Sam Brusco, Associate Editor01.16.23
Clinical-stage firm Lipogems enrolled the first patient in its ARISE U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) study, which will examine its MicroFat autologous, intra-articular injection versus corticosteroid injection to treat knee osteoarthritis (OA).
Dr. Yogesh Mittal, orthopedic surgeon, enrolls the first patient in the Lipogems ARISE Study, which aims to examine MicroFat versus corticosteroid injection for the treatment of knee osteoarthritis (OA).
"This is an exciting moment! We screened the first patient on December 30, 2022, and I'm proud to have enrolled the first patient for this trial," Dr. Yogesh Mittal, Board-Certified and Fellowship Trained Total Joint Surgeon at The Orthopaedic Clinic in Tulsa, Ok., and a site for NextStage Clinical Research, told the press. "Many of my patients suffering from Knee OA are not ready or do not qualify for a total knee arthroplasty (TKA) and I have very limited options to offer them after they have tried conservative therapies such as corticosteroids, HA injections, physical therapy, and activity modification. Lipogems provides these patients a single injection procedure that may help treat their knee OA or delay the need for TKA."
Lipogems’ ARISE IDE study will enroll at up to 20 U.S. sites to compare MicroFat with corticosteroid injection to treat pain and function for moderate knee OA.
"The ARISE study should prove we can effectively help patients with Knee OA, which is especially significant as these patients live longer, busier, and more highly active lives.", said Carl Llewellyn, CEO and president of Lipogems USA, "Backed by a growing body of clinical evidence, Lipogems has established itself as the leader in autologous adipose tissue transfer in orthopaedics. We are currently commercially available for broad use in orthopedics, but a specific Knee OA indication will permit us to better focus on this underserved patient base and help them manage this debilitating disease."
Dr. Yogesh Mittal, orthopedic surgeon, enrolls the first patient in the Lipogems ARISE Study, which aims to examine MicroFat versus corticosteroid injection for the treatment of knee osteoarthritis (OA).
Lipogems’ ARISE IDE study will enroll at up to 20 U.S. sites to compare MicroFat with corticosteroid injection to treat pain and function for moderate knee OA.
"The ARISE study should prove we can effectively help patients with Knee OA, which is especially significant as these patients live longer, busier, and more highly active lives.", said Carl Llewellyn, CEO and president of Lipogems USA, "Backed by a growing body of clinical evidence, Lipogems has established itself as the leader in autologous adipose tissue transfer in orthopaedics. We are currently commercially available for broad use in orthopedics, but a specific Knee OA indication will permit us to better focus on this underserved patient base and help them manage this debilitating disease."
