ACell®, Inc. Receives FDA Clearance for Concurrent Use of its Wound Management Devices
Columbia, MD – (March 23, 2016) – ACell, Inc. today announced that it has received additional 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.
About ACell, Inc.
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. ACell is committed to becoming and remaining an innovative leader in regenerative medical technology, offering superior healing options for doctors and patients. ACell is a privately held company and operates manufacturing facilities in Columbia, MD and Lafayette, IN. For more information, call 800-826-2926 or visit www.acell.com.
About Cytal Wound Matrix and MicroMatrix
Cytal Wound Matrix, Burn Matrix, and MicroMatrix products are based on the proprietary Extracellular Matrix composition generally referred to in scientific literature as urinary bladder matrix, or UBM. UBM contains the epithelial basement membrane from porcine urinary bladder, and facilitates a constructive tissue remodeling response by the patient’s body. Cytal and MicroMatrix products are intended for management of a wide range of wounds. Refer to the IFU supplied with each product for indications, contraindications and precautions. Cytal Wound and Burn Matrix devices have previously been marketed as MatriStem® Wound and Burn Matrix.