Esophageal dysplasia

Contrasts EsoCheck's powerful cell collection capabilities to "cruder, decades-old" technologies during comments on patient access to medical technology innovation NEW YORK, Feb. 15, 2024 /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 that its Chairman and Chief Executive Officer, Lishan Aklog, M.D., highlighted Lucid's EsoCheck® Cell Collection Device ("EsoCheck") during testimony before the U.S. House of Representatives' Committee on Small Business. Dr. Aklog was invited by the Congressional committee to testify on the importance of facilitating and protecting patient access to innovative life-enhancing and life-saving medical technology products, such as EsoCheck. "EsoCheck is a deceptively simple tool which allows precise, targeted collection of lower esophageal cells for precancer testing," Dr. Aklog said. "EsoCheck's gentle approach to noninvasive cell collection is a dramatic and elegant improvement over cruder, decades-old technology, which involves dragging a Brillo Pad-like 'sponge-on-a-string', indiscriminately scraping cells from the stomach, esophagus and mouth." Dr. Aklog further noted, in separate comments, that "EsoCheck's advanced features are a major contributor to EsoGuard's unprecedented early precancer detection results." EsoCheck and its patented, groundbreaking Collect & Protect® technology was invented by physician scientists at Case Western Reserve University, licensed by Lucid in 2018, and received FDA clearance in 2019. Manufacturing was transferred to a high-volume, low-cost contract manufacturer in 2022. EsoCheck is a vitamin pill-sized capsule containing a soft silicone balloon attached to a thin silicone catheter. When the balloon is inflated, subtle ridges on its surface are exposed, which permit gentle swabbing of the cells from the lower esophagus where esophageal precancer and cancer occur. When deflated, the balloon retracts into the capsule, protecting the sample from dilution and contamination by cells outside the target area during retrieval. Collect & Protect® technology allows precise, anatomically targeted collection of esophageal cells in a doctor's office, in less than two minutes, without the need for anesthesia or sedation. The efficiency of the cell collection process has allowed EsoCheck to be used in dozens of high-volume precancer testing events over the past year, with a single operator able to sample up to fifty patients in a day. No mechanical failures of the EsoCheck device have been reported to date. Data on nearly 1,500 patients undergoing EsoCheck cell collection, presented at Digestive Disease Week 2023, showed that 98% of patients successfully completed EsoCheck cell collection, with excellent DNA yields and patient satisfaction scores. Seminal data from the multi-center National Cancer Institute's BETRNet consortium, posted as a preprint pending peer review, demonstrated unprecedented esophageal precancer (including short-segment) and cancer detection results of Lucid's EsoGuard® Esophageal DNA Test on samples collected using EsoCheck. So-called "sponge-on-a-string" ("SOS") technologies were introduced in the early 1990's, as an alternative to invasive upper gastrointestinal endoscopy, with the launch of the EsophaCap® device (which Lucid acquired in 2022). A large medical device company briefly marketed the Cytosponge® device in conjunction with Trefoil Factor 3 (TFF-3), a non-molecular, conventional immunohistochemical test, before withdrawing it from the U.S. market. Data presented in 2021 from a U.S. study of Cytosponge/TFF-3 showed poor sensitivity, especially in patients with short segments of esophageal precancer. Troubling cases of mechanical failure of SOS devices were reported in this and other studies. All SOS devices, including repackaged/rebranded versions of Cytosponge, have fundamentally the same design and operation as the original decades-old technology. The patient swallows a spherical sponge with a roughened surface which is encapsulated in a gelatin capsule. After waiting up to ten minutes for the gelatin to dissolve in the stomach, the SOS is withdrawn, scraping cells from the stomach, entire esophagus, throat and mouth along the way. These first-generation devices lack EsoCheck's ability to anatomically target cell collection at the approximately two-inch segment of the esophagus near the stomach where esophageal precancer and cancer arise, and, importantly, lack EsoCheck's ability to protect these cells from dilution and contamination by cells outside the target area. About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage medical diagnostics company focused on cancer prevention, 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, is the first and only commercially available diagnostic test capable of serving as a widespread screening tool for at-risk patients to mitigate the risks of cancer and cancer deaths through early detection of esophageal precancer. For more information, please visit and for more information about its parent company PAVmed, please visit . 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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The World Trade Center Health Program will now cover the cost of EsoGuard testing for its more than 120,000 participants NEW YORK, Feb. 8, 2024 /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 that it has contracted with the World Trade Center Health Program ("WTCHP") to provide the EsoGuard® Esophageal DNA test as a covered benefit to the more than 120,000 responders and survivors who participate in the program. The WTCHP provides medical monitoring and treatment to those directly affected by the 9/11 terrorist attacks, including members of the Fire Department of the City of New York (FDNY) and other emergency responders at the World Trade Center, recovery and cleanup workers and those who were in the New York City Disaster Area on September 11, 2001, or in the months that followed. EsoGuard is now reimbursable at $2,475.81 per test prescribed by clinicians at one of WTCHP's Clinical Centers of Excellence. "We are grateful for the opportunity to provide EsoGuard esophageal precancer testing to those affected by the devastating 9/11 terrorist attacks," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. "As a result of their exposure to dust, smoke, and debris, these heroes are at increased risk of