Lucid Diagnostics Announces Publication of Landmark 12,000-Patient Real-World EsoGuard® Study

EsoGuard is now fully reimbursed by Medicare nationwide, as Lucid plans to accelerate commercialization in the coming months.

Rhea-AI Summary

Lucid Diagnostics (LUCD) announced peer-reviewed publication of a real-world study of esophageal precancer testing involving 11,991 patients in the journal Diagnostics.

Patients with clinical risk factors underwent EsoGuard testing using samples collected with EsoCheck between January 2023 and June 2024. Cell collection succeeded in 95% of patients, averaged less than two minutes, and had no reported device-related adverse events. Results were consistent across operators, including newly trained personnel. In a post-procedure survey, 82% reported very low discomfort and 0.2% rated it high; 96% would recommend testing, and 95% would repeat it if clinically indicated. Lucid said the findings support the feasibility of large-scale implementation.

9 points · 0 major

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0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointEsoGuard is now fully reimbursed by Medicare nationwide.
• Minor pointPeer-reviewed findings from 11,991 patients were published in Diagnostics.
• Minor pointEsoCheck cell collection succeeded in 95% of patients, including across newly trained operators.
• Minor pointAverage cell collection time was less than two minutes.
• Minor pointDevice-related adverse events: none reported in the study.

4 minor points

• Minor pointPost-procedure discomfort was very low for 82% of survey respondents; 0.2% rated it high.
• Minor pointTest recommendation willingness reached 96% among post-procedure survey respondents.
• Minor pointRepeat-testing willingness reached 95% among survey respondents, if clinically indicated.
• Minor point. Forward-looking: it has not happened yet and may not happen.Lucid plans to accelerate commercialization across diverse clinical settings in the coming months.

Negative

• None.

News Explained

Lucid now describes EsoGuard as fully reimbursed by Medicare nationwide; an October 22, 2026 headline had described the company as beginning to receive Medicare reimbursement.

Sources and calculations

• Lucid Diagnostics Announces Publication of Landmark 12,000-Patient Real-World EsoGuard® Study (2026-11-03)
• Lucid Diagnostics Begins Receiving Medicare Reimbursement for EsoGuard® and Closes $15 Million Financing (2026-10-22)

Key Figures

Study participants: 11,991 patients Successful cell collection: 95% Average collection time: Less than two minutes +5 more

Study participants

11,991 patients

Real-world EsoGuard study

Successful cell collection

95%

Study participants

Average collection time

Less than two minutes

EsoCheck cell collection

Device-related adverse events

None reported

Study participants

Very low discomfort

82%

Post-procedure survey

High discomfort

0.2%

Post-procedure survey

Would recommend the test

96%

Post-procedure survey

Would undergo the test again

95%

If clinically indicated

Key Terms

barrett's esophagus, dna methylation-based assay, adverse events

3 terms

barrett's esophagus medical

"Non-Endoscopic Screening for Barrett's Esophagus"

A condition where the cells lining the lower esophagus change after repeated acid injury from stomach reflux, creating tissue that looks and behaves differently than normal. It matters to investors because this change raises the long-term risk of esophageal cancer and therefore drives demand for diagnostic tests, monitoring programs, medical procedures and drug development; like spotting damaged wallpaper that signals the need for repairs, its detection can affect healthcare costs and market opportunities.

dna methylation-based assay technical

"Using a DNA Methylation-Based Assay: Real-World Experience"

A DNA methylation-based assay is a laboratory test that reads chemical tags placed on DNA that change how genes are turned on or off — like sticky notes on an instruction manual that tell the cell which pages to use. Investors care because these tests can enable earlier or more precise detection, prognosis, or treatment decisions, which can drive clinical adoption, regulatory approval, recurring test revenue, and licensing or partnership opportunities that affect a medical or diagnostics company's commercial value.

adverse events medical

"no reported device-related adverse events"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

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

NEW YORK, Nov. 3, 2026 /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.

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SOURCE Lucid Diagnostics

FAQ

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What did Lucid Diagnostics' 11,991-patient EsoGuard study show?

EsoCheck cell collection succeeded in 95% of patients, took less than two minutes on average, and had no reported device-related adverse events. The study involved patients with clinical risk factors tested between January 2023 and June 2024, with findings published in Diagnostics.