Milan, 10 giugno 2022 – Lipogems is pleased to announce the unconditional approval by the U.S. Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) study in the US for the treatment of knee osteoarthritis (OA) compared to corticosteroids.
Lipogems is a market stage biotech company that manufactures and markets a device used to process adipose tissue for general applications in orthopaedics, wound management, colorectal surgery and other specialties. Lipogems has been used in 50,000+ procedures worldwide and within the US under the current FDA 510K clearance.
The Lipogems system has been used in multiple pathologies and is supported by 115+ independent peer reviewed publications from well-respected international institutions.
Giorgio Ninzoli the Group CEO of Lipogems, stated “We are very proud of this achievement which will open the way to the use of Lipogems in US for the treatment of knee OA, one of the most common diseases worldwide affecting millions of people every year. We anticipate that the approved IDE study will demonstrate the compelling safety and efficacy data of Lipogems’ Microfragmented Fat (MFat) in knee osteoarthritis leading the process of reimbursement in the US. This achievement is a milestone that will also boost the adoption of Lipogems worldwide, improving the quality of life for many patients.”