Sam Brusco, Associate Editor10.04.23
Lipogems has been awarded another investigational device exemption (IDE) study from the U.S. Food and Drug Administration (FDA) for using MicroFat to treat knee osteoarthritis (OA).
The second IDE study will evaluate safety and efficacy to treat knee OA compared to saline, and will take place at 15-20 academic and private practice orthopedic institutions. The first IDE study began in January 2023.
Lipogems says its tech has been used in over 60,000 procedures worldwide, supported by over 140 peer-reviewed publications. It’s currently FDA-cleared for general applications in orthopedics, arthroscopy, and nine other specialties since 2014.
Carl Llewellyn, CEO of Lipogems USA, told the press, "We are thrilled to announce another milestone in our pursuit for specific indication in knee osteoarthritis. The enrollment in our first study comparing MicroFat vs corticosteroid has been impressive and we see this momentum carrying into the saline study. The completion of both IDE Studies in knee OA and anticipated approval will permit Lipogems to educate directly to physicians and millions of consumers that have tried conservative options but are not ready or do not qualify for a total knee replacement. We pursued this specific indication because over 40+ independent peer-reviewed publications with up to 5 years follow up showed extremely positive results using MicroFat for Knee OA."
The second IDE study will evaluate safety and efficacy to treat knee OA compared to saline, and will take place at 15-20 academic and private practice orthopedic institutions. The first IDE study began in January 2023.
Lipogems says its tech has been used in over 60,000 procedures worldwide, supported by over 140 peer-reviewed publications. It’s currently FDA-cleared for general applications in orthopedics, arthroscopy, and nine other specialties since 2014.
Carl Llewellyn, CEO of Lipogems USA, told the press, "We are thrilled to announce another milestone in our pursuit for specific indication in knee osteoarthritis. The enrollment in our first study comparing MicroFat vs corticosteroid has been impressive and we see this momentum carrying into the saline study. The completion of both IDE Studies in knee OA and anticipated approval will permit Lipogems to educate directly to physicians and millions of consumers that have tried conservative options but are not ready or do not qualify for a total knee replacement. We pursued this specific indication because over 40+ independent peer-reviewed publications with up to 5 years follow up showed extremely positive results using MicroFat for Knee OA."