Company Overview - Lucid Diagnostics Inc is a commercial-stage cancer prevention company focused on esophageal precancer screening[4] - The company's mission is to prevent esophageal cancer deaths in at-risk patients through a comprehensive precancer screening solution[6] - Lucid's solution includes EsoCheck for esophageal cell collection and EsoGuard Esophageal DNA Test for detecting epigenetic changes[24, 32] Market Opportunity - The total addressable U S market for EsoGuard is approximately $60 billion, targeting ~30 million at-risk GERD patients recommended for screening[8, 52] - The Medicare payment for EsoGuard is approximately $1,938 per test[52] - The company boasts over 90% gross margin per test[53] Clinical and Financial Performance - EsoGuard has a 96% sensitivity for detecting esophageal cancer and precancer[39] - Since launch, approximately 36,000 cumulative EsoGuard tests have been performed[79] - The company's pro forma cash as of 2Q25, including September CMPO, is $58.1 million[81] Esophageal Cancer Context - Esophageal cancer has a low 5-year survival rate of 13%[14] - The incidence of Esophageal Adenocarcinoma (EAC) has increased by 573% from 1975 to 2020[16] - Approximately 16,250 estimated U S deaths from esophageal cancer in 2025[17]

Accessibility StatementSkip Navigation Scelfo to strengthen and scale Lucid's market access infrastructure ahead of key upcoming reimbursement milestones—including Medicare coverage for EsoGuard—and to accelerate commercial coverage expansion NEW YORK, Sept. 16, 2025 /PRNewswire/ --Â Lucid Diagnostics Inc.(Nasdaq: LUCD)Â ("Lucid" or the "Company"), a commercial-stage cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced the appointment of Danielle Scelfo ...

Group 1 - The conference call is hosted by Lucid Diagnostics, featuring remarks from the Senior Director of Investor Relations and the CEO [2][3] - The discussion will cover various topics including the September 4 contractors Advisory Committee meeting, reimbursement strategies, and regulatory milestones [3] - The PAC meetings are advisory and do not establish coverage determinations, indicating the nature of the discussions [3] Group 2 - The company emphasizes that forward-looking statements are based on current expectations and may differ materially from actual outcomes [2][4] - Important factors affecting actual results are detailed in SEC filings, including risk factors in the most recent annual and quarterly reports [4]

Summary of Lucid Diagnostics Conference Call Company Overview - **Company**: Lucid Diagnostics (NasdaqCM: LUCD) - **Industry**: Medical diagnostics, specifically focusing on esophageal cancer detection through the EsoGuard test Key Points and Arguments 1. **Positive Outcome of MOLDEX CAC Meeting**: The recent Contractor Advisory Committee (CAC) meeting was overwhelmingly positive, with broad clinician support for EsoGuard, exceeding expectations [4][5][6] 2. **Clinical Need and Evidence**: There is a strong clinical need for EsoGuard, supported by a robust body of clinical evidence. Medical experts unanimously agreed that Medicare should cover the test for detecting precancerous conditions [5][6][8] 3. **EsoGuard's Performance**: EsoGuard has a 99% negative predictive value, making it a reliable rule-out test for esophageal precancer and cancer. The test is designed to avoid unnecessary endoscopies for the majority of patients [16][20][24] 4. **Consensus on Clinical Validity**: The test performs well across various conditions, including short-segment Barrett's esophagus, which is critical as a significant portion of the target population has this condition [22][24] 5. **Unmet Screening Needs**: Only about 10% of eligible patients currently undergo screening for esophageal cancer, compared to 40-50% for colorectal cancer. Increasing this percentage could save thousands of lives annually [51][54] 6. **Patient Compliance**: EsoGuard has shown to improve patient compliance for follow-up endoscopies, with 85% of patients referred for endoscopy actually undergoing the procedure [32][33] 7. **Guidelines and Support**: Major gastroenterology societies support non-endoscopic testing like EsoGuard, which aligns with established guidelines for managing patients with precancerous conditions [36][38] 8. **Next Steps for Coverage**: The publication of a draft Local Coverage Determination (LCD) is expected, indicating a move towards Medicare coverage for EsoGuard. This is seen as a significant milestone for the company [44][46][49] Additional Important Insights 1. **Real-World Clinical Experience**: Primary care physicians and gastroenterologists shared their positive experiences with EsoGuard, emphasizing its utility in practice and the ease of incorporating it into patient care [39][40][61] 2. **Addressing Endoscopy Deserts**: The discussion highlighted the challenges faced by patients in rural areas who lack access to endoscopy services, underscoring the need for non-invasive testing options like EsoGuard [27][64] 3. **Future Opportunities**: There is potential for expanding the use of EsoGuard to asymptomatic patients, supported by ongoing research and grants [58][60] 4. **Marketing and Implementation**: The company has been actively marketing EsoGuard to primary care physicians, emphasizing its non-invasive nature and the importance of early detection in high-risk populations [59][61] This summary encapsulates the key discussions and insights from the Lucid Diagnostics conference call, focusing on the company's strategic direction, clinical evidence, and the potential impact of EsoGuard in the medical diagnostics landscape.

