Columbia, MD – (July 10, 2015) – ACell, Inc. today announced that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This 510(k) covers expanded indications for ACell’s 2-, 3- and 6-layer surgical devices, branded respectively as MatriStem® Surgical Matrix RS, PSM, and PSMX. The new indications include implantation to reinforce soft tissue in plastic and reconstructive surgery for all of these device configurations, and increases the company’s total number of 510(k) clearances to nine. MatriStem Pelvic Floor Matrix continues to be indicated for urological and gynecological surgery.
“This most recent FDA clearance facilitates the further growth of ACell, and is indicative of our strategy to continue expanding the number of markets we reach,” said CEO James A. D’Orta, MD. “We have a deep pipeline of new regulatory applications, products, and clinical applications we are prepared to roll out over the next three years that will systematically grow our product portfolio and should greatly assist surgeons with addressing unmet patient needs.”
“We continue to explore new uses for our proprietary platform UBM technology,” Chief Science Officer Thomas Gilbert, Ph.D., said. “Adoption of our current product lines has been increasing at a rapid pace, and our research and product development activities are demonstrating exciting potential for additional clearances and even broader clinical uses of MatriStem technology in the future.”
ACell also manufactures and distributes a line of wound management devices including MatriStem® Wound Matrix sheets and MicroMatrix® micronized particles.
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.
MatriStem products contain the epithelial basement membrane from porcine urinary bladder, and are based on the proprietary ECM composition generally referred to in scientific literature as urinary bladder matrix, or UBM. UBM is a segment of tissue layers that facilitates a constructive tissue remodeling response by the patient’s body. MatriStem products are indicated for use in general surgery, gynecological surgery, and in the management of a wide range of wounds. Refer to the IFU supplied with each product for indications, contraindications and precautions. All MatriStem products are made in the USA.Return to News