FDA grants Lipogems IDE approval for clinical trial for treatment of osteoarthritis of the knee


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The FDA has granted Lipogems an investigational device exemption for a clinical trial of the company’s microfragmented fat system for the treatment of osteoarthritis of the knee versus corticosteroids, according to a press release.

The Lipogems Microfragmented Fat (MFat) System has been used to treat adipose tissue for general orthopedic, arthroscopic and nine specialty applications in more than 50,000 procedures under its current FDA 510(k) clearance and CE mark and is expected to be approved for osteoarthritis of the knee, according to the statement.

FDA headquarters in Washington
Source: Adobe Stock

“We are excited to reach this important milestone to pursue a specific indication in knee osteoarthritis and have worked closely with the FDA to establish a premarket approval pathway for the Lipogems system in this indication,” Carl Llewellyn, CEO of Lipogems, said in the release. “Knee osteoarthritis is a debilitating 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 gap The decision to pursue this specific indication is based on the positive results observed in more than 30 independent peer-reviewed publications with up to 3 years of follow-up assessing pain, function, quality of life and economic benefits We anticipate that the approved IDE study will demonstrate compelling data on the safety and efficacy of Lipogems MFat in knee osteoarthritis,” added Llewellyn.


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