Aclarion Announces Addition of Keck Medical Center of USC as CLARITY Trial Site
Aclarion (NASDAQ: ACON) has announced the addition of Keck Medical Center of USC as a site for its CLARITY clinical trial. The trial aims to evaluate Nociscan, Aclarion's technology that uses biomarkers and AI algorithms to identify sources of chronic low back pain. The CLARITY study will enroll 300 patients across multiple US centers, including Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute, and Texas Back Institute.
The randomized trial will assess patients scheduled for 1- or 2-level discogenic low back pain surgery, with surgeons either blinded or unblinded to Nociscan results at a 1:1 ratio. The primary endpoint is measuring change in back pain using a 100mm VAS Back scale at 12 months compared to baseline. Nociscan is positioned as the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful lumbar spine discs.
Aclarion (NASDAQ: ACON) ha annunciato l'inserimento del Keck Medical Center of USC come sito per il suo studio clinico CLARITY. Lo studio mira a valutare Nociscan, la tecnologia di Aclarion che utilizza biomarcatori e algoritmi di intelligenza artificiale per identificare le cause del dolore cronico alla parte bassa della schiena. Lo studio CLARITY recluterà 300 pazienti in diversi centri negli Stati Uniti, inclusi Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute e Texas Back Institute.
Lo studio randomizzato valuterà pazienti programmati per interventi chirurgici a 1 o 2 livelli per dolore discogenico lombare, con chirurghi che saranno ciechi o non ciechi ai risultati di Nociscan in un rapporto 1:1. L'endpoint primario è la misurazione della variazione del dolore lombare utilizzando una scala VAS Back da 100mm a 12 mesi rispetto al basale. 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.
Aclarion (NASDAQ: ACON) ha anunciado la incorporación del Keck Medical Center of USC como sitio para su ensayo clínico CLARITY. El ensayo tiene como objetivo evaluar Nociscan, la tecnología de Aclarion que utiliza biomarcadores y algoritmos de IA para identificar las fuentes de dolor lumbar crónico. El estudio CLARITY inscribirá a 300 pacientes en varios centros de EE.UU., incluyendo Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute y Texas Back Institute.
El ensayo aleatorizado evaluará a pacientes programados para cirugía de dolor discogénico lumbar de 1 o 2 niveles, con cirujanos cegados o no a los resultados de Nociscan en una proporción 1:1. El objetivo principal es medir el cambio en el dolor lumbar usando una escala VAS Back de 100 mm a los 12 meses en comparación con la línea base. Nociscan se posiciona como la primera plataforma SaaS respaldada por evidencia para ayudar de forma no invasiva a los médicos a distinguir entre discos lumbares dolorosos y no dolorosos.
Aclarion (NASDAQ: ACON)은 Keck Medical Center of USC를 CLARITY 임상시험 사이트로 추가했다고 발표했습니다. 이 임상시험은 만성 요통의 원인을 식별하기 위해 바이오마커와 AI 알고리즘을 사용하는 Aclarion의 기술 Nociscan을 평가하는 것을 목표로 합니다. CLARITY 연구는 Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute, Texas Back Institute를 포함한 미국 내 여러 센터에서 300명의 환자를 모집할 예정입니다.
무작위 배정된 이 임상시험은 1~2 레벨 디스크병성 요통 수술을 앞둔 환자들을 대상으로 하며, 수술 의사는 Nociscan 결과에 대해 1:1 비율로 블라인드 또는 비블라인드 상태로 진행됩니다. 주요 평가 지표는 기준선 대비 12개월 후 100mm VAS Back 척도를 이용한 요통 변화 측정입니다. Nociscan은 통증이 있는 요추 디스크와 통증이 없는 디스크를 비침습적으로 구분하는 최초의 근거 기반 SaaS 플랫폼으로 자리매김하고 있습니다.
Aclarion (NASDAQ : ACON) a annoncé l'ajout du Keck Medical Center of USC comme site pour son essai clinique CLARITY. L'essai vise à évaluer Nociscan, la technologie d'Aclarion qui utilise des biomarqueurs et des algorithmes d'IA pour identifier les sources de douleurs lombaires chroniques. L'étude CLARITY recrutera 300 patients dans plusieurs centres américains, dont Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute et Texas Back Institute.
L'essai randomisé évaluera des patients programmés pour une chirurgie du bas du dos discogénique à 1 ou 2 niveaux, avec des chirurgiens soit aveugles, soit non aveugles aux résultats de Nociscan dans un rapport 1:1. Le critère principal est la mesure de l'évolution de la douleur dorsale à l'aide d'une échelle VAS Back de 100 mm à 12 mois par rapport au départ. Nociscan se positionne comme la première plateforme SaaS soutenue par des preuves pour aider non invasivement les médecins à distinguer les disques lombaires douloureux des disques non douloureux.
