Aclarion Launches the Clinical Utility and Economic (CLUE) Trial to Quantify How Often Nociscan’s AI Generated Biomarker Data Changes Surgical Treatment Plans
Aclarion (NASDAQ: ACON) has launched the Clinical Utility and Economic (CLUE) Trial to quantify how often Nociscan's AI-generated biomarker data changes surgical treatment plans for chronic low back pain. The multi-center study aims to provide insights into the real-world value of Nociscan as a decision support tool. Surgeons will determine their treatment plan before and after receiving Nociscan data, allowing Aclarion to assess the tool's influence on surgical decisions.
The CLUE trial complements the ongoing CLARITY study, which focuses on demonstrating improved surgical outcomes with Nociscan. CLUE's format is inspired by HeartFlow's evidence strategy, which led to changes in coronary artery disease assessment. Aclarion expects multiple physicians and sites to enroll in CLUE in the coming months, adding practical data to their expanding clinical evidence base.
Aclarion (NASDAQ: ACON) ha lanciato il Clinical Utility and Economic (CLUE) Trial per quantificare con quale frequenza i dati biomarcatori generati dall'AI di Nociscan modificano i piani di trattamento chirurgico per il dolore lombare cronico. Lo studio multicentrico mira a fornire informazioni sul valore reale di Nociscan come strumento di supporto alle decisioni. I chirurghi stabiliranno il loro piano di trattamento prima e dopo aver ricevuto i dati di Nociscan, consentendo ad Aclarion di valutare l'influenza dello strumento sulle decisioni chirurgiche.
Il trial CLUE integra lo studio in corso CLARITY, che si concentra sul dimostrare il miglioramento dei risultati chirurgici con Nociscan. Il formato di CLUE si ispira alla strategia basata su prove di HeartFlow, che ha portato a cambiamenti nella valutazione della malattia coronarica. Aclarion prevede che nel corso dei prossimi mesi più medici e siti si iscriveranno al CLUE, aggiungendo dati pratici alla loro crescente base di evidenze cliniche.
Aclarion (NASDAQ: ACON) ha lanzado el Clinical Utility and Economic (CLUE) Trial para cuantificar con qué frecuencia los datos de biomarcadores generados por la IA de Nociscan cambian los planes de tratamiento quirúrgico para el dolor lumbar crónico. El estudio multicéntrico tiene como objetivo proporcionar información sobre el valor real de Nociscan como herramienta de apoyo a la decisión. Los cirujanos determinarán su plan de tratamiento antes y después de recibir los datos de Nociscan, lo que permitirá a Aclarion evaluar la influencia de la herramienta en las decisiones quirúrgicas.
El ensayo CLUE complementa el estudio en curso CLARITY, que se centra en demostrar la mejora en los resultados quirúrgicos con Nociscan. El formato de CLUE se inspira en la estrategia de evidencia de HeartFlow, que llevó a cambios en la evaluación de la enfermedad arterial coronaria. Aclarion espera que múltiples médicos y sitios se inscriban en CLUE en los próximos meses, agregando datos prácticos a su creciente base de evidencia clínica.
Aclarion (NASDAQ: ACON)은 Nociscan의 AI 생성 바이오마커 데이터가 만성 요통에 대한 수술 치료 계획을 얼마나 자주 변경하는지를 정량화하기 위해 Clinical Utility and Economic (CLUE) Trial을 시작했습니다. 이 다기관 연구는 Nociscan이 의사결정 지원 도구로서의 실제 가치를 제공하는 것을 목표로 하고 있습니다. 외과의사들은 Nociscan 데이터를 받기 전과 후에 자신의 치료 계획을 결정하여 Aclarion이 이 도구가 수술 결정에 미치는 영향을 평가할 수 있도록 합니다.
CLUE 시험은 Nociscan으로 수술 결과를 개선하는 데 초점을 맞춘 진행 중인 CLARITY 연구를 보완합니다. CLUE의 형식은 관상 동맥 질환 평가에서 변화를 이끌어낸 HeartFlow의 증거 전략에서 영감을 받았습니다. Aclarion은 앞으로 몇 달 내에 여러 의사와 사이트가 CLUE에 등록할 것으로 예상하며, 그들의 확장되는 임상 증거 기반에 실용적인 데이터를 추가할 것입니다.
Aclarion (NASDAQ: ACON) a lancé l'Clinical Utility and Economic (CLUE) Trial pour quantifier à quelle fréquence les données de biomarqueurs générées par l'IA de Nociscan modifient les plans de traitement chirurgical pour le mal de dos chronique. Cette étude multicentrique vise à fournir des informations sur la valeur réelle de Nociscan en tant qu'outil d'aide à la décision. Les chirurgiens détermineront leur plan de traitement avant et après avoir reçu les données de Nociscan, permettant à Aclarion d'évaluer l'influence de l'outil sur les décisions chirurgicales.
Le procès CLUE complète l'étude en cours CLARITY, qui se concentre sur la démonstration d'une amélioration des résultats chirurgicaux grâce à Nociscan. Le format du CLUE s'inspire de la stratégie fondée sur des preuves de HeartFlow, qui a conduit à des changements dans l'évaluation des maladies coronariennes. Aclarion s'attend à ce que plusieurs médecins et sites s'inscrivent au CLUE dans les mois à venir, ajoutant des données pratiques à leur base de preuves cliniques en expansion.
