NEW YORK, Aug. 5, 2024 /PRNewswire/ -- Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company"), a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced that management will participate in the following upcoming investor conferences: 9th Annual Needham Virtual MedTech & Diagnostics 1x1 Conference Dates: August 12-13, 2024 Canaccord Genuity 44th Annual Growth Conference Fireside Chat: Tuesday, August 13, 2024, at 1:30 PM ET The ...

Conference Call and Webcast at 8:30AM Eastern Time Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at luciddx.com. For more information, please visit www.luciddx.com and for more information about its parent company PAVmed, please visit www.pavmed.com. The webcast will be available at the investor relations section of the Company's website at luciddx.com. Alternatively, to access the conference call by telepho ...

"Our commercial and clinical teams remain relentlessly focused on expanding awareness of, demand for and access to EsoGuard esophageal precancer testing at physician offices, integrated health systems and #CheckYourFoodTube testing events," said Lishan Aklog, M.D., Lucid's Chairman and Chief Executive Officer. About Lucid Diagnostics This press release includes forward-looking statements that involve risk and uncertainties. Forward-looking statements are any statements that are not historical facts. Such fo ...

NEW YORK, July 11, 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), today announced the launch of its newly redesigned corporate website, www.luciddx.com. "We designed the new website to highlight our mission to prevent esophageal cancer and offer patients, healthcare professionals, investors, and other interested parties a user-friendly experi ...

Core Viewpoint - Lucid Diagnostics has reached a significant milestone with the 4,000th firefighter undergoing esophageal precancer testing using its EsoGuard® Esophageal DNA test, highlighting the proactive measures taken by the firefighter community to combat the elevated cancer risks they face [1][6]. Company Overview - Lucid Diagnostics Inc. 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 [3][8]. - The EsoGuard® Esophageal DNA Test is designed for early detection of esophageal precancer through a noninvasive procedure using the EsoCheck® Esophageal Cell Collection Device, which is the first and only commercially available tool aimed at preventing cancer through early detection [3][6]. Event Details - The CheckYourFoodTube event, organized in partnership with Mass General Brigham and Boston Firefighters Local 718 IAFF, is part of a series of initiatives aimed at screening firefighters for esophageal precancer [1][2]. - This event marks the 105th occurrence of the CheckYourFoodTube initiative, which is integral to Lucid's strategy to increase test volume and awareness among at-risk populations [2][6]. Industry Context - Firefighters face a 62% increased risk of developing esophageal cancer and a 39% increased risk of dying from it, according to the Firefighter Cancer Support Group [6]. - The American Cancer Society estimates that in 2024, there will be 22,370 new cases of esophageal cancer, with 16,130 deaths attributed to the disease [6].

Exhibit 99.1 Lucid Diagnostics Provides Business Update and First Quarter 2024 Financial Results Quarterly EsoGuardtest volume increased 10 percent Strengthened balance sheet following completion of $29.8 million Series B Preferred Stock Of ering MolDX pre-submission meeting scheduled for July 17, 2024 Conference call and webcast to be held today, May 13 at 8:30 AM EDT NEW YORK, May 13, 2024 - Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diag ...

