Merit Med Sys Inc Stock Price, News & Analysis

Merit Medical Systems (NASDAQ: MMSI) has received Health Canada approval for its WRAPSODY Cell-Impermeable Endoprosthesis (CIE), a device designed to treat vascular access stenosis in hemodialysis patients. The device features a unique tri-layer design with superior clinical outcomes demonstrated in the WAVE trial. At 12 months, WRAPSODY showed significantly higher target lesion primary patency (70.1% vs 41.6%) and access circuit primary patency (58.1% vs 34.4%) compared to standard angioplasty. The device, which received FDA approval in December 2024 and CE Mark for European use, will be immediately commercialized throughout Canada from Merit's Toronto distribution center. The innovative design includes an expandable nitinol stent frame, a cell-impermeable middle layer, and a novel inner layer to reduce complications.

Merit Medical Systems (NASDAQ: MMSI) has announced 12-month efficacy results for its WRAPSODY Cell-Impermeable Endoprosthesis (CIE) device from the single-arm arteriovenous graft (AVG) cohort of the WAVE trial. The study included 112 patients with AVG treated with WRAPSODY CIE.

Key findings include:

• 6-month target lesion primary patency (TLPP) of 81.4%, exceeding the performance goal of 60% by 21.4 percentage points
• 12-month TLPP of 60.2%
• Access circuit primary patency (ACPP) at 6 and 12 months were 69.2% and 36.2% respectively
• 95.4% of patients were free from adverse events, surpassing the safety goal of 89.0%

The WRAPSODY CIE is currently available in Brazil, the European Union, and is approved for commercial distribution in the United States.

Merit Medical Systems (MMSI) reported strong Q1 2025 financial results with revenue reaching $355.4 million, up 9.8% year-over-year. The company demonstrated solid performance with constant currency revenue growth of 10.9% and organic growth of 6.0%.

Key financial metrics include GAAP operating margin of 11.5% (up from 11.1%), non-GAAP operating margin of 19.3% (up from 17.0%), and GAAP EPS of $0.49 (up 2.0%). Non-GAAP EPS increased 14.8% to $0.86.

The company maintained its 2025 revenue guidance of $1.470-$1.490 billion but updated its non-GAAP EPS guidance to $3.29-$3.42, reflecting strong Q1 results offset by impacts from recent trade policies. As of March 31, 2025, Merit had cash and cash equivalents of $395.5 million and total debt of $747.5 million.

Merit Medical Systems (NASDAQ: MMSI) has announced the US commercial launch of its Ventrax™ Delivery System, the latest addition to its electrophysiology and cardiac rhythm management portfolio. The system is designed to facilitate ablation procedures for treating ventricular tachycardia (VT), a condition contributing to approximately 75% of sudden cardiac deaths in the US.

The Ventrax system features a 95-cm sheath for targeted access, ultralow-profile transition between sheath and pigtail-dilator, and an angled tip to enhance ablation catheter reach. It provides retrograde aortic access, offering improved access to certain ventricle areas compared to traditional methods.

Key medical experts from Duke Health, including Dr. Albert Sun and Dr. Jason Koontz, contributed to the system's development. The device addresses a growing need in VT ablation procedures, which represent one of the fastest-growing areas in electrophysiology.

Merit Medical Systems (NASDAQ: MMSI) has announced it will release its Q1 2025 financial results on April 24, 2025, after market close. The company will host an investor conference call the same day at 5:00 p.m. Eastern time.

Founded in 1987, Merit Medical Systems is a global manufacturer and marketer of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, with focus on cardiology, radiology, oncology, critical care, and endoscopy. The company maintains a global presence with over 800 sales and clinical support professionals and approximately 7,300 employees worldwide.

Merit Medical Systems (NASDAQ: MMSI) announced that the American Society for Gastrointestinal Endoscopy (ASGE) has updated its clinical guidelines to include Transoral Incisionless Fundoplication (TIF 2.0) and cTIF procedures as evidence-based approaches for managing GERD.

The company's EsophyX Z+ Device is designed for these procedures, which help restore anatomy and reconstruct the gastroesophageal valve. A recent multicenter study showed impressive results with a 94% clinical success rate and significant improvements in patient satisfaction from 8% to 79%.

GERD, affecting approximately 20% of Americans, occurs when stomach acid flows into the esophagus. The updated ASGE guidelines suggest TIF for patients with small hiatal hernias (≤2 cm) and cTIF or surgical therapy for those with larger hernias (>2 cm), based on multidisciplinary review.

Merit Medical Systems (NASDAQ: MMSI) has announced significant results from their WRAPSODY Arteriovenous Access Efficacy (WAVE) trial, evaluating their WRAPSODY Cell-Impermeable Endoprosthesis (CIE) device for hemodialysis patients. The device, which received FDA approval in December 2024, showed impressive efficacy in treating venous stenosis.

The multicenter trial compared WRAPSODY CIE (n=122) against standard angioplasty (PTA, n=123). At 6 months, WRAPSODY demonstrated superior results with 89.8% target lesion primary patency versus 62.8% for PTA, and 72.6% access circuit primary patency versus 57.9%. At 12 months, the device maintained significantly higher rates with 70.1% target lesion primary patency versus 41.6%, and 58.1% access circuit primary patency versus 34.4%.

Merit Medical began U.S. commercialization in January 2025, with the device already available in the European Union and Brazil.

Merit Medical Systems (NASDAQ: MMSI) is set to celebrate its 35-year partnership with Nasdaq by ringing the opening bell at the Nasdaq MarketSite in Times Square on March 19, 2025. Chairman and CEO Fred Lampropoulos will lead the ceremony starting at 9:15 A.M. (EDT), with the bell ringing at 9:30 A.M.

Founded in 1987, Merit Medical has established itself as a global leader in healthcare technology, specializing in proprietary medical devices for interventional, diagnostic, and therapeutic procedures. The company focuses on cardiology, radiology, oncology, critical care, and endoscopy sectors.

With a workforce of approximately 7,400 people worldwide, Merit Medical maintains a robust presence through its domestic and international sales force and clinical support team of over 800 individuals.

Merit Medical Systems (NASDAQ: MMSI) has announced the enrollment of the first patient in its PREEMIE study, evaluating the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants.

The multicenter, prospective study aims to enroll at least 55 premature infants weighing between 600g and 2,500g at up to ten U.S. sites. The study will evaluate the safety and efficacy of the device through six months as part of the premarket approval application.

The Bloom system is designed as a minimally invasive treatment option, using a flexible delivery system to insert a self-expanding nitinol device that blocks blood flow through the PDA. Currently, there is no approved device for PDA treatment in premature infants as small as 600 grams.