ACell Announces CE Mark Approval
Milestone Paves the Way for MicroMatrix and Cytal Wound Management Devices in European Union
Columbia, MD, December 22, 2020 ‐‐ ACell, Inc., a leading regenerative medicine company, announced today that it has received CE mark approval for its MicroMatrix®, Cytal® Wound Matrix, and Cytal® Burn Matrix devices. This regulatory approval allows ACell to distribute these products throughout the 27 countries of the European Union.
President and CEO Patrick McBrayer said, “The CE Mark approval is a significant accomplishment for ACell, which required rigorous regulatory review against stringent safety and clinical standards. We are proud to be one step further to offering our wound management products to patients and their health care providers throughout Europe.”
About Cytal Wound Matrix and MicroMatrix
MicroMatrix, Cytal Wound Matrix, and Cytal Burn Matrix have received CE Mark approval according to the Medical Device Directive and are intended for the management of wounds including partial and full‐thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic tunneled/undermined wounds, surgical wounds (donor sites/grafts, post‐mohs surgery, post‐laser surgery podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second‐degree burns, skin tears), and draining wounds. These devices are intended for one‐time use.
About ACell, Inc.
ACell, Inc. is a leading regenerative medicine company focused on the development, manufacture and sale of products primarily used in acute care settings as part of the treatment and management of moderate to severe wounds and reinforcement of soft tissue surgical defects. ACell’s products utilize its proprietary porcine urinary bladder matrix platform technology to facilitate remodeling of site‐appropriate tissue.