Aclarion Announces Northwestern Medicine as First CLARITY Trial Site
Aclarion (NASDAQ: ACON) has announced Northwestern Medicine as the first site for its pivotal CLARITY trial, designed to demonstrate Nociscan's clinical and economic value in spine surgery. Northwestern Medicine, which led over 6,900 clinical studies with 372,561 participants in 2024, will participate in this groundbreaking randomized controlled trial.
The CLARITY trial is a fully funded, prospective, multi-center study that will evaluate 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain. The study will compare surgical outcomes between surgeons who are blinded and unblinded to Nociscan results. Nociscan is the first evidence-supported SaaS platform that helps physicians distinguish between painful and nonpainful discs in the lumbar spine through MR Spectroscopy and AI technology.
Aclarion (NASDAQ: ACON) ha annunciato Northwestern Medicine come il primo sito per il suo trial fondamentale CLARITY trial, progettato per dimostrare il valore clinico ed economico di Nociscan nella chirurgia della colonna vertebrale. Northwestern Medicine, che ha guidato oltre 6.900 studi clinici con 372.561 partecipanti nel 2024, parteciperà a questo innovativo trial controllato randomizzato.
Il trial CLARITY è uno studio prospettico, multicentrico e completamente finanziato che valuterà 300 pazienti programmati per trattamento chirurgico di dolore lombare discogenico a 1 o 2 livelli. Lo studio confronterà i risultati chirurgici tra chirurghi che sono abilitati o meno a vedere i risultati di Nociscan. Nociscan è la prima piattaforma SaaS supportata da prove che aiuta i medici a distinguere tra dischi dolorosi e non dolorosi nella colonna lombare attraverso la spettroscopia MRI e la tecnologia AI.
Aclarion (NASDAQ: ACON) ha anunciado a Northwestern Medicine como el primer sitio para su ensayo pivotal CLARITY trial, diseñado para demostrar el valor clínico y económico de Nociscan en la cirugía de columna. Northwestern Medicine, que lideró más de 6,900 estudios clínicos con 372,561 participantes en 2024, participará en este innovador ensayo controlado aleatorio.
El ensayo CLARITY es un estudio prospectivo, multicéntrico y completamente financiado que evaluará a 300 pacientes programados para tratamiento quirúrgico de dolor lumbar discogénico a 1 o 2 niveles. El estudio comparará los resultados quirúrgicos entre cirujanos que están cegados y no cegados a los resultados de Nociscan. Nociscan es la primera plataforma SaaS respaldada por evidencia que ayuda a los médicos a distinguir entre discos dolorosos y no dolorosos en la columna lumbar a través de espectroscopia de RM y tecnología de IA.
Aclarion (NASDAQ: ACON)는 Nociscan의 임상 및 경제적 가치를 척추 수술에 증명하기 위해 설계된 주요 CLARITY trial의 첫 번째 사이트로 Northwestern Medicine을 발표했습니다. 2024년에 372,561명의 참가자가 포함된 6,900개 이상의 임상 연구를 주도한 Northwestern Medicine은 이 혁신적인 무작위 대조 시험에 참여합니다.
CLARITY trial은 1개 또는 2개 레벨의 디스크성 요통에 대한 외과적 치료를 받을 예정인 300명의 환자를 평가할 예정인 완전 자금 지원된 다기관 연구입니다. 이 연구는 Nociscan 결과를 아는 외과의사와 모르는 외과의사 간의 외과적 결과를 비교합니다. Nociscan은 MRI 분광법 및 AI 기술을 통해 요추에서 고통스러운 디스크와 비고통성 디스크를 구별하는 데 도움을 주는 첫 번째 증거 기반 SaaS 플랫폼입니다.
Aclarion (NASDAQ: ACON) a annoncé Northwestern Medicine comme le premier site pour son essai clinique fondamental CLARITY trial, conçu pour démontrer la valeur clinique et économique de Nociscan dans la chirurgie de la colonne vertébrale. Northwestern Medicine, qui a dirigé plus de 6 900 études cliniques avec 372 561 participants en 2024, participera à cet essai contrôlé randomisé innovant.
L'essai CLARITY est une étude prospective, multicentrique et entièrement financée qui évaluera 300 patients prévus pour un traitement chirurgical de la douleur lombaire discogène à 1 ou 2 niveaux. L'étude comparera les résultats chirurgicaux entre les chirurgiens informés et non informés des résultats de Nociscan. Nociscan est la première plateforme SaaS soutenue par des preuves qui aide les médecins à distinguer les disques douloureux des disques non douloureux dans la colonne vertébrale lombaire grâce à la spectroscopie IRM et à la technologie d'IA.
Aclarion (NASDAQ: ACON) hat Northwestern Medicine als ersten Standort für seine entscheidende CLARITY trial bekannt gegeben, die entwickelt wurde, um den klinischen und wirtschaftlichen Wert von Nociscan in der Wirbelsäulenchirurgie nachzuweisen. Northwestern Medicine, das im Jahr 2024 über 6.900 klinische Studien mit 372.561 Teilnehmern geleitet hat, wird an dieser bahnbrechenden randomisierten kontrollierten Studie teilnehmen.
