Lucid Diagnostics (LUCD) investor relations material

Market opportunity and commercial strategy

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

• Over 90% gross margin per test, with Medicare payment set at $1,938 per test.

• Early market adoption and a highly effective commercialization strategy targeting primary care, gastroenterologists, and health systems.

• 45,000+ cumulative EsoGuard tests performed since launch, with significant revenue growth.

Product innovation and clinical value

• First and only commercial solution for widespread early detection of esophageal precancer and cancer.

• EsoCheck is a non-endoscopic, office-based cell collection device with a 95% success rate and high patient satisfaction.

• EsoGuard is a DNA test using next-generation sequencing, recommended in major clinical guidelines.

• Clinical studies demonstrate high sensitivity (up to 96%) and negative predictive value (99%) for cancer detection.

• Supported by robust clinical evidence from multiple pivotal and utility studies.

Regulatory, reimbursement, and operational milestones

• FDA 510(k) clearance for EsoCheck; CLIA-certified and CAP-accredited laboratory for EsoGuard.

• Near-term reimbursement milestones include a Multi-Jurisdictional Contractor Advisory Committee (CAC) meeting and LCD reconsideration for Medicare coverage.

• Strong consensus among medical experts for nonendoscopic precancer testing in high-risk patients.

• VA Federal Supply Schedule contract enables standardized procurement by VA facilities; system-wide implementation at Hoag Health System.