Financial Data and Key Metrics Changes - The company reported a non-GAAP loss of $9.4 million for Q1 2024, reflecting a $500,000 sequential improvement compared to Q4 2023 and a $400,000 improvement year-over-year [15][37] - Revenue for Q1 2024 was just over $1 million, flat compared to Q4 2023 but representing a 124% increase year-over-year [38][95] - The average quarterly burn rate for the trailing four quarters was $9.5 million, with Q1 2024 burn including $7 million from ongoing operations and $2.5 million from a management services agreement [37][67] Business Line Data and Key Metrics Changes - Test volume for Q1 2024 was 2,420 tests, a 10% increase quarter-over-quarter and a 31% increase year-over-year [38][95] - The gross margin at current volumes is approximately 90%, facilitating the business's ability to generate revenue [97] - The company has implemented a streamlined telehealth operation to enhance testing efficiency, particularly during high-volume health events [7][95] Market Data and Key Metrics Changes - The total addressable market opportunity for the company's tests is approximately $50 billion, with over 30 million patients at risk for esophageal cancer [6] - The average allowed amount for out-of-network claims remains stable at just under the Medicare rate of $1,938 per test [76][99] - Approximately 75% of claims submitted have been adjudicated, with nearly half resulting in an allowable amount by insurance companies [128] Company Strategy and Development Direction - The company is focused on securing medical policy coverage with regional plans and engaging in direct contracting with self-insured entities [60][80] - The company plans to ramp up its direct contracting initiatives during the second half of the year, targeting large groups of patients [79] - The company is actively pursuing biomarker legislation states to enhance coverage opportunities [9][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming MolDX pre-submission meeting scheduled for July 17, which aims to secure coverage for EsoGuard [60][116] - The management highlighted the importance of improving revenue cycle management processes, including prior authorization programs to reduce denials [67][76] - The company is confident in its technology's ability to detect pre-cancer effectively, which is critical for impacting cancer death rates [64][77] Other Important Information - The company completed a $29.8 million Series B preferred stock offering, strengthening its balance sheet and extending its operational runway [75][76] - The company has not experienced any device failures with EsoCheck in over 10,000 tests, contrasting with issues faced by competitors [68][84] - The company is preparing for a significant presence at the upcoming DDW meeting, which is a major event in the gastroenterology field [47][98] Q&A Session Summary Question: What are the expectations for the upcoming MolDX pre-submission meeting? - The meeting aims to review data with the MolDX group for a technical assessment seeking coverage of EsoGuard under Medicare [108] Question: Can you provide an update on the reimbursement landscape? - Approximately 75% of claims submitted have been adjudicated, with nearly half resulting in allowable amounts, indicating progress in the reimbursement process [128] Question: How does the company view the competitive landscape, especially with recent recalls in the industry? - The company believes that recent issues faced by competitors, such as the Cytosponge recall, may provide a competitive advantage for its products [119][120]

Part I - Financial Information This section provides Lucid Diagnostics Inc.'s unaudited condensed consolidated financial statements and management's discussion and analysis for the three months ended March 31, 2024 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Lucid Diagnostics Inc.'s unaudited condensed consolidated financial statements for Q1 2024 and 2023, including balance sheets, statements of operations, equity changes, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity at specific points in time | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Total Assets | $32,048 | $27,270 | | Total Liabilities | $20,154 | $29,581 | | Total Stockholders' Equity (Deficit) | $11,894 | $(2,311) | - Total assets increased by **$4,778 thousand**, driven by a rise in cash from **$18,896 thousand** to **$24,769 thousand**[9](index=9&type=chunk) - Total liabilities decreased significantly by **$9,427 thousand**, primarily due to a reduction in 'Due To: PAVmed Inc.' and the Senior Secured Convertible Note[9](index=9&type=chunk) - Stockholders' Equity shifted from a deficit of **$(2,311) thousand** to a positive **$11,894 thousand**[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines the company's financial performance over a period, detailing