Amedica Corporation, an emerging leader in the design and development of innovative orthopedic devices, today announced that it has received clearance from the United States Food and Drug Administration (the "FDA") for market distribution of its Arx™ Ceramic Spinal Spacer System™.
With this FDA marketing clearance, Amedica believes its Arx spinal spacers are the world's first ceramic spinal implants cleared for use in humans.
"This clearance is a great leap forward for us," said Ashok Khandkar, Ph.D., president and chief executive officer of Amedica. "We are very excited to take the next step toward offering what we believe is the world's first FDA-cleared ceramic spinal implant system."
The Arx Ceramic Spinal Spacer System provides innovative, biocompatible implants based on Amedica's patented MC2™ technology that offers physicians and patients an alternative to other synthetic and allograft bone implants used for the restoration of spinal anatomy. Such spinal implants are estimated to comprise an annual U.S. market segment of more than $600 million.
"We believe that this FDA clearance indicates that our MC2 technology platforms and forthcoming products have great promise," Dr. Khandkar said. "We are currently finalizing the next generation of spinal implants based on an even more advanced MC2 ceramic technology. When we introduce these ceramic spinal implants to the marketplace, we expect they will offer many innovations that may lead to better patient outcomes."
Amedica's Arx spinal implants are designed as vertebral body replacements for use in the thoraco-lumbar region of the spine to replace collapsed, damaged or unstable vertebral bodies, resulting from such causes as degenerative disease and/or trauma. These spinal implants combine strength, imaging clarity and bio-mimetic characteristics which the company believes are unique to its products. Amedica anticipates surgeons using its ceramic spinal implants will quickly appreciate the ease of use, reproducibility and predictability provided by its products in spinal procedures.
"Although there are alternative implants in the marketplace, such as those made with titanium and PEEK polymer, as well as grafts taken from human cadavers, each falls short of the combined valuable attributes of Amedica's ceramic spinal spacer system," said Darrel Brodke, M.D., associate professor in the Department of Orthopedic Surgery, University of Utah School of Medicine, and Chief of the Spine Service and Medical Director of the University Spine Center. "Amedica's ceramic spinal implants uniquely combine strength, with the advanced ability to bind with bone, and simultaneously provide the image compatibility necessary for medical diagnostic imaging."
"We are pleased at the prospect of being able to offer the first ceramic spinal implants to our customers," Dr. Khandkar said. "We expect to file for FDA clearance of our next generation of ceramic spinal implant products during the first half of 2006. This is part of our overall effort to offer a comprehensive range of innovative products for surgical treatment of spinal disorders as well as hip and knee joint pain."
Amedica Corporation currently has several other products in development using its proprietary and patented technology platforms: MC2 ceramic femoral heads for use in hip replacement surgery; Infinia™ knee implants; Altia™ spinal disc implants for use in disc replacement surgery; and the CSC™ platform for its ZeTA™ spinal fixation implants which substantially mimic natural bone. The company's technology platforms allow its products the potential to offer unprecedented strength, durability, imaging characteristics and bio-safety over existing products.