First Patient Enrolled in Merit Medical’s MOTION Study
- Breakthrough device designation by the FDA for Embosphere Microspheres for GAE.
- Prospective, randomized, controlled MOTION study to enroll 264 adults with symptomatic knee osteoarthritis globally.
- Collaboration with leading experts to establish Embosphere Microspheres as a game-changing treatment option.
- Strong legacy of Merit Medical Systems as a market leader of embolotherapies.
- Embosphere Microspheres are not currently approved in any country as an embolic agent for osteoarthritis of the knee.
The commencement of Merit Medical Systems' multicenter, prospective, randomized, controlled trial (RCT) for genicular artery embolization (GAE) using Embosphere® Microspheres represents a significant step in the advancement of non-surgical interventions for knee osteoarthritis. The clinical trial, which aims to enroll up to 264 adults, is designed to assess the safety and effectiveness of GAE compared to corticosteroid injections, a current standard of care. The study's outcome could potentially disrupt the current treatment paradigm for millions of individuals suffering from knee osteoarthritis, offering a minimally invasive alternative to surgery. The 'breakthrough device designation' by the FDA underscores the potential of this technology to offer substantial benefits over existing treatments. If the results are favorable, Merit Medical Systems could see an expansion in the use of Embosphere® Microspheres, providing a new revenue stream and possibly capturing a significant market share in osteoarthritis management.
From a market perspective, the initiation of the MOTION study by Merit Medical Systems is likely to be closely watched by investors and competitors alike. With over 650 million adults globally affected by knee osteoarthritis, the demand for effective non-surgical treatments is substantial. A successful trial outcome could position Merit Medical Systems as a frontrunner in this space, potentially leading to increased stock market valuation. It is important to monitor the enrollment progress and interim results, as these can serve as indicators of the trial's success and impact on the company's financial performance. Additionally, the study's international scope suggests a strategic move to tap into global markets, which could significantly enhance the company's growth prospects should the treatment receive regulatory approval.
Merit Medical Systems' focus on evidence-based medicine and patient-centric care through the MOTION study aligns with broader industry trends towards personalized and less invasive medical treatments. GAE's potential to alleviate pain and inflammation by targeting hypervascularity in the knee could offer a novel approach to managing knee osteoarthritis symptoms. The industry will be observing the long-term outcomes of this study, particularly the 24-month follow-up data, to determine the durability and cost-effectiveness of GAE compared to other treatments. The outcome of this study could influence future research and development investments not only for Merit Medical Systems but also for competitors and startups looking to innovate in the orthopedic space.
SOUTH JORDAN, Utah, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the successful enrollment of the first patient in its multicenter, prospective, randomized, controlled trial comparing genicular artery embolization (GAE) using Embosphere® Microspheres to corticosteroid injections for the treatment of symptomatic knee osteoarthritis (MOTION) study.
Globally, more than 650 million adults are affected by osteoarthritis of the knee.1 Injections of corticosteroids (intra-articular injections) are commonly used to relieve pain associated with knee osteoarthritis. However, the long-term benefit of intra-articular injections is limited. Hypervascularity (increased blood vessels) and inflammatory processes are key contributors to the development and progression of knee osteoarthritis. GAE is a minimally invasive procedure that selectively reduces blood flow to areas of the knee where hypervascularity has been identified, helping to alleviate pain and inflammation associated with knee osteoarthritis.
In 2022, the United States Food and Drug Administration (FDA) granted Merit’s Embosphere Microspheres “breakthrough device designation” for GAE. Under this designation, Embosphere Microspheres received priority review by the FDA, which allowed for accelerated review and development of the MOTION study protocol.
The MOTION study is designed to enroll up to 264 adults with symptomatic knee osteoarthritis across medical centers in North America, Brazil, Europe, Australia, and New Zealand. In conducting the study, Merit intends to randomize patients 1:1 to receive either GAE using Embosphere Microspheres or intra-articular corticosteroid injections. The study is structured to evaluate primary safety and effectiveness of Embosphere Microspheres at 6 months with continued patient follow up through 24 months.
“The commencement of this randomized controlled study is a testament to our commitment to evidence-based medicine and patient-centric care,” said Sandeep Bagla, MD, Co-Global Principal Investigator of the MOTION study. “Through rigorous research and collaboration with leading experts, we aim to establish Embosphere Microspheres as a game-changing treatment option, setting a new standard in knee-pain management.”
“We look forward to the results of this study, as we feel it can offer another solution to the millions of people globally who suffer from arthritic knee pain every year,” said Craig J. McAsey, MD, Co-Global Principal Investigator of the MOTION study, and paid consultant of Merit. “In orthopedics, we are still searching for an effective alternative to surgery when possible; I am hopeful that this will actually bring us closer to that goal.”
“We are proud of our strong legacy as a market leader of embolotherapies, such as Embosphere Microspheres, that have meaningfully improved patients’ quality of life,” said Fred Lampropoulos, Merit’s Chairman and CEO. “We anticipate that the results from the MOTION study will allow us to expand the clinical benefits of Embosphere Microspheres to help clinicians safely and effectively treat patients with symptomatic knee osteoarthritis.”
The MOTION study is an Investigational Device Exemption (IDE) study; Embosphere Microspheres are not currently approved in any country as an embolic agent for osteoarthritis of the knee.
For additional information on the MOTION study, including ongoing updates, please visit: https://clinicaltrials.gov/study/NCT05818150
Reference
1Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020;29-30:100587.
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 in excess of 700 individuals. Merit employs approximately 7,100 people worldwide.
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FAQ
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