Amedica/US Spine® Further Expands Reach Within the Stem Cell Biotechnology Market
Secures Distribution/Licensing Agreement with BioDlogics® for Amniotic Stem Cell Spinal Repair Products
SALT LAKE CITY, Nov. 16, 2010 /PRNewswire/ -- Amedica/US Spine, a spine and reconstructive implant and instrument manufacturer focused on unique silicon nitride (SiN) technologies, recently completed a distribution/licensing agreement with Memphis, Tenn.-based BioDlogics that will clearly expand its presence in the growing spine and orthopaedic biotechnology arena. Amedica/US Spine will distribute stem cell products indicated for spinal fusion, adhesion barrier and nerve protection.
BioDlogics procures and processes human cellular and tissue-based products/allografts derived from the amniotic tissue of healthy, pre-screened live donors through scheduled caesarian births. From aseptic recovery of the tissue during childbirth to timely processing of the allografts, all of the company's standards meet or exceed all applicable industry standards for the use of human cellular and tissue-based products.
"This important agreement enables us to grow our unique portfolio of osteo biologics products for the spine marketplace and will further enhance our market position as a significant developer, manufacturer and distributor of open and minimally invasive spinal applications. These new offerings are a natural complement to our MC2 Silicon Nitride spine spacers and our complete line of spinal implants," said Ben Shappley , Chief Executive Officer, President and Director of Amedica/US Spine.
The BioDfactor liquid product is derived from human amnion living tissue and is cryopreserved to provide viable tissue for clinical use. Amniotic fluid and tissue have been recognized as a versatile injectable allograft with a rich source of proteins, growth factors and pluripotent cells essential for fetal growth and development, enhancing the body's natural regenerative process aiding in certain indicated fusion procedures.
The BioDfence allograft is a sterile structural tissue derived from human amniotic tissue that forms a physical barrier between the dura and surrounding soft tissue or paraspinal muscles to reduce fibroblast infiltration into the epidural space where post-operative scar tissue normally forms. This reduces epidural fibrosis at the surgical site. The allograft also acts as a structural barrier to preserve the plane between the dura and the surrounding soft tissue to reduce the tethering of adhesions to the dura or nerve roots. The unique biological structure of the amniotic tissue acts to reduce both the accumulation of scar tissue and the tenacity of the scar tissue that does form. In the event a surgical revision is later required, it also should significantly reduce the operative time necessary to perform any such procedure.
Amedica/US Spine markets a complete suite of biologic products, including human amniotic stem cells, injectable 100percent DBM, allograft bone, hydroxyapatite and beta tricalcium phosphate synthetic bone.
Both BioDfence and BioDfactor are processed and packaged at an FDA-registered tissue bank in accordance with CGTP standards.
For more information about Amedica/US Spine, visit www.amedicacorp.com.
About Amedica/US Spine:
Amedica/US Spine is ISO 13485 certified and its products are FDA cleared and CE and ANVISA approved. The company is an emerging spine and orthopaedic implant and device manufacturing and distribution concern with advanced surgical applications including silicon nitride ceramic technologies. The company's platform technologies represent a new standard for implants and biologics based on superior performance, safety and efficacy.
SOURCE Amedica Corporation
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