Core Viewpoint - Merit Medical Systems, Inc. (MMSI) has received FDA premarket approval for its WRAPSODY Cell-Impermeable Endoprosthesis, which is expected to enhance its market position in the vascular intervention space and drive future revenue growth [20][19]. Company Summary - MMSI currently has a market capitalization of $5.72 billion, with fiscal 2024 revenue estimates at $1.35 billion, reflecting a 7.2% growth from fiscal 2023 [2]. - The WRAPSODY device is designed to improve long-term vessel patency in dialysis patients, addressing complications such as stenosis and thrombosis [12][4]. - The WRAPSODY WAVE pivotal trial showed promising results, with primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months [13]. - Following the FDA approval announcement, MMSI's shares increased by 2.03% to $98.22, with a 29.9% gain over the past year compared to the industry’s 2.2% growth [10]. Industry Summary - The global hemodialysis market was valued at $76.9 billion in 2022 and is projected to reach $111.8 billion by 2032, growing at a CAGR of 3.8% [21]. - The need for improved dialysis access solutions is underscored by the prevalence of chronic cardiac diseases and end-stage renal disease, driving demand for advanced medical devices like the WRAPSODY [21][22]. - The FDA approval of the WRAPSODY device positions Merit Medical to capitalize on the growing market for vascular interventions, enhancing its competitive edge and opening new revenue streams [19].

Core Insights - Merit Medical Systems, Inc. has received premarket approval from the US FDA for the WRAPSODY Cell-Impermeable Endoprosthesis, allowing for commercialization in the USA starting in 2025 [6] - The WRAPSODY device is designed to improve long-term vessel patency in hemodialysis patients, addressing common issues such as stenosis and thrombosis [12][19] - Clinical trial results indicate high efficacy of the WRAPSODY device, with primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months [18] Company Overview - Merit Medical, founded in 1987, specializes in the development, manufacture, and distribution of proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures [10] - The company employs approximately 7,200 individuals globally and serves hospitals worldwide with a dedicated sales force and clinical support team [10] Product Details - The WRAPSODY device features a unique design with a nitinol stent frame and a multi-layer structure aimed at reducing tissue accumulation and improving blood flow [7][12] - The device is indicated for use in treating stenosis or occlusion in the dialysis access outflow circuit, specifically in peripheral veins of individuals with AV fistulas and at the venous anastomosis of synthetic AV grafts [11] Market Context - In the United States, approximately 687,000 procedures are performed annually to maintain dialysis access, with nearly 100,000 involving stent placement [17] - The WRAPSODY device is expected to set a new standard of care in the treatment of vascular access complications for dialysis patients, as indicated by the positive outcomes from the WAVE trial [19]

SOUTH JORDAN, Utah, Dec. 16, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI) ("Merit" or the "Company"), a global leader of healthcare technology, today announced the resignation of its President, Joseph C. Wright, effective January 3, 2025. The Company noted that prior to Mr. Wright's resignation, Merit had received notice of allegations regarding his conduct, which Merit's independent directors investigated with the assistance of independent counsel. The allegations were unrelated to Me ...

Investors looking for stocks in the Medical - Dental Supplies sector might want to consider either Merit Medical (MMSI) or West Pharmaceutical Services (WST) . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look.The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Sty ...

Company Overview - Merit Medical Systems, Inc. (MMSI) announced positive six-month findings from the single-arm Arteriovenous Graft (AVG) cohort of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial, which assesses the efficacy and safety of the WRAPSODY device [1][3] - The WRAPSODY Cell-Impermeable Endoprosthesis is currently not approved for commercial distribution in the United States but is available in Brazil and the European Union [2] - The device is being used in the U.S. under an Investigational Device Exemption from the FDA, with findings from the WAVE trial supporting the premarket approval application for commercial use [3] Market Position and Financials - Merit Medical has a market capitalization of $6.12 billion and a projected earnings per share growth of 11.6%, higher than the industry's 7.5% [6] - The company delivered an earnings surprise of 7.5% in the last reported quarter [6] - Following the announcement of the trial findings, shares of the company lost nearly 0.4% at closing, despite historical synergies from product launches and positive trial outcomes [5] Product Significance - The WRAPSODY device is designed to restore and extend vessel access (patency) in hemodialysis patients, which is critical for patient survival [7] - Favorable results from the AVG arm of the WAVE trial are encouraging for physicians managing AVG patients, given the historically low patency rates [8] Industry Prospects - The global hemodialysis market was valued at $76.9 billion in 2022 and is anticipated to reach $111.8 billion by 2032, growing at a CAGR of 3.8% [9] - Factors driving the market include increasing awareness of hemodialysis and the rising prevalence of chronic cardiac diseases and end-stage renal disease [9] - The positive trial outcome is expected to solidify Merit Medical's foothold in the hemodialysis market [10] Recent Developments - In September, MMSI announced positive six-month findings from the randomized arteriovenous fistula arm of its WRAPSODY WAVE pivotal trial [11] - Over the past year, shares of the company have gained 46.2%, outperforming the industry's 9.1% rise and the S&P 500's 31.6% growth [12]

Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. However, it isn't easy to find a great growth stock.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Sty ...

Merit Medical Systems, Inc. (MMSI) witnessed strong momentum in the year-to-date period. Shares of the company have rallied 37.9% compared with the industry’s growth of 3.6%. The S&P 500 composite has risen 24% in the same period.With healthy fundamentals and strong growth opportunities, this Zacks Rank #2 (Buy) company appears to be a solid wealth creator for its investors at the moment.Merit Medical specializes in providing products for peripheral and cardiac interventions, targeting conditions in interve ...

Have you been paying attention to shares of Merit Medical (MMSI) ? Shares have been on the move with the stock up 8.8% over the past month. The stock hit a new 52-week high of $102.88 in the previous session. Merit Medical has gained 34.2% since the start of the year compared to the 4% move for the Zacks Medical sector and the 4.3% return for the Zacks Medical - Dental Supplies industry.What's Driving the Outperformance?The stock has a great record of positive earnings surprises, as it hasn't missed our ear ...

Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. However, it isn't easy to find a great growth stock.By their very nature, these stocks carry above-average risk and volatility. Moreover, if a company's growth story is over or nearing its end, betting on it could lead to significant loss.However, the Zacks Growth Style Score (part of the Zacks Style Scores system), which looks beyond the tr ...

SOUTH JORDAN, Utah, Nov. 01, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader in healthcare technology, today reported that it has completed the acquisition of Cook Medical’s lead management portfolio. The purchase consideration consisted of a cash payment of approximately $210 million and the assumption of certain liabilities. Merit funded the acquisition payment through a combination of cash on hand and borrowings under its long-term credit facility. “We are pleased to ...