#United States #Atlanta #Osteoarthritis #Lipogems #Medical Trials

Lipogems Marks Completion of ARISE I Clinical Trial

Lipogems International is pleased to announce the successful conclusion of the ARISE I clinical trial, which was pivotal in evaluating its innovative microfat technology for treating knee osteoarthritis (OA). On May 7, 2025, the company confirmed that the last patient's visit in the U.S. FDA Investigational Device Exemption (IDE) study had been successfully completed. This marks a significant milestone in a journey that seeks to provide a viable alternative to patients not yet ready for knee replacement surgery.

The ARISE I study was designed as a double-blinded, randomized controlled trial that enrolled 173 participants across 18 respected clinical sites in the United States. The primary goals of this trial were to assess improvements in pain and function over a 12-month period following treatment. Results regarding the efficacy and safety of the Lipogems technology are anticipated to be released in late 2025, creating anticipation within the medical community and among potential patients.

Carl Llewellyn, CEO of Lipogems USA, expressed his enthusiasm about reaching this significant milestone. He stated, "We are thrilled to reach this significant milestone, which brings us one step closer to making Lipogems a mainstream treatment option for patients with knee osteoarthritis that historically have had limited options." This remark underscores the dedication and hard work invested by the Lipogems team, the participating clinical sites, and the patients who have placed their trust in this innovative approach.

Although Lipogems technology has been FDA-cleared for a decade for use in orthopedic and arthroscopic surgeries, the ARISE studies represent the largest clinical trials conducted by the company to date. Specifically, the ARISE I and II studies aim to support Lipogems' efforts in securing a unique indication for its application in knee OA. This effort highlights a commitment to offering less invasive and more natural treatment alternatives that can enhance healing and recovery.

In the coming months, the data gathered from this trial will be meticulously analyzed to determine not only the safety of the Lipogems technology but also how effectively it relieves pain and restores functionality in patients with mild to moderate knee osteoarthritis. This innovative solution, using patient-derived adipose tissue, aims to promote recovery and improve the quality of life for those who seek it.

About Lipogems

Lipogems International is a privately held medical device company dedicated to harnessing adipose tissue solutions to restore patient lifestyles and enhance recovery. Their products find application across various specialties, particularly in orthopedics, and they are actively exploring other relevant applications in the medical field. With a presence in 29 countries, Lipogems is committed to advancing patient care through scientific excellence and expansive reach.

As they move forward, the vision of Lipogems is to facilitate the return of patients to their daily lives by ensuring the accessibility of their innovative solutions. The ongoing progression in clinical trials, particularly with knee osteoarthritis, positions Lipogems at the forefront of medical advancements that prioritize patient outcomes and well-being.