LIPOGEMS ANNOUNCES LAST PATIENT LAST VISIT FOR ARISE 1 KNEE OSTEOARTHRITIS TRIAL
ATLANTA, May 7, 2025 /PRNewswire/ — Lipogems is proud to announce the completion of the ARISE I U.S. FDA IDE Study with the last patient's last visit successfully completed. This milestone marks the conclusion of a key phase in the advancement of Lipogems for the treatment of knee osteoarthritis (OA) in patients who are not yet ready for or do not qualify for knee replacement.
The double-blinded, randomized controlled trial enrolled 173 subjects across 18 well-respected U.S. sites. The primary endpoints evaluate improvement in pain and function at 12 months post-injection. Efficacy and safety results from ARISE studies are expected to be announced in late 2025.
'We are thrilled to reach this significant milestone,' said Carl Llewellyn, Chief Executive Officer of Lipogems USA. 'This accomplishment brings us one step closer to making Lipogems a mainstream treatment option for patients with knee osteoarthritis that historically have had limited options. The successful conclusion of this trial represents the hard work and dedication of our team, clinical sites, and the patients that have placed their trust in us.'
While the Lipogems device has been and remains FDA cleared for use broadly in orthopaedics and arthroscopic surgery for 10 years, these studies represent the largest clinical trials to date for the company. The ARISE I and II studies are designed to support Lipogems in obtaining a separate indication specifically for knee OA. The data will be analyzed in the coming months to assess the safety and efficacy of Lipogems, specifically how Lipogems improves pain and function for patients with mild to moderate knee OA.
Lipogems remains committed to making this technology more available to patients by obtaining reimbursement for the growing demand of patients that need less invasive, more natural treatment options that promote healing and recovery.
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.
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