revenues, expenses, and net loss | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $1,001 | $446 | | Total Operating Expenses | $11,793 | $14,763 | | Operating Loss | $(10,792) | $(14,317) | | Net Loss attributable to Lucid Diagnostics Inc. | $(10,612) | $(16,247) | | Net Loss per share (basic and diluted) | $(0.40) | $(0.40) | - Revenue increased by **124.4%** year-over-year[11](index=11&type=chunk) - Total operating expenses decreased by **20.1%** due to lower general and administrative expenses and research and development[11](index=11&type=chunk) - The net loss attributable to Lucid Diagnostics Inc. improved by **34.6%** from **$(16,247) thousand** to **$(10,612) thousand**, despite a deemed dividend on preferred stock in 2024[11](index=11&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) This section details the changes in the company's equity over time, including preferred stock, common stock, and accumulated deficit | Metric (in thousands) | Balance as of Dec 31, 2023 | Balance as of Mar 31, 2024 | | :-------------------- | :------------------------- | :------------------------- | | Preferred Stock Amount | $18,625 | $44,285 | | Common Stock Amount | $42 | $47 | | Additional Paid-In Capital | $129,763 | $136,411 | | Accumulated Deficit | $(150,741) | $(168,849) | | Total Stockholders' Equity (Deficit) | $(2,311) | $11,894 | - The company's total stockholders' equity significantly improved from a deficit of **$(2,311) thousand** at December 31, 2023, to a positive **$11,894 thousand** at March 31, 2024[13](index=13&type=chunk) - This was primarily driven by the issuance of Series B Preferred Stock (**$44,285 thousand**) and settlement of 'Due To: PAVmed Inc.' in common stock (**$4,675 thousand**), partially offset by a net loss and a deemed dividend on preferred stock exchange[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities for the period | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Net Cash Flows Used in Operating Activities | $(12,612) | $(7,120) | | Net Cash Flows Used in Investing Activities | $(37) | $(17) | | Net Cash Flows Provided by Financing Activities | $18,522 | $24,185 | | Net Increase (Decrease) in Cash | $5,873 | $17,048 | | Cash, End of Period | $24,769 | $39,522 | - Cash used in operating activities increased significantly from **$(7,120) thousand** in Q1 2023 to **$(12,612) thousand** in Q1 2024[15](index=15&type=chunk) - Cash provided by financing activities decreased from **$24,185 thousand** to **$18,522 thousand**, primarily due to lower proceeds from the issue of preferred stock and convertible notes compared to the prior year[15](index=15&type=chunk) - Despite increased operating cash burn, the company ended Q1 2024 with **$24,769 thousand** in cash, an increase of **$5,873 thousand** for the quarter[15](index=15&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of significant accounting policies, financial instruments, and other relevant disclosures supporting the financial statements [Note 1 — The Company](index=8&type=section&id=Note%201%20%E2%80%94%20The%20Company) This note describes Lucid Diagnostics Inc.'s business, its focus on early detection of esophageal precancer, and its flagship products - Lucid Diagnostics Inc. is a commercial-stage medical diagnostics technology company focused on early detection of esophageal precancer and cancer (EAC) in GERD patients[16](index=16&type=chunk) - Its flagship product, EsoGuard Esophageal DNA Test, performed with the EsoCheck Esophageal Cell Collection Device, is presented as the first and only commercially available diagnostic test for widespread early detection of esophageal precancer[17](index=17&type=chunk) - EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device utilizing proprietary Collect+Protect™ technology for targeted cell sampling[19](index=19&type=chunk) [Note 2 — Liquidity and Going Concern](index=9&type=section&id=Note%202%20%E2%80%94%20Liquidity%20and%20Going%20Concern) This note addresses the company's financial viability, highlighting its current liquidity position and ability to continue operations - The Company generated **$1.0 million** in revenue for Q1 2024 but does not expect positive cash flows from operating activities in the near future[23](index=23&type=chunk) - Lucid incurred a net loss of approximately **$18.1 million** and used **$12.6 million** in operating cash flows for Q1 2024[24](index=24&type=chunk) - As of March 31, 2024, working capital was approximately **$7.6 million**, including **$24.8 million** in cash[24](index=24&type=chunk) - These factors raise substantial doubt about the Company's ability to continue as a going concern within one year, contingent on generating substantial revenue from third-party reimbursement and raising additional capital[25](index=25&type=chunk) [Note 3 — Summary of Significant Accounting