ACell, Inc. a leading regenerative medicine company, has received additional US FDA clearance for its MicroMatrix device, which describes the concurrent use of MicroMatrix in conjunction with Cytal Wound Matrix or Cytal Burn Matrix devices.
MicroMatrix—the micronized particulate form of ACell’s patented Urinary Bladder Matrix (UBM) technology—facilitates coverage of the wound bed, especially in irregular wounds. Cytal Wound Matrix (1-Layer, 2-Layer, 3-Layer and 6-Layer) and Cytal Burn Matrix are sheet forms of UBM and provide a robust scaffold for cell infiltration and host tissue deposition.
“This is the third major FDA clearance over the last year for ACell, and we have a pipeline of new regulatory and clinical applications planned, as we continue commercializing expanded uses of our UBM technology,” said Patrick A. McBrayer, president and CEO.
This latest FDA clearance also provides for the modification of the MicroMatrix Instructions for Use to include the option for hydration of the device in sterile saline prior to application, in order to facilitate ease of use and adherence to the wound bed.
MicroMatrix and Cytal Matrix devices are intended for use in various wound management applications. ACell also manufactures a distinct line of surgical products, based upon the same UBM technology.
ACell, Inc. is a leading regenerative medicine company focused on the development, manufacturing and commercialization of unique proprietary extracellular matrix (ECM) products to facilitate the repair and remodeling of damaged tissues.