Aclarion Launches the Clinical Utility and Economic (CLUE) Trial to Quantify How Often Nociscan’s AI Generated Biomarker Data Changes Surgical Treatment Plans

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

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.

Investor Contacts:
Kirin M. Smith
PCG Advisory, Inc.
646.823.8656
ksmith@pcgadvisory.com

Media Contacts:
Jodi Lamberti
SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com

FAQ

What is the purpose of Aclarion's CLUE Trial for Nociscan?

The CLUE Trial aims to quantify how often Nociscan's AI-generated biomarker data changes surgical treatment plans for chronic low back pain, providing insights into the real-world value of Nociscan as a decision support tool.

How does the CLUE Trial complement Aclarion's CLARITY study?

While CLARITY focuses on demonstrating improved surgical outcomes with Nociscan, CLUE provides near-term insights into how often Nociscan data influences surgeons to change their original treatment decisions, potentially indicating CLARITY's probability of success.

What is the significance of Aclarion's CLUE Trial design?

The CLUE Trial's design is inspired by HeartFlow's evidence strategy, which led to changes in coronary artery disease assessment. It allows for independent and scalable study of Nociscan's impact on surgical decision-making across multiple physicians and sites.

How can physicians participate in Aclarion's CLUE Trial for Nociscan (ACON)?

Any physician with access to Nociscan can easily participate in the CLUE Trial using a survey tool to build their own evidence and data, which can be used when advocating for insurance coverage of Nociscan.