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Aclarion Launches CLUE Trial for Nociscan Impact Evaluation

Aclarion Launches CLUE Trial for Nociscan Impact Evaluation

Aclarion Launches the CLUE Trial

Surgeons will establish their surgical treatment plans prior to utilizing Nociscan, and they will also report how frequently these plans change after they receive data from Nociscan.

In the upcoming months, multiple physicians and sites will participate in the CLUE Trial, contributing valuable real-world data to Aclarion’s growing body of clinical evidence.

Aclarion, Inc. (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW) is a healthcare technology firm that utilizes biomarkers and proprietary augmented intelligence algorithms to assist physicians in pinpointing the source of chronic low back pain. Today, the company announced the launch of the multi-center CLUE Trial, which aims to measure how often surgeons modify their initial treatment plans after accessing proprietary Nociscan data. The insights gathered from CLUE will shed light on the real-world benefits of incorporating the Nociscan decision support tool into existing diagnostic evaluation methods for managing chronic low back pain.

The Significance of CLUE

“Identifying the source of chronic low back pain poses a considerable challenge for clinicians, often leading to incorrect treatment decisions regarding discs that may not lead to improved clinical outcomes,” explained Ryan Bond, Chief Strategy Officer of Aclarion. “Evidence suggests that incorporating Nociscan information into the treatment planning process significantly enhances outcomes. CLUE is specifically designed to quickly assess how impactful Nociscan is in determining which discs a physician chooses to treat.”

CLARITY and Its Connection to CLUE

Earlier this year, Aclarion introduced CLARITY, a trial aimed at conclusively demonstrating improved surgical outcomes when Nociscan data is integrated into the surgical decision-making process. CLARITY is a gold standard, multicenter, prospective randomized trial. In contrast, CLUE focuses on providing immediate insights into the likelihood of success for CLARITY by quantifying how often Nociscan data leads surgeons to alter their original treatment decisions.

Benefits for Physicians

“CLUE offers a unique opportunity to investigate the application of Nociscan in an independent and scalable manner. Any physician with access to Nociscan can utilize this survey tool to gather their own evidence and data to support insurance coverage for Nociscan,” stated Brent Ness, Chief Executive Officer of Aclarion. “The structure of CLUE closely mirrors the evidence strategy employed by HeartFlow, whose findings ultimately transformed the patient pathway for evaluating coronary artery disease. We are dedicated to leading with evidence as we strive to change how data is leveraged to enhance outcomes in chronic low back pain, which is the most costly diagnosis in healthcare globally.”

About Aclarion, Inc.

Aclarion is a healthcare technology company that utilizes Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is initially targeting the chronic low back pain market with Nociscan, the first evidence-supported SaaS platform designed to noninvasively assist physicians in distinguishing between painful and nonpainful discs in the lumbar spine. Nociscan connects to the cloud, receiving MRS data from an MRI machine for each lumbar disc under evaluation. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers that have been shown to correlate with disc pain. This biomarker data is processed through proprietary algorithms to determine if a disc may be a source of pain. When combined with other diagnostic tools, Nociscan provides crucial insights into the location of a patient’s low back pain, enabling physicians to refine their treatment strategies.

For more information, please visit www.aclarion.com.

Frequently Asked Questions

What is the CLUE Trial?

The CLUE Trial is designed to measure how often surgeons adjust their treatment plans after receiving data from Nociscan.

What is Nociscan?

Nociscan is a decision support tool that aids physicians in distinguishing between painful and nonpainful discs using biomarkers and MRI data.

Who is conducting the CLUE Trial?

Aclarion, Inc. is leading the CLUE Trial, which involves multiple physicians and medical sites.

How will the CLUE Trial benefit patients?

The trial aims to enhance surgical outcomes for chronic low back pain by incorporating Nociscan data into the treatment decision-making process.

What are the primary goals of Aclarion?

Aclarion seeks to utilize advanced technology to improve the diagnosis and treatment of chronic low back pain, ultimately optimizing clinical outcomes.

About The Author

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