Aclarion Welcomes Advocate Health as CLARITY Trial Site
Aclarion (NASDAQ: ACON) announced that Advocate Aurora Research Institute, part of Advocate Health, has joined as a site for their CLARITY trial. The trial aims to demonstrate the clinical and economic value of Nociscan, Aclarion's diagnostic platform that uses biomarkers and AI to identify sources of chronic low back pain.
The CLARITY trial is a prospective, randomized study that will enroll 300 patients across multiple US sites, evaluating surgical treatment of 1- or 2-level discogenic low back pain. The study will compare outcomes between surgeons who are blinded and unblinded to Nociscan results, with the primary endpoint measuring change in back pain at 12 months. Dr. Nicholas Theodore of Johns Hopkins Medicine serves as the principal investigator.
Aclarion (NASDAQ: ACON) ha annunciato che il Advocate Aurora Research Institute, parte di Advocate Health, si è unito come sito per il loro studio CLARITY. Lo studio mira a dimostrare il valore clinico ed economico di Nociscan, la piattaforma diagnostica di Aclarion che utilizza biomarcatori e intelligenza artificiale per identificare le cause del dolore cronico alla parte bassa della schiena.
Lo studio CLARITY è una ricerca prospettica e randomizzata che arruolerà 300 pazienti in diversi siti negli Stati Uniti, valutando il trattamento chirurgico del dolore discogenico lombare a 1 o 2 livelli. Lo studio confronterà i risultati tra chirurghi che sono ciechi o non ciechi ai risultati di Nociscan, con l'endpoint primario che misura la variazione del dolore lombare a 12 mesi. Il dott. Nicholas Theodore della Johns Hopkins Medicine è il ricercatore principale.
Aclarion (NASDAQ: ACON) anunció que el Advocate Aurora Research Institute, parte de Advocate Health, se ha unido como sitio para su ensayo CLARITY. El ensayo tiene como objetivo demostrar el valor clínico y económico de Nociscan, la plataforma diagnóstica de Aclarion que utiliza biomarcadores e inteligencia artificial para identificar las fuentes del dolor lumbar crónico.
El ensayo CLARITY es un estudio prospectivo y aleatorizado que inscribirá a 300 pacientes en múltiples sitios de EE. UU., evaluando el tratamiento quirúrgico del dolor lumbar discogénico de 1 o 2 niveles. El estudio comparará los resultados entre cirujanos que están cegados y no cegados a los resultados de Nociscan, con el punto final primario que mide el cambio en el dolor de espalda a los 12 meses. El Dr. Nicholas Theodore de Johns Hopkins Medicine es el investigador principal.
Aclarion (NASDAQ: ACON)은 Advocate Health의 일부인 Advocate Aurora Research Institute가 CLARITY 임상시험 사이트로 참여한다고 발표했습니다. 이 임상시험은 만성 요통의 원인을 식별하기 위해 바이오마커와 인공지능을 사용하는 Aclarion의 진단 플랫폼 Nociscan의 임상적 및 경제적 가치를 입증하는 것을 목표로 합니다.
CLARITY 임상시험은 전향적 무작위 연구로, 미국 내 여러 사이트에서 300명의 환자를 등록하여 1~2단계 디스크성 요통에 대한 수술 치료를 평가합니다. 연구는 Nociscan 결과를 알지 못하는(블라인드) 외과의사와 아는 외과의사 간의 결과를 비교하며, 주요 평가 지표는 12개월 후 요통 변화입니다. Johns Hopkins Medicine의 Nicholas Theodore 박사가 책임 연구원입니다.
Aclarion (NASDAQ : ACON) a annoncé que le Advocate Aurora Research Institute, faisant partie d'Advocate Health, a rejoint l'étude CLARITY en tant que site participant. Cette étude vise à démontrer la valeur clinique et économique de Nociscan, la plateforme diagnostique d'Aclarion qui utilise des biomarqueurs et l'intelligence artificielle pour identifier les sources de douleurs chroniques lombaires.
L'étude CLARITY est une étude prospective randomisée qui recrutera 300 patients dans plusieurs sites aux États-Unis, évaluant le traitement chirurgical de la douleur discogénique lombaire à 1 ou 2 niveaux. L'étude comparera les résultats entre les chirurgiens aveugles et non aveugles aux résultats de Nociscan, avec comme critère principal la variation de la douleur lombaire à 12 mois. Le Dr Nicholas Theodore de Johns Hopkins Medicine est l'investigateur principal.
Aclarion (NASDAQ: ACON) gab bekannt, dass das Advocate Aurora Research Institute, Teil von Advocate Health, als Standort für ihre CLARITY-Studie hinzugekommen ist. Die Studie soll den klinischen und wirtschaftlichen Nutzen von Nociscan, der diagnostischen Plattform von Aclarion, die Biomarker und KI zur Identifikation von Ursachen chronischer Rückenschmerzen einsetzt, nachweisen.
Die CLARITY-Studie ist eine prospektive, randomisierte Untersuchung, die 300 Patienten an mehreren Standorten in den USA einschließt und die chirurgische Behandlung von 1- oder 2-Ebenen-Discogenem Rückenschmerz bewertet. Die Studie vergleicht die Ergebnisse zwischen Chirurgen, die gegenüber den Nociscan-Ergebnissen verblindet sind, und solchen, die nicht verblindet sind. Der primäre Endpunkt ist die Veränderung der Rückenschmerzen nach 12 Monaten. Dr. Nicholas Theodore von Johns Hopkins Medicine ist der Hauptprüfer.
