Aclarion Announces Texas Back Institute as New CLARITY Trial Site
Aclarion (NASDAQ: ACON) has announced the addition of Texas Back Institute (TBI) as a new site for its CLARITY clinical trial. The trial aims to demonstrate the effectiveness of Nociscan, Aclarion's technology that uses MR Spectroscopy and AI to identify sources of chronic low back pain. The CLARITY study will enroll 300 patients across multiple US sites, including Johns Hopkins Medicine, Northwestern Medicine, and Advocate Aurora Research Institute.
The randomized trial will evaluate patients scheduled for 1- or 2-level discogenic low back pain surgery, with surgeons either blinded or unblinded to Nociscan results. The primary endpoint is measuring change in back pain after 12 months. Nociscan is positioned as the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful lumbar spine discs, targeting a global market of approximately 266 million people suffering from degenerative spine disease and low back pain.
Aclarion (NASDAQ: ACON) ha annunciato l'inclusione del Texas Back Institute (TBI) come nuovo centro per il suo studio clinico CLARITY. Lo studio mira a dimostrare l'efficacia di Nociscan, la tecnologia di Aclarion che utilizza la spettroscopia RM e l'intelligenza artificiale per identificare le cause del dolore cronico alla parte bassa della schiena. Lo studio CLARITY arruolerà 300 pazienti in diversi centri negli Stati Uniti, tra cui Johns Hopkins Medicine, Northwestern Medicine e Advocate Aurora Research Institute.
Lo studio randomizzato valuterà pazienti programmati per interventi chirurgici a 1 o 2 livelli per dolore discogenico alla parte bassa della schiena, con chirurghi che saranno o meno a conoscenza dei risultati di Nociscan. L'endpoint primario sarà la variazione del dolore alla schiena dopo 12 mesi. Nociscan si presenta come la prima piattaforma SaaS supportata da evidenze per aiutare in modo non invasivo i medici a distinguere tra dischi lombari dolorosi e non dolorosi, rivolgendosi a un mercato globale di circa 266 milioni di persone affette da malattie degenerative della colonna vertebrale e dolore lombare.
Aclarion (NASDAQ: ACON) ha anunciado la incorporación del Texas Back Institute (TBI) como nuevo centro para su ensayo clínico CLARITY. El ensayo tiene como objetivo demostrar la eficacia de Nociscan, la tecnología de Aclarion que utiliza espectroscopia por RM y IA para identificar las fuentes de dolor lumbar crónico. El estudio CLARITY inscribirá a 300 pacientes en varios sitios de EE. UU., incluyendo Johns Hopkins Medicine, Northwestern Medicine y Advocate Aurora Research Institute.
El ensayo aleatorizado evaluará a pacientes programados para cirugía de dolor discogénico lumbar de 1 o 2 niveles, con cirujanos que estarán cegados o no a los resultados de Nociscan. El objetivo principal es medir el cambio en el dolor lumbar después de 12 meses. Nociscan se posiciona como la primera plataforma SaaS respaldada por evidencia para ayudar de manera no invasiva a los médicos a distinguir entre discos lumbares dolorosos y no dolorosos, apuntando a un mercado global de aproximadamente 266 millones de personas que sufren de enfermedades degenerativas de la columna vertebral y dolor lumbar.
Aclarion (NASDAQ: ACON)은 Texas Back Institute (TBI)를 CLARITY 임상시험의 새로운 기관으로 추가했다고 발표했습니다. 이 임상시험은 MR 분광법과 인공지능을 활용하여 만성 요통의 원인을 식별하는 Aclarion의 기술인 Nociscan의 효과를 입증하는 것을 목표로 합니다. CLARITY 연구는 Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute 등 미국 내 여러 기관에서 300명의 환자를 등록할 예정입니다.
무작위 배정된 이 시험은 1~2단계 디스크성 요통 수술 예정 환자를 대상으로 하며, 외과의는 Nociscan 결과를 알거나 모르는 상태로 진행됩니다. 주요 평가 지표는 12개월 후 요통의 변화 측정입니다. Nociscan은 통증이 있는 요추 디스크와 통증이 없는 디스크를 비침습적으로 구분할 수 있도록 의사를 지원하는 최초의 근거 기반 SaaS 플랫폼으로, 약 2억 6,600만 명의 퇴행성 척추 질환 및 요통 환자를 대상으로 합니다.
Aclarion (NASDAQ : ACON) a annoncé l'ajout du Texas Back Institute (TBI) comme nouveau site pour son essai clinique CLARITY. Cet essai vise à démontrer l'efficacité de Nociscan, la technologie d'Aclarion utilisant la spectroscopie RM et l'IA pour identifier les sources de douleurs lombaires chroniques. L'étude CLARITY recrutera 300 patients dans plusieurs centres aux États-Unis, notamment Johns Hopkins Medicine, Northwestern Medicine et Advocate Aurora Research Institute.
