What is Lipoderma?
Lipoderma is a human adipose tissue allograft used for the repair, reconstruction, or replacement of adipose tissue defects. It preserves the native architecture and components of fat, including the extracellular matrix and signaling molecules, to restore natural volume and support healthy tissue remodeling.
How is Lipoderma classified?
Lipoderma meets the FDA’s requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) under Section 361 of the Public Health Service Act. It is FDA-registered and manufactured in compliance with American Association of Tissue Banks (AATB) standards for donor screening, recovery, and processing.
How is Lipoderma processed?
Lipoderma is produced from adipose tissue recovered from eligible cadaveric donors. Donors are fully screened and tested in accordance with Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB) requirements. The tissue is aseptically processed in a cleanroom environment and each lot is tested for sterility to ensure product safety and quality.
Does Lipoderma contain viable cells?
No. Lipoderma contains intact, but devitalized adipocytes.
Does Lipoderma revascularize?
Yes. Nonclinical studies demonstrate host-driven revascularization, with new vessel formation observed as early as three days after implantation.
What happens to the DNA within Lipoderma?
Residual DNA within devitalized adipocytes is naturally degraded after implantation. In vivo testing shows no detectable human DNA by four weeks post-implantation.
Does Lipoderma trigger an immune response?
No. The manufacturing process removes immunogenic components such as lymph nodes and blood cells while retaining the structural adipocytes. Devitalization reduces antigenicity, and both in vitro and in vivo studies confirm that Lipoderma does not elicit an immune response.
What are the safety data to date?
To date, zero product-related adverse events have been reported. Lipoderma has demonstrated an excellent safety profile in clinical use.