ATLANTA, March 5, 2025 /PRNewswire/ -- Lipogems has announced the final patient enrolled in the ARISE II U.S. FDA IDE Study, which aims to evaluate the efficacy and safety of MicroFat injections compared to saline for the treatment of Knee Osteoarthritis (OA). The double blinded, randomized, controlled trial enrolled 173 subjects in 9 months across 16 well-respected U.S. sites. The primary endpoints evaluate improvement in pain and function at 6 months post-injection. Efficacy and safety results from ARISE II are expected to be announced in late 2025.
The ARISE I and II studies are designed to support Lipogems in obtaining a separate indication specifically forknee OA. While the Lipogems device has been FDA cleared for use in orthopaedics and arthroscopic surgery for the closed-loop processing and transfer of lipoaspirate tissue for 10 years, these studies represent the largest clinical trials to date for the company.
“With an aging population and more individuals at risk, we are excited to provide Lipogems as a treatment option for patients that are not ready or do not qualify for a knee replacement. We are confident these studies will prove that Lipogems will not only help improve pain and function but also positively impact the patient’s quality of life so they can enjoy their families, sports, and hobbies,” said Martin Roche, MD, Director of Arthroplasty and Robotics at Hospital for Special Surgery.
“As a responsible company, the goal of these studies is to prove the efficacy of Lipogems for this patient population and ultimately apply and obtain reimbursement for this indication making the technology more available for the growing demand of patients that have tried conservative options with limited relief and are not ready for a knee replacement. Lipogems is excited to have received confirmation from FDA to apply for a modular Premarket Approval Application (PMA) and has already moved forward with that process,” said Carl Llewellyn, Chief Executive Officer, Lipogems USA.
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 applications and indications in several other applicable specialties. Lipogems is available in 29 countries with the vision of getting patients back to their lives through our global reach and scientific excellence.
Website www.understandlipogemsphysicians.com or www.understandlipogems.com
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SOURCE LIPOGEMS
