Business Performance - Lucid Diagnostics achieved a record quarterly revenue of $1.2 million in Q3 2024, a 20% increase compared to the previous quarter[6] - EsoGuard test volume reached 2,787 in Q3 2024[6] - Over 7,000 firefighters have undergone EsoGuard esophageal precancer testing[6] - Year-to-date revenue for 3Q24 reached $3.149 million, a $1.761 million increase compared to $1.388 million in 3Q23[34] Strategic Accomplishments - The ESOGUARD BE-1 clinical validation study was accepted for peer-reviewed publication[8] - A key patent underlying EsoGuard received a Notice of Allowance[8] - Lucid Diagnostics met with CMS Medicare Administrative Contractor (MAC) Palmetto GBA's Molecular Diagnostics Program (MolDX) to discuss EsoGuard clinical evidence package for upcoming submission for Medicare coverage[8] Financials - Cash reserves decreased from $24.920 million in 2Q24 to $14.489 million in 3Q24, a decrease of $10.431 million[32] - Net loss for 3Q24 was $(12.371) million, compared to $(14.208) million in 3Q23, an improvement of $1.837 million[34] - Non-GAAP adjusted loss per share improved from $(0.22) in 3Q23 to $(0.20) in 3Q24[34] - Shares outstanding increased from 49.3 million in 2Q24 to 51.6 million in 3Q24, an increase of 2.3 million shares[32]

You know what I love about kids. I love how honest they are. I was working at a school-based health clinic the other day and I asked one of the kids, "What's your favorite subject?" Without missing a beat, he replied, "Lunch." And he's not alone.Did you know that 93% of Americans love to eat. But in all seriousness, here's the thing. That moment made me think about food, health, and nutrition in a way that I hadn't in a while.You see, 12 years ago, I was a pathology resident. A pathologist is a doctor that ...

You know what I love about kids. I love how honest they are. I was working at a school-based health clinic the other day and I asked one of the kids, "What's your favorite subject?" Without missing a beat, he replied, "Lunch." And he's not alone.Did you know that 93% of Americans love to eat. But in all seriousness, here's the thing. That moment made me think about food, health, and nutrition in a way that I hadn't in a while.You see, 12 years ago, I was a pathology resident. A pathologist is a doctor that ...

Core Insights - Lucid Diagnostics Inc. has appointed Danielle Scelfo as Senior Vice President of Market Access & Government Affairs to enhance market access infrastructure and accelerate commercial coverage expansion for its EsoGuard Esophageal DNA Test [1][2] - The company is at a critical juncture, aiming to expand patient access to the EsoGuard test, with Medicare coverage anticipated following a positive MolDX CAC meeting [2][3] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of esophageal precancer and cancer [3] - The EsoGuard test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients [3] Leadership and Experience - Danielle Scelfo brings over 25 years of experience in market access, reimbursement, and government affairs, having held senior roles in various diagnostics companies [2][3] - Her previous positions include Vice President at ClearNote Health and leadership roles at CareDx, Hologic, Adaptive Biotechnologies, and Genomic Health [2]

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]

Group 1 - Lucid Diagnostics Inc. announced a virtual public meeting on September 4, 2025, to discuss the reconsideration of Local Coverage Determination (LCD) L39256 for its EsoGuard® Esophageal DNA Test [1] - The meeting will involve Medicare Administrative Contractors and medical experts, focusing on the clinical literature related to esophageal precancer testing [2] - Lucid's CEO expressed optimism about the meeting's potential to lead to a positive Medicare coverage policy outcome, citing broad consensus in the GI community regarding the clinical utility of EsoGuard [2] Group 2 - Lucid Diagnostics is a commercial-stage company focused on cancer prevention, specifically targeting patients with gastroesophageal reflux disease (GERD) at risk of esophageal precancer [3] - The EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer through a noninvasive procedure, representing a significant advancement in cancer prevention tools [3]

