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MolDX to Convene Expert Medical Panel on Medicare Local Coverage Determination (LCD) for Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Prnewswire· 2025-07-16 11:31
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]
Major California Health System Launches Comprehensive Esophageal Precancer Testing Program Using Lucid Diagnostics' EsoGuard® Esophageal DNA Test
Prnewswire· 2025-06-18 16:02
Core Viewpoint - Lucid Diagnostics has partnered with Hoag to enhance access to EsoGuard esophageal precancer testing, aiming to combat the rising incidence of esophageal cancer in Orange County [1][2]. 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]. - The EsoGuard® Esophageal DNA Test is the first and only commercially available tool designed for early detection of esophageal precancer in at-risk patients, performed through a non-invasive office procedure [3]. Partnership Details - Hoag has launched a comprehensive esophageal precancer testing program using Lucid's EsoGuard test, integrating it into its digestive health, primary care, and concierge medicine programs [1]. - The partnership is seen as a significant milestone in expanding access to EsoGuard within large healthcare systems, with expectations that it will serve as a model for other health systems [2]. Industry Context - The incidence of esophageal cancer has increased tenfold over the past four decades, highlighting the need for effective screening methods [2]. - The EsoGuard test offers a 3-minute non-endoscopic procedure aimed at identifying at-risk patients, which is critical for early intervention and potentially saving lives [2]. Hoag Overview - Hoag is a nonprofit regional healthcare delivery system in Orange County, California, recognized for its comprehensive personalized care and consisting of 1,800 physicians, 17 urgent care facilities, and two award-winning hospitals [5]. - It is ranked as the highest hospital in Orange County by U.S. News & World Report and is known for its specialized services in various health areas, including cancer and digestive health [5].
Lucid Diagnostics(LUCD) - 2025 FY - Earnings Call Transcript
2025-06-18 16:00
Financial Data and Key Metrics Changes - The meeting confirmed that a majority of shares were represented, constituting a quorum for the voting process [9] - The preliminary vote tallies indicated that management nominees were elected as directors and the issuance of common stock under the senior secured convertible notes was approved [20] Business Line Data and Key Metrics Changes - The proposal to approve the issuance of shares under the senior secured convertible notes was discussed, with a majority of shares voting in favor [14][16] Market Data and Key Metrics Changes - No specific market data or key metrics were provided during the meeting Company Strategy and Development Direction and Industry Competition - The company is focused on maintaining compliance with Nasdaq listing rules and ensuring proper governance through the election of board members and the appointment of auditors [10][17] Management's Comments on Operating Environment and Future Outlook - Management did not provide specific comments on the operating environment or future outlook during this meeting Other Important Information - The meeting was conducted via live webcast, allowing stockholders to vote and submit questions [3][4] - The final vote tallies will be disclosed in public filings with the SEC after the meeting [20] Q&A Session Summary - No questions were submitted during the meeting, and management indicated that they would respond to appropriate questions after the meeting [21]
Lucid Diagnostics Inc. (LUCD) Q1 2025 Business Update Call Transcript
Seeking Alpha· 2025-05-14 17:51
Core Viewpoint - Lucid Diagnostics Inc. provided a business update and financial results for Q1 2025 during a conference call, highlighting key developments and future outlooks for the company [1][2][3]. Group 1: Company Overview - The conference call featured key participants including Matt Riley (Senior Director of Investor Relations), Dr. Lishan Aklog (Chairman and CEO), and Dennis McGrath (CFO) [1][3]. - The press release detailing the business update and financial results is accessible on Lucid's official website [3]. Group 2: Financial Results - Specific financial metrics and performance indicators were likely discussed during the call, although detailed figures are not provided in the available text [1][2][3].
