LIPOGEMS® Receives IDE Approval from the U.S. FDA to begin a pivotal clinical study on the safety and effectiveness of the LIPOGEMS system for the treatment of knee osteoarthritis.
Atlanta, GA, June 9, 2022
Lipogems is pleased to announce the unconditional approval by the U.S. Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) study for treatment of knee osteoarthritis (OA) compared to corticosteroids for a period of 12 months.
Lipogems is a market stage medical device company that has received FDA 510(k) clearance since 2014 for their device, which is used to process adipose tissue for general applications in orthopaedics, arthroscopy and nine specialties and has been used in 50,000+ procedures worldwide under the current FDA clearance and CE mark. The Lipogems system has been used in multiple pathologies and is supported by 115+ independent peer reviewed publications from well-respected institutions worldwide and military installations. Physicians may continue to use Lipogems for currently cleared on-label indications in orthopaedics, arthroscopic surgery and nine other specialties. This study is separate from the existing FDA clearances. The completion of this study and anticipated approval in the setting of knee OA will permit Lipogems to educate directly to physicians and consumers for the treatment of this pathology.
Carl Llewellyn, CEO of Lipogems USA, stated “We are excited to achieve this milestone to pursue a specific indication in knee OA and have worked closely with the FDA to establish a pathway for Premarket Approval of the Lipogems System in this indication. Knee osteoarthritis is a crippling disease for millions of people that have tried conservative options but are not ready and/or do not qualify for a total knee replacement, a segment known as the treatment gap. The decision to pursue this specific indication is based on the positive results seen in 30+ independent peer-reviewed publications with up to 3 years follow-up evaluating pain, function, quality of life, and economic advantages. We anticipate that the approved IDE study will demonstrate compelling safety and efficacy data of patented Lipogems’ Microfragmented Fat (MFat) in knee osteoarthritis.”
Independent Lab Studies
As part of the IDE submission, independent labs conducted studies to demonstrate the preservation of MFat’s cell and tissue microarchitecture, the improved lubricity compared to commercially available Hyaluronic acid, and its ability to reduce the inflammatory cytokine cascade. This activity, and the positive results seen, help to further define the function of the Lipogems patented technology.
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The information presented is intended to demonstrate a Lipogems product. A surgeon must always refer to the package insert, product label, and/or instructions for use before using any Lipogems product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets.
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