EDISON, N.J., July 11, 2013 /PRNewswire/ -- MTF, the Musculoskeletal Transplant Foundation, announced today that it is the first tissue bank to receive approvals to market human allografts in Australia under the new Australian Biologics Framework, implemented in May 2011.
The first two approved biologics in Australia are:
- DBX® Putty - an osteoinductive bone allograft processed from donated human tissue, specifically designed to meet the Australian medical and regulatory requirements, and
- FlexHD® and FlexHD® Pliable allografts processed from donated human skin and packaged in an ethanol solution.
According to Bruce Stroever, MTF President & Chief Executive Officer, "These were complicated, multi-year projects and we are delighted that our facilities, processes and people have met the Australian Therapeutic Goods Act requirements. Of special note, our new in-process bioburden testing method and isolator technology were critical in achieving approval of DBX® from the Australian authorities."
DBX®, a Demineralized Bone Matrix, is an allograft bone void filler used for the treatment of surgically created bone defects, or bone defects created from traumatic injuries. It can be used as a bone extender in orthopaedic, spine and trauma applications. DBX® has been approved for use in over 50 countries.
FlexHD® and FlexHD® Pliable are intended for use in the replacement of damaged or inadequate integumental tissue, or for the reinforcement or supplemental support of soft tissue defects. These allografts have been used extensively for hernia repair as well as for patients needing breast reconstruction following mastectomy.
Stroever noted that MTF's quality and safety standards now meet or exceed the requirements of the American Association of Tissue Banks (AATB), US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA).
The Musculoskeletal Transplant Foundation (www.MTF.org), one of the nation's leading tissue bank, changes lives by connecting donors and transplant recipients. As a non-profit service organization, MTF is dedicated to providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. Since our inception in 1987, MTF has received tissue from more than 100,000 donors and distributed more than 5.5 million-grafts for transplantation.
For information: Cindy Gordon, Issues Management LLC, 609-252-1300
SOURCE Musculoskeletal Transplant Foundation