Policies](index=9&type=section&id=Note%203%20%E2%80%94%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements, including revenue recognition and fair value measurements - The financial statements are prepared in accordance with U.S. GAAP and SEC rules, consolidating the Company and its wholly-owned subsidiaries, with all intercompany transactions eliminated[27](index=27&type=chunk) - Revenue is primarily generated from EsoGuard Esophageal DNA tests, recognized upon release of patient test results to healthcare providers, with consideration being variable or fixed depending on payer contracts[32](index=32&type=chunk)[33](index=33&type=chunk) - The March 2023 Senior Secured Convertible Note is accounted for under the fair value option (FVO) election, with changes in fair value recognized in the statement of operations[40](index=40&type=chunk)[42](index=42&type=chunk) [Note 4 — Revenue from Contracts with Customers](index=13&type=section&id=Note%204%20%E2%80%94%20Revenue%20from%20Contracts%20with%20Customers) This note details the company's revenue recognition policies and the sources of its revenue from customer contracts | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Revenue | $1,001 | $446 | | Cost of Revenue | $1,656 | $1,338 | - Revenue recognized from EsoGuard test results increased by **124.4%** year-over-year[48](index=48&type=chunk)[50](index=50&type=chunk) - Cost of revenue increased by **23.8%** primarily due to laboratory operations and EsoCheck device supplies[48](index=48&type=chunk)[50](index=50&type=chunk) [Note 5 — Related Party Transactions](index=13&type=section&id=Note%205%20%E2%80%94%20Related%20Party%20Transactions) This note discloses transactions between the company and its related parties, including fees and settlements with PAVmed Inc | Metric (in thousands) | Balance - Dec 31, 2023 | Balance - Mar 31, 2024 | | :-------------------- | :--------------------- | :--------------------- | | Total Due To: PAVmed Inc. | $9,339 | $1,871 | - The MSA Fee with PAVmed Inc. increased to **$833 thousand** per month effective January 1, 2024, from **$750 thousand** per month in Q1 2023[52](index=52&type=chunk) - On January 26, 2024, PAVmed elected to receive payment of **$4,675 thousand** in fees and reimbursements through the issuance of **3,331,771 shares** of Lucid Diagnostics common stock[53](index=53&type=chunk) [Note 6 — Prepaid Expenses, Deposits, and Other Current Assets](index=15&type=section&id=Note%206%20%E2%80%94%20Prepaid%20Expenses,%20Deposits,%20and%20Other%20Current%20Assets) This note provides details on the company's prepaid expenses, deposits, and other short-term assets | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Total prepaid expenses, deposits and other current assets | $2,355 | $2,854 | - Prepaid expenses, deposits, and other current assets decreased by **$499 thousand** from December 31, 2023, to March 31, 2024, primarily due to reductions in prepaid insurance and deposits[55](index=55&type=chunk) [Note 7 — Leases](index=15&type=section&id=Note%207%20%E2%80%94%20Leases) This note describes the company's lease arrangements, including right-of-use assets and lease liabilities | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Operating lease right-of-use assets | $1,039 | $1,307 | | Total lease payments | $1,088 | N/A | | Present value of lease liabilities | $1,038 | $1,305 | - The company's operating lease right-of-use assets and lease liabilities decreased from December 31, 2023, to March 31, 2024[56](index=56&type=chunk)[58](index=58&type=chunk) - Future lease payments total **$1,088 thousand**, with the majority due in the remainder of 2024[56](index=56&type=chunk)[58](index=58&type=chunk) [Note 8 — Intangible Assets, net](index=16&type=section&id=Note%208%20%E2%80%94%20Intangible%20Assets,%20net) This note provides information on the company's intangible assets, including their amortization and net carrying value | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Total Intangible assets | $5,305 | $5,305 | | Less Accumulated Amortization | $(4,253) | $(3,881) | | Intangible Assets, net | $1,052 | $1,424 | - Net intangible assets decreased by **$372 thousand** due to amortization expense[59](index=59&type=chunk) - Amortization expense for Q1 2024 was **$372 thousand**, down from **$505 thousand** in Q1 2023, as some assets became fully amortized[59](index=59&type=chunk)[144](index=144&type=chunk) [Note 9 — Financial Instruments Fair Value Measurements](index=17&type=section&id=Note%209%20%E2%80%94%20Financial%20Instruments%20Fair%20Value%20Measurements) This note explains the valuation methodologies and assumptions used for financial instruments measured at fair value | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | March 2023 Senior Convertible Note (Fair Value) | $13,140 | $13,950 | - The March 2023 Senior