Summary of Lucid Diagnostics (LUCD) Conference Call Company Overview - **Company**: Lucid Diagnostics Inc. - **Industry**: Cancer prevention and diagnostics - **Product**: EsoGuard® molecular diagnostic test for detecting esophageal precancer non-invasively in office settings [1][4] Key Points and Arguments 1. **Medicare Coverage Progress**: - Lucid Diagnostics is in the late stages of securing Medicare coverage for the EsoGuard® test, having worked closely with the Multi-X group for several years [4][5] - A recent multi-jurisdictional Contractor Advisory Committee meeting provided clinical context to the evidence submitted, which included multiple studies on clinical validity and utility [5][6] 2. **Clinical Validity and Utility**: - The test has a negative predictive value of 99% and a positive predictive value that enhances patient compliance for endoscopy [6][7] - Patients with a positive EsoGuard test have double the compliance rate for endoscopy, leading to a nearly threefold increase in diagnostic yield [7][8] 3. **Impact of Esophageal Cancer**: - Esophageal cancer is highlighted as a significant health issue, with a high mortality rate, emphasizing the need for effective early detection [9][10] 4. **Next Steps for Coverage**: - The next milestone is the publication of a draft Local Coverage Determination (LCD), which indicates a positive direction towards coverage [19][20] - Following the draft, there will be a 45-day comment period before finalization [23] 5. **Commercialization Strategy**: - Lucid Diagnostics plans to target Medicare patients more aggressively, as historically only 10-15% of their patients were Medicare beneficiaries [24][25] - The company is also engaging with commercial payers and has begun securing contracts with regional plans [26][27] 6. **Sales Force and Operational Efficiency**: - The company intends to maintain a cautious approach with its existing sales force while ensuring operational efficiency [29] - The Medicare payment rate is set at $1,938, with a cost of goods at $1,200, providing a favorable margin for the business [30] 7. **Patient Awareness and Education**: - Lucid Diagnostics is focused on educating patients about the link between heartburn and esophageal cancer, which is crucial for driving test adoption [34][36] - The company has plans for direct-to-consumer marketing once broader coverage is achieved [35] 8. **Future Research and Development**: - Ongoing clinical studies, including a significant NIH study, aim to expand market opportunities for the EsoGuard test [39] - The company is exploring potential markets in Europe, particularly the UK, where there is growing awareness of esophageal cancer [41] 9. **Key Catalysts for Next Year**: - Securing Medicare coverage and increasing the proportion of Medicare patients to align with the target population [42] Additional Important Content - The meeting included discussions with leading medical experts, emphasizing the importance of clinical context in diagnostics [6][18] - Anecdotal evidence from physicians highlighted the effectiveness of the EsoGuard test in identifying precancerous conditions, showcasing its potential life-saving impact [10][11]

Core Points - Lucid Diagnostics Inc. will host a conference call on September 8, 2025, at 8:30 AM ET to discuss the recent Contractor Advisory Committee meeting regarding the reconsideration of Local Coverage Determination for its EsoGuard® Esophageal DNA Test [1][2] - The EsoGuard® test is aimed at patients with GERD who are at risk of developing esophageal precancer and cancer, utilizing a noninvasive procedure for early detection [4] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [4] - The company focuses on early detection of esophageal precancer in at-risk patients through its EsoGuard® Esophageal DNA Test and EsoCheck® Esophageal Cell Collection Device [4]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [3] - The company focuses on patients with GERD (chronic heartburn) who are at risk of developing esophageal precancer and cancer [3]. Product Information - Lucid's flagship product is the EsoGuard® Esophageal DNA Test, which is performed using the EsoCheck® Esophageal Cell Collection Device [3]. - These tools are designed for the early detection of esophageal precancer in at-risk patients, aiming to prevent esophageal cancer and related deaths [3]. Upcoming Event - Lishan Aklog, M.D., Chairman and CEO of Lucid, will participate in a fireside chat at the Cantor Global Healthcare Conference 2025 on September 5, 2025, at 8:35 AM EDT [1][2]. - The event will be available via live and archived webcast, accessible through the company's Investor Relations section [2].

