UHealth — University of Miami Health System and the University of Miami Miller School of Medicine provide world-class research and renowned clinical expertise in spine surgeryCLARITY is a prospective, randomized clinical trial designed to demonstrate Nociscan’s ability to improve surgical outcomes for chronic low back pain Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence (AI) BROOMFIELD, Colo., June 10, 2025 (GLOBE NEW ...

BROOMFIELD, Colo., May 20, 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 the addition of Keck Medical Center of USC as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's ...

MR Spectroscopy, Augmented Intelligence, and Low Back Pain - a New Gold Standard. Spine Summit 2025 Presenter: Nick Theodore, MD Aclarion 2023 3 THE PROBLEM & THE SOLUTION Aclarion 2023 5 Problem Disclosure Aclarion (NASDAQ: ACON) Forward Looking Statements This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's curr ...

Financial Performance - Total revenue for Q1 2025 was $18,991, an increase of $8,877, or 88%, from $10,114 in Q1 2024, driven by additional patient-pay scans at Radnet facilities [132]. - Total cost of revenue for Q1 2025 was $23,479, an increase of 21% from $19,476 in Q1 2024, attributed to volume-related costs including partner fees [133]. - The company recorded a net loss of $2,037,436 in Q1 2025, an improvement of $361,665 compared to a net loss of $2,399,102 in Q1 2024 [130]. Expenses - Sales and marketing expenses rose to $302,584 in Q1 2025, an increase of $121,528, or 67%, primarily due to the initiation of the CLARITY trial [134]. - Research and development expenses decreased to $198,190 in Q1 2025, down $40,852, or 17%, due to reduced regulatory and quality system work [135]. - General and administrative expenses increased to $986,663 in Q1 2025, up $140,816, or 17%, due to additional financial operations and investor relations support [136]. Cash Flow and Financing - Cash and cash equivalents as of March 31, 2025, totaled $14,760,272, including $10,000 of restricted cash [150]. - The company raised $20.1 million in gross proceeds during Q1 2025 through public offerings and direct offerings [151]. - Cash used in operating activities was $2,510,782 in Q1 2025, compared to $2,238,557 in Q1 2024 [154]. - The company incurred $672,500 in penalties and settlements related to a dispute under an investment banking agreement [141]. - The company sold an aggregate of 100,000 common shares and 143,900,000 pre-funded warrants, generating net proceeds of $13.4 million from the public offering [160]. - The public offering price for each unit was $0.10, with the underwriter exercising an option to purchase an additional 21,000,000 shares and warrants [160]. - As of March 31, 2025, all pre-funded warrants have been exercised, resulting in the issuance of approximately 14.7 million common shares from Series B warrant exercises [162]. - The company redeemed all Series B Preferred Stock for a cash payment of $1,213,590 on January 22, 2025 [163]. - During Q1 2025, holders of Series C warrants exercised 5,685,049 warrants, generating payments of $336,411 [166]. - The company completed a public offering of 5,175,000 units at a price of $0.58 per unit, resulting in gross proceeds of approximately $3.0 million during Q1 2024 [167]. - The remaining outstanding balance of principal and interest on unsecured non-convertible notes was $898,380 after a payment of $300,974 in Q1 2024 [168]. - The company issued 644,142 shares of common stock in exchange for $1,519,779 principal and accrued interest on notes during Q1 2024 [169]. Business Outlook - Developing medical technology products is a costly and uncertain process, indicating a need for substantial additional funds to achieve business objectives [170]. - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million [177].

Core Viewpoint - Aclarion, Inc. has announced the Texas Back Institute as a new site for its pivotal CLARITY trial, which aims to demonstrate the clinical and economic value of its Nociscan technology in spine surgery [1][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 identifying pain sources [1][6]. - The company's Nociscan platform is the first evidence-supported SaaS solution designed to noninvasively differentiate between painful and nonpainful lumbar discs [4][7]. 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 [3]. - The trial will randomize patients in a 1:1 ratio between surgeons blinded to Nociscan results and those unblinded, guiding surgical treatment decisions [3]. - The primary endpoint is the change in back pain measured on a 100mm Visual Analog Scale (VAS) at 12 months compared to baseline [3]. Texas Back Institute's Role - Texas Back Institute is recognized for its excellence in research and has participated in various studies related to spine treatments [2][4]. - The institute's involvement in the CLARITY trial is expected to enhance the study's credibility and align with its patient population [2][4]. Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting the significant healthcare challenge it presents [4]. - Aclarion's Nociscan aims to improve surgical outcomes by providing critical insights into the sources of low back pain through advanced diagnostic techniques [4][7].

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]