Convertible Note is classified as a Level 3 financial instrument and its fair value is determined using a Monte Carlo simulation with both observable and unobservable inputs[61](index=61&type=chunk)[62](index=62&type=chunk) | Valuation Assumption | March 31, 2024 | December 31, 2023 | | :------------------- | :------------- | :---------------- | | Required rate of return | 9.80% | 10.00% | | Conversion Price | $5.00 | $5.00 | | Value of common stock | $0.81 | $1.41 | | Expected term (years) | 0.97 | 1.22 | | Volatility | 55.00% | 60.00% | | Risk free rate | 4.93% | 4.56% | [Note 10 — Debt](index=18&type=section&id=Note%2010%20%E2%80%94%20Debt) This note details the company's debt obligations, including convertible notes, their terms, and related transactions | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | March 2023 Senior Convertible Note (Face Value Principal) | $10,936 | $11,019 | | March 2023 Senior Convertible Note (Fair Value) | $13,140 | $13,950 | - The March 2023 Senior Convertible Note has a face value principal of **$11.1 million**, a **7.875%** annual interest rate, a **$5.00** conversion price, and matures on March 21, 2025[66](index=66&type=chunk) - In Q1 2024, approximately **$83 thousand** of principal and **$436 thousand** of interest were settled by issuing **543,298 common shares**, resulting in a **$167 thousand** debt extinguishment loss[75](index=75&type=chunk) - The company is subject to financial covenants, including maintaining a minimum of **$5.0 million** in available cash and a market capitalization of at least **$30 million**, with which it was in compliance as of March 31, 2024[73](index=73&type=chunk) [Note 11 — Stock-Based Compensation](index=19&type=section&id=Note%2011%20%E2%80%94%20Stock-Based%20Compensation) This note describes the company's stock-based compensation plans, including expense recognition and outstanding awards | Metric (in thousands) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Total stock-based compensation expense | $933 | $3,208 | - Total stock-based compensation expense decreased significantly from **$3,208 thousand** in Q1 2023 to **$933 thousand** in Q1 2024, primarily due to a large decrease in general and administrative stock-based compensation[83](index=83&type=chunk) - As of March 31, 2024, **8,332,713 stock options** were outstanding with a weighted average exercise price of **$1.74**, and **2,297,440 unvested restricted stock awards** were outstanding[79](index=79&type=chunk)[81](index=81&type=chunk) [Note 12 — Stockholders' Equity](index=23&type=section&id=Note%2012%20%E2%80%94%20Stockholders'%20Equity) This note provides details on the company's equity structure, including preferred and common stock issuances, and deemed dividends - On March 13, 2024, the Company issued **44,285 shares** of Series B Convertible Preferred Stock for **$18.1 million** and exchanged all outstanding Series A and Series A-1 Preferred Stock for Series B Preferred Stock[86](index=86&type=chunk)[101](index=101&type=chunk) - The Series B Preferred Stock has a stated value of **$1,000 per share**, an initial conversion price of **$1.2444**, and includes dividend rights and a one-time liquidation preference[87](index=87&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk) - A deemed dividend of **$7,495 thousand** was recognized and charged to accumulated deficit on March 13, 2024, due to the Series B Preferred Stock issuance and exchange[102](index=102&type=chunk) - Subsequent to March 31, 2024, on May 6, 2024, the Company issued **11,634 shares** of Series B-1 Convertible Preferred Stock for **$11.6 million**, with similar terms to Series B but a conversion price of **$0.7228**[94](index=94&type=chunk)[95](index=95&type=chunk) [Note 13 — Net Loss Per Share](index=26&type=section&id=Note%2013%20%E2%80%94%20Net%20Loss%20Per%20Share) This note presents the calculation of basic and diluted net loss per share, including factors affecting dilutive securities | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :----- | :-------------------------------- | :-------------------------------- | | Net loss attributable to Lucid Diagnostics Inc. common stockholders | $(18,108) | $(16,247) | | Weighted average common shares outstanding, basic and diluted | 45,014,410 | 40,970,504 | | Net loss per share - basic and diluted | $(0.40) | $(0.40) | - Net loss per share remained at **$(0.40)** for both periods, despite a higher net loss attributable to common stockholders in Q1 2024 due to a **$7,496 thousand** deemed dividend on preferred stock[108](index=108&type=chunk) - Common stock equivalents, including stock options, unvested restricted stock awards, and preferred stock, were excluded from diluted EPS calculation as their inclusion would be anti-dilutive due to the company's net loss position[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of