What is mVASC™?
- The mVASC™ product consists of microvascular tissue derived from voluntarily donated human tissue.
- mVASC™ tissue is aseptically processed, freeze dried to remove moisture while preserving biologic components and terminally sterilized (SAL 10-6).
- mVASC™ is an off the shelf and ready to use product stored at room temperature.
- Each vial of mVASC™ contains microvascular tissue fragments (capillaries and venules) and associated cells such as endothelial and blood cells, and a high proportion of multipotent cells and pericytes which are naturally present in the microvasculature.
- mVASC™ is a natural biologically-active tissue with rich source of cytokines, growth factors and chemokines.
- mVASC™ tissue is restricted to homologous use for the reconstruction, repair, or replacement of microvascular tissues.
Microvascular Tissue Reconstruction, Repair, or Replacement.
mVASC™ contains key components for the Reconstruction, Repair, or Replacement of microvascular tissue. With few exceptions, all tissues have an underlying microcirculation that is composed of arterioles, capillaries and venules in which key liquid and solid exchanges occur. Microvascular tissue is the key underlying structure in which all tissues grow and remodel. Microvascular tissue includes the microcirculatory components, a variety of cell types and tissue matrix components – all of which contribute to the biologic nature of the tissue.
MVT uses proprietary methods that minimally manipulate donated human adipose tissue and prepare the microvascular tissue whereupon the tissue, cells, and structure remain intact. There are no living cells in the mVASC™ product. In fact, all cells are carefully deactivated so they no longer multiply but remain intact, leaving the biologic nature of the tissue in place. As such, delivery of this microvascular tissue to tissue sites that require Reconstruction, Repair, or Replacement is appropriate.
mVASC™ Regulatory Classification.
- mVASC™ microvascular tissue is classified by the U.S. Food and Drug Administration (FDA) regulations as a human tissue intended for transplantation.
- mVASC™ is obtained, processed, and sold in accordance with FDA’s requirements for banked human tissue (21 CFR Parts 1270 and 1271), as well as the American Association of Tissue Banks (AATB) Standards for Tissue Banking.