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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 (Nasdaq: LUCD) announced its participation in The MedTech Conference 2024, scheduled for October 15-17 in Toronto, Canada. The company will showcase its EsoGuard® and EsoCheck® technologies in the conference's Innovation Pavilion, offering live demonstrations to attendees. Lishan Aklog, M.D., Lucid's Chairman and CEO, will participate in a CEOs Unplugged event alongside industry leaders. Additionally, Shaun O'Neil, Lucid's President and COO, will deliver the company's presentation at the conference's Investor Forum.
Lucid's presence at the conference, organized by AdvaMed, provides an opportunity to engage with industry leaders, potential partners, and investors. The event is expected to attract over 1,500 companies and attendees from 45 countries, highlighting its significance in the medical technology industry.
Lucid Diagnostics Inc. (Nasdaq: LUCD) held its inaugural #CheckYourFoodTube Precancer Testing Event for former NFL players in Cincinnati, Ohio. The initiative aims to raise awareness about the link between chronic heartburn and esophageal cancer, and promote EsoGuard® Esophageal DNA Test for precancer detection. The event included an educational session and on-site testing for at-risk former NFL players.
Solomon Wilcots, former Cincinnati Bengals player, emphasized the importance of early detection and encouraged fellow athletes to take proactive steps. Dr. Lishan Aklog, Lucid's CEO, highlighted the opportunity to prevent esophageal cancer through awareness and testing. Lucid plans to expand these events to other cities nationwide, targeting former NFL players and their fans who have risk factors such as heartburn, age over 50, male gender, white race, obesity, smoking, or family history.
Lucid Diagnostics Inc. (Nasdaq: LUCD) announced that its EsoGuard® Esophageal DNA Test for early detection of esophageal precancer will be highlighted at the American Foregut Society's (AFS) 2024 Annual Meeting from September 26-28, 2024. Dr. Dan Lister, AFS President-elect, will lead a session titled "Finding Barrett's - Time to Ditch the Scope?" discussing EsoGuard as a non-invasive alternative to screening upper endoscopy.
This follows the AFS's recent open letter advocating for medical policy coverage of EsoGuard by commercial payors, emphasizing its strong scientific evidence and incorporation in AFS physicians' practices. The session will explore EsoGuard's role in triaging at-risk patients and enabling efficient use of endoscopy resources for early detection and prevention of esophageal cancer.
PAVmed Inc. (Nasdaq: PAVM) announced efforts to regain compliance with Nasdaq's listing requirements, including the deconsolidation of Lucid Diagnostics (Nasdaq: LUCD) from PAVmed's financial statements. This move will no longer reflect Lucid's operating losses in PAVmed's consolidated financials, while maintaining PAVmed's holdings of Lucid common stock. The deconsolidation is part of a series of steps to address Nasdaq's determination that PAVmed had not met continued listing standards for 180 consecutive days.
PAVmed also announced board changes, including the appointment of Dr. Sundeep Agrawal, a seasoned biotech investor, to replace departing directors. The company will request a hearing before a Nasdaq Hearings Panel to appeal the delisting determination, expected in October.
Lucid Diagnostics (Nasdaq: LUCD) announced its participation as the sole Diamond Sponsor at the 20th International Society for Diseases of the Esophagus (ISDE) World Congress in Edinburgh, Scotland, from September 22-24, 2024. The company will showcase its EsoGuard® Esophageal DNA Test for early detection of esophageal precancer.
Lucid will host a symposium on Non-Endoscopic Screening for Barrett's Esophagus, chaired by experts Dr. Vani Konda and Dr. Nicholas Shaheen. The panel discussion will include Dr. Vivek Kaul and Dr. Rehan Haidry. This event highlights Lucid's commitment to being a leading voice in esophageal cancer prevention through early detection of precancer.
The ISDE World Congress is a global platform for collaboration and knowledge exchange among experts in esophageal diseases, covering topics such as diagnostics, novel therapies, and latest advancements in the field.