Lucid Diagnostics Inc.'s financial condition and operational results for Q1 2024, covering business overview, recent developments, detailed financial performance, liquidity, and critical accounting estimates [Overview](index=28&type=section&id=Overview) This section introduces Lucid Diagnostics Inc.'s business, its flagship product EsoGuard, and its role in early detection of esophageal precancer - Lucid Diagnostics is a commercial-stage medical diagnostics company focused on early detection of esophageal precancer and cancer (EAC) in at-risk patients[117](index=117&type=chunk) - The flagship product, EsoGuard Esophageal DNA Test, performed with the EsoCheck Esophageal Cell Collection Device, is positioned as the first and only widespread diagnostic tool for early detection of esophageal precancer, including Barrett's Esophagus (BE)[118](index=118&type=chunk) - EsoGuard demonstrated high analytical sensitivity (**97%**), specificity (**95%**), and accuracy (**98%**), with clinical validation showing **84%** sensitivity and **86%** specificity for BE detection[119](index=119&type=chunk) [Recent Developments](index=29&type=section&id=Recent%20Developments) This section highlights key business and financing events that have occurred recently, impacting the company's operations and capital structure [Business](index=29&type=section&id=Business) This section details recent operational and regulatory updates, including changes to the MSA with PAVmed and FDA's LDT rule impact - The management services agreement (MSA) with PAVmed was amended to increase the monthly fee to **$0.83 million**, effective January 1, 2024[122](index=122&type=chunk) - PAVmed elected to receive approximately **$4.7 million** in fees and reimbursements through the issuance of **3,331,771 shares** of Lucid's common stock on January 26, 2024[123](index=123&type=chunk) - The FDA's final rule on LDTs will not immediately impact Lucid's regulatory strategy, as EsoGuard was marketed prior to May 6, 2024, and is NYS CLEP-approved, thus remaining under continued enforcement discretion[124](index=124&type=chunk) [Financing](index=29&type=section&id=Financing) This section outlines recent capital-raising activities, including preferred stock offerings and their impact on the company's financial position - On March 13, 2024, the company completed a Series B Preferred Stock offering and exchange, raising **$18.16 million** and converting all Series A and A-1 Preferred Stock into Series B Preferred Stock[126](index=126&type=chunk)[127](index=127&type=chunk) - Subsequent to March 31, 2024, on May 6, 2024, the company issued Series B-1 Convertible Preferred Stock, raising an additional **$11.6 million**, concluding its Board-approved **$30 million** preferred stock offering[128](index=128&type=chunk)[129](index=129&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance for the three months ended March 31, 2024, versus 2023 [The three months ended March 31, 2024 as compared to three months ended March 31, 2023](index=33&type=section&id=The%20three%20months%20ended%20March%2031,%202024%20as%20compared%20to%20three%20months%20ended%20March%2031,%202023) This section offers a detailed comparative analysis of key financial metrics and their changes between the two periods [Revenue](index=33&type=section&id=Revenue) This section analyzes the company's revenue performance, highlighting growth drivers and key contributing factors | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Revenue | $1.0 | $0.4 | - Revenue increased by **$0.6 million**, or **150%**, primarily due to increased EsoGuard Esophageal DNA Test performance in the company's CLIA laboratory[141](index=141&type=chunk) [Cost of revenue](index=33&type=section&id=Cost%20of%20revenue) This section examines the changes in the costs directly associated with generating revenue, including supplies and compensation | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Cost of revenue | $1.7 | $1.3 | - Cost of revenue increased by **$0.4 million**, or **30.8%**, mainly due to higher EsoCheck and EsoGuard supplies costs and increased compensation-related costs, including stock-based compensation[142](index=142&type=chunk) [Sales and marketing expenses](index=33&type=section&id=Sales%20and%20marketing%20expenses) This section details the trends and drivers behind the company's sales and marketing expenditures | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Sales and marketing expenses | $4.2 | $4.1 | - Sales and marketing expenses increased by **$0.1 million**, or **2.4%**, primarily due to higher compensation-related costs from changes in headcount, bonus structure, and travel expenses[142](index=142&type=chunk) [General and administrative expenses](index=33&type=section&id=General%20and%20administrative%20expenses) This section analyzes the