LIPOGEMS ANNOUNCES FIRST PATIENT ENROLLED IN THE SECOND U.S. FDA IDE STUDY FOR THE TREATMENT OF KNEE OSTEOARTHRITIS
05 Apr 2024
ATLANTA, April 5, 2024 /PRNewswire/ -- Lipogems, a clinical stage- global medical technology company, announces the first patient enrolled in the ARISE II U.S. FDA IDE research study, which aims to examine investigational MicroFat versus saline injection for the treatment of 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, Oklahoma. "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."
Shockingly, knee OA patients that have tried conservative options with limited relief may suffer for 9-20 years from debilitating pain, inactivity, depression, reduced quality of life, 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 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.
Reference:
1. London NJ et al. Clinical and economic consequences of the treatment gap in knee osteoarthritis management. Medical Hypotheses. 2011; 76:887-892.
About Lipogems
Lipogems International is a privately held medical device company that uses adipose tissue solutions to help maintain or restore patient lifestyles and to improve quality of life and recovery times. Lipogems' products are used in a variety of specialties, including orthopaedics. Lipogems is exploring products for wound care and more. Lipogems is available in 29 countries and the aim is getting patients back to their lives through our global reach and scientific excellence.
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