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First Patient Enrolled in Aclarion's Groundbreaking CLARITY Trial
Globenewswire· 2025-06-25 10:00
Core Insights - Aclarion, Inc. has initiated the first patient enrollment in the CLARITY trial, which aims to evaluate the clinical and economic value of its Nociscan platform in spine surgery for chronic low back pain [1][6] Company Overview - Aclarion is a healthcare technology company that utilizes Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to enhance clinical treatments [5] - The company is focusing on the chronic low back pain market with Nociscan, the first evidence-supported SaaS platform designed to help physicians differentiate between painful and nonpainful discs in the lumbar spine [5] Trial Details - The CLARITY trial is a prospective, randomized multi-center study that will enroll 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain across multiple high-volume sites in the US [2] - The trial will randomize patients in a 1:1 ratio between surgeons who are blinded and unblinded to the Nociscan results, with the primary endpoint being the change in back pain measured on a 100mm VAS scale at 12 months compared to baseline [2][6] - The first patient was enrolled at the Texas Back Institute, which has a strong history in advancing spine care through clinical trial research [2][6] Market Context - Chronic low back pain is a significant global healthcare issue, affecting approximately 266 million people worldwide with degenerative spine disease and low back pain [3] - Aclarion's Nociscan solution aims to objectively quantify chemical biomarkers associated with disc pain, potentially leading to improved surgical outcomes [3][6]
Aclarion to Present NOCISCAN Technology at Leading Spine Innovation Forum
Globenewswire· 2025-06-24 11:00
For a copy of the NOCISCAN presentation, please email: info@aclarion.com To find a NOCISCAN center, view our site map here. Dr. Kris Radcliff to Highlight MR Spectroscopy and Augmented Intelligence (AI)-Based Platform at State of Spine Surgery Think Tank BROOMFIELD, Colo., June 24, 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 ...
Aclarion Adds UHealth, University of Miami Miller School of Medicine as CLARITY Trial Site
Globenewswire· 2025-06-10 10:00
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].
Aclarion Announces Addition of Keck Medical Center of USC as CLARITY Trial Site
Globenewswire· 2025-05-20 10:00
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 ...
Aclarion Announces Texas Back Institute as New CLARITY Trial Site
Globenewswire· 2025-05-12 11:34
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].
Aclarion Welcomes Advocate Health as CLARITY Trial Site
Globenewswire· 2025-05-05 10:00
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]
Aclarion Announces Commercial Agreement with Spine Institute of Louisiana
Globenewswire· 2025-04-29 10:00
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 Releases Updated Investor Presentation in Connection with Appearance at Planet MicroCap Showcase: VEGAS 2025
Newsfilter· 2025-04-23 10:00
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]
Aclarion Announces Publication of Seminal Nociscan Cost-Effectiveness Analysis
Newsfilter· 2025-04-21 10:00
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]