Merit Medical's Embosphere Microspheres gain EU approval for genicular artery embolisation to treat knee osteoarthritis.
Quiver AI Summary
Merit Medical Systems, Inc. announced that its Embosphere® Microspheres have received approval in the European Union for use in genicular artery embolisation (GAE) to treat knee osteoarthritis (OA), a condition affecting approximately 595 million people globally. GAE, performed by interventional radiologists, reduces blood flow to the inflamed joint lining, providing significant pain relief and improved mobility without the need for surgery. Clinical data indicate that over 75% of patients experienced lasting pain relief for up to 24 months using Embosphere, with better outcomes than corticosteroid injections. The product, known for its reliability in embolotherapy for over 25 years, is recognized as a trusted treatment option for various conditions. Merit’s CEO emphasized the company’s commitment to innovation in minimally invasive therapies that enhance patient care.
Potential Positives
- Embosphere® Microspheres are now indicated in the EU for genicular artery embolisation (GAE), expanding the product's market reach and potential customer base in an area with a high prevalence of knee osteoarthritis.
- The data show that over 75% of patients treated with Embosphere for GAE achieved clinical success with significant reductions in knee pain sustained through 24 months, highlighting its effectiveness.
- GAE with Embosphere has demonstrated consistently higher clinical success compared to corticosteroid injections, showcasing a competitive advantage in pain management therapies.
- This announcement aligns with the broader trend toward minimally invasive, image-guided pain management therapies, positioning Merit Medical as an innovator in the healthcare technology sector.
Potential Negatives
- Recent FDA approvals are critical and the company may face scrutiny on how quickly they can gain traction in the competitive market for knee osteoarthritis treatments given the substantial existing alternatives.
- The release does not mention any existing or potential regulatory challenges related to the newly approved indication in the EU, which could impact future growth and market access.
- The press release lacks detailed information on any potential side effects or patient risks associated with GAE using Embosphere, which is vital for informed patient and physician decision-making.
FAQ
What is Embosphere® Microspheres used for?
Embosphere® Microspheres are now indicated for genicular artery embolisation (GAE) to treat knee osteoarthritis (OA) in the EU.
How does GAE benefit patients with knee OA?
GAE selectively reduces blood flow to the inflamed synovium, providing pain relief and improving joint function and mobility.
What evidence supports the effectiveness of Embosphere for GAE?
Over 75% of patients treated with Embosphere for GAE achieved clinical success, with significant pain reductions sustained for 24 months.
How does GAE compare to corticosteroid injections?
GAE with Embosphere consistently achieved higher clinical success rates and greater improvements in pain and quality of life compared to corticosteroid injections.
What is the history of Embosphere as a treatment?
Embosphere has been used for over 25 years, treated more than 800,000 patients, and is proven effective for various conditions beyond OA.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$MMSI Congressional Stock Trading
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- REPRESENTATIVE LISA C. MCCLAIN purchased up to $15,000 on 07/22.
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$MMSI Insider Trading Activity
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- FRED P. LAMPROPOULOS (President and CEO) has made 0 purchases and 4 sales selling 40,400 shares for an estimated $3,872,144.
- F. ANN MILLNER sold 21,250 shares for an estimated $2,049,987
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We have seen 181 institutional investors add shares of $MMSI stock to their portfolio, and 228 decrease their positions in their most recent quarter.
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$MMSI Analyst Ratings
Wall Street analysts have issued reports on $MMSI in the last several months. We have seen 8 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- Piper Sandler issued a "Overweight" rating on 07/31/2025
- Wells Fargo issued a "Overweight" rating on 07/31/2025
- Raymond James issued a "Outperform" rating on 07/31/2025
- Barrington Research issued a "Outperform" rating on 07/31/2025
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$MMSI Price Targets
Multiple analysts have issued price targets for $MMSI recently. We have seen 8 analysts offer price targets for $MMSI in the last 6 months, with a median target of $106.5.
