Lucid Diagnostics Releases Positive Data Demonstrating Clinical Utility of EsoGuard Esophageal Precancer Detection

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Lucid Diagnostics Releases Positive Data Demonstrating Clinical Utility of EsoGuard Esophageal Precancer Detection

Lucid Diagnostics Inc. (Nasdaq: LUCD) and majority-owned subsidiary of PAVmed (NASDAQ: PAVM ) Inc. (Nasdaq: PAVM, PAVMZ) ( "PAVmed"), today announced it has released positive data from a retrospective analysis demonstrating real-world clinical utility of EsoGuard® Esophageal DNA testing for the detection of esophageal precancer in a large cohort of fire fighters.

The study documents 100 percent concordance between clinically directed EsoGuard test results and subsequent medical decision-making by the prescribing physician. It demonstrates that EsoGuard can efficiently test large populations at risk for esophageal precancer, allowing physicians to utilize EsoGuard results 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 of EsoGuard® as a Triage Test for Endoscopy to Identify Barrett's Esophagus in Fire Fighters, has been posted on the leading health sciences preprint server, medRxiv, pending peer review and publication. The release of these data closely aligns with and strongly supports recently proposed federal legislation seeking to fund guaranteed firefighter access to early detection tests such as EsoGuard.

"The release of these results represents a very important milestone for Lucid. We can now, for the first time, demonstrate to payors that physicians are clinically utilizing EsoGuard to appropriately guide their referral of at-risk patients for confirmatory endoscopy, namely—that our diagnostic test has meaningful real-world clinical utility," said Natalie Carfora, Lucid's new Vice President, Market Access. "Such clinical utility data, along with claims history, has been a key gating item for us to engage payors to secure in-network EsoGuard coverage. This retrospective analysis is the first of four clinical utility studies that we will be releasing as preprints just prior to submission for peer review and publication."

"The most direct measure of the clinical utility of any diagnostic test which returns a positive or negative result, as EsoGuard does, is whether the prescribing physician uses the binary test result to make the appropriate medical decision for the patient. Based on recently updated professional society guidelines, the appropriate decision following an EsoGuard result is clearcut. Patients with positive results should be referred for confirmatory endoscopy and those with negative results should not undergo endoscopy unless another indication emerges," Ms. Carfora added.

The manuscript reports on prospectively collected and retrospectively analyzed clinical utility data from Lucid's first #CheckYourFoodTube Precancer Testing Event held earlier this year in partnership with the San Antonio Fire Department (SAFD). 391 SAFD fire fighters who were deemed by a physician to be at-risk for esophageal precancer participated in the event. A Lucid clinician performed successful nonendoscopic esophageal cell sampling using Lucid's EsoCheck® Cell Collection Device in 388 fire fighters—a 99 percent technical success rate. The 372 samples with sufficient DNA (97 percent) underwent EsoGuard testing at Lucid's CLIA-certified, CAP-accredited molecular diagnostic laboratory in Lake Forest, California. The prescribing physician referred all of the 28 fire fighters with positive EsoGuard results (7 percent) to a gastroenterologist for confirmatory endoscopy and referred none of the firefighters with negative EsoGuard results for endoscopy. This represents 100 percent concordance between EsoGuard test results and subsequent physician medical decision-making. By providing the prescribing physician with binary EsoGuard results and enabling triage of only EsoGuard-positive patients to endoscopy, EsoGuard eliminated the need for hundreds of costly, invasive, and inconvenient endoscopy procedures, while remaining consistent with screening recommendations from professional society guidelines.

"These outstanding results of our first clinical utility study could not be more timely," said Lishan Aklog, M.D., Lucid's Chairman & Chief Executive Officer. "We have been gearing up to fully engage with payors for some time and are now armed with excellent clinical utility data and an expanding claims history to support these engagements. The timing aligns with our recent transition to an upgraded revenue cycle management provider, which continues to have a positive impact on claims processing, allowances, and collections. It also aligns with the addition of Natalie Carfora as our new VP of Market Access. Ms. Carfora brings a proven track record of successful payor engagement with both private and government insurers, and a highly creative and strategic approach, including a variety of pilot programs with payors and self-insured entities, and utilizing clinical utility studies to drive larger coverage policies."

"The release of these results also aligns with the recent flurry of attention cancer prevention in fire fighters has garnered as a result of recently proposed federal legislation which seeks to fund guaranteed fire fighter access to early detection tests such as EsoGuard," Dr. Aklog added. "The epidemiologic data driving this attention is overwhelming and unequivocal. Fire fighters have a substantially increased occupational risk of many different types of cancer, but their relative risk of esophageal cancer (162 percent) and esophageal cancer death (138 percent) is second only to mesothelioma, for which no early detection test is currently available. Although blood-based multi-cancer early detection (MCED) tests have the potential to offer early detection of multiple cancers in firefighters and others, it simply cannot do so for esophageal cancer. Not only is MCED's published sensitivity in early-stage esophageal cancer poor, but it is also well established that the high mortality in Stage I esophageal cancer mandates early precancer detection. EsoGuard provides an unprecedented precancer sensitivity of over 80 percent, while no other single or multi-cancer early detection test, blood-based or otherwise, provides any sensitivity in detecting esophageal precancer."

This summer, Congressman Josh Gottheimer (NJ-5) introduced the bipartisan Firefighter Investments to Recognize Exposure to Cancer Act ("FIRE Cancer Act") in the U.S. House of Representatives, garnering widespread stakeholder support through endorsements by the New Jersey Firefighters Mutual Benevolent Association, the International Association of Fire Fighters, the Professional Firefighters Association of New Jersey, the New Jersey State Firemen's Association, and the National Association of Government Employees. The FIRE Cancer Act seeks to amend the Federal Fire Prevention and Control Act of 1974 to "make available under the assistance to firefighters grant program the establishment of cancer prevention programs…" and, more specifically, "to establish cancer prevention programs for firefighting personnel, including providing multi-cancer early detection testing or other forms of preventative tests…to be appropriated $700,000,000 for grants."

"Last month, I had the pleasure of traveling to DC to meet with Congressman Gottheimer's deputy chief of staff and legislative director to discuss the bill and the critical role EsoGuard will play in fulfilling the bill's mission to prevent the cancers which fire fighters disproportionately suffer from as a direct result of their heroic work. I applauded Congressman Gottheimer and his co-sponsor, Congressman Anthony D'Esposito (NY-4), for leading this critically important bipartisan effort and committed to doing our part to ensure the legislation becomes law so that these at-risk brave men and women have guaranteed access to the early detection tests they deserve," Dr. Aklog concluded.

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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