Die CLARITY-Studie ist eine vollständig finanzierte, prospektive, multizentrische Studie, die 300 Patienten evaluiert, die für eine chirurgische Behandlung von 1- oder 2-level diskogenen Rückenschmerzen eingeplant sind. Die Studie wird die chirurgischen Ergebnisse zwischen Chirurgen vergleichen, die über die Ergebnisse von Nociscan informiert sind und solche, die das nicht sind. Nociscan ist die erste evidenzbasierte SaaS-Plattform, die Ärzten hilft, schmerzhafte und nicht schmerzhafte Disks in der Lendenwirbelsäule durch MRT-Spektroskopie und KI-Technologie zu unterscheiden.
- Secured Northwestern Medicine, a major clinical research institution, as first CLARITY trial site
- Trial is fully funded and will involve 300 patients across multiple high-volume US sites
- Study targets chronic low back pain market affecting 266 million people worldwide
- Results from the CLARITY trial are pending and success is not guaranteed
- Commercial adoption depends on successful trial outcomes
Insights
The announcement of Northwestern Medicine as CLARITY's first trial site marks a pivotal moment for Aclarion's Nociscan technology. This development carries substantial weight for several reasons:
The trial's design is particularly robust:
- 300-patient enrollment across multiple high-volume sites
- 1:1 randomization between blinded and unblinded surgeons
- Primary endpoint measuring VAS Back pain improvement at 12 months
- Focus on 1-2 level discogenic low back pain surgical treatment
The market opportunity is significant, with 266 million people globally affected by degenerative spine disease and low back pain. Nociscan's positioning as the first evidence-supported SaaS platform for noninvasive disc pain identification addresses a critical diagnostic gap in spine care.
The technology's potential impact on healthcare economics is compelling. By helping physicians distinguish between painful and nonpainful discs, Nociscan could:
- Reduce unnecessary surgical procedures
- Improve patient outcomes through more targeted interventions
- Lower overall healthcare costs through better diagnostic accuracy
Northwestern's participation, with their track record of 6,900+ clinical studies and 372,561 study participants in 2024, provides significant credibility. The leadership of Dr. Nicholas Theodore from Johns Hopkins as principal investigator further strengthens the trial's scientific rigor.
This study could establish Nociscan as a standard of care in spine diagnostics, particularly given the increasing adoption of AI-driven healthcare solutions. The focus on both clinical and economic outcomes suggests a comprehensive approach to demonstrating value to all stakeholders in the healthcare system.
Northwestern Medicine is a global leader in clinical trial research, including spine
CLARITY is a randomized study designed to demonstrate Nociscan’s ability to improve surgical outcomes while reducing costs 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., Feb. 06, 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 Northwestern Medicine as the initial site in the pivotal CLARITY trial, which is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
“Northwestern Medicine is a leader in clinical trials. In 2024, Northwestern led over 6,900 clinical studies with 372,561 study participants,” said Alpesh Patel, MD, Professor and Co-Director of the Northwestern Center for Spine Health. “We are pleased to participate in Aclarion’s CLARITY trial, a groundbreaking randomized controlled trial examining Nociscan’s impact on discogenic low back pain surgical outcomes. Low back pain is a complex problem and advancements like Nociscan are helping to advance our understanding of low back pain in fundamentally important ways.”
Aclarion recently announced that the CLARITY trial is fully funded and will be led by Dr. Nicholas Theodore of Johns Hopkins as principal investigator. 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.
“We are pleased to launch the CLARITY trial with a prestigious institution like Northwestern and renowned spine expert Dr. Alpesh Patel. I saw firsthand from my earlier experiences commercializing algorithms in the cardiology space how well-designed clinical trials could drive the adoption of cloud-based, augmented intelligence platforms. When compared to traditional testing options, these technologies improved diagnostic accuracy, reduced unnecessary procedures and ultimately saved the health system significant costs,” said Brent Ness, CEO, Aclarion. “At Aclarion, we are committed to building the same level of evidence to ensure adoption of Nociscan for all stakeholders is a logical and well-supported step for chronic low back pain.”
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
This press release is for informational purposes only and is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or to buy any securities or a solicitation of any proxy, consent, vote or approval with respect to any securities of Aclarion, Inc. No offer, sale, issuance or transfer of securities shall be made in any jurisdiction in which such offer, sale, issuance or transfer would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
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, 2023, 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 primary endpoint of Aclarion's CLARITY trial for ACON stock?
How many patients will be enrolled in Aclarion's CLARITY trial?
Who is leading Aclarion's CLARITY trial as principal investigator?
What is the randomization ratio in Aclarion's CLARITY trial?
How many clinical studies did Northwestern Medicine conduct in 2024?
