Report includes nearly 12,000 patients who underwent Lucid's EsoGuard® Esophageal DNA Test on samples collected using its EsoCheck® Esophageal Cell Collection Device
Real-world data confirm excellent technical performance, very rapid cell-collection times, and appropriate physician use, consistent with previously published studies
NEW YORK, Dec. 9, 2025 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced new data from the largest reported real-world experience of non-endoscopic esophageal precancer (Barrett's esophagus or BE) detection, which evaluated its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device. The manuscript, entitled Non-Endoscopic Screening for Barrett's Esophagus Using a DNA Methylation-Based Assay: 18-Month Real-World Experience in 11,991 Patients, is currently available on the leading health sciences preprint server, medRxiv, while undergoing peer review for publication. The study authors concluded that "the largest real-world experience of EsoGuard and EsoCheck to date" demonstrates "excellent safety, tolerability, and scalability… supporting its utility as a non-invasive BE screening tool."
The 18-month retrospective analysis evaluated 11,991 at-risk patients who underwent EsoCheck cell collection and EsoGuard testing in routine clinical practice between January 2023 and June 2024. EsoCheck demonstrated a 95% technical success rate, with 95% of procedures completed in under two minutes and no serious adverse events. The vast majority of patients met U.S. gastroenterology society guideline criteria for BE screening, reflecting appropriate physician use of EsoGuard in routine practice.
"This extensive real-world experience demonstrates that EsoGuard has advanced from an aspirational 'missing link' in esophageal cancer prevention to the linchpin of a clinically viable and scalable early detection program," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "Together with previously published data establishing EsoGuard's unprecedented clinical validity and utility, these real-world results-most notably EsoCheck cell-collection times of under two minutes-set a very high performance standard that any clinically viable, widespread esophageal precancer screening tool must meet."
"We have now confirmed that EsoGuard and EsoCheck perform in everyday clinical practice exactly as they have in published studies," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "EsoCheck esophageal cell collection was completed safely and efficiently, with high technical success across nearly 12,000 patients. It was reliably performed in office and health fair settings by Lucid's nurses, medical assistants, or other trained personnel-demonstrating true scalability across diverse clinical settings. It's clear that physicians are utilizing EsoGuard exactly as intended, identifying patients who need confirmatory endoscopy while sparing the vast majority from unnecessary invasive procedures. These findings, in such a large patient population, provide strong real-world affirmation of EsoGuard's value and support its widespread adoption."
About Lucid Diagnostics
Lucid Diagnostics Inc. is a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM). Lucid is focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer. Lucid's EsoGuard® Esophageal DNA Test, performed on samples collected in a brief, noninvasive office procedure with its EsoCheck® Esophageal Cell Collection Device, represent the first and only commercially available tools designed with the goal of preventing cancer and cancer deaths through widespread, early detection of esophageal precancer in at-risk patients.
For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com.
Forward-Looking Statements
This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such forward-looking statements, which are based upon the current beliefs and expectations of Lucid's management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of Lucid's common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid's products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid's clinical and preclinical studies; whether and when Lucid's products are cleared by regulatory authorities; market acceptance of Lucid's products once cleared and commercialized; Lucid's ability to raise additional funding as needed; and other competitive developments. In addition, Lucid continues to monitor the COVID-19 pandemic and the pandemic's impact on Lucid's businesses. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid's control. In addition, new risks and uncertainties may arise from time to time and are difficult to predict. For a further list and description of these and other important risks and uncertainties that may affect Lucid's future operations, see Part I, Item 1A, "Risk Factors," in Lucid's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, "Risk Factors" in any Quarterly Report on Form 10-Q filed by Lucid Diagnostics after its most recent Annual Report. Lucid disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.
SOURCE Lucid Diagnostics
