Core Insights - Aclarion, Inc. is participating in the State of Spine Surgery Think Tank to showcase its NOCISCAN platform, which utilizes biomarkers and AI to identify chronic low back pain [1][2] - Dr. Kris Radcliff will present the NOCISCAN platform, emphasizing its innovative approach to objectively identify discogenic pain [2] - The conference highlights the increasing interest in NOCISCAN's clinical and commercial value, as noted by Aclarion's Chief Strategy Officer [3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, leveraging Magnetic Resonance Spectroscopy (MRS) and AI algorithms [6] - NOCISCAN is the first evidence-supported SaaS platform designed to noninvasively distinguish between painful and nonpainful lumbar discs [4][6] - The platform quantifies chemical biomarkers associated with disc pain, providing critical insights when used alongside other diagnostic tools [4][6] Market Context - Chronic low back pain affects approximately 266 million people globally, representing a significant healthcare challenge [4] - The integration of NOCISCAN into clinical practice aims to develop personalized and effective surgical strategies for patients [2][3]

Core Viewpoint - Aclarion, Inc. announced the addition of UHealth — University of Miami Health System as a trial site for the CLARITY study, which aims to demonstrate the clinical and economic value of its Nociscan technology in spine surgery [1][2]. 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]. - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4][6]. 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, with the primary endpoint being the change in back pain measured on a 100mm VAS at 12 months [3]. - UHealth joins other prestigious institutions like Johns Hopkins Medicine and Northwestern Medicine as a trial site [2][3]. Clinical Significance - Chronic low back pain affects approximately 266 million people globally, highlighting the need for effective diagnostic and treatment solutions [4]. - Nociscan aims to improve surgical outcomes by providing critical insights into the location of low back pain through the analysis of chemical biomarkers [4][8]. Research and Development - The CLARITY trial represents a unique opportunity to advance the spine industry and showcase the research capabilities of the University of Miami [2][7]. - Aclarion's technology leverages Magnetic Resonance Spectroscopy (MRS) to optimize clinical treatments for chronic low back pain [6][7].

Core Insights - Aclarion, Inc. announced the addition of Keck Medical Center of USC as a site for the CLARITY trial, aimed at demonstrating the clinical and economic value of Nociscan in spine surgery [1][2] - The CLARITY trial will evaluate 300 patients undergoing surgical treatment for discogenic low back pain, with a primary endpoint of measuring changes in back pain at 12 months [3][4] Company Overview - Aclarion is a healthcare technology company utilizing biomarkers and AI algorithms to assist physicians in identifying 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 [4][6] Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving multiple high-volume sites across the US, including notable institutions like Johns Hopkins Medicine and Northwestern Medicine [2][3] - The trial will randomize patients in a 1:1 ratio between surgeons who are blinded and unblinded to Nociscan results [3] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting a significant healthcare challenge [4] - Aclarion's Nociscan aims to improve surgical outcomes by providing insights into the sources of low back pain through advanced diagnostic techniques [4][7]

Nociscan Solution & Market Opportunity - Nociscan leverages MR Spectroscopy and Augmented Intelligence for patients with pain of spinal origin [9] - Nociscan labels each disc as painful or pain free based upon a biochemical signal and correlation with provocative discography, leading to lower cost, better outcomes, and higher value care [14] - The U S low back & neck pain market represents an ultimate market of $135 billion [17] - The U S lumbar spine market (fusion & non-fusion surgery plus presurgical care) represents an expansion market of $40 billion [16] - The U S lumbar fusion & disc replacement market represents an actionable market of $10 billion [17] Foundational Science & Technology - Elevated Lactate is associated with Nociceptor Activation, Excessive Cellular Demand, Cell Death and Reduced PG Synthesis [23] - Spectroscopy analyzes the chemical composition of tissue, transforming raw spectral data into clear biomarkers [26] - Nociscan uses six ratios for each disc, with pain markers in the numerator and structural integrity markers in the denominator, leveraging AI for major advancements [30, 33] Clinical and Economic Evidence - MRS (NOCI+/–) compared to PD (P/NP) with an accuracy of 87%, sensitivity of 100%, and specificity of 80% [47] - The positive predictive value (PPV) in herniated discs, and negative predictive value (NPV) in non-herniated discs, were 100% [47] - MRS with the Nociscan diagnostic algorithm demonstrates cost-effectiveness dominance over PD for identifying CLBP surgical candidates, with annualized US savings estimated between $283 million and $441 million [51, 53] Intellectual Property & Availability - Aclarion has 23 issued U S Patents and 13 Pending Patent Applications [39, 38] - Over 1,100 Commercial Nociscans have been performed [97]

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]