developing cancer, just as firefighters are in general. In fact, nearly 35,000 have already been certified as suffering from gastroesophageal reflux disease (GERD), and therefore are at increased risk of developing esophageal cancer. Lucid remains deeply committed to expanding patient access to EsoGuard testing, with the ultimate goal of preventing esophageal cancer and cancer deaths. We look forward to offering EsoGuard testing to WTCHP participants through dedicated #CheckYourFoodTube Precancer Testing events in the New York metropolitan area. This new program is the product of our ongoing, intensive efforts to drive coverage for EsoGuard testing through direct contracting initiatives." About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage medical diagnostics company focused on cancer prevention, 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, is the first and only commercially available diagnostic test capable of serving as a widespread screening tool for at-risk patients to mitigate the risks of cancer and cancer deaths through early detection of esophageal precancer. For more information, please visit and for more information about its parent company PAVmed, please visit . 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. Company Codes: NASDAQ-NMS:LUCD, NASDAQ-SMALL:PAVM

Studies demonstrate real-world clinical utility of EsoGuard testing to detect esophageal precancer NEW YORK, Dec. 12, 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 that three manuscripts providing interim results from the Prospective REView of Esophageal Precancer DetectioN in AT-Risk Patients (PREVENT) Registry, the CLinical Utility of EsoGuard (CLUE) study, and full data from the San Antonio Firefighter study, have been published—the first peer-reviewed publications demonstrating real-world clinical utility of Lucid's EsoGuard® Esophageal DNA test to detect esophageal precancer. The publications are: PREVENT Registries - Englehardt R, Samarasena JB, Bildzukewicz NA, Hamblin R, Lee VT, deGuzman BJ, Aklog L. (2023). Real-World Experience and Clinical Utility of EsoGuard® – Interim Data from the Lucid Registry. J Gastro & Digestive Systems, 7(2), 43-53. Interim analysis of 409 of 517 enrolled patients with complete clinical utility data in the PREVENT and PREVENT-FF registries of patients undergoing EsoGuard testing by Lucid personnel. CLUE Study - Lister D, Fine A, Maheshwari S, Bradley PS, Lee VT, deGuzman BJ, Verma S, Aklog L. Clinical Utility of EsoGuard® on Samples Collected with EsoCheck® as a Triage to Endoscopy for Identification of Barrett's Esophagus – Interim Data from the CLUE Study. Archives of Clinical and Biomedical Research, 7 (2023): 626-634. Interim analysis of 220 of 275 enrolled patients with complete clinical utility data in the prospective, multicenter CLUE study of at-risk patients referred for EsoGuard testing. San Antonio Firefighter Study - Hamblin R, Lee VT, DeGuzman BJ, Verma S, Aklog L (2023). Clinical Utility of EsoGuard® as a Barrett's Esophagus Triage Test for On-duty Firefighters. J Gastrointest Dig Syst 13: 764. Prospectively collected and retrospectively analyzed clinical utility data in 391 San Antonio firefighters who underwent EsoGuard testing at #CheckYourFoodTube Precancer Testing Events. Collectively, the published studies document near-perfect concordance between EsoGuard results and the prescribing physician's decision whether to refer patients for upper endoscopy. 100 percent of EsoGuard-positive patients were referred for confirmatory upper endoscopy and approximately 98 percent of EsoGuard-negative patients were not—eliminating the need for hundreds of costly, invasive, and inconvenient endoscopies. These results demonstrate that, in real-world use, EsoGuard allows physicians to appropriately triage at-risk patients, consistent with established professional society guidelines, and ensure cost-effective utilization of endoscopy in esophageal precancer detection. The CLUE study has completed enrollment and data from the full cohort of over 500 patients, including data on patient compliance with referral for endoscopy, will be released and submitted for publication when patient follow-up and data analysis is complete. The PREVENT registries are open-ended and have enrolled over 600 patients to date, penetrating even further into the patient journey, beyond the initial medical decision-making. Additional publications on the expanded registry cohorts are planned in the coming months. "These clinical utility studies, encompassing over 1,000 patients, clearly demonstrate that prescribing physicians are properly leveraging EsoGuard results to guide their medical decision making," said Victoria T. Lee, M.D., Senior Vice President and Chief Medical Officer of Lucid and PAVmed, who oversees Lucid's clinical research activities. "EsoGuard allowed physicians to effectively triage patients at increased risk for esophageal precancer to endoscopy. We look forward to ongoing expansion of our increasingly robust EsoGuard clinical utility and validity evidence base." "The publication of three clinical utility studies, with excellent results, in peer-reviewed journals, provides us with critical evidence to expand our ongoing engagement with commercial payors on medical policy and coverage for EsoGuard," said Natalie Carfora, Lucid's Vice President, Market Access of Lucid. "These outstanding clinical utility results complement existing clinical validity data on EsoGuard's unprecedented precancer detection performance. This evidence, coupled with multiple national society guidelines and consensus statements supporting EsoGuard esophageal precancer detection, provides us with a strong foundation for our ongoing market access and reimbursement efforts." About Lucid Diagnostics Lucid Diagnostics Inc. is a commercial-stage medical diagnostics company focused on cancer prevention, 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, is the first and only commercially available diagnostic test capable of serving as a widespread screening tool for at-risk patients to mitigate the risks of cancer and cancer deaths through early detection of esophageal precancer. For more information, please visit and for more information about its parent company PAVmed, please visit . 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. Company Codes: NASDAQ-SMALL:PAVM, NASDAQ-NMS:LUCD