Lipogems Receives FDA Approval for Second IDE Study on MicroFat Treatment for Knee Osteoarthritis

Lipogems, a prominent medical device company renowned for its adipose tissue solutions, has been granted another Investigational Device Exemption (IDE) study by the U.S. Food and Drug Administration (FDA). This second study focuses on the use of MicroFat for the treatment of knee osteoarthritis (OA). We are proud to be the exclusive distributor of Lipogems kits in the UK and able to provide training for orthopaedic purposes.

The FDA’s recent approval is a significant milestone, indicating progress in understanding and expanding the applications of MicroFat in orthopaedic care. As the sole distributor of Lipogems kits in the UK, plays a pivotal role in bringing this innovative medical solution to patients in the region.

The second IDE Study, aimed at evaluating the safety and efficacy of MicroFat compared to saline for treating knee OA, will include collaboration with 15-20 renowned academic and private practice orthopaedic institutions. Lipogems, a versatile medical solution, has been successfully used in over 50,000 procedures worldwide, securing FDA clearance for general applications in orthopaedics, arthroscopy, and nine other specialties since 2014.

Dr. Brandon Broome, a distinguished orthopaedic surgeon, expressed confidence in Lipogems, stating, “Lipogems has proven its effectiveness in numerous applications, and this second IDE Study focusing on knee osteoarthritis adds to the growing body of evidence supporting its versatility and potential in orthopaedic care.”

Lipogems has been working closely with the FDA to secure a separate clearance specifically for the treatment of knee OA. While awaiting approval, physicians can continue using Lipogems for the general indications outlined in the existing FDA clearance.

Carl Llewellyn, CEO of Lipogems USA, highlighted the company’s excitement, saying, “We are thrilled to announce another milestone in our pursuit of a specific indication in knee osteoarthritis. The success of our first study comparing MicroFat versus corticosteroid has been remarkable, and we anticipate this momentum to carry into the saline study.”

Llewellyn further emphasised the potential impact of Lipogems in reaching millions of patients who may not be ready or eligible for a total knee replacement, providing a valuable alternative to those who have exhausted conservative treatment options.

The completion and anticipated approval of both IDE Studies in knee OA will enable Lipogems to directly educate physicians and consumers about the benefits of MicroFat. This aligns with Lipogems’ commitment to improving patient lifestyles and recovery times across various medical specialties.

In the UK, the Living Room Health Regenerative Treatments serves as the exclusive distributor of Lipogems kits, bringing cutting-edge medical solutions to orthopaedics, aesthetics, and veterinary specialties. Lipogems, with FDA and CE mark approval, continues to revolutionise treatments across diverse medical domains.

For more information about Lipogems and its innovative adipose tissue solutions, visit UnderstandingLipogems.com, or contact us for exclusive access to Lipogems kits in the UK.