Elucid Announces Favorable Medicare Coverage of AI Coronary Plaque Analysis

New policy to make company’s PlaqueIQ^TM image analysis software available to eligible patients with suspected coronary artery disease

Elucid has announced that four of the seven Medicare Administrative Contractors (MACs) will extend coverage for AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ^TM image analysis software, beginning November 24, 2024. The updated policy will allow for Medicare patients whose claims are administered within the four MACs who present with acute or stable chest pain and no known history of cardiovascular disease to be assessed with AI-enabled plaque imaging software that can help physicians accurately diagnose and potentially personalize treatment for cardiovascular disease.

“In the United States, one person dies every 33 seconds from cardiovascular disease.ⁱ The most common cause of death and disability, CAD is largely driven by myocardial infarction and ischemic stroke caused by atherosclerosis," said Nehal Mehta, MD MSCE, cardiologist and Professor of Medicine at George Washington University School of Medicine. "The decision by four of the seven Medicare Administrative Contractors to extend coverage for Elucid's PlaqueIQ image analysis software expands its value as a tool to help physicians identify coronary artery disease - and the plaque that can lead to it - in a non-invasive manner. The sooner these plaques are detected, the sooner effective therapies to prevent plaque rupture can be started."

Elucid’s PlaqueIQ is the first FDA-cleared non-invasive software that can objectively quantify and classify plaque morphology based on ground-truth histology, the gold standard for characterization of plaques. PlaqueIQ is designed to give physicians new, clinically validated information to help stratify patients and inform patient-specific treatment pathways.

“Elucid commends the MACs’ recognition of the importance of innovation in quantifying and classifying coronary artery plaque, which is the strongest predictor of heart attack and stroke in patients,” said Kelly Huang, CEO of Elucid. “The agency’s extended coverage will allow us to provide physicians and patients greater access to ground-truth histology-based technology that offers new insights into plaque to help aid diagnosis, influence treatment decisions, and reduce the devastating impact of cardiovascular disease. We are thankful to our partners who include physicians, medical societies, and industry colleagues for their support of our input into improving access to AI plaque quantification for patients who can benefit the most.”

PlaqueIQ utilizes first-line diagnostic CCTA and develops comprehensive, interactive reports to help physicians virtually “see” and quantify plaque. With its basis in histology, the software is uniquely able to non-invasively quantify and characterize plaque and its components such as lipid-rich necrotic core (LRNC), giving potential insights into high-risk plaques that are key drivers of risk of heart attack and stroke. In addition, use of the software has the potential to enable earlier identification of higher-risk plaque before presence of symptoms or major adverse events.

About Elucid

Elucid is a Boston-based AI medical technology company dedicated to developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQ^TM product is designed to help physicians prioritize and personalize treatment based on actual disease, rather than population-based risk of disease. PlaqueIQ is the only FDA-cleared computed tomography angiography (CTA) algorithm that objectively quantifies plaque morphology validated against ground truth histology, the gold standard for characterization of plaque, as indicated by renowned pathologists. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively. For more information, visit elucid.com.

ⁱ National Center for Health Statistics. Multiple Cause of Death 2018–2022 on CDC WONDER Database. Accessed May 3, 2024. https://wonder.cdc.gov/mcd.html

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