Merit Medical(US:MMSI) Globenewswire·2025-11-13 21:05Core Viewpoint - Merit Medical Systems, Inc. announced that the U.S. Centers for Medicare & Medicaid Services has deferred its application for Transitional Pass-Through incremental payment for the WRAPSODY Cell-Impermeable Endoprosthesis, with the earliest effective date now set for January 1, 2027 [1][2] Group 1: Company Strategy and Market Position - The company plans to withdraw its application for TPT incremental payment and will immediately begin full commercialization of the WRAPSODY CIE in the U.S. [2] - A new commercial strategy is being enacted to increase patient access and optimize the adoption and utilization of the WRAPSODY CIE, which is expected to improve patient outcomes and generate strong revenue growth [2] - The WRAPSODY CIE aims to restore vascular access for hemodialysis patients, with strong clinical evidence supporting its efficacy [2] Group 2: Financial Forecast - For the full year 2025, Merit forecasts U.S. revenue from WRAPSODY CIE sales to be in the range of $2 million to $4 million [2] Group 3: Regulatory Approvals - The WRAPSODY CIE received premarket approval from the U.S. FDA on December 19, 2024, and was approved by Health Canada on April 30, 2025 [3] - The device has also received the CE Mark for commercial use in the European Union and is available in Brazil [3] Group 4: Clinical Evaluation - Real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which aims to enroll up to 250 patients [5]