Core Insights - Lucid Diagnostics Inc. announced positive data from a National Cancer Institute-sponsored study showing that its EsoGuard® Esophageal DNA Test can effectively detect esophageal precancer in at-risk patients without GERD symptoms, potentially expanding its market opportunity [1][2][3] Company Overview - Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., focusing on patients with gastroesophageal reflux disease (GERD) who are at risk of developing esophageal precancer and cancer [4] Study Findings - The study enrolled patients without GERD symptoms who met AGA recommendations for Barrett's Esophagus (BE) screening, demonstrating a 100% negative predictive value (NPV) for detecting esophageal precancer [2] - The prevalence of Barrett's Esophagus in the study was found to be 8.4%, comparable to rates in symptomatic GERD patients [2] Market Opportunity - If the ongoing multicenter NIH-sponsored study replicates the promising results, the market opportunity for EsoGuard esophageal precancer testing could increase by as much as 70%, potentially reaching a total of approximately $60 billion [3]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Offering Details - Lucid Diagnostics announced its intention to offer shares of common stock through an underwritten public offering, with plans to grant underwriters a 45-day option to purchase additional shares. Proceeds from the offering are expected to support working capital and general corporate purposes [1]. - Canaccord Genuity LLC is acting as the sole bookrunner for the offering, while Maxim Group LLC is serving as co-manager [2]. Regulatory Information - The offering is being made pursuant to a shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission on December 6, 2022. A prospectus supplement will be filed with the SEC [3].

Financial Data and Key Metrics Changes - The company generated $1,200,000 in revenue for the fourth quarter, reflecting a 15% increase compared to the same quarter last year [27][28] - Test volume exceeded 4,000 tests in the fourth quarter, representing a record quarterly test volume [7][28] - The quarterly burn rate was $10,100,000, lower than the average burn rate of $11,000,000 for the preceding four quarters [25] Business Line Data and Key Metrics Changes - The EsoGuard sales channels have seen significant advancements, with a focus on expanding coverage and reimbursement [6][9] - The concierge medicine cash pay program has signed 20 contracts within a few weeks of launch, indicating strong initial traction [8][20] Market Data and Key Metrics Changes - The company has submitted claims to 400 payers, with ongoing conversations with numerous commercial payers [94] - The NCCN guidelines now include a section on screening for esophageal precancer, which is expected to influence positive policy coverage decisions from commercial payers [10][70] Company Strategy and Development Direction - The company is focused on driving revenue through expanded sales channels, including direct contracting with employers and concierge medicine [14][19] - The recent positive insurance coverage policy from Highmark Blue Cross Blue Shield is seen as a precedent for future engagements with commercial payers [9][81] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for significant growth in test volume and revenue in the second half of the year, particularly with the expected Medicare coverage [22][60] - The company is confident in its ability to scale operations and target the Medicare population effectively once coverage is secured [59][61] Other Important Information - The company secured an $8,000,000 NIH grant to study EsoGuard for expanded indications, which could significantly increase the total addressable market [12][48] - The balance sheet was strengthened through long-term debt refinancing and a registered direct common stock offering, extending the runway well past key reimbursement milestones [11][24] Q&A Session Summary Question: How should we think about the volume metric going forward? - Management advised to remain conservative on test volume expectations, focusing more on revenue rather than just volume [36][37] Question: Why was the effective ASP lower than expected? - The lower ASP was attributed to the timing of payments rather than a direct reflection of payment rates [42][44] Question: Can you size the opportunity from the $8,000,000 NIH grant? - The opportunity is significant, potentially adding 20 million patients to the screening recommendations [48][50] Question: What happens if Medicare coverage is secured? - The company plans to aggressively target the Medicare population and expects to submit a backlog of claims [60][86] Question: How will NCCN inclusion help the company? - Inclusion in NCCN guidelines is expected to serve as a powerful tool in discussions with commercial payers [70][72]

Company Overview - Lucid Diagnostics Inc. is a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc. [5] - The company focuses on patients with gastroesophageal reflux disease (GERD), who are at risk of developing esophageal precancer and cancer [5]. Recent Offering - Lucid Diagnostics announced subscription agreements to sell 13,939,331 shares of common stock at a price of $1.10 per share, expecting gross proceeds of approximately $15.3 million [1]. - The offering is being managed by Canaccord Genuity as the sole placement agent, with the closing expected around March 5, 2025, subject to customary conditions [2]. Use of Proceeds - The net proceeds from the offering will be used for working capital and other general corporate purposes [2]. Regulatory Information - The securities are being offered under a registration statement on Form S-3, which was declared effective by the SEC on December 6, 2022 [3]. - A prospectus supplement will be filed with the SEC regarding the securities being offered [3]. Product Information - Lucid's EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer in at-risk patients, utilizing a noninvasive office procedure with the EsoCheck® Esophageal Cell Collection Device [5].