TITAN SPINE RECEIVES MARKET REGISTRATION APPROVAL IN AUSTRALIA AND NEW ZEALAND FOR ITS ENDOSKELETON® INTERBODY FUSION DEVICES Expands registration to Four Broad Global Markets: US, EU, Australia and New Zealand Underscores growing adoption of titanium devices that participate in the fusion process
MEQUON, Wis., —Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has received separate registration approval from both the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) to commercially market its full line of Endoskeleton® interbody fusion devices in the two countries.
Kevin Gemas, President of Titan Spine, said,“The recent marketing authorization approvals in Australia and New Zealand are a significant milestone for Titan Spine as they effectively expand the availability of our Endoskeleton® interbody fusion devices to four broad global markets, including the United States and the European Union. Entry into our two most recent markets underscores the increasing global adoption of our titanium implants that feature a unique surface technology designed to participate in the fusion process by upregulating the body’s own bone growth factors. We look forward to developing relationships with spine surgeons in these two countries, with the ultimate goal of providing patients with an option for faster and more robust fusion.”
Andrew Shepherd, Vice President, Marketing of Titan Spine, said, “We are pleased to expand our offerings into Australia and New Zealand on the heels of our recent growth in Europe. We will continue to identify markets that embrace the science of surface technology and its potential benefits for surgeons and patients alike.”
The full line of Endoskeleton® devices features Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. This combination of surface levels is designed to create an enhanced environment for bone growth at the cellular level, encouraging natural production of bone morphogenetic proteins (BMPs), and creating the potential for a faster and more robust fusion.
In addition to Australia and New Zealand, Titan’s line of Endoskeleton® interbody fusion devices is available throughout Europe and the United States. For more information on Titan’s devices and proprietary surface technology, please visit www.titanspine.com.
About Titan Spine
Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and Germany through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.
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