Aclarion (NASDAQ: ACON) hat die Clinical Utility and Economic (CLUE) Trial ins Leben gerufen, um quantifizieren zu können, wie oft die von Nociscan generierten, KI-basierten Biomarker-Daten die chirurgischen Behandlungspläne für chronische Rückenschmerzen ändern. Die multizentrische Studie zielt darauf ab, Erkenntnisse über den realen Wert von Nociscan als Entscheidungsunterstützungstool zu liefern. Chirurgen werden ihren Behandlungsplan vor und nach Erhalt der Nociscan-Daten festlegen, sodass Aclarion den Einfluss des Tools auf chirurgische Entscheidungen bewerten kann.
Die CLUE-Studie ergänzt die laufende CLARITY-Studie, die sich darauf konzentriert, verbesserte chirurgische Ergebnisse mit Nociscan zu demonstrieren. Das Format von CLUE ist inspiriert von der Evidenzstrategie von HeartFlow, die zu Änderungen in der Bewertung von koronaren Herzkrankheiten führte. Aclarion erwartet, dass in den kommenden Monaten mehrere Ärzte und Standorte an CLUE teilnehmen werden, wodurch praktische Daten zu ihrer wachsenden klinischen Evidenzbasis hinzugefügt werden.
- Launch of CLUE Trial to quantify Nociscan's impact on surgical treatment plans
- Potential to demonstrate real-world value of Nociscan in chronic low back pain treatment
- Complements ongoing CLARITY study for comprehensive clinical evidence
- Scalable study design allowing easy physician participation and data collection
- None.
The launch of Aclarion's CLUE trial marks a significant step in validating the clinical utility of Nociscan for chronic low back pain diagnosis. This study aims to quantify the impact of Nociscan's AI-generated biomarker data on surgical treatment plans, potentially revolutionizing the approach to this costly health issue.
The trial's design, allowing surgeons to compare their initial treatment plans with those informed by Nociscan data, is particularly noteworthy. It could provide robust evidence of the technology's real-world value in improving diagnostic accuracy and treatment outcomes. If successful, this could lead to:
- Reduced unnecessary surgeries
- More targeted and effective treatments
- Potential cost savings in chronic low back pain management
However, it's important to note that while promising, the true impact will depend on the trial's results and subsequent adoption by the medical community. Investors should monitor the progress and outcomes of both CLUE and the ongoing CLARITY trial for a comprehensive understanding of Nociscan's potential market impact.
Aclarion's launch of the CLUE trial represents a strategic move in the competitive healthcare AI landscape. By focusing on quantifying the frequency of treatment plan changes based on Nociscan data, Aclarion is addressing a critical aspect of technology adoption in healthcare: demonstrating clear, measurable impact on clinical decision-making.
The trial's design, mirroring HeartFlow's successful evidence strategy, is particularly astute. It could potentially:
- Accelerate insurance coverage for Nociscan
- Enhance physician adoption rates
- Strengthen Aclarion's market position
However, investors should be aware that success hinges on positive trial outcomes and subsequent integration into clinical practice. The chronic low back pain market is substantial, with global costs exceeding
Surgeons Will Determine Their Surgical Treatment Plan Before Nociscan and Report on How Often the Surgical Plan Changes After Receiving Nociscan Data
Multiple Physicians and Sites Will Enroll in CLUE in the Coming Months Adding Practical Real-world Data to Aclarion’s Expanding Body of Clinical Evidence
BROOMFIELD, CO, Aug. 21, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today the launch of the multi-center CLUE Trial to quantify how often a surgeon changes their original treatment plan once they have access to proprietary Nociscan data. Data from CLUE will provide tremendous insight into the real-world value of adding the Nociscan decision support tool to existing diagnostic evaluation methods for the treatment of chronic low back pain.
“Diagnosing the source of chronic low back pain is a significant challenge for clinicians and often results in the omission or inclusion of treatment on discs that do not correlate to improved clinical outcomes,” said Ryan Bond, Chief Strategy Officer of Aclarion. “Evidence points to a significant improvement in outcomes when Nociscan information is added to the treatment planning process. CLUE is specifically designed to quickly determine how influential Nociscan is in evaluating which discs a physician decides to treat.”
Aclarion announced the launch of CLARITY earlier this year to definitively demonstrate better surgical outcomes when Nociscan data is included in the surgical decisioning process. CLARITY is a gold standard, multicenter, prospective randomized trial. CLUE is aimed at providing near term insights into the probability of success of CLARITY by quantifying how often Nociscan data results in a surgeon changing their original treatment decision.
“CLUE represents an opportunity to study the use of Nociscan in an independent and scalable fashion. Any physician with access to Nociscan can easily access this survey tool to build their own evidence and body of data to use when advocating for insurance coverage of Nociscan,” said Brent Ness, Chief Executive Officer of Aclarion. “The format for CLUE closely follows the evidence strategy demonstrated by HeartFlow, whose findings ultimately rewrote the patient pathway for assessing coronary artery disease. We remain committed to leading with evidence as we work to change the way data is used to improve outcomes in chronic low back pain, the highest cost diagnosis in healthcare worldwide.”
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.
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FAQ
What is the purpose of Aclarion's CLUE Trial for Nociscan?
How does the CLUE Trial complement Aclarion's CLARITY study?
What is the significance of Aclarion's CLUE Trial design?
How can physicians participate in Aclarion's CLUE Trial for Nociscan (ACON)?