Aclarion (NASDAQ: ACON) hat die Aufnahme des Keck Medical Center of USC als Standort für seine CLARITY-Studie bekanntgegeben. Die Studie zielt darauf ab, Nociscan zu evaluieren, Aclarions Technologie, die Biomarker und KI-Algorithmen nutzt, um Ursachen chronischer Rückenschmerzen zu identifizieren. Die CLARITY-Studie wird 300 Patienten an mehreren US-Zentren einschließen, darunter Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute und Texas Back Institute.
Die randomisierte Studie wird Patienten bewerten, die für eine 1- oder 2-Ebenen-Discogenese-Lumbaloperation geplant sind, wobei Chirurgen im Verhältnis 1:1 entweder verblindet oder nicht verblindet gegenüber den Nociscan-Ergebnissen sind. Der primäre Endpunkt ist die Messung der Veränderung der Rückenschmerzen anhand einer 100mm VAS Back-Skala nach 12 Monaten im Vergleich zum Ausgangswert. Nociscan gilt als die erste evidenzbasierte SaaS-Plattform, die Ärzten nichtinvasiv hilft, schmerzhafte von schmerzfreien Lendenwirbelscheiben zu unterscheiden.
- None.
- Results from the clinical trial won't be available for at least 12 months
- Technology still requires clinical validation through the CLARITY trial
- Uncertain market adoption pending trial results
Insights
USC joining Aclarion's CLARITY trial strengthens study credibility and advances Nociscan's path toward becoming standard care for chronic low back pain.
The addition of Keck Medical Center of USC as a site for Aclarion's CLARITY trial represents a significant enhancement to this pivotal clinical study. This multicenter randomized trial now includes five prestigious institutions, with USC joining Johns Hopkins, Northwestern Medicine, Advocate Aurora, and Texas Back Institute. The 300-patient study is designed to evaluate Nociscan's ability to improve surgical outcomes for chronic low back pain patients undergoing 1-2 level discogenic procedures.
The trial design is particularly robust, employing a 1:1 randomization between surgeons blinded and unblinded to Nociscan results, with the primary endpoint measuring change in back pain on a 100mm VAS scale at 12 months post-surgery. This methodology will provide compelling evidence regarding Nociscan's clinical utility in guiding surgical decision-making between fusion and total disc replacement.
The participation of USC, with its reputation for spine treatment excellence, adds significant credibility and potential patient recruitment capabilities. Dr. Patrick Hsieh's involvement as a neurological spine surgeon further strengthens the investigative team led by Dr. Nicholas Theodore of Johns Hopkins. The increasing roster of prestigious medical centers suggests growing clinical interest in Nociscan's MR Spectroscopy and AI approach to pain source identification.
The global market context is substantial, with 266 million people suffering from degenerative spine disease and low back pain worldwide. If successful, this trial could position Nociscan as the first evidence-supported, non-invasive diagnostic tool to differentiate between painful and non-painful discs, potentially transforming treatment approaches for this widespread condition.
- USC Spine Center, part of Keck Medicine of USC, specializes in treating complex spine conditions with the latest cutting-edge technologies
- 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 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 clinical and economic value in spine surgery.
“Keck Medicine of USC strives to offer patients access to new treatments and procedures, and tailored treatment options for all types of spine conditions – from simple to complex,” says Patrick Hsieh, MD, neurological spine surgeon with Keck Medicine of USC. “The USC Spine Center’s participation in the CLARITY trial demonstrates our commitment to deepening our understanding of spinal conditions to best serve patients’ specific care needs.”
Keck Medicine of USC is the latest CLARITY trial site, joining Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute and Texas Back 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 USC Spine Center has a long history of being at the forefront of innovation and research to advance patient care and we look forward to partnering with Dr. Hsieh and the USC Spine Center team on the CLARITY trial,” said Ryan Bond, Chief Strategy Officer at Aclarion. “We anticipate the CLARITY trial to represent a turning point in how physicians are able to leverage Nociscan to understand and diagnose chronic low back pain for the millions of patients suffering from this debilitating condition.”
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.
Investor Contacts:
Kirin M. Smith
PCG Advisory, Inc.
ksmith@pcgadvisory.com
Media Contacts:
Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com
FAQ
What is the purpose of Aclarion's (ACON) CLARITY clinical trial?
Which medical centers are participating in Aclarion's CLARITY trial?
How does Aclarion's (ACON) Nociscan technology work?
What is the primary endpoint of the CLARITY trial for ACON stock?
What is the market potential for Aclarion's Nociscan technology?
