Lucid Diagnostics Announces Positive Data from the Largest Reported Real-World Experience of Esophageal Precancer Detection

Rhea-AI Summary

Lucid Diagnostics (Nasdaq: LUCD) reported real-world data from an 18-month retrospective analysis of 11,991 at-risk patients who underwent EsoCheck cell collection and EsoGuard DNA testing between January 2023 and June 2024.

Key findings: 95% technical success, 95% of collections completed in under two minutes, and no serious adverse events. Authors concluded the results show safety, tolerability, scalability, and appropriate physician use consistent with prior studies.

Positive

• Real-world cohort of 11,991 patients
• 95% technical success rate for EsoCheck collections
• 95% of procedures completed in under two minutes
• No serious adverse events reported across the cohort
• Observed appropriate physician use consistent with guidelines

Negative

• None.

Key Figures

Patient count 11,991 patients Real-world EsoGuard/EsoCheck experience over 18 months

Study duration 18 months Retrospective analysis period Jan 2023–Jun 2024

Technical success rate 95% EsoCheck technical success in real-world use

Fast procedures 95% EsoCheck procedures completed in under two minutes

Market Reality Check

$0.3500 Last Close

Volume Volume 475,620 is below the 20-day average of 662,923, suggesting limited pre-news positioning. normal

Technical Shares traded at $1.05, below the $1.20 200-day MA, indicating a longer-term downtrend pre-news.

Peers on Argus

Peers showed mixed moves, with ICAD up 3.48%, PROF up 2.57%, HYPR down 4.63%, and RCEL down 2.82%, indicating stock-specific rather than sector-wide drivers for LUCD.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Sep 16	Management appointment	Positive	+0.9%	Senior VP hire to drive market access and coverage for EsoGuard.
Sep 11	Equity offering close	Negative	+4.9%	Completion of common stock offering with resulting cash inflow.
Sep 10	Equity offering pricing	Negative	-19.7%	Pricing of public equity offering at $1.00 per share.
Sep 09	Equity offering launch	Negative	-19.7%	Announcement of proposed underwritten common stock offering.
Sep 05	Investor call notice	Neutral	-0.7%	Scheduled call to discuss MolDX CAC meeting on EsoGuard coverage.

Pattern Detected

Equity offerings have previously led to sharp negative reactions, while corporate and access-related updates saw modest positive or muted moves.

Recent Company History

Over the past few months, Lucid reported multiple capital raises and corporate updates. September 2025 saw a sequence of underwritten offerings and related prospectus filings, which coincided with ~-19.7% single-day drops on two occasions. A later closing announcement produced a +4.9% move, diverging from the generally negative sentiment around dilution. Management changes to bolster market access, and communications around reimbursement discussions for EsoGuard, resulted in small positive or limited price reactions. Today’s positive real-world EsoGuard data builds on this commercialization and reimbursement-focused backdrop.

Market Pulse Summary

The stock moved +6.2% in the session following this news. A strong positive reaction aligns with the favorable real-world validation of EsoGuard and EsoCheck across 11,991 patients and a 95% technical success rate. Historically, the stock reacted sharply to financing events, while operational progress generated smaller moves. Any large upside could face risks from prior dilution overhang and the company’s funding needs, as noted in recent filings. Sustainability would likely depend on how this data translates into adoption and reimbursement traction.

Key Terms

esophageal precancer medical

"real-world experience of non-endoscopic esophageal precancer (Barrett's esophagus or BE) detection"

Esophageal precancer describes abnormal cell changes in the lining of the esophagus that are not yet invasive cancer but have a higher risk of becoming malignant over time, like early cracks in paint that can lead to rot if left unchecked. It matters to investors because the need for earlier detection, monitoring and preventive treatments creates market opportunities for diagnostics, drugs and medical devices, and influences regulatory approvals, reimbursement and future revenue potential.

barrett's esophagus medical

"non-endoscopic esophageal precancer (Barrett's esophagus or BE) detection"

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 medical

"Non-Endoscopic Screening for Barrett's Esophagus Using a DNA Methylation-Based Assay"

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.

endoscopy medical

"identifying patients who need confirmatory endoscopy while sparing the vast majority"

A medical procedure that uses a thin, flexible tube with a tiny camera and small tools to look inside and sometimes treat organs through natural openings or small cuts — like sending a flashlight and repair kit down a pipe to inspect and fix problems. Investors care because the number of procedures, new device designs, safety records, regulatory approvals and reimbursement rules drive sales and profits for hospitals, equipment makers and suppliers.

AI-generated analysis. Not financial advice.

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.

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SOURCE Lucid Diagnostics

FAQ

What did Lucid Diagnostics (LUCD) report on December 9, 2025 about EsoGuard real-world data?

Lucid reported an 18-month real-world analysis of 11,991 patients showing 95% technical success, rapid collection times, and no serious adverse events.

How many patients were included in the EsoGuard and EsoCheck real-world study (LUCD)?

The retrospective study evaluated 11,991 at-risk patients tested between January 2023 and June 2024.

What were EsoCheck cell-collection times reported by Lucid (LUCD)?

The report found 95% of cell collections were completed in under two minutes.

Did Lucid (LUCD) report any serious adverse events in the EsoGuard real-world study?

No; the report states there were no serious adverse events across the nearly 12,000-patient cohort.

How did physicians use EsoGuard in routine practice according to Lucid (LUCD)?

Physician use largely matched U.S. gastroenterology guideline criteria, reflecting appropriate use in routine practice.

What settings and personnel performed EsoCheck collections in Lucid's (LUCD) real-world data?

Collections were performed in office and health fair settings by nurses, medical assistants, or other trained personnel, demonstrating scalability.