Michael Barbella, Managing Editor04.10.24
Lipogems has enrolled the first patient in its ARISE II study. The U.S. Food and Drug Administration (FDA) Investigational Ddevice Exemption research trial will assess investigational MicroFat versus saline injection for treating knee osteoarthritis (OA).
"We are thrilled to randomize the first patient in both the ARISE I and II studies," said Dr. Yogesh Mittal, board-certified and fellowship trained total joint surgeon at The Orthopaedic Clinic in Tulsa, Okla. "The number of patients that are not ready or do not qualify for total knee arthroplasty (TKA) 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."
Knee OA patients that have tried conservative options with limited relief may suffer for nine to 20 years from debilitating pain, inactivity, depression, and reduced quality of life, and develop other chronic diseases manifested by the lack of physical activity.1
"For over 10 years, Lipogems has been the international leader in autologous adipose tissue transfer in orthopedics and has been utilized at more than 250 U.S. institutions, including military installations. We are honored to have U.S. 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," Lipogems USA President/CEO Carl Llewellyn stated.
Lipogems International is a privately held medical device company that uses adipose tissue solutions to help maintain or restore patient lifestyles and to improve recovery times. Lipogems' products are used in various specialties, including orthopaedics. The company is exploring products for wound care and more. Lipogems' solutions are available in 29 countries.
Reference
1 London NJ et al. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Medical Hypotheses. 2011; 76:887-892.
"We are thrilled to randomize the first patient in both the ARISE I and II studies," said Dr. Yogesh Mittal, board-certified and fellowship trained total joint surgeon at The Orthopaedic Clinic in Tulsa, Okla. "The number of patients that are not ready or do not qualify for total knee arthroplasty (TKA) 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."
Knee OA patients that have tried conservative options with limited relief may suffer for nine to 20 years from debilitating pain, inactivity, depression, and reduced quality of life, and develop other chronic diseases manifested by the lack of physical activity.1
"For over 10 years, Lipogems has been the international leader in autologous adipose tissue transfer in orthopedics and has been utilized at more than 250 U.S. institutions, including military installations. We are honored to have U.S. 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," Lipogems USA President/CEO Carl Llewellyn stated.
Lipogems International is a privately held medical device company that uses adipose tissue solutions to help maintain or restore patient lifestyles and to improve recovery times. Lipogems' products are used in various specialties, including orthopaedics. The company is exploring products for wound care and more. Lipogems' solutions are available in 29 countries.
Reference
1 London NJ et al. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Medical Hypotheses. 2011; 76:887-892.