Lipogems was granted unconditional approval by FDA to conduct an Investigational Device Exemption (IDE) study for the treatment of knee osteoarthritis (OA) compared to corticosteroids for a period of 12 months.
Lipogems is a market-stage medical device company that received FDA 510(k) clearance in 2014 for their device, which is used to process adipose tissue for general applications in orthopedics, arthroscopy and nine other specialties and has been used in 50,000+ procedures worldwide under the current FDA clearance and CE Mark.
Physicians may continue to use Lipogems for currently cleared on-label indications. This study is separate from the existing FDA clearances.
Carl Llewellyn, CEO of Lipogems USA, said, “The decision to pursue this specific indication is based on the positive results seen in 30+ 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’ Microfragmented Fat (MFat) in knee osteoarthritis.”
Lipogems was granted unconditional approval by FDA to conduct an Investigational Device Exemption (IDE) study for the treatment of knee osteoarthritis (OA) compared to corticosteroids for a period of 12 months.
Lipogems is a market-stage medical device company that received FDA 510(k) clearance in 2014 for their device, which is used to process...
Lipogems was granted unconditional approval by FDA to conduct an Investigational Device Exemption (IDE) study for the treatment of knee osteoarthritis (OA) compared to corticosteroids for a period of 12 months.
Lipogems is a market-stage medical device company that received FDA 510(k) clearance in 2014 for their device, which is used to process adipose tissue for general applications in orthopedics, arthroscopy and nine other specialties and has been used in 50,000+ procedures worldwide under the current FDA clearance and CE Mark.
Physicians may continue to use Lipogems for currently cleared on-label indications. This study is separate from the existing FDA clearances.
Carl Llewellyn, CEO of Lipogems USA, said, “The decision to pursue this specific indication is based on the positive results seen in 30+ 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’ Microfragmented Fat (MFat) in knee osteoarthritis.”
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