FDA grants Lipogems IDE approval for clinical trial on treatment for knee OA
The FDA has awarded Lipogems an investigational device exemption for a clinical trial on the company’s microfragmented fat system for treatment of knee osteoarthritis compared with corticosteroids, according to a press release.
The Lipogems microfragmented fat (MFat) system has been used to process adipose tissue for general applications in orthopedics, arthroscopy and nine specialties in more than 50,000 procedures under its current FDA 510(k) clearance and CE mark and is anticipated for approval in the setting of knee OA, according to the release.
“We are excited to achieve this milestone to pursue a specific indication in knee OA and have worked closely with the FDA to establish a pathway for premarket approval of the Lipogems system in this indication,” Carl Llewellyn, CEO of Lipogems, said in the release. “Knee OA is a crippling disease for millions of people that have tried conservative options but are not ready and/or do not qualify for a total knee replacement, a segment known as the treatment gap. The decision to pursue this specific indication is based on the positive results seen in 30-plus independent peer-reviewed publications with up to 3 years follow-up evaluating pain, function, quality of life and economic advantages. We anticipate that the approved IDE study will demonstrate compelling safety and efficacy data of Lipogems' MFat in knee osteoarthritis,” Llewellyn added.
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