Core Insights - Aclarion, Inc. announced the addition of Advocate Aurora Research Institute as a site for the CLARITY trial, which aims to demonstrate the clinical and economic value of its Nociscan platform in spine surgery [1][4][5] 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][8] - The Nociscan platform is the first evidence-supported SaaS solution designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [5][8] CLARITY Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain [4] - The trial will randomize patients at a 1:1 ratio between surgeons blinded to Nociscan results and those unblinded, with the primary endpoint being the change in back pain measured on a 100mm VAS at 12 months [4][5] - The principal investigator is Dr. Nicholas Theodore from Johns Hopkins Medicine [4] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting a significant healthcare challenge [5] - Traditional imaging methods often fail to clearly identify the source of pain, which Nociscan aims to address by providing insights into disc pain [5][8]

Core Insights - Aclarion, Inc. has established a commercial agreement with the Spine Institute of Louisiana (SIL) to introduce Nociscan, a technology aimed at identifying chronic low back pain [1][2][4] - Nociscan is now available at 17 commercial centers across eight states and four countries, enhancing its accessibility [3] - The technology utilizes Magnetic Resonance Spectroscopy (MRS) to help physicians distinguish between painful and nonpainful discs in the lumbar spine, addressing a significant global healthcare issue affecting approximately 266 million people [4][5] Company Overview - Aclarion is a healthcare technology company that leverages biomarkers and proprietary AI algorithms to optimize clinical treatments, specifically targeting chronic low back pain with its Nociscan platform [5] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively assist physicians in identifying the source of low back pain, demonstrating a 97% surgical success rate when treating identified pain-positive discs [4][5] Industry Context - Chronic low back pain (cLBP) is a prevalent global healthcare challenge, with a significant number of individuals suffering from degenerative spine disease [4] - The introduction of Nociscan at SIL aligns with the institute's commitment to innovative and less invasive treatment techniques for chronic low back pain [2]

Aclarion (ACON) Conference Call Summary Company Overview - Aclarion focuses on addressing chronic low back pain, a significant healthcare issue in the United States and globally [1] - The company has a strong financial position with nearly $14.6 million in cash, zero debt, and is fully compliant with NASDAQ requirements [2][26] Industry Context - Chronic low back pain affects approximately 266 million people worldwide, making it the leading cost ailment in healthcare [3][4] - In the U.S., there are 635,000 spinal fusion surgeries annually, with high costs averaging $58,000 for one-level and $71,000 for two-level procedures [4] - Surgical success rates are low, with only 48-54% achieving success, and 80% of patients experiencing discomfort post-surgery [4][5] Market Opportunity - The initial addressable market for Aclarion's product, NOSI Scan, is estimated at $6.03 billion based on the fusion and disc replacement market [6] - The potential revenue increases significantly when considering other spine procedures and chiropractic care [7] Product and Technology - NOSI Scan utilizes spectroscopy to measure pain biomarkers and structural integrity within spinal discs, providing a non-invasive diagnostic alternative to traditional methods [9][12] - The technology is patented with over 40 patents worldwide, covering various aspects of the product and its application [13] Clinical Evidence and Trials - Aclarion is conducting a national randomized controlled trial called CLARITY, which is fully funded at $4.6 million, to provide robust evidence for the efficacy of NOSI Scan [3][16] - Previous studies indicate that 85% of patients improved when treated based on NOSI Scan results, compared to 63% without treatment [15][16] Regulatory and Market Strategy - The company has secured payer approvals in the UK, covering over 5.2 million people, and is working to expand its market presence [17][19] - Aclarion aims to transition its CPT codes from category three to category one to facilitate reimbursement in the U.S. [20] Management Team - The management team has extensive experience in healthcare and technology, with zero turnover since the IPO [21][24] - Key team members include a board-certified neurosurgeon and executives with backgrounds in major healthcare companies [22][24] Challenges and Future Outlook - The introduction of new technology into the payer community is challenging and requires tactical efforts to gain acceptance [34] - Aclarion is focused on building KOL advocacy and societal support to overcome reimbursement barriers [33][34] Key Takeaways - Aclarion is positioned to address a significant healthcare issue with a unique, non-invasive diagnostic tool that has strong market potential [25] - The company is well-funded and has a clear roadmap for expanding its commercial footprint and driving payer acceptance [26][27]

Core Insights - Aclarion, Inc. 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 will present at the Planet MicroCap Showcase: VEGAS 2025 on April 23, 2025, highlighting recent initiatives aimed at enhancing value [2][1] - Aclarion has released an updated investor presentation available on its website [3] Company Overview - Aclarion leverages Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments for chronic low back pain [4] - The company's primary product, Nociscan, is a SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4] - Nociscan utilizes cloud technology to analyze MRS data from MRI machines, extracting chemical biomarkers associated with disc pain to provide insights for treatment optimization [4]

