Lucid Diagnostics 公布 12,000 例 EsoGuard 真实世界研究结果

Largest peer-reviewed study of nonendoscopic esophageal precancer testing to date demonstrates the efficiency and scalability of EsoCheck^® cell collection in under two minutes

, /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 the peer-reviewed publication of findings from the largest real-world clinical experience of nonendoscopic esophageal precancer testing to date, using the EsoGuard^® Esophageal DNA Test and EsoCheck^® Esophageal Cell Collection Device.

The manuscript, "Non-Endoscopic Screening for Barrett's Esophagus Using a DNA Methylation-Based Assay: Real-World Experience in 11,991 Patients," published in the journal Diagnostics, reported that EsoCheck cell collection was rapid, well tolerated, and consistent across operators, including newly trained personnel.

"These findings provide compelling real-world evidence supporting the feasibility of large-scale implementation of EsoGuard testing," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "With EsoGuard now fully reimbursed by Medicare nationwide, efficient and scalable clinical implementation will be critical as we accelerate commercialization across diverse clinical settings in the coming months."

The study included 11,991 patients with clinical risk factors who underwent EsoGuard testing on samples collected with EsoCheck between January 2023 and June 2024. Cell collection was successful in 95% of patients, with an average collection time of less than two  minutes and no reported device-related adverse events. In a post-procedure survey, 82% reported very low discomfort and only 0.2% rated it as high. 96%  would recommend the test to others, and 95% said they would undergo it again if clinically indicated.

"We are very encouraged by the real-world performance of adveEsoGuard and EsoCheck in this large cohort of patients referred for esophageal precancer testing," said Victoria T. Lee, M.D., Lucid's Chief Medical Officer. "The high cell collection success rate across operators, including among newly trained personnel, high patient satisfaction scores, and short average procedure time strongly support large-scale implementation to broadly expand access to esophageal precancer testing in at-risk patients."

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 Diagnostics' 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 Diagnostics' common stock; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required to advance Lucid Diagnostics' products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from Lucid Diagnostics' clinical and preclinical studies; whether and when Lucid Diagnostics' products are cleared by regulatory authorities; market acceptance of Lucid Diagnostics' products once cleared and commercialized; Lucid Diagnostics' ability to raise additional funding as needed; and other competitive developments. These factors are difficult or impossible to predict accurately and many of them are beyond Lucid Diagnostics' 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 Diagnostics' future operations, see Part I, Item 1A, "Risk Factors," in Lucid Diagnostics' 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 Diagnostics 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