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Investing.com -- Merit Medical Systems, Inc. (NASDAQ:MMSI) stock dropped 7.9% in after-hours trading Thursday following news that the U.S. Centers for Medicare & Medicaid Services (CMS) has deferred the company’s application for Transitional Pass-Through incremental payment for its WRAPSODY Cell-Impermeable Endoprosthesis.
The healthcare technology company announced that CMS has deferred the application to the Calendar Year 2027 Outpatient Prospective Payment System rule, pushing the earliest possible effective date to January 1, 2027. This deferral affects payment for WRAPSODY procedures in outpatient and ambulatory surgery center settings.
In response to the setback, Merit Medical has decided to withdraw its application for incremental payment and immediately begin full U.S. commercialization of the WRAPSODY device, which is designed to treat hemodialysis patients with venous outflow obstructions.
"While we are disappointed with the deferral of our application for TPT incremental payment, we believe this presents an opportunity for an important strategic pivot," said Martha G. Aronson, Merit’s President and CEO. "Our efforts to secure incremental payment in the outpatient and ASC settings have impacted the pace of U.S. commercialization of our innovative solution for physicians treating hemodialysis patients suffering from venous outflow obstructions."
Despite the change in strategy, Merit Medical maintained its full-year 2025 forecast for U.S. revenue from WRAPSODY sales at $2 million to $4 million.
The WRAPSODY device received FDA premarket approval in December 2024 and has also secured regulatory approvals in Canada, the European Union, and Brazil.
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