Lipogems has announced the successful completion of its ARISE I clinical trial, a significant milestone in its efforts to expand treatment options for patients with knee osteoarthritis (OA). This double-blind, randomized controlled trial enrolled 173 patients across 18 leading clinical sites in the U.S. and marks the final patient visit under the U.S. FDA Investigational Device Exemption (IDE). The study aims to evaluate the safety and efficacy of the Lipogems MicroFat system in improving pain and function among patients with mild to moderate knee OA who are not yet eligible for or do not wish to undergo total knee replacement.

The ARISE I study is one of the largest clinical trials ever conducted by Lipogems and represents a critical step toward gaining a new, specific FDA-approved indication for knee osteoarthritis. While the Lipogems device has already been FDA-cleared for general orthopedic and arthroscopic procedures for the past decade, these trials could lead to expanded use for treating knee OA specifically. The primary endpoints focus on patient-reported improvements in pain and functional mobility at 12 months post-injection. Final data analysis is underway, with results anticipated in late 2025.

With the ARISE I study now complete, Lipogems is one step closer to mainstream adoption of its technology as a less invasive, biologic alternative to surgery. The company remains focused on making this option accessible to more patients by pursuing reimbursement pathways and additional regulatory support. If the study results are favorable, Lipogems could offer a promising solution to the millions of OA sufferers seeking non-surgical treatments that promote natural healing and long-term joint function.