Merit Medical Provides Update on U.S. Reimbursement and Commercial Strategies for WRAPSODY® Cell-Impermeable Endoprosthesis

Rhea-AI Summary

Merit Medical (NASDAQ: MMSI) said CMS has deferred consideration of its Transitional Pass-Through incremental payment application for the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE) to the CY 2027 Outpatient Prospective Payment System, making Jan 1, 2027 the earliest possible effective date. Merit has withdrawn the TPT application and will begin full U.S. commercialization immediately. The company reiterated a 2025 U.S. revenue forecast of $2 million to $4 million for WRAPSODY CIE and cited 24-month efficacy results from its WRAPSODY WAVE Trial as a commercial differentiator. The device has FDA PMA (Dec 19, 2024), Health Canada approval (Apr 30, 2025), CE mark, and availability in Brazil.

Positive

• FDA premarket approval on Dec 19, 2024
• Health Canada approval on Apr 30, 2025
• Forecasted U.S. WRAPSODY revenue of $2M–$4M for 2025
• Immediate start of full U.S. commercialization

Negative

• CMS deferred TPT decision to CY 2027 (earliest effective Jan 1, 2027)
• Withdrawal of TPT application delays potential incremental outpatient/ASC payment

Insights

Healthcare reimbursement and commercial strategy analyst

CMS deferred the TPT decision to the CY2027 rule; Merit will withdraw and begin U.S. commercialization immediately.

Merit will pursue commercial adoption of the WRAPSODY CIE without interim Transitional Pass-Through incremental payment, relying on direct sales into hospital, outpatient, and ASC settings. The company projects U.S. revenue of $2 million to $4 million for full year 2025, and cites FDA premarket approval on December 19, 2024 and Health Canada approval on April 30, 2025 as regulatory milestones that enable immediate market access.

The near-term commercial path depends on physician adoption, hospital and ASC purchasing decisions, and payer negotiations absent TPT incremental payment. Merit also references robust 24-month efficacy results from its WRAPSODY WAVE Trial and ongoing real-world evidence collection via the WRAP North America Registry (designed to enroll up to 250 patients) and the WRAP Global Registry; these data assets are the primary levers cited for payer and provider engagement.

Key risks include the delayed CMS TPT timeline (effective date earliest January 1, 2027) and any slow uptake that could limit initial revenue growth. Watch the CMS final rule for CY2027, quarterly commercialization metrics versus the $2M–$4M forecast, and enrollment progress in the WRAP North America Registry as measurable near-term indicators, all within the next 12–24 months.

SOUTH JORDAN, Utah, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today that the U.S. Centers for Medicare & Medicaid Services (“CMS”) has notified Merit that its application for Transitional Pass-Through (“TPT”) incremental payment for WRAPSODY^® Cell-Impermeable Endoprosthesis (“CIE”) procedures in the outpatient and ambulatory surgery center (“ASC”) settings requires further consideration prior to CMS making a final decision. CMS notified Merit that it has deferred Merit’s application for the WRAPSODY^® CIE to the Calendar Year 2027 Outpatient Prospective Payment System rule, making January 1, 2027, the earliest possible effective date.

“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. We are enacting a new commercial strategy that increases patient access and optimizes adoption and utilization of our clinically superior technology. We expect this strategy to improve patient outcomes, reduce the cost of treating this large and growing patient population, and generate strong, margin-accretive revenue growth for Merit in the years to come. We have elected to withdraw our application for TPT incremental payment and intend to begin our full commercialization of the WRAPSODY CIE in the U.S. immediately.”

Ms. Aronson continued, “The WRAPSODY CIE was developed to help physicians restore vascular access for patients. The clinical evidence supporting this device is remarkable, particularly the recently announced 24-month efficacy results from both the randomized arteriovenous fistula arm and single-arm arteriovenous graft cohort of our WRAPSODY WAVE Trial. This impressive clinical data represents not only an invaluable tool in our discussions with physicians, hospital administrators, and payers, but also is a key differentiator versus existing competitors. Armed with the best technology, the strongest clinical evidence, and a focused and engaged commercial team, we believe we are well positioned to penetrate the U.S. dialysis access maintenance market opportunity in the coming years.”

For the full year 2025 period, Merit continues to forecast U.S. revenue from the sales of the WRAPSODY CIE in the range of $2 million to $4 million.

On December 19, 2024, the WRAPSODY CIE received premarket approval from the U.S. Food and Drug Administration (FDA). On April 30, 2025, the device was approved by Health Canada. The WRAPSODY CIE previously received the Conformité Européenne (CE) Mark for commercial use in the European Union and is available in Brazil.

For more information on the WRAPSODY CIE within the United States, please visit: https://www.merit.com/product/WRAPSODY-cie/. For information on the device outside of the United States, please visit: https://www.merit.com/product/merit-WRAPSODY/.

In the United States and Canada, real-world clinical outcomes of the WRAPSODY CIE are being evaluated in the WRAP North America Registry, which is designed to enroll up to 250 patients. For additional information on Merit’s WRAP North America Registry, please visit: https://clinicaltrials.gov/study/NCT06807099.

Outside of North America, real-world outcomes of the WRAPSODY CIE are being evaluated in the WRAP Global Registry.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Any forward-looking statements set forth in this release are subject to risks and uncertainties such as those described in Merit's filings with the U. S. Securities and Exchange Commission (“SEC”). For discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, which Merit updated in Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, which Merit filed with the SEC. Actual results will likely differ, and may differ materially, from anticipated results.

ABOUT MERIT

Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,400 people worldwide. 

TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.  

CONTACTS 
PR/Media Inquiries 
Sarah Comstock 
Merit Medical 
+1-801-432-2864 | sarah.comstock@merit.com 

INVESTOR INQUIRIES 
Mike Piccinino, CFA, IRC 
ICR Healthcare 
+1-443-213-0509 | mike.piccinino@icrhealthcare.com 

FAQ

What did Merit announce about the CMS decision for WRAPSODY CIE (MMSI) on Nov 13, 2025?

CMS deferred Merit’s TPT incremental payment application to the CY 2027 OPPS rule; Merit withdrew the application and will commercialize the device in the U.S. immediately.

When could incremental CMS payment for WRAPSODY CIE (MMSI) take effect?

CMS indicated Jan 1, 2027 as the earliest possible effective date after deferral to the CY 2027 rule.

How much U.S. revenue does Merit forecast for WRAPSODY CIE (MMSI) in 2025?

Merit reiterated a U.S. revenue forecast for WRAPSODY CIE of $2 million to $4 million for 2025.

Does WRAPSODY CIE have regulatory approvals in major markets for MMSI?

Yes; WRAPSODY CIE has FDA PMA (Dec 19, 2024), Health Canada approval (Apr 30, 2025), a CE mark, and is available in Brazil.

What clinical evidence does Merit cite to support WRAPSODY CIE adoption (MMSI)?

Merit cites 24-month efficacy results from the randomized AV fistula arm and single-arm AV graft cohort of the WRAPSODY WAVE Trial as a differentiator.

Will Merit continue commercialization of WRAPSODY CIE without CMS incremental payment (MMSI)?

Yes; Merit elected to withdraw the TPT application and plans to begin full U.S. commercialization immediately.