Lipogems, an Italy-based clinical stage- global medical technology company, announced on Wednesday that it has completed enrolment of patients in the ARISE I US FDA IDE study.
The study is intended to evaluate MicroFat versus corticosteriod injection for the treatment of Knee Osteoarthritis (OA). Efficacy and safety outcomes from ARISE 1 are expected to be revealed in 2025.
The double blinded-randomised controlled trial commenced in January 2023 at 20 sites across the United States and at orthopaedic institutions where 173 patients were enrolled. After the lipoaspiration, patients received either MicroFat or corticosteroid injection. The primary endpoints assess improvement in pain and function at one-year post-injection.
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