Lipogems, a clinical stage- global medical technology company, announces it has completed enrollment in the ARISE I U.S. FDA IDE study, which aims to examine MicroFat versus corticosteriod injection for the treatment of Knee Osteoarthritis (OA). Efficacy and safety results from ARISE 1 are expected to be announced in 2025.
“It is a tremendous accomplishment to complete enrollment in the Lipogems ARISE 1 FDA IDE Study ahead of expectations! I’m proud of our team, the principal investigators and their dedicated teams, as well as our collaboration with Alira Health to achieve this significant milestone in only 14 months,” said Giorgio Ninzoli, Chief Executive Officer, Lipogems International.
“Lipogems could be the answer to help the growing global demand of patients suffering from Knee OA by treating the disease in the earlier stages.”, said Carl Lewellyn, Chief Executive Officer, Lipogems USA. “We are confident this study will prove that Lipogems is a safe, effective, natural and minimally invasive option to treat this debilitating disease or delay the need for a knee replacement.”
This double blinded-randomized controlled trial was initiated in January 2023 at 20 sites across the United States and at well-respected orthopaedic institutions where 173 subjects were enrolled. Following the lipoaspiration, patients received either MicroFat or corticosteroid injection. The primary endpoints evaluate improvement in pain and function at 1-year post-injection.
For the past 10 years, Lipogems has been FDA cleared for use in orthopaedics and arthroscopic surgery and 9 other specialties. The ARISE I and II studies will permit Lipogems to pursue a separate and specific indication in knee osteoarthritis. Lipogems is supported by 160+ peer-reviewed publications but the ARISE studies are the largest studies to date for Lipogems.