changes in general and administrative costs, including stock-based compensation and professional fees | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | General and administrative expenses | $4.1 | $6.9 | - General and administrative expenses decreased by **$2.8 million**, or **40.6%**, mainly due to a **$2.4 million** decrease in stock-based compensation and a **$0.9 million** decrease in third-party professional fees, partially offset by a **$0.3 million** increase from the amended MSA with PAVmed[143](index=143&type=chunk)[146](index=146&type=chunk) [Research and development expenses](index=33&type=section&id=Research%20and%20development%20expenses) This section reviews the company's research and development expenditures, focusing on changes in clinical trial and consulting costs | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Research and development expenses | $1.5 | $1.9 | - Research and development expenses decreased by **$0.4 million**, or **21.1%**, primarily due to a reduction in development costs, particularly in clinical trial activities and outside professional and consulting fees related to EsoCure[143](index=143&type=chunk) [Amortization of Acquired Intangible Assets](index=33&type=section&id=Amortization%20of%20Acquired%20Intangible%20Assets) This section discusses the amortization expense related to acquired intangible assets and factors influencing its change | Metric (in millions) | Q1 2024 | Q1 2023 | | :------------------- | :------ | :------ | | Amortization of acquired intangible assets | $0.4 | $0.5 | - Amortization expense decreased by **$0.1 million**, or **20%**, as certain acquired intangible assets were fully amortized in February 2024[144](index=144&type=chunk) [Other Income and Expense](index=33&type=section&id=Other%20Income%20and%20Expense) This section covers non-operating income and expenses, including fair value adjustments of financial instruments - The change in fair value of the March 2023 Senior Convertible Note resulted in **$0.3 million** of income in Q1 2024, compared to an initial **$0.8 million** non-cash expense recognized on the issue date in Q1 2023[145](index=145&type=chunk) [Loss on Issue and Offering Costs - Senior Secured Convertible Note](index=34&type=section&id=Loss%20on%20Issue%20and%20Offering%20Costs%20-%20Senior%20Secured%20Convertible%20Note) This section details the costs and losses incurred in connection with the issuance of the Senior Secured Convertible Note - In Q1 2023, the company recognized **$1.2 million** in lender fees and offering costs related to the March 2023 Senior Convertible Note; no such costs were incurred in Q1 2024[147](index=147&type=chunk) [Loss on Debt Extinguishment](index=34&type=section&id=Loss%20on%20Debt%20Extinguishment) This section explains the loss recognized from the settlement of debt obligations through the issuance of common stock - A debt extinguishment loss of approximately **$0.2 million** was recognized in Q1 2024 due to the settlement of principal and interest repayments of the March 2023 Senior Convertible Note through the issuance of common stock[148](index=148&type=chunk) [Deemed Dividend on Series A and Series A-1 Convertible Preferred Stock Exchange Offer](index=34&type=section&id=Deemed%20Dividend%20on%20Series%20A%20and%20Series%20A-1%20Convertible%20Preferred%20Stock%20Exchange%20Offer) This section describes the deemed dividend recognized due to the exchange of preferred stock and its impact on accumulated deficit | Metric (in millions) | March 13, 2024 | | :------------------- | :------------- | | Deemed Dividend Charged to Accumulated Deficit | $7.5 | - A **$7.5 million** deemed dividend was recognized and charged to accumulated deficit on March 13, 2024, as a result of the Series B Convertible Preferred Stock issuance and the exchange of Series A and A-1 Preferred Stock[149](index=149&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations, including cash position and future funding needs - The company's current operations focus on commercializing EsoGuard through various sales channels and developing expanded clinical evidence for insurance reimbursement[150](index=150&type=chunk) - Lucid experienced a net loss of approximately **$10.6 million** and used **$12.6 million** in operating cash flows in Q1 2024, ending the quarter with **$24.8 million** in cash[152](index=152&type=chunk) - The company expects continued losses and negative cash flow, necessitating future debt and/or equity financing to fund operations and address existing convertible debt obligations, raising substantial doubt about its ability to continue as a going concern[152](index=152&type=chunk)[153](index=153&type=chunk) - The company has raised approximately **$29.8 million** from Series B and Series B-1 Preferred Stock offerings, concluding its Board-approved **$30 