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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 that a consortium of academic medical centers has received an $8 million NIH R01 grant for a five-year clinical study of its EsoCheck® and EsoGuard® technologies. The study will evaluate esophageal precancer detection in at-risk individuals without GERD symptoms.
The research, led by investigators from Case Western Reserve University and University Hospitals, will involve 800 patients across five research centers. The study aims to improve Barrett's Esophagus (BE) detection in non-GERD at-risk populations, who account for nearly half of esophageal cancer cases but are currently excluded from screening guidelines.
The study could potentially expand EsoGuard's target population for esophageal precancer testing. The technology was originally developed at CWRU and UH, with Lucid licensing the technologies exclusively in 2018.
Lucid Diagnostics (Nasdaq: LUCD) has successfully regained compliance with Nasdaq's minimum bid price requirement, the company announced on February 25, 2025. The commercial-stage cancer prevention medical diagnostics company, a subsidiary of PAVmed Inc. (Nasdaq: PAVM), had previously been notified of non-compliance for failing to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days.
To resolve this issue, Lucid was required to maintain a minimum closing bid price of $1.00 per share for at least 10 consecutive trading days, a condition that was satisfied on February 21, 2025. Following this achievement, the company's common stock will continue to trade on the Nasdaq Capital Market under the symbol "LUCD".
Lucid Diagnostics (LUCD) has signed its first concierge medicine contract with LEAA Health, enabling LEAA's membership-based patients to access EsoGuard® Esophageal DNA Test for esophageal precancer testing on a cash-pay basis. This strategic move aims to generate contractually-guaranteed revenue by tapping into the growing concierge medicine market, which is projected to reach $10.9 billion by 2032.
The partnership aligns with Lucid's strategy to expand EsoGuard revenue streams while pursuing Medicare and commercial coverage. LEAA Health will incorporate EsoGuard testing into its enhanced personalized care services, focusing on early detection and preventive healthcare. The collaboration represents a significant step in making innovative precancer detection tools more accessible to patients seeking premium healthcare services.
PAVmed (NASDAQ: PAVM, PAVMZ) has successfully regained compliance with Nasdaq Capital Market's Continued Listing Standards after receiving written notification from Nasdaq's Listing Qualifications Department on February 14, 2025. The company met the requirement of maintaining stockholders' equity of at least $2.5 million under Listing Rule 5550(b)(1).
The compliance was achieved through strategic initiatives, including the deconsolidation of Lucid Diagnostics subsidiary and restructuring of convertible debt. PAVmed will be subject to a mandatory panel monitor for one year, during which any non-compliance with stockholders' equity requirements will result in a delisting letter, requiring prompt attention and a potential new hearing.
Lucid Diagnostics (Nasdaq: LUCD), a commercial-stage cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), has announced its participation in the 12th Annual BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference. The conference is scheduled for February 11-12, 2024, at the Cliff Lodge in Snowbird, UT.
Shaun O'Neil, who serves as Lucid's President and Chief Operating Officer, will be available for one-on-one meetings throughout the conference. Interested investors are advised to contact their BTIG representative to schedule meetings.
Lucid Diagnostics (LUCD) reported record-breaking quarterly performance for its EsoGuard® Esophageal DNA Tests in Q4 2024, with 4,042 tests completed. This represents a 45% increase from Q3 2024 and an 84% year-over-year growth from Q4 2023.
The company is focusing on three key commercial revenue drivers: traditional claims submissions, direct contracting with employers and self-insured entities, and a new cash pay program targeting concierge medicine practices. Lucid aims to secure Medicare coverage and expects these initiatives to boost revenue growth and expand EsoGuard testing accessibility.
Full financial results for Q4 and full-year 2024 are expected to be released in mid-March 2025. The current figures are preliminary and subject to quarter-end closing and audit procedures.
Lucid Diagnostics (Nasdaq: LUCD) has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement. The company now has until June 16, 2025 to maintain a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days. The notification does not immediately affect LUCD's listing status, and shares will continue trading on the Nasdaq Capital Market. The company plans to take appropriate actions to regain compliance before the deadline.
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.
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