Lucid processed 2,756 EsoGuard® 2Q25 tests, recognized revenue of $1.2 million, and secured CAC meeting on Medicare LCD for EsoGuard to be held on September 4 Veris Health completed 2Q25 financing, relaunched development of implantable physiological monitor, and initiated integration steps to launch commercial phase with OSU-The James Conference call and webcast to be held today, August 14, at 8:30 AM EDT NEW YORK, Aug. 14, 2025 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diver ...

Summary of Lucid Diagnostics Conference Call Company Overview - **Company**: Lucid Diagnostics - **Founded**: 2018 - **Technology**: Focuses on detecting precancerous conditions for esophageal cancer, which is the second most deadly cancer [3][4] Industry Context - **Esophageal Cancer**: High mortality rate; early detection is crucial for prevention [4][5] - **Target Population**: Patients with heartburn and at least three out of six risk factors (e.g., over 50, white male, obese, smoker, family history) have about a 10% chance of having precancer [6] Core Technology and Testing Method - **Testing Method**: Non-invasive molecular test using a swallowable balloon capsule to collect samples from the lower esophagus [7][8] - **Performance Metrics**: - 99% negative predictive value [9] - 80% of patients can avoid invasive tests [10] - Approximately 40,000 tests performed to date [11] Financial and Coverage Insights - **Medicare Payment**: Established at $19.38 in 2021; ongoing efforts to secure coverage from Medicare and commercial payers [12] - **Current Testing Volume**: Approximately 2,756 tests in the latest quarter, a decrease from previous quarters due to waiting for coverage [14][15] - **Claim Denials**: About 83% of claims were denied in the quarter, primarily due to lack of medical policy coverage [20][21] Strategic Focus - **Coverage Strategy**: Engaging with payers to secure coverage; significant focus on building a clinical evidence package [12][19] - **Regional Plans**: Increased engagement with regional commercial plans, which are more willing to discuss coverage [24] - **Health System Partnerships**: Long-term partnerships with health systems to integrate testing into broader cancer prevention programs [25][26] Future Outlook - **Medicare Coverage Anticipation**: Expecting to secure Medicare coverage soon, which will allow for increased test volume and revenue growth [30][72] - **Market Opportunity**: Approximately 30 million patients recommended for screening, with 40-50% being Medicare age [30] - **Revenue Growth**: Anticipated solid revenue growth next year, with plans to ramp up operations post-Medicare approval [70][72] Competitive Landscape - **Comparison with Other Tests**: Lucid's test is positioned as more effective than sponge-based devices and blood tests for detecting precancerous conditions [82][88] - **Partnership Potential**: Opportunities for collaboration with other companies in the space to enhance market reach [81] Conclusion - **Growth Potential**: Lucid Diagnostics is poised for significant growth with the anticipated Medicare coverage and increasing commercial payer engagement, targeting a substantial market opportunity in esophageal cancer prevention [90][91]

Company Performance - Lucid Diagnostics Inc. reported a quarterly loss of $0.1 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, representing an earnings surprise of -11.11% [1] - The company posted revenues of $1.16 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 29.22%, compared to revenues of $0.98 million a year ago [2] - Over the last four quarters, Lucid Diagnostics has not surpassed consensus EPS estimates, but it has topped consensus revenue estimates twice [2] Stock Movement and Outlook - Lucid Diagnostics shares have increased approximately 21.8% since the beginning of the year, outperforming the S&P 500's gain of 9.6% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.09 on $1 million in revenues, and for the current fiscal year, it is -$0.41 on $5 million in revenues [7] Industry Context - The Medical - Instruments industry, to which Lucid Diagnostics belongs, is currently ranked in the bottom 39% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Lucid Diagnostics' stock performance [5]