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Merit Medical Releases 12-Month Efficacy Results for the Single-Arm Arteriovenous Graft (AVG) Cohort of the WRAPSODY® Arteriovenous Efficacy (WAVE) Trial

1. WRAPSODY CIE achieved 60.2% TLPP at 12 months in the trial. 2. Six-month TLPP was 81.4%, exceeding performance goals by 21.4 percentage points. 3. Performance found to be positive for improving patient outcomes with AVG. 4. FDA approval and commercial distribution in the U.S. boost market confidence. 5. Merit's portfolio continues to expand, driving growth in healthcare solutions.

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Why Bullish?

The successful trial results signify potential market demand and increased revenues for MMSI.

How important is it?

The article highlights significant product performance, likely impacting investor interest and stock valuation.

Why Long Term?

Long-term impacts expected as the WRAPSODY CIE expands in U.S. and international markets, possibly boosting future earnings.

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In the AVG cohort of the US pivotal trial, the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) achieved 60.2% target lesion primary patency (TLPP) at 12 months. May 05, 2025 09:25 ET  | Source: Merit Medical Systems, Inc. SOUTH JORDAN, Utah, May 05, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced that the 12-month results from the single-arm cohort of the WAVE trial were presented at the annual Charing Cross Symposium held in London, England, on April 23, 2025, during the Vascular Access Masterclass session. Following the scientific podium presentation, results were presented during a Merit-sponsored symposium. The single-arm cohort of the WAVE trial included 112 patients with an AVG who were treated with the WRAPSODY CIE device. The primary efficacy measure, 6-month TLPP, was compared to an efficacy performance goal for covered stents. At 6 months, the TLPP associated with the WRAPSODY CIE was 81.4%, a result 21.4 percentage points higher than the performance goal of 60%. The proportion of AVG patients who were free from an adverse event was higher than the safety performance goal (95.4% vs. 89.0%, p=0.016). At 12 months, the TLPP associated with the WRAPSODY CIE was 60.2%. Access circuit primary patency (ACPP) at 6 and 12 months were 69.2% and 36.2%, respectively. “Patients with a failing AVG have limited options available to restore functionality of their access,” said Robert G. Jones, MBChB, FRCR, Consultant Interventional Radiologist at Queen Elizabeth Hospital Birmingham in Birmingham, England, and Co-Principal Investigator of the WAVE trial. “Therefore, it was exciting to present findings to my colleagues, so they are aware of WRAPSODY’s potential to improve care for this vulnerable patient population.” “We are pleased to have the opportunity to share the positive findings of WRAPSODY with our physician partners, and we look forward to working with them to improve patient outcomes,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. Twelve-month findings from the randomized arm of the WAVE trial (TLPP: 70.1%; ACPP: 58.1%) were previously presented at the annual Society of Interventional Radiology meeting held in Nashville, TN. Six-month efficacy results (TLPP: 89.8%; ACPP: 72.6%) were published in Kidney International. The Merit WRAPSODY CIE is available in Brazil and in the European Union and is approved for commercial distribution in the United States. For additional information on Merit Medical’s WAVE study, please visit: https://clinicaltrials.gov/ct2/show/NCT04540302.  ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable 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 7,300 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  Westwicke - ICR  +1-443-213-0509 | mike.piccinino@westwicke.com 

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