Core Insights - Aclarion, Inc. has published a peer-reviewed article demonstrating the cost-effectiveness of its Nociscan solution compared to provocative discography for identifying chronic low back pain surgery candidates [1][2] - The study indicates that Nociscan saves approximately $1,712 per patient and improves surgical success rates by 10% [5] 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 non-painful discs [4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively assist in diagnosing disc-related pain [4] Industry Context - Chronic low back pain affects around 266 million people globally, highlighting the significant healthcare challenge it presents [2] - The publication in ClinicoEconomics and Outcomes Research emphasizes the need for more evidence on clinical and economic improvements in healthcare diagnostics [1]

Company Overview - Aclarion, Inc. is a healthcare technology company focused on leveraging biomarkers and proprietary augmented intelligence algorithms to assist physicians in identifying the location of chronic low back pain [1][3] - The company is addressing the chronic low back pain market with its product Nociscan, which is the first evidence-supported SaaS platform designed to noninvasively help physicians distinguish between painful and non-painful discs in the lumbar spine [3] Product Details - Nociscan utilizes Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments [3] - The platform receives MRS data from MRI machines and processes it in the cloud to extract and quantify chemical biomarkers associated with disc pain [3] - Nociscan provides critical insights into the location of a patient's low back pain, enabling physicians to optimize treatment strategies [3] Upcoming Events - Aclarion will present at the Planet MicroCap Showcase: VEGAS 2025 on April 23, 2025, at 12:30 PM ET, hosted by CEO Brent Ness [1][2] - The presentation will be accessible via a live webcast, and 1x1 investor meetings can be scheduled at the conference venue [2]

Cash and Cash Equivalents - As of December 31, 2024, the company had cash and restricted cash totaling $463,661, primarily invested in demand deposit accounts and money market funds[450] - The company considers all highly liquid debt instruments purchased with a maturity of three months or less as cash equivalents[450] Investment Objectives and Risks - The primary objectives of the company's investing activities are capital preservation, meeting liquidity needs, and generating interest income while maintaining the safety of principal[450] - The company's cash equivalents are subject to market risk due to changes in interest rates, which may adversely affect the market value of fixed-rate securities[451] - Future investment income may fall short of expectations due to changes in interest rates, potentially leading to losses in principal if securities are sold at a decline in market value[451]

Core Insights - Aclarion, Inc. has expanded its Nociscan product availability to Santa Monica, enhancing access to its diagnostic services for chronic low back pain [3][4] - The Medical Imaging Center of Southern California (MICSC) is now offering Nociscan, which was previously exclusive to its Beverly Hills location, thereby replicating the benefits for patients and physicians in a new market [4] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing biomarkers and proprietary AI algorithms to assist physicians in diagnosing pain sources [3][9] - Nociscan is the first evidence-supported SaaS platform that noninvasively helps distinguish between painful and nonpainful discs in the lumbar spine, providing critical insights when used alongside other diagnostic tools [7][9] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting the significant healthcare challenge it presents [5] - Los Angeles, with a population exceeding 3.8 million, is a strategically important market for Aclarion, being the most populous city in California and the second-most populous in the United States [5][6]

Core Insights - Aclarion, Inc. has expanded the availability of its Nociscan product to Santa Monica, enhancing access to its MRI and diagnostic imaging services for chronic low back pain [1][2] - Nociscan is the first evidence-supported SaaS platform that helps physicians differentiate between painful and nonpainful discs in the lumbar spine, utilizing biomarkers and AI algorithms [4][6] - Chronic low back pain affects approximately 266 million people globally, highlighting the significant market potential for Aclarion's solutions [3] Company Overview - Aclarion, Inc. leverages Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments, specifically targeting the chronic low back pain market with its Nociscan platform [6] - The company’s Nociscan solution quantifies chemical biomarkers associated with disc pain, providing critical insights when used alongside other diagnostic tools [4][6] Market Context - Los Angeles, with a population exceeding 3.8 million, represents a strategically important market for Aclarion, alongside New York City [3] - The expansion of Nociscan services to Santa Monica is part of MICSC's commitment to adopting innovative solutions that enhance patient care and physician support [2]

Core Insights - Aclarion, Inc. has raised over $20 million in Q1 2025, with nearly $15 million in cash on hand, and maintains a clean capital structure with no debt or preferred equity [1][6] - The company is fully compliant with Nasdaq requirements, meeting both bid price and shareholder equity standards [1][6] - The pivotal CLARITY trial for Aclarion's Nociscan is fully funded, with initial interim results expected in Q2 2026 [1][6] Financial and Strategic Highlights - Aclarion has significantly improved its financial positioning and Nasdaq compliance, positioning itself to execute its strategic plan for Nociscan [2] - The company is rapidly enrolling sites for the CLARITY trial, aiming to demonstrate that Nociscan data enhances surgical decision-making and outcomes [2] - Aclarion has secured additional payer approvals in England and expanded physician referral and commercial support for Nociscan in the U.S. [4][6] Product and Market Context - Chronic low back pain (cLBP) affects approximately 266 million people globally, presenting a significant healthcare challenge [4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively help physicians differentiate between painful and nonpainful discs in the lumbar spine [4][5] - The platform utilizes magnetic resonance spectroscopy (MRS) data to quantify chemical biomarkers associated with disc pain, achieving a 97% surgical success rate when treating identified pain-positive discs [4][5]