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Lipogems announces the first patient enrolled in the ARISE II U.S. FDA Investigational Device Exemption research study, which aims to examine investigational MicroFat versus saline injection for the treatment of Knee Osteoarthritis (OA).
Lipogems received FDA 510(k) clearance in 2018 to market a Microfragmented Adipose Tissue Transplant system for use in orthopedic and arthroscopic procedures.
Packaged as a comprehensive kit, the treatment uses a minimally invasive procedure to harvest, concentrate, and then transfer autologous adipose tissue, typically from the patient’s lower torso. The method can be performed in an office or surgical setting in under an hour. After a saline rinse to remove contaminants, the system resizes (“microfragments”) the tissue to an optimal size to support repair, replacement or reconstruction of injured tissue.
“We are thrilled to randomize the first patient in both the ARISE I and II studies!” said Dr. Yogesh Mittal, Total Joint Surgeon at The Orthopaedic Clinic in Tulsa, Oklahoma. “The number of patients that are not ready or do not qualify for total knee arthroplasty is growing exponentially and sadly there are not many FDA-cleared options available for them after they have tried conservative therapy. Lipogems provides these patients a single injection procedure that may help treat their knee OA or delay the need for TKA.”
“For over 10 years, Lipogems has been the international leader in autologous adipose tissue transfer in orthopaedics and has been utilized at more than 250 well-respected U.S. institutions, including military installations. We are honored and excited to have leading US research centers now enrolling patients in the ARISE II Study which aims to prove that a single autologous, intra-articular injection of Lipogems’ proprietary MicroFat can effectively treat patients with Knee OA,” said Carl Llewellyn, CEO and President of Lipogems USA.
Source: Lipogems
Lipogems announces the first patient enrolled in the ARISE II U.S. FDA Investigational Device Exemption research study, which aims to examine investigational MicroFat versus saline injection for the treatment of Knee Osteoarthritis (OA).
Lipogems received FDA 510(k) clearance in 2018 to market a Microfragmented Adipose Tissue Transplant...
Lipogems announces the first patient enrolled in the ARISE II U.S. FDA Investigational Device Exemption research study, which aims to examine investigational MicroFat versus saline injection for the treatment of Knee Osteoarthritis (OA).
Lipogems received FDA 510(k) clearance in 2018 to market a Microfragmented Adipose Tissue Transplant system for use in orthopedic and arthroscopic procedures.
Packaged as a comprehensive kit, the treatment uses a minimally invasive procedure to harvest, concentrate, and then transfer autologous adipose tissue, typically from the patient’s lower torso. The method can be performed in an office or surgical setting in under an hour. After a saline rinse to remove contaminants, the system resizes (“microfragments”) the tissue to an optimal size to support repair, replacement or reconstruction of injured tissue.
“We are thrilled to randomize the first patient in both the ARISE I and II studies!” said Dr. Yogesh Mittal, Total Joint Surgeon at The Orthopaedic Clinic in Tulsa, Oklahoma. “The number of patients that are not ready or do not qualify for total knee arthroplasty is growing exponentially and sadly there are not many FDA-cleared options available for them after they have tried conservative therapy. Lipogems provides these patients a single injection procedure that may help treat their knee OA or delay the need for TKA.”
“For over 10 years, Lipogems has been the international leader in autologous adipose tissue transfer in orthopaedics and has been utilized at more than 250 well-respected U.S. institutions, including military installations. We are honored and excited to have leading US research centers now enrolling patients in the ARISE II Study which aims to prove that a single autologous, intra-articular injection of Lipogems’ proprietary MicroFat can effectively treat patients with Knee OA,” said Carl Llewellyn, CEO and President of Lipogems USA.
Source: Lipogems
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
