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]

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]

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]

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]

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][3] - The company plans to file its 10K report by the end of March, which will include a more detailed corporate update [2] Company Overview - Aclarion leverages Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments [3] - The company's primary product, Nociscan, is a SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [3] - Nociscan processes MRS data from MRI machines to extract and quantify chemical biomarkers associated with disc pain, providing critical insights for treatment optimization [3]

Aclarion (ACON) Update Summary Company Overview - Aclarion is a healthcare technology company focused on leveraging augmented intelligence algorithms and MR spectroscopy to identify pain biomarkers in lumbar spine discs [3][4] Core Technology and Problem Addressed - The technology aims to differentiate between painful and non-painful discs, addressing the challenge that pain is not visible on standard imaging studies [5][6] - Aclarion's MR spectroscopy technology analyzes the chemical makeup of lumbar discs, providing surgeons with reports on which discs are likely causing pain [6][10] Clinical Studies and Results - A study published in the European Spine Journal showed that 97% of patients whose surgeries matched the technology's predictions experienced significant clinical improvement at one year, compared to 54% in the mismatch group [8][9] - The technology is projected to save approximately $1,700 per patient, including the cost of the technology, while improving outcomes by 10% [10] Future Studies and NIH Involvement - Aclarion is entering a large 300-patient prospective randomized study to further validate its technology, with early results expected in 2026 [11][12] - The company is involved in NIH studies addressing opioid addiction, focusing on chronic low back pain as a primary cause [13][14] Competitive Landscape - Aclarion's main competitor, the invasive discogram procedure, is falling out of favor due to its subjective nature and higher costs [17][19] - Aclarion's technology is non-invasive, more objective, and less expensive than discograms, positioning it favorably in the market [19] Market Opportunity - The lumbar fusion market is a starting point, with a total addressable market of approximately $135 billion annually in the U.S. for low back pain [20][21] - There are about 16 million people in the U.S. suffering from significant low back pain, indicating a substantial market need [21] Regulatory and Reimbursement Strategy - Aclarion has secured regulatory approvals and is working towards obtaining category one CPT codes to facilitate reimbursement [22][23] - The company aims to partner with surgeons to drive adoption and secure payer coverage decisions, which are critical for market penetration [24][25] Key Opinion Leaders and Partnerships - Aclarion has established relationships with leading surgeons and institutions, which are essential for driving technology adoption and securing payer coverage [28][29] Financial Overview - As of the last filing, Aclarion had $1.3 million in cash and a quarterly burn rate of $1.6 million, indicating a need for capital [33][34] Conclusion - Aclarion is positioned to address a significant healthcare challenge with its innovative technology, backed by strong clinical evidence and a strategic approach to market entry and reimbursement [34]

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.