The second IDE Study will be conducted for the safety and efficacy for the treatment of knee OA compared to saline and will include 15-20 well-respected academic and private practice orthopaedic institutions
Dr. Brandon Broome, orthopaedic surgeon, performs Lipogems procedure. (Credit: PR Newswire/ Lipogems)
The U. S. Food and Drug Administration (FDA) has awarded Lipogems another Investigational Device Exemption (IDE) study for the use of MicroFat for the treatment of knee osteoarthritis (OA). The second IDE Study will be conducted for the safety and efficacy for the treatment of knee OA compared to saline and will include 15-20 well-respected academic and private practice orthopaedic institutions.
Lipogems has been used in more than 60,000 procedures worldwide, is supported by 140+ peer-reviewed publications, and is currently FDA cleared for use in general applications in orthopaedics, arthroscopy, and nine other specialties since 2014. Lipogems has worked closely with the FDA to seek a separate FDA clearance for a specific indication in knee OA and while Lipogems pursues the Knee OA indication physicians may continue to use the product for the general indications specified in the existing FDA clearance.
Carl Llewellyn, CEO of Lipogems USA, stated “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.”
Source: Company Press Release