GHP 2018 Pharmaceutical Manufacturing & Packaging Awards

GHP / Pharmaceutical Manufacturing & Packaging Awards 2018 17 orthopaedic conditions and this number is expected to increase substantially in the next two decades. Patients are seeking treatment options for their orthopaedic conditions and physicians desire to keep their patients satisfied and provide them different options throughout their course of treatment. There are a myriad of solutions available, however they are not all the same, and some are not even cleared for use by the FDA. For example, many clinics are offering fat that is processed using enzymes and isolates a specific cell. This is not cleared for use by the FDA. Many clinics, run by non-surgeon providers, are offering stem cell treatments at high prices. Also, many clinics may offer adipose-derived stem cells that are not compliant with the FDA standards. To ensure quality and assure patients, LIPOGEMS offers orthopaedic physicians and patients a compliant option that is cleared by the FDA and a technology that is supported by strong science. In November 2017, the FDA announced new guidelines for Human and Cell Tissue. The LIPOGEMS system meets the criteria for minimal manipulation of the tissue and homologous use of the tissue. The Lipogems® system is a single-use, disposable device which is used for the harvesting, processing, concentrating, and transferring of autologous adipose tissue when such transfer is desired. The device is intended for use in orthopedic surgery, arthroscopic surgery, neurosurgery, and other surgical specialties. The FDA has provided guidance that such tissue must be used for the repair, replacement, cushioning, and support of damaged or injured tissues. The company is continuously working with the FDA to ensure that the product and promotion meet their guidelines. This will remain its ongoing focus as it seeks to grow and build upon its current success. Currently, Lipogems is offered by leading orthopaedic physicians from the best orthopaedic institutions. Physicians from Hospital for Special Surgery, Emory, Duke, Cleveland Clinic, Harvard, Cornell, CORE Institute, Hughston Clinic, etc offer LIPOGEMS to their patients. Typically, orthopaedic physicians offer the technology at affordable fee or offer financing options to ensure that they are able to provide these options to their patients. The physicians are excited to offer a compliant solution that uses the patient’s own fat with a simple and efficient procedure, has strong science behind the technology and partner with a company that has responsible promotion. The company is dedicated to education and offers a variety of education programs for the physicians and their teams, and its future focus will remain on supporting its clients and patients alike. Company: Lipogems Contact: Amisha Patel Address: 1880 Beaver Ridge Circle, Norcross, GA 30071

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