Lucid Diagnostics Releases Positive Data from First Prospective Clinical Utility Study of EsoGuard® Esophageal Precancer Detection

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Lucid Diagnostics Inc. has released positive interim data from the multicenter CLUE study, demonstrating the real-world clinical utility of EsoGuard Esophageal DNA testing. The study shows excellent concordance between test results and subsequent medical decision-making by multiple physicians.

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• Lucid Diagnostics Inc. has released positive interim data from the CLUE study, showing excellent concordance between EsoGuard test results and medical decision-making by multiple physicians. The study demonstrates the clinical utility of EsoGuard in appropriately triaging patients for confirmatory endoscopy. The results document 100 percent concordance in EsoGuard-positive patients and a 99 percent concordance in EsoGuard-negative patients. EsoGuard eliminated the need for over 150 costly and invasive endoscopies, consistent with professional society guidelines.

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Multicenter observational study documents excellent concordance of EsoGuard results with subsequent medical decision-making by multiple physicians

NEW YORK, Sept. 7, 2023 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ( "PAVmed"), today announced it has released positive interim data from the multicenter, CLinical Utility of EsoGuard (CLUE) study. This is the Company's first report of prospective data from multiple physicians demonstrating real-world clinical utility of EsoGuard® Esophageal DNA testing for the detection of esophageal precancer; and supplements its recently released positive data from a retrospective analysis of EsoGuard's clinical utility in firefighters.

The study documents near perfect concordance, including 100 percent concordance in EsoGuard-positive patients, between clinically-directed EsoGuard test results and subsequent medical decision-making by multiple different prescribing physicians. It demonstrates that EsoGuard allows physicians to appropriately triage those requiring confirmatory endoscopy in a manner broadly consistent with established, and recently updated, professional society guidelines. The manuscript entitled Clinical Utility Study of EsoGuard^® on Samples Collected with EsoCheck^® as a Triage Test for Endoscopy to Identify Barrett's Esophagus – Interim Data of the First 275 Subjects is available on the leading health sciences preprint server, medRxiv, pending peer review and publication.

"Prospective clinical utility data involving multiple physicians provides the strongest level of evidence to payors, and other stakeholders, that a diagnostic test such as EsoGuard has real-world clinical utility driving appropriate medical decision making," said Victoria T. Lee, M.D., PAVmed's Senior Vice President and Chief Medical Officer of PAVmed, who oversees all of Lucid's clinical research activities. "We designed CLUE to demonstrate to payors that a diverse group of physicians across multiple centers will clinically utilize EsoGuard to appropriately refer at-risk patients with positive results for confirmatory endoscopy, and not refer those with negative results unless another indication for endoscopy emerges. These outstanding interim results in our first 275 patients document that the physicians do make the appropriate referrals, consistent with professional society guidelines. We continue to expand the number of study sites and enroll additional patients in the CLUE study. We plan to release subsequent reports on a larger CLUE cohort along with additional clinical utility data documenting patient compliance with the endoscopy referral following a positive EsoGuard result."

The manuscript reports on the first 275 patients at-risk for esophageal precancer enrolled in the prospective multicenter CLUE study at four U.S. sites. 264 patients underwent successful nonendoscopic esophageal cell sampling using Lucid's EsoCheck^® Cell Collection Device—a 96 percent technical success rate. Of the 232 patients for whom results were available 220 had sufficient DNA (95 percent) for EsoGuard testing. The prescribing physician referred all 68 patients with positive EsoGuard results (29 percent) for confirmatory endoscopy. 151 of the 152 patients with negative EsoGuard results were not referred for endoscopy. One EsoGuard-negative patient was referred for endoscopy as part of a surgical evaluation, not for precancer screening. These results document 100 percent concordance between a positive EsoGuard test result and subsequent physician medical decision-making, and a 99 percent concordance with a negative result. EsoGuard eliminated the need for over one-hundred fifty costly, invasive, and inconvenient endoscopies at the four practices, consistent with professional society guidelines.

"These outstanding results add to a growing evidence base of EsoGuard's clinical utility and clinical validity, which was recently strengthened by unprecedented esophageal precancer and cancer detection results from the NCI-funded BETRNet study," said Lishan Aklog, M.D., Lucid's Chairman & Chief Executive Officer. "We look forward to using these data to accelerate our engagement with payors and continuing to expand EsoGuard's clinical utility and clinical validity evidence base over the coming quarters."

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 - 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.

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SOURCE Lucid Diagnostics

FAQ

What is the CLUE study?

The CLUE study is a multicenter study that demonstrates the clinical utility of EsoGuard Esophageal DNA testing.

What are the results of the study?

The study shows excellent concordance between EsoGuard test results and subsequent medical decision-making by multiple physicians. It demonstrates the clinical utility of EsoGuard in appropriately triaging patients for confirmatory endoscopy.

How many patients were included in the study?

The study included the first 275 patients at-risk for esophageal precancer.

What percentage of patients had positive EsoGuard results?

29 percent of patients had positive EsoGuard results and were referred for confirmatory endoscopy.

How many endoscopies were eliminated by using EsoGuard?

EsoGuard eliminated the need for over 150 costly and invasive endoscopies at the four practices, consistent with professional society guidelines.