Lucid Diagnostics Inc. (LUCD) Reports Q1 Loss, Lags Revenue Estimates
ZACKS· 2025-05-14 14:16
Core Viewpoint - Lucid Diagnostics Inc. reported a quarterly loss of $0.16 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.09, marking an earnings surprise of -77.78% [1][2] Financial Performance - The company posted revenues of $0.83 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 36.31%, compared to revenues of $1 million in the same quarter last year [2] - Over the last four quarters, Lucid Diagnostics has not surpassed consensus EPS estimates and has topped revenue estimates only once [2] Stock Performance - Lucid Diagnostics shares have increased approximately 45.4% since the beginning of the year, significantly outperforming the S&P 500's gain of 0.1% [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $1.4 million, and for the current fiscal year, it is -$0.32 on revenues of $7 million [7] - The estimate revisions trend for Lucid Diagnostics is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Instruments industry, to which Lucid Diagnostics belongs, is currently in the top 32% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]
Lucid Diagnostics(LUCD) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:32
Financial Data and Key Metrics Changes - The company reported revenue of $800,000 for the first quarter, which fell short of expectations due to external headwinds and a greater concentration of testing through healthcare events [8][27] - The cash balance at the end of the first quarter was $25.2 million, which does not include the net proceeds from a recent public offering that raised approximately $16.1 million, bringing pro forma cash to over $41 million [23][11] - The non-GAAP net loss for the first quarter was $11.2 million, slightly higher than the trailing average of $10.8 million, with a non-GAAP net loss per share of $0.16 [29][28] Business Line Data and Key Metrics Changes - The company performed 3,034 EsoGuard tests in the first quarter, exceeding the target range of 2,500 to 3,000 tests [7] - The company doubled the number of contracts in its concierge medicine program and employer contracts in the first quarter [9][10] - The average allowable amount per test from adjudicated claims was approximately $13.62, with a median at the Medicare rate of $19.38 [32] Market Data and Key Metrics Changes - The company is experiencing delays in cash collections primarily from United Healthcare due to a national issue with a new claims processing system [27] - The percentage of Medicare volume is currently estimated at 10-15%, with a goal to increase this to 40% once Medicare coverage is secured [60][61] Company Strategy and Development Direction - The company is focused on driving commercialization of EsoGuard and enhancing long-term shareholder value, with a strong emphasis on securing Medicare coverage [5][6] - The company is actively engaging with regional commercial insurers to secure EsoGuard coverage and has seen positive developments with Highmark Blue Cross Blue Shield of New York [14][15] - The company is also targeting cash pay and contracted programs with concierge medicine practices and employers to diversify revenue streams [10][81] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the imminent Medicare coverage decision and believes it will significantly enhance commercialization efforts [38][40] - The company is preparing for a potential increase in test volumes and revenue once Medicare coverage is secured, while also managing cash burn effectively [70][82] - Management highlighted the importance of ongoing clinical studies to support expanded indications for EsoGuard, particularly in asymptomatic patients [44][46] Other Important Information - The company has secured a significant NIH grant for a larger study to replicate initial positive findings regarding EsoGuard's effectiveness in patients without GERD symptoms [46] - The company is actively involved in legislative efforts to promote biomarker testing coverage, although it acknowledges the challenges in translating state mandates into payer reimbursements [84][85] Q&A Session Summary Question: Impact of weather on Q1 volumes - Management indicated that there was no evidence that weather impacted volumes, noting a shift towards larger testing events which can create lumpier revenue [35][36] Question: Status of Medicare coverage discussions - Management confirmed ongoing engagement with the Medicare group and expressed confidence in the upcoming decision based on previous discussions [38][39] Question: Future studies related to EsoGuard - Management stated that additional data from the NIH study will be crucial for expanding clinical indications and market opportunities [41][46] Question: Trends in Medicare mix - Management noted that the current Medicare volume is lower than desired but plans to increase this significantly post-approval [60][61] Question: Marketing strategies for concierge medicine - Management explained that they are optimizing patient-facing materials and processes to effectively market EsoGuard within concierge practices [72][73] Question: Legislative efforts for biomarker testing - Management is actively engaged in legislative efforts to promote biomarker testing coverage but does not expect it to be a complete solution [84][85]
Lucid Diagnostics(LUCD) - 2025 Q1 - Earnings Call Transcript
2025-05-14 13:30
Lucid Diagnostics (LUCD) Q1 2025 Earnings Call May 14, 2025 08:30 AM ET Speaker0 Good morning, and welcome to the Lucid Diagnostics First Quarter twenty twenty five Business Update Conference Call. Please note this event is being recorded. I would now like to turn the conference call over to Mr. Matt Reilly, Lucid Diagnostics Senior Director of Investor Relations. Please go ahead. Speaker1 Thank you, operator. Good morning, everyone. Thank you for participating in today's business update call. Joining me to ...
Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Results
2025-05-14 12:20
Exhibit 99.1 Lucid Diagnostics Provides Business Update and Reports First Quarter 2025 Financial Results Processed 3,034 EsoGuard tests and recognized revenue of $0.8 million in 1Q25 Secured capital to extend runway well past key upcoming reimbursement milestones; ended 1Q25 with over $40 million in proforma cash Conference call and webcast to be held today, May 14, at 8:30 AM EDT NEW YORK, May 14, 2025 - Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention ...
