Merit Medical withdraws reimbursement application, pivots strategy

Merit Medical Systems Inc. (NASDAQ: MMSI) announced it will withdraw its application for transitional pass-through incremental payment for its WRAPSODY Cell-Impermeable Endoprosthesis and begin full U.S. commercialization immediately.

The Centers for Medicare & Medicaid Services deferred Merit's application to the Calendar Year 2027 Outpatient Prospective Payment System rule, making January 1, 2027 the earliest possible effective date for incremental payment in outpatient and ambulatory surgery center settings.

"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. "We are enacting a new commercial strategy that increases patient access and optimizes adoption and utilization of our clinically superior technology."

The WRAPSODY device treats hemodialysis patients with venous outflow obstructions. Merit maintains its 2025 U.S. revenue forecast for the device at $2 million to $4 million.

The device received FDA premarket approval in December 2024 and Health Canada approval in April 2025. It previously obtained CE Mark approval for European Union commercial use and is available in Brazil.

Merit is evaluating real-world clinical outcomes through the WRAP North America Registry, designed to enroll up to 250 patients in the United States and Canada. A separate WRAP Global Registry operates outside North America.

Founded in 1987, Merit Medical develops medical devices for interventional, diagnostic and therapeutic procedures. The company employs approximately 7,400 people worldwide.

You May Also Be Interested In

• FDA clears path for Protagenic's PT00114 anxiety drug IND submission
• Founder Group wins $1.5M solar subcontract in Malaysia's Kedah
• Olenox Industries reports July Bitcoin mining output of 15.13 BTC