MORRISVILLE, N.C. , Sept.
17, 2024 /PRNewswire/ -- Sparta Biomedical, a private medical device company focused on osteoarthritis repair solutions, today announced that it has successfully implanted its Ormi device in patients with focal knee lesions as part of its first-in-human clinical trial. The ongoing prospective, multi-center, single-arm study is being conducted at sites in the Dominican Republic and Colombia , where patients have already been enrolled and treated. The first-in-human study is focused on assessing the safety of Ormi in patients experiencing knee pain due to the loss of articular cartilage in the femoral condyle.
The device's unique design allows surgeons to address cartilage damage with or without involvement of the underlying bone. Following implantation, study investigators will monitor patients closely using imaging, physical exams, and patient-reported outcome measures. The Ormi device leverages Sparta Biomedical's Galene platform, a novel synthetic cartilage that closely replicates the properties of native hyaline cartilage.
Ormi integrates Galene with a proprietary titanium stemmed base to ensure secure fixation during the repair of cartilage lesions. Ormi aims to address the limitations of current conservative and surgical treatments for knee osteoarthritis, offering a potential solution that supports weight-bearing and full range of motion while minimizing pain within a short timeframe. "Helping patients with knee focal lesions restore mobility a.