoption and payer coverage decisions [33][34] Additional Important Content 1. **Competitive Landscape**: Aclarion's noninvasive diagnostic method is positioned as superior to traditional discograms, which are invasive and subjective [20][21] 2. **Intellectual Property**: Aclarion holds a broad patent portfolio covering its technology and processes, licensed from UCSF [22] 3. **Management Team**: The leadership team has extensive experience in medical technology and commercialization, with a focus on driving the company's growth [35][36] 4. **International Expansion**: Aclarion has seen success in the UK, where surgeons have successfully advocated for payer coverage, setting a precedent for similar efforts in the U.S. [31][32] 5. **Future Expectations**: The company anticipates increased MRI activations and scan volumes, which will translate into revenue as more payers begin to cover the scans [44][48] This summary encapsulates the key insights from Aclarion's recent investor briefing, highlighting the company's innovative approach to addressing low back pain and its strategic plans for growth and market penetration.

BROOMFIELD, CO, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc. (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today that it will be presenting at the upcoming Virtual Investor Summit on August 20th, 2024. Investors may request a one-on-one meeting with management by registering here: https://investorsummitgroup.co ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-41358 ACLARION, INC. (Exact name of registrant as specified in its charter) Delaware 47- ...

Core Insights - Aclarion, Inc. has established a commercial agreement with Sheridan Community Hospital to introduce Nociscan, a healthcare technology solution for chronic low back pain, to central Michigan [1][3] - Nociscan is the first evidence-supported SaaS platform that helps physicians noninvasively distinguish between painful and nonpainful discs in the lumbar spine, utilizing biomarkers and augmented intelligence algorithms [2][4] Company Overview - Aclarion is focused on addressing the chronic low back pain market with its Nociscan platform, which leverages Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments [4] - The Nociscan solution quantifies chemical biomarkers associated with disc pain and provides critical insights when used alongside other diagnostic tools, enhancing treatment strategies for physicians [4] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting the significant healthcare challenge that Aclarion aims to address with its innovative technology [2] - The introduction of Nociscan in markets like Sheridan is a step towards broader payer coverage in the US, following recent insurance coverage announcements in the UK [3]