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

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Jun 09, 2022, 16:12 ET

ATLANTA , June 9, 2022 /PRNewswire/ -- 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. 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 Lipogems' Microfragmented Fat (MFat) in knee osteoarthritis."

About Lipogems

Lipogems 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 diverse range of areas, including plastic and reconstructive surgery, orthopaedics, general surgery, exploring products for wound care and more. Lipogems is available in 29 countries and the aim is getting patients back to their lives through our global reach and scientific excellence. Information about Lipogems can be found on: http://www.understandinglipogems.com/

SOURCE Lipogems