Lucid Diagnostics (Nasdaq: LUCD) has signed a memorandum of understanding (MOU) with Front Line Mobile Health to enhance early detection of esophageal cancer in firefighters. The collaboration aims to expand patient access to Lucid's EsoGuard® Esophageal DNA test through co-marketing initiatives. Firefighters face a 62% higher risk of developing esophageal cancer, making this partnership important for their health and safety.
The MOU builds on Lucid's previous collaboration with Front Line, which facilitated a major #CheckYourFoodTube Precancer Testing Event. By leveraging Front Line's resources and expertise in caring for firefighters, Lucid aims to increase access to esophageal precancer testing and drive revenue through contracted high-volume testing events.
Lucid Diagnostics, a subsidiary of PAVmed, has published an analytical validation study of its EsoGuard® Esophageal DNA test in the peer-reviewed journal Diagnostics. The study demonstrates excellent analytical performance of the EsoGuard assay on samples collected with the EsoCheck® Esophageal Cell Collection Device for diagnosing esophageal precancer (Barrett's Esophagus) and esophageal adenocarcinoma.
Key findings include:
- 89% analytical sensitivity
- 100% analytical specificity
- 96% analytical accuracy
- 100% inter- and intra-assay precision
EsoGuard uses next-generation sequencing to detect DNA methylation at 31 sites on two genes associated with conditions along the BE-EAC spectrum. This study complements EsoGuard's existing clinical validity and utility evidence base.
The American Foregut Society (AFS) has formally requested health insurance providers to update their medical policies to include Lucid Diagnostics' (Nasdaq: LUCD) EsoGuard® Esophageal DNA test as a covered service. This move aims to enhance early detection of esophageal precancer (Barrett's Esophagus) and prevent highly lethal esophageal cancer. The AFS, a leading society of gastroenterologists and surgeons, highlighted the strong scientific evidence supporting EsoGuard as a minimally invasive screening alternative to endoscopy.
The AFS emphasized that expanding access to EsoGuard will empower providers with an essential triage for upper endoscopy, enabling early detection of Barrett's Esophagus. As a point-of-care test in primary care offices, EsoGuard can reduce health disparities in endoscopy access. The society urged immediate coverage of the test, aligning with recent gastroenterology society guidelines and state legislation mandating coverage of such biomarker tests.
PAVmed Inc. (NASDAQ: PAVM) provided a business update and Q2 2024 financial results. Key highlights include:
- Lucid reported record quarterly EsoGuard® test volume of 3,147, up 31% from Q1
- EsoGuard revenue was $1.0 million, up 514% year-over-year
- Veris Health launched a pilot program with The Ohio State's James Cancer Hospital
- Q2 operating expenses were $14.6 million
- GAAP net loss was $10.9 million or $(1.19) per share
- Non-GAAP adjusted loss was $7.7 million or $(0.84) per share
- Cash and equivalents of $25.5 million as of June 30, 2024
The company is focused on strengthening finances by making subsidiaries independently financeable. Lucid remains PAVmed's strongest asset, while Veris Health and PortIO are pursuing independent financing.
Lucid Diagnostics Inc. (NASDAQ: LUCD) reported its Q2 2024 financial results and business update. Key highlights include:
- EsoGuard® test volume increased 31% quarterly and 44% annually
- EsoGuard revenue was $1.0M, flat compared to Q1 but up 514% year-over-year
- 3,147 commercial EsoGuard tests performed, a single-quarter record
- Positive clinical data released from ENVET-BE and ESOGUARD BE-1 studies
- Cash and cash equivalents of $24.9M as of June 30, 2024
- GAAP net loss of $11.0M or $(0.23) per share
- Non-GAAP adjusted loss of $9.7M or $(0.20) per share
The company is focused on securing broad coverage and reimbursement to drive EsoGuard revenue growth.
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