Endoscopic anti-reflux therapy recognized as evidence-based approach to providing relief of GERD symptoms.SOUTH JORDAN, Utah, March 27, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today that the American Society for Gastrointestinal Endoscopy (ASGE) updated its guideline on the diagnosis and management of gastroesophageal reflux disease (GERD) to include Transoral Incisionless Fundoplication (TIF 2.0) and TIF 2.0 Consecutive Transo ...

Merit Medical Systems (MMSI) released 12-month efficacy results for its WRAPSODY Cell-Impermeable Endoprosthesis (“CIE”), demonstrating strong performance in vascular access maintenance. Designed to enhance long-term outcomes for patients with end-stage renal disease, WRAPSODY CIE leverages advanced technology to improve vessel patency and reduce complications.This milestone underscores Merit Medical's dedication to innovation in interventional medicine. With promising clinical data, WRAPSODY CIE reinforces ...

At 6 months, the WRAPSODY CIE achieved 89.8% and 72.6% target lesion primary patency and access circuit primary patency, respectively.At 12 months, the WRAPSODY CIE achieved 70.1% and 58.1% target lesion primary patency and access circuit primary patency, respectively. SOUTH JORDAN, Utah, March 25, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced that the six-month results from the randomized arm of the WRAPSODY Arteriovenous Acc ...

SOUTH JORDAN, Utah, March 18, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced that Chairman and Chief Executive Officer, Fred Lampropoulos, will visit the Nasdaq MarketSite in Times Square to ring the opening bell on Wednesday, March 19, 2025. The ceremony begins at 9:15 A.M. (EDT) and the bell ringing takes place at 9:30 A.M. "Merit’s listing on Nasdaq for 35 years marks a significant milestone in our company’s history,” said Lampropo ...

Group 1 - Medical technology companies have experienced a "flight to safety" in 2025, benefiting from increased investor interest [1] - Merit Medical (NASDAQ: MMSI) has outperformed the market, with shares rising nearly 20% since the last analysis [1]

Company Overview - Merit Medical Systems, Inc. (MMSI) has initiated the enrollment of the first patient in its multicenter, prospective PREEMIE study for the Bloom Micro Occluder System aimed at treating patent ductus arteriosus (PDA) in premature infants [1][2] - The Bloom Micro Occluder System is currently not approved for PDA treatment [1] Study Details - The PREEMIE study plans to enroll at least 55 premature infants with significant PDA across up to 10 U.S. study sites, targeting infants weighing between 600 g and 2,500 g [2] - The study will evaluate the safety and efficacy of the device over a six-month period as part of the premarket approval (PMA) application [2][4] Significance of the Study - PDA is a common congenital heart condition in premature infants, and the Bloom Micro Occluder System is designed as a minimally invasive treatment option [4] - An expert noted that there is currently no approved device for treating PDA in infants weighing 600 grams, making this study crucial for this high-risk population [5] Management Expectations - Merit Medical's management anticipates that the PREEMIE study will significantly enhance care for vulnerable premature infants who could benefit from PDA closure using a transcatheter device [6] Industry Prospects - The global PDA treatment market was valued at $2.4 billion in 2022 and is projected to reach $7.34 billion by 2030, growing at a CAGR of 15% [7] - The increasing demand for diagnostic tests and the rising incidence of PDA in infants are expected to drive market growth, positioning Merit Medical favorably within this niche [7] Recent Developments - Merit Medical reported robust revenue growth in its Cardiovascular unit in its fourth-quarter 2024 results [8] - The company received FDA PMA approval for the WRAPSODY Cell-Impermeable Endoprosthesis, allowing for commercialization in 2025 [8] - Positive six-month findings from the WAVE pivotal trial for the WRAPSODY device were also announced [9] Competitive Landscape - Boston Scientific Corporation (BSX) has entered into an agreement to acquire SoniVie Ltd. to expand its offerings in interventional cardiology [10] - AngioDynamics, Inc. (ANGO) has initiated a randomized study for the Auryon Atherectomy System [12] - Medtronic plc (MDT) released positive two-year results from the SMART Trial, showcasing its competitive position in the cardiovascular space [13]

SOUTH JORDAN, Utah, March 10, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a global leader of healthcare technology, today announced enrollment of the first patient in its multicenter, prospective study of the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in premature infants (PREEMIE study). PDA is a congenital heart condition that occurs when the ductus arteriosus, a blood vessel connecting the aorta and pulmonary artery, does not close following bi ...

