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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 announced positive results from its ESOGUARD BE-1 clinical validation study for EsoGuard, a test for detecting esophageal precancer. The study showed an 87.5% sensitivity and a 98.6% negative predictive value (NPV). The study was conducted across multiple international centers, including major U.S. and European institutions. The results support the upcoming Medicare LCD pre-submission and ongoing commercial payor engagements. The study involving 93 subjects confirmed the test's efficiency and safety, potentially making esophageal cancer screening more accessible and effective.
Lucid Diagnostics announced that its EsoGuard® Esophageal DNA test has been used on the 4,000th firefighter as part of the #CheckYourFoodTube Precancer Testing Event, held by Mass General Brigham physicians and Boston Firefighters Local 718. The event aims to address the elevated risk of esophageal cancer among firefighters. This milestone event is part of Lucid Diagnostics' broader strategy to increase test volumes and highlights the importance of early cancer detection. Firefighters face a 62% higher risk of developing esophageal cancer and a 39% higher risk of dying from it. Estimates from the American Cancer Society suggest 22,370 new cases and 16,130 deaths from esophageal cancer in 2024.
PAVmed (NASDAQ: PAVM) provided a business update and reported financial results for Q1 2024. The company held a webcast on May 14, 2024, to discuss the results. Lucid Diagnostics, a subsidiary, completed a $29.8 million Series B offering, securing key reimbursement milestones. Veris Health signed an MOU with The Ohio State's James Cancer Hospital. Financially, PAVmed reported $1.0 million in EsoGuard revenues, flat quarter-over-quarter but a 124% increase from Q1 2023. Operating expenses were $15.0 million with a GAAP net loss of $22.8 million. Cash reserves stood at $25.5 million as of March 31, 2024.
Lucid Diagnostics Inc., a cancer prevention medical diagnostics company, provided a business update and financial results for the first quarter of 2024. The company reported a 10% increase in EsoGuard test volume, a strengthened balance sheet after a $29.8 million Series B Preferred Stock Offering, and a MolDX pre-submission meeting scheduled for July 17, 2024. Lucid also highlighted revenue growth, clinical study outcomes, and market access strategy.
Lucid Diagnostics Inc. announced that the EsophaCap sponge-on-a-string esophageal cell collection device has been subjected to a Class II FDA recall due to serious device failures reported. Lucid's EsoCheck® remains unaffected by the recall and continues to be the gold standard for non-endoscopic cell collection. The recall stemmed from two serious device failures reported in a recent publication of one of the studies using the EsophaCap device. Lucid's EsoCheck® is a modern technology enabling precise, targeted cell collection for esophageal precancer testing, offering unprecedented early precancer detection without causing any serious adverse events.
Lucid Diagnostics Inc. (Nasdaq: LUCD) has successfully closed a Series B-1 Preferred Stock offering, generating $29.8 million in gross proceeds. The offering was led by a long-time institutional investor, providing the company with substantial working capital. As part of this development, Dennis Matheis, a seasoned healthcare industry veteran, has been appointed to the Board of Directors. Matheis currently holds the position of President and CEO at Sentara Health, a prominent not-for-profit integrated health system in the U.S. Lucid aims to leverage this funding to achieve key reimbursement milestones and enhance its operational capabilities.
Lucid Diagnostics, a cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., will hold a business update conference call and webcast on May 13, 2024, at 8:30 AM ET. The call will feature Lucid's CEO providing an operational overview and growth strategy, along with the CFO discussing first-quarter 2024 financial results. Investors can access the webcast on the company's website or join via telephone.
Lucid Diagnostics Inc. (Nasdaq: LUCD) announced the publication of positive data from a National Cancer Institute-sponsored study on EsoGuard® Esophageal Precancer Testing, showing 89% sensitivity in detecting early precancer. The study strengthens EsoGuard's clinical data and supports efforts for commercial and Medicare coverage.
Lucid Diagnostics, a cancer prevention medical diagnostics company, partners with the Esophageal Cancer Action Network (ECAN) to raise awareness during Esophageal Cancer Awareness Month. The partnership aims to educate about the link between heartburn and esophageal cancer, promoting early detection for prevention. Public service videos are being displayed in Times Square, emphasizing the importance of screening for those at risk.
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