L'essai randomisé évaluera des patients programmés pour une chirurgie du bas du dos à un ou deux niveaux discogéniques, avec des chirurgiens soit aveugles, soit informés des résultats de Nociscan. Le critère principal est la mesure de l'évolution de la douleur lombaire après 12 mois. Nociscan est présenté comme la première plateforme SaaS fondée sur des preuves pour aider de manière non invasive les médecins à distinguer les disques lombaires douloureux des non douloureux, ciblant un marché mondial d'environ 266 millions de personnes souffrant de maladies dégénératives de la colonne vertébrale et de douleurs lombaires.
Aclarion (NASDAQ: ACON) hat die Aufnahme des Texas Back Institute (TBI) als neuen Standort für seine CLARITY-Studie bekannt gegeben. Die Studie soll die Wirksamkeit von Nociscan nachweisen, Aclarions Technologie, die MR-Spektroskopie und KI verwendet, um Ursachen chronischer Rückenschmerzen im unteren Bereich zu identifizieren. Die CLARITY-Studie wird 300 Patienten an mehreren US-Standorten einschließen, darunter Johns Hopkins Medicine, Northwestern Medicine und das Advocate Aurora Research Institute.
Die randomisierte Studie wird Patienten untersuchen, die sich einer 1- oder 2-Ebenen-Operation wegen discogenem Rückenschmerz unterziehen, wobei die Chirurgen entweder über die Nociscan-Ergebnisse informiert sind oder nicht. Der primäre Endpunkt ist die Messung der Veränderung der Rückenschmerzen nach 12 Monaten. Nociscan gilt als die erste evidenzbasierte SaaS-Plattform, die Ärzten nichtinvasiv hilft, schmerzhafte von schmerzfreien Lendenwirbelscheiben zu unterscheiden, und richtet sich an einen globalen Markt von etwa 266 Millionen Menschen mit degenerativen Wirbelsäulenerkrankungen und Rückenschmerzen.
- Addition of prestigious Texas Back Institute as a trial site strengthens credibility
- Trial includes other major medical institutions like Johns Hopkins Medicine
- Large-scale study with 300 patients across multiple US sites
- Addresses a significant market of 266 million people with spine disease globally
- Results of the trial won't be available for at least 12 months
- Technology still requires clinical validation through the CLARITY trial
Insights
Texas Back Institute joining Aclarion's CLARITY trial strengthens study credibility and advances Nociscan's potential as a diagnostic standard.
The addition of Texas Back Institute (TBI) to Aclarion's CLARITY trial represents a significant enhancement to the study's credibility and potential impact. TBI joins an impressive roster of prestigious institutions including Johns Hopkins Medicine, Northwestern Medicine, and Advocate Aurora Research Institute, with Johns Hopkins' Dr. Nicholas Theodore serving as principal investigator.
The CLARITY trial design is methodologically robust—a prospective, randomized multi-center study with 300 patients undergoing treatment for 1-2 level discogenic low back pain. The 1:1 randomization between surgeons blinded and unblinded to Nociscan results creates a strong comparative framework to evaluate the technology's impact on surgical decision-making and outcomes.
The primary endpoint—change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline—is a clinically relevant metric that directly addresses patient-centered outcomes. This focus on quantifiable pain reduction aligns with both regulatory expectations and clinical practice priorities.
Nociscan's technology differentiates itself through its non-invasive approach to distinguishing between painful and non-painful discs using MR Spectroscopy and AI algorithms to quantify chemical biomarkers associated with disc pain. This addresses a critical diagnostic challenge in spine care where identifying pain generators remains difficult with conventional imaging.
With chronic low back pain affecting approximately 266 million people worldwide, the potential market for a validated diagnostic tool is substantial. The structured approach to validating clinical utility through this trial demonstrates appropriate scientific rigor before wider commercial adoption.
- Texas Back Institute is a world leader in advancing spine technology, science, and education, as well as patient care
- CLARITY is a 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., May 12, 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 the Texas Back Institute (TBI) as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
“Texas Back Institute has a rich tradition of excellence in research. We remain focused on the relationship between diagnostic evaluations and treatment outcomes,” said Alexander Satin, MD, board certified orthopedic spine surgeon, Texas Back Institute. “We have participated in numerous studies involving discography, MRI, minimally invasive procedures, and total disc replacement. The CLARITY trial is exciting, in part, because it builds on previously published evidence and aligns well with our patient population at Texas Back Institute. Our physicians and research leaders are pleased to participate in this important trial.”
Texas Back Institute joins the growing roster of previously announced CLARITY trial sites, which includes Johns Hopkins Medicine, Northwestern Medicine and Advocate Aurora Research Institute. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine.
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 Texas Back Institute’s reputation for excellence in patient care, innovation and research is renowned,” said Ryan Bond, Chief Strategy Officer at Aclarion. “It is common, at spine society meetings, that TBI physicians and research leaders are not only in attendance but actively presenting their extensive research to advance the spine industry. We are grateful to have this expert group of physicians and researchers participating in the CLARITY trial.”
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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