LIPOGEMS® RECEIVES IDE APPROVAL FROM THE U.S. FDA TO BEGIN A PIVOTING CLINICAL STUDY ON THE SAFETY AND EFFECTIVENESS OF THE LIPOGEMS SYSTEM FOR THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE
Carl LlewellynCEO of Lipogems UNITED STATESsaid, “We are delighted to reach this important milestone to pursue a specific indication in osteoarthritis of the knee and have worked closely with the FDA to establish a pre-market approval pathway for the Lipogems system in this indication. . Knee osteoarthritis is a disabling disease for millions of people. who have tried conservative options but are not ready and/or not eligible for total knee replacement surgery, a segment known as the treatment gap The decision to pursue this specific indication is based on the positive results observed in more than 30 independent peer-reviewed studies published with up to 3 years follow-up assessing pain, function, quality of life and economic benefit. We anticipate that the approved IDE study will demonstrate compelling data on the safety and efficacy of Lipogems microfragmented fat (MFat) in knee osteoarthritis.
Lipogems is a private medical device company that uses adipose tissue solutions to help maintain or restore patients’ lifestyles and improve quality of life and recovery times. Lipogems products are used in a wide range of fields, including plastic and reconstructive surgery, orthopedics, general surgery, wound care product exploration and more. Lipogems is available in 29 countries and the goal is to bring patients back to life through our global reach and scientific excellence. Information about Lipogems can be found at: http://www.understandinglipogems.com/