other material
confidence high
sentiment negative
materiality 0.55
Merit Medical withdraws WRAPSODY TPT application; CMS deferral delays payment to Jan 2027
MERIT MEDICAL SYSTEMS INC
- CMS deferred Merit's Transitional Pass-Through incremental payment application for WRAPSODY CIE to CY2027 rule; Jan 1, 2027 earliest effective date.
- Merit withdraws TPT application and will immediately begin full U.S. commercialization of WRAPSODY CIE.
- CEO cites strong 24-month efficacy data from WRAPSODY WAVE Trial as key differentiator vs. competitors.
- FY2025 U.S. WRAPSODY CIE revenue forecast remains $2M-$4M.
- Device received FDA premarket approval Dec 2024; approved by Health Canada Apr 2025.