Welcome to our dedicated page for Merit Med Sys news (Ticker: MMSI), a resource for investors and traders seeking the latest updates and insights on Merit Med Sys stock.
Overview
Merit Medical Systems, Inc. (NASDAQ: MMSI) is a globally recognized manufacturer and distributor of advanced medical devices that are instrumental in diagnostic, cardiology, and interventional radiology procedures. With a long-standing history in the development of disposable medical tools, Merit operates from its headquarters in South Jordan, Utah and serves a worldwide customer base through a combination of direct sales and distributor networks. The company is renowned for its commitment to precision, quality, and innovation in the medical device industry, continuously enhancing its product portfolio to meet the evolving demands of minimally invasive procedures.
Products and Services
At its core, Merit Medical Systems develops, manufactures, and markets a diverse range of proprietary disposable medical devices. These devices are vital components in procedures such as angioplasty, stent placement, discography, and embolization therapies. Key product categories include:
- Inflation and Angioplasty Devices: Engineered for precision in opening narrowed vessels, these devices support interventions such as stent placement and discography.
- Diagnostic and Therapeutic Catheters: Designed for use in both diagnostic and therapeutic settings in cardiology and radiology, offering versatility and reliability.
- Guide Wires: Essential for the careful placement of balloon angioplasty catheters, ensuring safe navigation through coronary arteries.
- Embolic Devices: Including innovative embolic products that enhance the accuracy and efficiency of procedures that occlude blood vessels to manage bleeding or treat abnormal tissue growth.
- Ancillary Products and Custom Kits: These encompass angiography accessories and specifically tailored angiography kits that support a wide range of clinical applications.
The company’s product development not only addresses the critical needs of diagnostic and interventional procedures but also extends to applications in oncology, critical care, and endoscopy. By integrating state-of-the-art design with robust manufacturing processes, Merit Medical ensures that its products deliver reliable performance and improved patient outcomes in fast-paced clinical environments.
Market Position and Business Model
Merit Medical Systems stands out within the competitive landscape by focusing on innovation, quality, and comprehensive clinical support. The company generates revenue primarily through direct sales channels in the United States and Europe as well as via a global network of distributors. This diversified sales model allows Merit to directly engage with hospitals, clinics, and physicians, ensuring that its advanced medical devices are consistently positioned as trusted solutions in critical care. By maintaining strict quality standards and achieving key regulatory clearances, Merit has built a reputation for excellence and continues to bolster its market position through strategic product portfolio expansions and acquisitions that enhance its capabilities in high-margin segments such as electrophysiology and cardiac rhythm management.
Research, Innovation, and Clinical Support
Innovation is at the forefront of Merit Medical’s strategy. The company invests in research and development to bring new product solutions to market, supported by extensive clinical trials and regulatory reviews. Merit collaborates with medical professionals and thought leaders to design devices that not only meet current clinical needs but also address emerging challenges in patient care. This focus on innovation is complemented by a strong clinical support team that works closely with healthcare practitioners to provide education, training, and technical assistance, ensuring that the advantages of Merit’s devices are fully realized in real-world clinical settings.
Competitive Landscape
Operating in a dynamic and highly competitive medical device market, Merit Medical Systems differentiates itself by combining technical expertise with a deep understanding of clinical practices. While the industry features multiple players offering various medical technologies, Merit’s specialization in interventional and diagnostic procedures, along with its commitment to continuous innovation and quality assurance, establishes it as an authoritative and trusted partner in patient care. The company’s ongoing investments in new technologies and strategic acquisitions further strengthen its competitive position, supporting its role as a key contributor to advancements in minimally invasive treatment.
Regulatory Excellence and Global Reach
Merit Medical’s success is underpinned by its adherence to stringent regulatory standards. With multiple products gaining clearance or approval from major regulatory agencies, the company demonstrates its commitment to safe and effective medical device manufacturing. This regulatory excellence, combined with a robust global distribution network, enables Merit to serve a broad spectrum of healthcare institutions and maintain enduring partnerships with clinicians worldwide.
Conclusion
In summary, Merit Medical Systems, Inc. is a pivotal force in the field of healthcare technology. Through its innovative medical devices, unwavering commitment to quality, and strategic global presence, Merit empowers healthcare professionals to deliver more reliable, precise, and minimally invasive treatments. The company continues to be a cornerstone in advancing interventional, diagnostic, and therapeutic procedures, reinforcing its position as a trusted partner within the medical community.
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.
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.
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