million** preferred stock offering[129](index=129&type=chunk)[154](index=154&type=chunk)[156](index=156&type=chunk) [Critical Accounting Estimates](index=38&type=section&id=Critical%20Accounting%20Estimates) This section discusses the significant judgments and assumptions used in preparing the financial statements that could materially affect reported results - The company's financial statements rely on estimates and assumptions, particularly for fair value of debt obligations, stock-based equity awards, intangible assets, incremental borrowing rates, and income taxes[31](index=31&type=chunk) - Management's assessment of the company's going concern ability also involves estimating future cash flows[31](index=31&type=chunk) - There have been no material changes to critical accounting policies and estimates in Q1 2024[166](index=166&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes to internal controls over financial reporting during the quarter [Evaluation of Disclosure Controls and Procedures](index=38&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section reports on management's assessment of the effectiveness of the company's disclosure controls and procedures - Management, including the principal executive and financial officers, concluded that disclosure controls and procedures were effective as of March 31, 2024, providing reasonable assurance that required information is recorded, processed, summarized, and reported timely[167](index=167&type=chunk) [Changes to Internal Controls Over Financial Reporting](index=38&type=section&id=Changes%20to%20Internal%20Controls%20Over%20Financial%20Reporting) This section discloses any material changes to the company's internal controls over financial reporting during the quarter - There were no changes in internal control over financial reporting during the fiscal quarter ended March 31, 2024, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[168](index=168&type=chunk) Part II - Other Information This section provides additional disclosures not covered in the financial statements, including legal proceedings, equity sales, and other relevant information [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) This section addresses potential legal actions and claims the company may face in the ordinary course of business, particularly during commercialization - The company is not aware of any pending legal or other proceedings that are reasonably likely to have a material impact on its business, financial position, results of operations, or cash flows[170](index=170&type=chunk) - Legal proceedings are subject to inherent uncertainties, and an unfavorable outcome could result in monetary damages or excessive verdicts, potentially having a material adverse impact[170](index=170&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=39&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on any unregistered sales of equity securities and the use of proceeds during the reporting period - On March 22, 2024, the company approved the issuance of a three-year option to acquire **100,000 common shares** at an exercise price of **$1.50 per share** to an investor relations firm, exempt from registration requirements under Section 4(a)(2) of the Securities Act[171](index=171&type=chunk) - No other unregistered securities were sold, and no securities were repurchased during the three months ended March 31, 2024, beyond what was previously disclosed[172](index=172&type=chunk) [Item 5. Other Information](index=39&type=section&id=Item%205.%20Other%20Information) This section provides other information not covered elsewhere in the report - During the fiscal quarter ended March 31, 2024, none of the company's directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement"[173](index=173&type=chunk) [Item 6. Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of this Quarterly Report on Form 10-Q - The exhibit index includes various documents such as Certificates of Designation for Series B and B-1 Preferred Stock, Exchange Agreements, Registration Rights Agreements, and certifications required by the Sarbanes-Oxley Act[181](index=181&type=chunk)

EsophaCap device recalled due to recent publication of serious device failures Lucid Diagnostics' EsoCheck® unaffected by recall and remains the gold standard for non-endoscopic cell collection NEW YORK, May 9, 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"), announced that the legacy EsophaCap sponge-on-a-string (SOS) esophage ...

Final closing yields total gross proceeds of $29.8 million from offering Mr. Matheis serves as President and CEO of Sentara Health, one of the largest not-for-profit integrated health systems in the U.S., which encompasses hospitals, a physician group, and an affiliated health plan NEW YORK, May 7, 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: PAV ...