Lucid Diagnostics (LUCD) investor relations material

Market opportunity and product overview

• Addresses a $60 billion U.S. market with over 30 million at-risk GERD patients recommended for screening.

• Offers EsoCheck, a non-endoscopic cell collection device, and EsoGuard, an esophageal DNA test, as a comprehensive screening solution.

• EsoGuard is the first and only commercially available test for widespread early detection of esophageal precancer and cancer.

• Over 50,000 cumulative EsoGuard tests performed since launch, with claims paid approaching $140 million.

• Achieves over 90% gross margin per test.

Clinical performance and guidelines

• EsoGuard demonstrates high sensitivity (up to 89%) and 99% negative predictive value for early precancer detection.

• Recommended in major clinical guidelines, including ACG, AGA, and NCCN, since 2022.

• Supported by multiple pivotal and real-world clinical studies published in leading journals.

• Non-endoscopic biomarker testing now included in esophageal precancer screening guidelines.

• EsoCheck is FDA 510(k) cleared, non-invasive, office-based, and achieves a 95% success rate.

Commercialization and reimbursement

• Near-term reimbursement milestones include a key MoIDX CAC meeting in September 2025.

• Strong consensus among medical experts supports non-endoscopic precancer testing for high-risk patients.

• VA Federal Supply Schedule contract enables standardized procurement by VA facilities nationwide.

• Hoag Health System has launched a comprehensive EsoGuard testing program.

• CMS and commercial coverage pathways are being actively pursued, with draft and final LCDs expected.