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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) 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.
Merit Medical Systems (NASDAQ: MMSI) announced its participation in the 2024 Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Congress in Lisbon, Portugal. The company will present updates on two pivotal studies:
1. 6-month clinical outcomes from the WAVE study during the FIRST@CIRSE Clinical Trial session.
2. An overview of the MOTION study design and methodology during the News on Stage session.
Merit will also sponsor two symposia focusing on:
- Clinical management of synovial arterial hypervascularity in the knee (September 15)
- Maintaining long-term patency for hemodialysis patients (September 16)
These sessions can be viewed with a free myCIRSE account, with on-demand access available within 24 hours after the live sessions.
Merit Medical Systems (NASDAQ: MMSI) reported strong Q2 2024 results, with revenue of $338.0 million, up 5.6% year-over-year. Constant currency revenue increased 6.6%, while organic constant currency revenue grew 5.0%. The company's GAAP EPS rose 75.7% to $0.61, and non-GAAP EPS increased 16.8% to $0.92. Merit's GAAP operating margin improved to 13.6% from 9.0% in the prior year period, while non-GAAP operating margin expanded to 20.1% from 19.1%.
Based on these results, Merit has raised its full-year 2024 guidance. The company now expects net sales of $1,335 - $1,345 million, representing 6-7% growth, and non-GAAP EPS of $3.27 - $3.35, a 15-17% increase year-over-year. This updated guidance includes the impact of the EndoGastric Solutions acquisition completed on July 1, 2024.
Merit Medical Systems (NASDAQ: MMSI) announced plans to release findings from its WAVE study, examining the safety and efficacy of the WRAPSODY Cell-Impermeable Endoprosthesis for treating stenosis in the venous outflow circuit. The study enrolled 245 patients with arteriovenous fistula (AVF) stenosis and 113 with arteriovenous graft (AVG) stenosis.
Six-month safety and efficacy findings for the AVF cohort will be presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) on September 14, 2024, in Lisbon. Additional presentations are scheduled at CIRSE and the Controversies in Dialysis Access (CiDA) Symposium in October.
The WRAPSODY device is not yet approved in the US but has received CE Mark for use in the European Union and is available in Brazil. Results from the WAVE study are expected to support Merit's Premarket Approval application to the FDA for commercial use in the United States.
Merit Medical has announced the acquisition of EndoGastric Solutions’ assets for $105 million, integrating the EsophyX Z+ device into its endoscopy portfolio. This device offers a minimally invasive treatment for chronic GERD. The acquisition is expected to add approximately $30 million in annual revenue, focusing on the gastrointestinal endoscopy market. Updated financial guidance for 2024 includes the partial-year impact, projecting revenue between $1.324 and $1.340 billion and diluted non-GAAP EPS between $3.22 and $3.31. Though initially dilutive to 2024 GAAP net income, the acquisition is expected to be accretive in the first full year post-closing.
Merit Medical Systems (NASDAQ: MMSI) will release its Q2 2024 financial results on August 1, 2024, after market close. The company will also host an investor conference call at 5:00 p.m. Eastern on the same day. Stakeholders can pre-register for the call and access a live webcast via links provided on merit.com.
Founded in 1987, Merit Medical Systems is a global leader in healthcare technology, specializing in disposable medical devices used in various medical procedures. The company employs around 7,000 people globally and serves hospitals worldwide with a robust sales and clinical support team.
Merit Medical Systems (NASDAQ: MMSI) has announced the US launch of the basixSKY Inflation Device, expanding its portfolio of inflation devices. The device, designed for ease of use and efficiency, is available as a standalone product or in kits with Merit Angioplasty Packs. It is intended for procedures like balloon angioplasty and stent placement, which restore blood flow through blocked arteries. Merit Medical aims to enhance its leadership in the inflation device market with this new offering.
Merit Medical Systems (NASDAQ: MMSI) announced the election of Silvia M. Perez to its Board of Directors during the Annual Meeting of Shareholders on May 15, 2024. Perez, who is currently the President of the Commercial Branding and Transportation Division at 3M Company, brings over two decades of healthcare industry experience, covering clinical, regulatory, operations, marketing, and business leadership. Perez, along with re-elected directors Fred P. Lampropoulos and Stephen C. Evans, will serve three-year terms. Perez's varied background includes roles such as President of Commercial Solutions Division and Vice President of Acelity at 3M, the company's largest acquisition. She holds a pharmaceutical chemist degree and Six Sigma certifications. Merit Medical emphasizes her potential to contribute valuable industry and organizational insights to support its growth initiatives.
Merit Medical Systems announced the appointment of Joe Wright as President, effective immediately. Wright, who has been with the company for 19 years, previously served as Chief Commercial Officer and President of the International Division. He will oversee global commercial, marketing, and manufacturing operations. The appointment is part of Merit’s Continued Growth Initiatives Program, which emphasizes investment in talent to drive growth and profitability. The company is also in the process of identifying a successor for CEO Fred P. Lampropoulos, who will retire at the end of 2025.
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