Lucid Diagnostics(LUCD) - 2025 Q1 - Quarterly Report
2025-05-13 20:58
Financial Performance - Revenue for the three months ended March 31, 2025, was $0.8 million, a decrease of 20% compared to $1.0 million for the same period in 2024[141] - Cost of revenue for the three months ended March 31, 2025, was approximately $1.6 million, down from $1.7 million in the prior year, reflecting a decrease of about 5.88%[142] - Sales and marketing expenses for the three months ended March 31, 2025, were approximately $4.1 million, a slight decrease of 2.38% from $4.2 million in the same period last year[142] - General and administrative expenses increased to approximately $6.2 million for the three months ended March 31, 2025, compared to $4.1 million in the same period of the prior year, reflecting a net increase of $2.1 million[143] - Research and development costs decreased to approximately $1.4 million for the three months ended March 31, 2025, down from $1.5 million in the prior year, primarily due to a $0.3 million decrease in manufacturing costs related to EsoCheck devices[144] - The amortization of acquired intangible assets was approximately $0.1 million for the three months ended March 31, 2025, compared to $0.4 million in the prior year, a decrease of $0.3 million due to certain assets being fully amortized[146] - The company experienced a net loss of approximately $26.9 million and used approximately $12.5 million of cash in operations during the quarter ended March 31, 2025[152] - Cash on hand at the end of the quarter was $25.2 million as of March 31, 2025[152] Funding and Capital Raising - The Company closed on the sale of 14,375,000 shares at $1.20 per share in April 2025, resulting in net proceeds of approximately $16.1 million for working capital[122] - The company closed on the sale of 13,939,331 shares of common stock at $1.10 per share on March 5, 2025, resulting in net proceeds of approximately $14.9 million[156] - On April 11, 2025, the company sold 14,375,000 shares of common stock at $1.20 per share, generating net proceeds of approximately $16.1 million[157] - The company raised gross proceeds of $21.975 million from the sale of 12.0% Senior Secured Convertible Notes due 2029 on November 22, 2024, with net proceeds of $18.3 million after repaying the March 2023 Senior Convertible Note[160] - The company has entered into a committed equity facility allowing for the purchase of up to $50 million of common stock, with $1.8 million raised as of March 31, 2025[158] Product Development and Research - The EsoGuard Esophageal DNA Test has demonstrated a sensitivity of approximately 90% for detecting disease across the esophageal precancer to cancer spectrum, with a negative predictive value (NPV) of around 99%[119] - The Company plans to incur research and development expenses for the foreseeable future to support the development of existing products and new innovations[136] - An $8 million NIH grant was awarded for a five-year clinical study evaluating EsoCheck and EsoGuard for esophageal precancer detection among at-risk individuals without GERD symptoms[128] - EsoCheck is an FDA 510(k) and CE Mark cleared device that allows for non-invasive sampling of surface esophageal cells in a less than five-minute office procedure[120] Regulatory and Coverage Updates - A recent update to the NCCN Clinical Practice Guidelines now includes a section on Barrett's Esophagus (BE) screening, recommending non-endoscopic biomarker testing like EsoGuard as an alternative to invasive procedures[125] - Highmark Blue Cross Blue Shield issued a positive coverage policy for EsoGuard in New York, covering patients meeting established criteria for esophageal precancer testing[127] Accounting and Compliance - The company's financial statements are prepared in accordance with U.S. GAAP, requiring estimates and assumptions that may affect reported amounts[164] - There have been no material changes to the company's critical accounting estimates in the three months ended March 31, 2025[164] - As of March 31, 2025, the company had a payment obligation liability of $0.0 million, indicating no accrued obligations under the payroll and benefit expense reimbursement agreement or other operating expenses[163] Strategic Focus - The company is focused on the commercialization of EsoGuard and expanding insurance reimbursement coverage while developing additional products and services[150]
Will Lucid Diagnostics Inc. (LUCD) Report Negative Earnings Next Week? What You Should Know
ZACKS· 2025-05-07 15:05
Company Overview - Lucid Diagnostics Inc. (LUCD) is expected to report a quarterly loss of $0.09 per share, reflecting a year-over-year improvement of +57.1% [3] - Revenues for the upcoming quarter are anticipated to be $1.3 million, which is a 30% increase from the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 40% higher in the last 30 days, indicating a reassessment by analysts [4] - The Most Accurate Estimate for Lucid Diagnostics aligns with the Zacks Consensus Estimate, resulting in an Earnings ESP of 0% [10][11] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that a positive or negative reading indicates the likelihood of actual earnings deviating from consensus estimates, with a strong predictive power for positive readings [7][8] - Lucid Diagnostics currently holds a Zacks Rank of 2 (Buy), but this combination does not strongly indicate an earnings beat [11] Historical Performance - In the last reported quarter, Lucid Diagnostics was expected to post a loss of $0.15 per share but actually reported a loss of $0.19, resulting in a surprise of -26.67% [12] - The company has not beaten consensus EPS estimates in any of the last four quarters [13] Market Context - The upcoming earnings report for Lucid Diagnostics is scheduled for May 14, and the stock's movement will depend on whether the actual results exceed or fall short of expectations [2] - Other factors beyond earnings results may also influence stock performance, as stocks can decline despite an earnings beat or rise despite a miss [14][16]