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Merit Medical Systems, Inc. (NASDAQ: MMSI) delivers essential updates for stakeholders tracking innovations in minimally invasive medical devices. This dedicated news hub provides verified information about the company's advancements in cardiology, radiology, and vascular access technologies.
Investors and healthcare professionals will find timely updates on regulatory milestones, product launches, and strategic initiatives. Our curated collection includes earnings reports, clinical trial developments, and partnership announcements that shape Merit Medical's position in the $450B+ global medical device market.
Key coverage areas include new FDA clearances for diagnostic catheters, financial performance across international markets, and innovations in embolization technologies. All content undergoes strict verification to ensure compliance with financial reporting standards and medical industry regulations.
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Merit Medical Systems (NASDAQ: MMSI) reported strong Q4 2024 results with revenue of $355.2 million, up 9.4% year-over-year. The company achieved constant currency revenue growth of 10.1% and organic growth of 6.1%.
Key Q4 metrics include GAAP operating margin of 10.3%, non-GAAP operating margin of 19.6%, and GAAP EPS of $0.46. Free cash flow increased 18.4% to $65.3 million.
For full-year 2024, Merit reported revenue of $1.357 billion, up 7.9%, with GAAP EPS of $2.03 (up 25.3%) and free cash flow of $185.7 million (up 67.5%).
Notable developments include the acquisition of Cook Medical's lead management portfolio, FDA approval of the Wrapsody device for dialysis patients, and integration of the EsophyX Z+ device.
The company issued FY2025 guidance projecting revenue of $1.470-1.490 billion (8-10% growth) and non-GAAP EPS of $3.58-3.70 (4-7% growth).
Merit Medical Systems (NASDAQ: MMSI) has announced preliminary unaudited revenue for 2024 ranging between $1.355 billion and $1.357 billion, representing a year-over-year growth of approximately 7.7% to 7.9%. On a constant currency basis, revenue growth is estimated between 8.4% and 8.6% compared to 2023.
The company plans to release its complete financial results for Q4 and full-year 2024, along with fiscal year 2025 guidance, after market close on February 25, 2025. An investor conference call will be held the same day at 5:00 p.m. Eastern time to discuss the results.
Merit Medical Systems (NASDAQ: MMSI) has received FDA premarket approval for its WRAPSODY Cell-Impermeable Endoprosthesis, enabling US commercialization in 2025. The device is designed to extend long-term vessel patency in dialysis patients who rely on arteriovenous (AV) fistulas or grafts.
The WRAPSODY device features a unique three-layer design with a nitinol stent frame, addressing common complications like stenosis and thrombosis. Clinical results from the WRAPSODY WAVE trial showed impressive target lesion primary patency rates of 89.8% for AV fistula and 82.0% for AV graft patients at six months.
Merit will host an informational conference call on January 28, 2025, to discuss the commercial opportunity.
Merit Medical Systems (NASDAQ: MMSI) announced the resignation of President Joseph C. Wright, effective January 3, 2025, following allegations regarding his conduct that were investigated by independent directors and counsel. The allegations were unrelated to Merit's operations or financial performance. Fred P. Lampropoulos has been re-appointed as Merit's President. Merit Medical, founded in 1987, is a global healthcare technology company specializing in proprietary disposable medical devices for interventional, diagnostic, and therapeutic procedures. The company employs approximately 7,200 people worldwide and maintains a sales force and clinical support team of over 700 individuals serving hospitals globally.
Merit Medical Systems (NASDAQ: MMSI) announced positive six-month results from the single-arm AVG cohort of its WRAPSODY WAVE pivotal trial. The trial, involving 112 patients across 43 international sites, demonstrated 82% target lesion primary patency and 68.8% access circuit primary patency at six months. The WRAPSODY device achieved an efficacy rate of 81.4%, significantly exceeding the performance goal of 60% (p<0.0001). Safety outcomes were also favorable, with 95.4% of patients free from adverse events, surpassing the 89% performance goal (p=0.0162). The WRAPSODY Cell-Impermeable Endoprosthesis is designed to restore vessel access in hemodialysis patients and is currently available in Brazil and the European Union, pending FDA approval in the US.
Merit Medical Systems has completed the acquisition of Cook Medical's lead management portfolio for approximately $210 million, funded through cash on hand and credit facility borrowings. The acquired portfolio includes medical devices and accessories for lead management procedures in patients requiring pacemaker or defibrillator lead removal. This strategic move aims to strengthen Merit's electrophysiology and CRM business while enhancing its position in the global cardiac intervention market. The acquisition complements Merit's existing portfolio of steerable and specialty technologies used in cardiac rhythm disorder treatments.
Merit Medical Systems (NASDAQ: MMSI) reported strong Q3 2024 results with revenue of $339.8 million, up 7.8% year-over-year. The company achieved a GAAP operating margin of 11.0% and non-GAAP operating margin of 19.2%. GAAP EPS increased 8.0% to $0.48, while non-GAAP EPS grew 21.1% to $0.86. Free cash flow generation reached $120 million in the first nine months of 2024, up 116%. Based on strong performance, Merit raised its full-year 2024 guidance, projecting revenue between $1.344-$1.352 billion and non-GAAP EPS of $3.33-$3.38.
Merit Medical Systems (NASDAQ: MMSI) has announced it will release its financial results for the third quarter of 2024 on Wednesday, October 30, 2024, after the stock market closes. The company will hold an investor conference call on the same day at 5:00 p.m. Eastern time.
Interested parties can pre-register for the conference call to receive dial-in details. A live webcast and slide deck will also be available. Links for both the call registration and webcast will be provided on Merit's website.
Merit Medical Systems, founded in 1987, is a leading global manufacturer and marketer of healthcare technology. The company specializes in proprietary medical devices used in various medical procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit employs approximately 7,200 people worldwide and has a sales force and clinical support team of over 700 individuals serving customers globally.
Merit Medical Systems (NASDAQ: MMSI) has signed an agreement to purchase Cook Medical's lead management portfolio for $210 million. The acquisition is expected to add approximately $40 million in annual revenue starting in fiscal year 2025, strengthening Merit's electrophysiology and CRM business. The deal is projected to close in Q4 2024, subject to regulatory approvals.
Key points:
- Acquisition aligns with Merit's Continued Growth Initiatives (CGI)
- Expands Merit's presence in the cardiac intervention market
- Expected to be accretive to non-GAAP gross margin immediately
- Projected to be accretive to non-GAAP operating margin in the first full year post-close
- Anticipated to be accretive to non-GAAP earnings per share in the second full year post-close
Merit has updated its 2024 financial guidance to reflect the acquisition's impact, projecting net sales of $1.339 - $1.351 billion and non-GAAP earnings per share of $3.25 - $3.34.
Merit Medical Systems (NASDAQ: MMSI) announced positive 6-month results from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The study, involving 245 patients at 43 sites, compared WRAPSODY, a cell-impermeable endoprosthesis, to percutaneous transluminal angioplasty (PTA) for maintaining blood flow in dialysis patients' AV fistulas.
Key findings include:
- WRAPSODY achieved 89.8% target lesion primary patency at 6 months, compared to 62.8% for PTA (p<0.0001)
- Similar adverse event rates between WRAPSODY and PTA groups
- Results support WRAPSODY as a potential new standard of care for AV fistula patients
The data, presented at CIRSE 2024, will support Merit Medical's Premarket Approval application to the FDA for commercial use in the United States.
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