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SOUTH JORDAN, Utah - Merit Medical Systems, Inc. (NASDAQ: MMSI), a $5.53 billion market cap healthcare technology company with strong financial health according to InvestingPro analysis, has announced that Health Canada has approved its Wrapsody Cell-Impermeable Endoprosthesis (CIE), a device aimed at enhancing hemodialysis treatment. The company plans to initiate immediate commercialization in Canada, shipping from its Toronto distribution center.
The WRAPSODY CIE is designed to address the issue of vascular access stenosis—a common and potentially life-threatening complication for hemodialysis patients—by maintaining open blood vessels necessary for treatment. The device’s approval was bolstered by results from the WRAPSODY Arteriovenous Access Efficacy (WAVE) trial, which showed the WRAPSODY CIE’s superior performance in maintaining primary patency over traditional percutaneous transluminal angioplasty (PTA).
According to the trial’s findings, the WRAPSODY CIE demonstrated a target lesion primary patency rate of 89.8% versus 62.8% for PTA at six months, and 70.1% versus 41.6% at 12 months. Access circuit primary patency also favored the WRAPSODY CIE, with rates of 72.6% versus 57.9% at six months, and 58.1% versus 34.4% at 12 months.
The device features a unique tri-layer design including an expandable nitinol stent frame, a cell-impermeable middle layer to prevent tissue accumulation, and an innermost layer designed to reduce fibrin and thrombus formation. Merit Medical has demonstrated solid operational performance, with revenue growing 8.19% and maintaining healthy liquidity with a current ratio of 4.87, according to InvestingPro data.
Dr. Bart Dolmatch, a key contributor to the development of the WRAPSODY CIE, highlighted the advancements in the device, suggesting that it could lead to improved outcomes for patients undergoing hemodialysis.
The approval of WRAPSODY CIE in Canada follows its premarket approval by the US Food and Drug Administration in December 2024 and its commercialization in the United States since January 2025. The device has also received the CE Mark for commercial use in the European Union and is available in Brazil.
Merit Medical was founded in 1987 and has since been dedicated to developing medical devices across various fields, including cardiology and radiology. The company employs approximately 7,300 people globally.
This news is based on a press release statement from Merit Medical Systems, Inc.
In other recent news, Merit Medical Systems reported strong financial results for the first quarter of 2025, with earnings per share (EPS) of $0.86, surpassing the forecasted $0.75. The company’s revenue reached $355.4 million, slightly above the anticipated $352.52 million, marking a 9.8% year-over-year increase. Despite these positive results, Merit Medical’s stock target was cut to $100 by Needham, though the firm maintained a Buy rating. This adjustment follows the company’s unchanged revenue forecast for 2025, alongside a downward revision of its EPS guidance due to tariff impacts. Merit Medical’s organic revenue growth was consistent at 6.0% year-over-year in the first quarter. Additionally, the company reported a notable increase in gross margin by 250 basis points and an operating margin improvement of 230 basis points compared to the previous year. Free cash flow for the first quarter was $20 million, slightly down from the previous year’s $25 million. Furthermore, Merit Medical announced favorable results from its WAVE trial, evaluating the WRAPSODY CIE device, which showed promising outcomes for patients with arteriovenous grafts.
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