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- Larry Biegelsen from Wells Fargo set a target price of $100.0 on 07/31/2025
- Michael Petusky from Barrington Research set a target price of $103.0 on 07/31/2025
- Jayson Bedford from Raymond James set a target price of $102.0 on 07/31/2025
- Jason Bednar from Piper Sandler set a target price of $105.0 on 07/31/2025
- Mike Matson from Needham set a target price of $108.0 on 07/18/2025
- Jon Young from Canaccord Genuity set a target price of $112.0 on 05/21/2025
- David Rescott from Baird set a target price of $110.0 on 04/25/2025
Full Release
SOUTH JORDAN, Utah, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced that Embosphere ® Microspheres are now indicated in the European Union for use in genicular artery embolisation (GAE) to treat patients with knee osteoarthritis (OA).
The most common type of arthritis, OA affects about 595 million people worldwide; 1 with the knee being the most frequently affected joint. 2 Ageing populations, as well as increasing rates of injury and obesity, contribute to this number, and prevalence is expected to increase. 2
Performed by an interventional radiologist, GAE selectively reduces blood flow to the inflamed synovium (thin lining within the joint), offering meaningful reductions in knee pain, improved joint function and mobility, and the potential to delay or avoid surgical intervention. GAE represents a growing area within musculoskeletal embolisation and is part of a broader trend toward minimally invasive, image-guided pain management therapies.
“OA can be very debilitating, impacting patient quality of life,” said Professor Mark Little, BSc (hons), MSc (Distinction), MBBS (Distinction), DipIPEM, FHEA, FRCR, Principal Investigator of the GENESIS study sponsored by Merit and Consultant Interventional Radiologist and Director of Radiology Research at the Royal Berkshire NHS Foundation Trust in Reading, United Kingdom. “GAE is a non-surgical option that provides fast and lasting pain relief in patients with mild to moderate OA. CE Mark of Embosphere for GAE presents an exciting opportunity to advance this treatment option and further interventionalists’ ability to offer the positive results they expect from the procedure.”
Data show that over 75% of patients treated with Embosphere for GAE achieved clinical success with significant reductions in knee pain sustained through 24 months. 3 In addition to durable pain relief over time, Embosphere was associated with a decrease in pain-medication use and improvements in quality-of-life measures. 3 Compared to corticosteroid injections, GAE with Embosphere achieved consistently higher clinical success, with greater improvements at 3 months in pain and quality of life. 3
Made from a proprietary formulation of a tris-acrylic cross-linked co-polymer, Embosphere’s spherical shape provides complete and durable occlusion of targeted blood vessels. 3 Tighter calibration than competitive devices provide consistent and reliable performance, 3 which is important when treating small genicular arteries.
A proven embolotherapy solution for more than 25 years, Embosphere has been extensively studied in over 130 pivotal clinical articles and has been used to treat more than 800,000 patients worldwide. 3 Embosphere has shown long-term performance treating uterine fibroids, arteriovenous malformations (AVM), and benign prostatic hyperplasia (BPH). 3
Learn more about Embosphere Microspheres.
“This expanded indication underscores our commitment to continued innovation that supports the minimally invasive therapies our healthcare partners provide,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “In the case of Embosphere, a long-standing leader in the embolic space, it remains a trusted solution that’s use has grown in ways that have positively impacted patient lives and will pave the way for embolotherapy well into the future.”
ABOUT MERIT MEDICAL
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture, and distribution of proprietary disposable medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide.
TRADEMARKS
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors.
CONTACTS
PR/Media Inquiries
Sarah Comstock
Merit Medical
+1-801-432-2864 |
[email protected]
Investor Inquiries
Mike Piccinino, CFA, IRC
Westwicke - ICR
+1-443-213-0509 |
[email protected]
1. Institute for Health Metrics and Evaluation. 2023. “ Global, Regional, and National Burden of Osteoarthritis, 1990–2020 and Projections to 2050 .” Last modified August 21, 2023.
2. World Health Organization. 2023. “ Osteoarthritis .” Last modified July 14, 2023.
3. Data on file.