SOUTH JORDAN, Utah - Merit Medical Systems , Inc. (NASDAQ: NASDAQ:MMSI), a leader in healthcare technology with a market capitalization of $5.6 billion, announced that its WRAPSODY Cell-Impermeable Endoprosthesis has received premarket approval from the US Food and Drug Administration (FDA). According to InvestingPro analysis, the company maintains excellent financial health with strong liquidity metrics, positioning it well for this product launch. The device, which is designed to maintain long-term vessel patency in dialysis patients, is set to begin commercialization in the United States in 2025.
The WRAPSODY device addresses complications associated with arteriovenous (AV) fistula and AV grafts in patients undergoing dialysis. These vascular access sites are essential for treatment, and their maintenance is crucial for patient survival. However, complications such as stenosis and thrombosis can occur, necessitating nearly 100,000 stent placements annually in the US to preserve blood flow.
Developed in collaboration with Dr. Bart Dolmatch from the Palo Alto Medical (TASE:PMCN) Foundation, the WRAPSODY device integrates a nitinol stent frame with a polytetrafluoroethylene (PTFE) covering. It features a unique design aimed at reducing tissue accumulation within the device, a significant cause of stenosis in hemodialysis patients. The device's cell-impermeable layer is intended to prevent tissue migration and accumulation, while the nitinol frame offers enhanced radial force and compression resistance.
Clinical trial results have shown promising outcomes for the WRAPSODY device. The WRAPSODY WAVE pivotal trial demonstrated high patency rates at six months for patients treated with the device. Dr. Mahmood K. Razavi, Co-Principal Investigator of the WAVE trial, indicated that the device is associated with high patency rates and is likely to set a new standard of care.
Merit's Chairman and CEO, Fred P. Lampropoulos, expressed pride in the device's innovative solution and its demonstrated efficacy. The company, which has achieved 8.12% revenue growth in the last twelve months, plans to host an informational conference call on January 28, 2025, to discuss the commercialization opportunities of WRAPSODY in the US.
This news is based on a press release statement from Merit Medical Systems, Inc. The company, founded in 1987, specializes in developing, manufacturing, and distributing disposable medical devices used in various procedures, employing approximately 7,200 people worldwide. InvestingPro analysis indicates the stock is currently trading above its Fair Value, with 13 additional ProTips available to subscribers. For detailed insights into Merit Medical's valuation and growth prospects, access the comprehensive Pro Research Report, part of InvestingPro's coverage of 1,400+ US equities.
In other recent news, Piper Sandler analysts exhibited an optimistic outlook for healthcare companies such as ATEC, ATRC, and KIDS, expecting positive fiscal year projections. The analysts also anticipate potential upside for FNA and SIBN. Merit Medical Systems was highlighted for its confidence in surpassing Q4 projections and 2025 consensus estimates. Meanwhile, Procept BioRobotics has initiated a public offering of common stock valued at $175 million, reporting robust revenue growth of 66% in the third quarter.
Wells Fargo (NYSE:WFC) upgraded Merit Medical to Overweight, signaling a positive outlook for the company after reporting 17 consecutive quarters of revenue surpassing expectations and 14 quarters of operating margin growth. Additionally, the company acquired Cook Medical's lead management portfolio, expected to generate significant future revenue. Merit Medical also reported strong Q3 results with total revenue reaching $339.8 million, marking a 7.8% increase from the previous year.
Analysts from Piper Sandler, Wells Fargo, and other firms have provided these recent developments, indicating a positive inclination towards the future performance of these companies. Notably, these updates do not include any speculation or predictions about the companies' stocks or financial health.
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