Core Insights - Merit Medical Systems, Inc. has initiated a multicenter, prospective study named PREEMIE to evaluate the safety and efficacy of the Bloom Micro Occluder System for treating patent ductus arteriosus (PDA) in premature infants [1][4] - The Bloom Micro Occluder System is designed as a minimally invasive treatment option for hemodynamically significant PDAs, utilizing a flexible delivery system to insert a self-expanding nitinol device [3][4] - The study aims to enroll at least 55 premature infants weighing between 600 g and 2,500 g across up to ten U.S. study sites, with a focus on assessing safety and efficacy over a six-month period [3][4] Company Overview - Merit Medical Systems, Inc. was founded in 1987 and specializes in the development, manufacture, and distribution of proprietary medical devices for interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy [5] - The company has a global presence with a sales force and clinical support team of over 800 individuals and employs approximately 7,400 people worldwide [5] Industry Context - Patent ductus arteriosus (PDA) is a common congenital heart condition in premature, low-birth-weight infants, which can negatively impact health and often requires treatment [2] - Current treatment options for PDA in small premature infants are limited, making the Bloom Micro Occluder System a potentially significant advancement in pediatric interventional cardiology [4]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was reported at $355.2 million, representing a 9% year-over-year increase on a GAAP basis and a 10% increase on a constant currency basis [11][12] - Non-GAAP operating profit grew by 30%, with a non-GAAP operating margin of 19.6%, up approximately 305 basis points year-over-year [13][29] - Non-GAAP earnings per share increased by 26%, exceeding expectations [13][30] - Free cash flow generation for the fiscal year 2024 was over $185 million, up 67% year-over-year [14][30] Business Line Data and Key Metrics Changes - Cardiovascular segment sales grew by 8%, while the Endoscopy segment saw an impressive 88% growth [18] - Peripheral Intervention (PI) products increased by 5.5%, driven by strong sales in axis and embolotherapy products [20] - Cardiac Intervention product sales rose by 7%, with organic growth of approximately 1% [22] - OEM product sales surged by 22%, indicating strong demand in the U.S. despite challenges in international markets [23] Market Data and Key Metrics Changes - U.S. sales increased nearly 14% on a constant currency basis, exceeding expectations [24] - International sales grew by 5% year-over-year, with a 2% increase on an organic constant currency basis [24] - Sales in the APAC region showed modest growth of 4%, while EMEA sales were softer due to challenges in Russia and distributor markets [25] Company Strategy and Development Direction - The company aims for continued strong execution, solid constant currency growth, and improving profitability in 2025, alongside progress in its CGI program [15] - Financial guidance for 2025 includes net revenue growth of 8% to 10% year-over-year, with specific growth targets for cardiovascular and endoscopy segments [34] - The company is focused on maintaining a minimum of 5% organic constant currency growth and achieving operating margins of at least 20% [57] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum and the ability to meet financial guidance for 2025 [15] - The impact of tariffs and potential retaliatory measures remains uncertain, with management monitoring the situation closely [38][39] - The company is optimistic about the WRAPSODY program and its market response, with upcoming presentations expected to provide further insights [45][72] Other Important Information - The company generated $65 million of free cash flow in Q4 2024, contributing to a total of over $185 million for the fiscal year [30][31] - As of December 31, 2024, the company had cash and cash equivalents of $376.7 million and total debt obligations of $747.5 million [32] Q&A Session Summary Question: EPS guidance concerns - Management acknowledged the conservative EPS guidance due to increased interest expenses and accounting treatment of convertible debt, impacting growth expectations [48][52] Question: OEM growth expectations - Management indicated strong demand in the U.S. for OEM products, with confidence in maintaining growth levels [64][67] Question: WRAPSODY revenue guidance - WRAPSODY's revenue guidance of $7 million to $9 million was confirmed to be included in overall financial guidance [87] Question: Endoscopy segment guidance - Management provided insights on the integration of sales forces and expressed confidence in achieving the guidance set for the Endoscopy segment [90][91] Question: Currency impact on revenue - Management discussed the hedging strategies in place to minimize currency impact, with a projected headwind of approximately 20 basis points [93][94] Question: Supply chain challenges - Management reported improved confidence in resolving previous supply chain issues, with ongoing monitoring [116] Question: R&D expenses - The increase in R&D expenses was attributed to short-term investments related to WRAPSODY, with expectations to return to historical levels [124][125]

Merit Medical (MMSI) reported $355.16 million in revenue for the quarter ended December 2024, representing a year-over-year increase of 9.4%. EPS of $0.93 for the same period compares to $0.81 a year ago.The reported revenue represents a surprise of +0.93% over the Zacks Consensus Estimate of $351.87 million. With the consensus EPS estimate being $0.83, the EPS surprise was +12.05%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wal ...