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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:
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."