- Collaboration with major healthcare institution Advocate Health enhances trial credibility
- Nociscan platform offers innovative solution for diagnosing chronic low back pain, addressing a global market of 266 million patients
- First evidence-supported SaaS platform for noninvasively distinguishing between painful and nonpainful discs
- Results from the CLARITY trial are pending and success is not guaranteed
- Adoption and market penetration will depend on successful trial outcomes
Insights
Advocate Health joining CLARITY trial strengthens Aclarion's study examining Nociscan's ability to identify painful discs for better spine surgery outcomes.
The addition of Advocate Aurora Research Institute to Aclarion's CLARITY trial represents strategic progress in the clinical validation of their Nociscan platform. This technology addresses a fundamental challenge in spine medicine—identifying which discs are actually causing pain. Traditional imaging like MRIs show anatomical issues but often can't differentiate between painful and non-painful discs, leading to imprecise treatment targeting.
The CLARITY trial design is methodologically sound with 300 patients randomized between surgeons who are either blinded or unblinded to Nociscan results. This design will directly measure whether access to Nociscan's biomarker data improves surgical outcomes for chronic low back pain patients. The primary endpoint—change in VAS back pain scores at 12 months—is clinically relevant and patient-centered.
Advocate Health's participation is significant as they bring substantial research infrastructure and spine surgery volume. Their involvement provides both credibility and access to a robust patient population for the study. The fact that this is a post-market study indicates Nociscan already has regulatory clearance, with this trial focused on demonstrating clinical utility and economic value.
The technology itself represents innovation in diagnostic approaches, using MR Spectroscopy to analyze chemical biomarkers associated with disc pain and applying AI algorithms to quantify results. If validated through this trial, Nociscan could potentially establish a new standard in pre-surgical assessment for the 266 million people suffering from degenerative spine disease and low back pain globally.
Advocate Health's addition to CLARITY strengthens a well-designed RCT testing whether Nociscan's disc pain identification improves spine surgery outcomes.
The CLARITY trial represents a well-constructed clinical investigation with important implications for spine surgery. The study employs a prospective, randomized controlled design—the gold standard for clinical evidence—to evaluate whether Nociscan-guided surgical decision-making improves outcomes compared to standard approaches. The trial addresses a critical clinical challenge: accurately identifying pain generators in patients with chronic low back pain.
The trial's design includes several noteworthy strengths. The 1:1 randomization between surgeons blinded and unblinded to Nociscan creates a proper experimental framework to isolate the technology's impact. The multi-center approach increases generalizability of findings. The primary endpoint measuring VAS back pain reduction at 12 months is clinically meaningful and patient-centered.
Advocate Health's participation brings substantial value as a research site. Their spine surgery volume and research infrastructure will contribute to efficient execution. Having Dr. Nicholas Theodore of Johns Hopkins Medicine as principal investigator adds significant credibility to the trial.
The trial's focus on 1- or 2-level discogenic pain appropriately narrows the patient population to where the technology's benefit may be most clearly demonstrated. This patient selection strategy increases the trial's statistical power to detect meaningful differences between groups.
If positive, this trial could establish Nociscan as an important adjunctive tool for spine surgeons evaluating surgical candidates, potentially improving patient selection and procedure targeting for those suffering from chronic low back pain.
- Advocate Health actively participates in research studies and is an innovator in technology, including spine
- The CLARITY trial is 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., May 05, 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 Advocate Aurora Research Institute, part of Advocate Health, as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) site. CLARITY is a pivotal, randomized trial designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
“Advocate Aurora Research Institute conducts hundreds of unique research projects each year to advance healthcare worldwide. From groundbreaking clinical trials to academic and biorepository research – we’re translating the latest findings into better care, prevention strategies and treatments for patients and their families,” said Patrick Sugrue, MD, Neurosurgeon at Advocate Health.
“In addition to our vast clinical trial work, our spine surgeons diagnose and treat many patients who suffer from chronic low back pain, which is difficult to diagnose. Aclarion’s innovative Nociscan platform provides physicians with an advanced, adjunctive diagnostic tool for evaluating low back pain. We are pleased to participate in the CLARITY trial, a post-market, randomized controlled study examining Nociscan’s impact on discogenic low back pain surgical outcomes,” added Dr. Sugrue.
The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US, and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment (Fusion / TDR). The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine.
“Millions of people worldwide suffer from chronic low back pain yet identifying the source of pain is not clearcut with traditional imaging. Nociscan aims to change that by enabling physicians to ‘see’ the difference between painful and non-painful discs so they can create more precise treatment plans,” said Ryan Bond, Chief Strategy Officer at Aclarion. “We are honored to work with Dr. Sugrue and Advocate Health on the CLARITY trial to demonstrate the clinical value of Nociscan.”
Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. Aclarion’s Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes.
For more information about CLARITY, please visit: CLARITY Trial
To find a Nociscan center, view our site map here.
For more information on Nociscan, please email: info@aclarion.com
All organizations cited and/or quotes from individuals not part of Aclarion have reviewed and approved the contents herein.
About Aclarion, Inc.
Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit www.aclarion.com.
Forward Looking Statements
This press release contains 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 current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company’s current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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