OV Medi’s ‘Knee Osteoarthritis Treatment Device’ Designated a Breakthrough Device by the U.S. FDA; U.S. Expansion Gathers Pace

[Financial News]  Healthcare company OV Medi is stepping up its efforts to enter the U.S. market with its knee osteoarthritis treatment technology, MEST. Unlike the breakthrough device designations granted to Korean companies, which have focused primarily on artificial intelligence (AI) and diagnostic software, this case stands out because the company has entered the regulatory process with a therapeutic medical device applied directly inside the body.
According to OV Medi on the 17th, its medical device for alleviating pain caused by degenerative knee osteoarthritis, MEST (Muscle Enhancement and Support Therapy), has received final breakthrough device designation from the U.S. Food and Drug Administration (FDA).
BDD is a program that supports the development and review of innovative medical devices for serious diseases. Designated companies can take advantage of consultations with the FDA before filing and priority reviews. OV Medi plans to pursue follow-up clinical trials and regulatory approval procedures through its U.S. subsidiary, OV Medi Americas.
Unlike conventional approaches that treat the joint itself, MEST targets the vastus medialis, which supports the load placed on the knee. The device is implanted in the body to support weakened muscle and apply microstimulation, thereby helping relieve pain.
The company explained that, following preclinical studies, it confirmed improvements in pain and muscle strength through exploratory and multicenter confirmatory clinical trials involving a total of 171 participants and approved by the Ministry of Food and Drug Safety. It added that a real-world study of 62 patients with knee osteoarthritis conducted at Seoul National University Hospital found reduced pain and improved walking in 80.6% of participants.
Building on the BDD designation, OV Medi plans to refine its premarket authorization strategy with the FDA. It is also pursuing regulatory approval procedures under CE MDR, as well as in the Philippines, Vietnam and Paraguay.
A company official said, "Based on clinical data, we will refine our U.S. regulatory approval strategy and accelerate our expansion into global markets."


[email protected] Kim Kyung-ah Reporter