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Lucid Diagnostics Inc. (Nasdaq: LUCD) is a commercial-stage medical diagnostics company dedicated to cancer prevention, particularly focusing on patients with gastroesophageal reflux disease (GERD). GERD, commonly known as chronic heartburn or acid reflux, places millions at risk of developing esophageal precancer and the highly lethal esophageal adenocarcinoma. Lucid's groundbreaking products, EsoCheck and EsoGuard, are at the forefront of early detection and prevention.
EsoGuard is a bisulfite-converted Next Generation Sequencing (NGS) DNA assay performed on surface esophageal cells collected with the EsoCheck device. This test quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1), detecting esophageal precancer and cancer with over 90% sensitivity and specificity. EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device. This device can sample surface esophageal cells in less than five minutes, providing an effective, non-invasive alternative to costly and invasive endoscopy.
Lucid has shown substantial progress, including solid revenue growth on stable test volumes. Their revenue cycle management processes are improving, and the CYFT program targeting specific groups like firefighters is thriving. Their direct contracting initiative is also accelerating, with near-term prospects for delivering contracts, testing, and revenue.
Recently, Lucid announced a partnership with the Esophageal Cancer Action Network (ECAN) to highlight Esophageal Cancer Awareness Month. Public service videos run on Nasdaq's billboard in Times Square, spreading awareness about the link between heartburn and esophageal cancer.
Lucid's peer-reviewed publication of positive data from a National Cancer Institute (NCI)-sponsored study confirmed the high sensitivity and specificity of the EsoGuard test. This significant milestone supports their goal of widespread screening and early detection, moving towards Medicare coverage.
Lucid continues to advance its operations and strategies, recently closing a $30 million preferred stock financing to support their growth. They are on track to achieve key milestones, including expanded private and public coverage and direct contracting. Lucid's clinical evidence base for EsoGuard is robust, further enhancing their line of sight to Medicare coverage.
For more information, visit www.luciddx.com and their parent company PAVmed at www.pavmed.com.
Lucid Diagnostics (LUCD) has formed a strategic partnership with VITALExam to enhance access to its EsoGuard® Esophageal DNA Test for firefighters at risk of esophageal precancer. The partnership launched with a #CheckYourFoodTube Precancer Testing Event at Tuscaloosa Fire Rescue, as part of Lucid's expanded direct contracting initiative aimed at driving near-term EsoGuard revenue.
The collaboration is particularly significant as firefighters face a 62% increased risk of developing esophageal cancer and a 39% increased risk of dying from it. VITALExam, founded by Dr. Marci Vitale, specializes in providing comprehensive medical care for first responders, including cancer screenings and comprehensive physicals.
Lucid Diagnostics (NASDAQ: LUCD) announced the acceptance of its CLUE study manuscript for publication in Medicina, marking the fourth peer-reviewed publication supporting EsoGuard's clinical utility. The study demonstrated exceptional results, including 85% patient compliance with referral to confirmatory upper endoscopy following EsoGuard testing.
The prospective, multicenter study enrolled 502 patients across eight clinical centers, showing strong provider decision impact: 100% of EsoGuard-positive patients were referred for confirmatory EGD, while over 99% of EsoGuard-negative patients were not referred. The compliance rate was more than double the typical screening EGD referral rate in published literature.
Lucid Diagnostics has completed a convertible debt refinancing transaction that strengthens its financial position. The company issued five-year convertible notes worth $21.95 million to long-term equity shareholders. After retiring $3.61 million of existing convertible debt, the transaction yielded $18.34 million in net cash proceeds. This increases Lucid's pro forma cash to approximately $33 million as of Q3 end, extending its cash runway past key reimbursement milestones. The new convertible debt is structured to keep shares out of the market.
Lucid Diagnostics (LUCD) has submitted a clinical evidence package to MolDX seeking Medicare coverage for its EsoGuard® Esophageal DNA Test. The submission includes six new peer-reviewed publications, comprising three clinical validation studies, two clinical utility studies, and one analytical validation study. The package supports a Request for Reconsideration of Local Coverage Determination (LCD) L39256, aiming to secure Medicare coverage for EsoGuard testing. The company believes the data demonstrates strong clinical validity, utility, and analytical accuracy, particularly highlighting EsoGuard's precancer detection performance across all studies.
Lucid Diagnostics (Nasdaq: LUCD), a cancer prevention medical diagnostics company and PAVmed subsidiary, announced its upcoming presentation at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum in New York. The presentation is scheduled for Thursday, November 21, 2024, at 1:30 p.m. ET.
Investors can access both live and replay webcasts through the company's investor relations website at ir.luciddx.com. The webcast recording will remain available for a minimum of 30 days following the event.
PAVmed reported key developments in Q3 2024, including record quarterly EsoGuard® revenue of $1.2M, representing a 20% sequential increase. Lucid performed 2,787 commercial EsoGuard tests in Q3, with October seeing a record 1,400+ tests. The company completed Lucid's deconsolidation and is finalizing debt restructuring to maintain Nasdaq listing compliance. PAVmed reported Q3 operating expenses of $12.6M and GAAP net income of $64.3M. Cash position stood at $0.8M as of September 30, 2024, compared to $19.6M at end of 2023.
Lucid Diagnostics reported Q3 2024 financial results with EsoGuard® revenue of $1.2M, showing a 20% sequential increase from Q2 and 50% annual growth. The company performed 2,787 commercial EsoGuard tests in Q3, with October setting a single-month record of over 1,400 tests. Operating expenses were $12.9M, resulting in a GAAP net loss of $12.4M or $(0.25) per share. Cash position stood at $14.5M as of September 30, 2024. The company has secured agreements for $21.75M in Senior Secured Convertible Notes and expects to increase its cash runway by approximately $13.2M after redemption of existing notes.
Lucid Diagnostics (NASDAQ: LUCD) announced the acceptance of its ESOGUARD BE-1 study manuscript for publication in The American Journal of Gastroenterology. The study, led by Dr. Nicholas J. Shaheen, validates the EsoGuard® Esophageal DNA Test performance in detecting esophageal precancer. The test demonstrated approximately 88% sensitivity and 99% negative predictive value, with 81% specificity and 30% positive predictive value. This fourth clinical validation publication completes Lucid's evidence package for Medicare coverage submission. The multicenter study was conducted across leading U.S. and European medical centers, showing strong performance in screening populations with no serious adverse events reported.
Lucid Diagnostics (LUCD) announces expansion of its direct contracting initiative to drive near-term revenue for its EsoGuard® Esophageal DNA Test. The company is focusing on three main programs: fully-contracted #CheckYourFoodTube Precancer Testing Events, Concierge Medicine, and Employer Markets. To support these initiatives, Lucid has hired two experienced professionals from GRAIL, Inc. The company recently completed its first major directly-contracted testing event with Fort Worth Fire Department, where 200 firefighters received EsoGuard testing. The expansion targets self-insured entities, concierge medicine practices, and employer-funded health plans through strategic partnerships and broker networks.
PAVmed (Nasdaq: PAVM, PAVMZ), a commercial-stage medical technology company, has announced a business update conference call and webcast scheduled for November 14, 2024, at 8:30 AM ET. During the call, Chairman and CEO Lishan Aklog, M.D., will discuss company operations and growth strategy, while President and CFO Dennis McGrath will present third quarter 2024 financial results.
U.S. callers can join via 1-800-836-8184, while international participants should dial 1-646-357-8785. The webcast will be accessible through the company's investor relations website at pavmed.com, with a 30-day replay available afterward.
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