Titan Spine has obtained separate registration approval from both the Australian Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority to commercially market its full line of Endoskeleton interbody fusion devices in the two countries.
Titan Spine president Kevin Gemas said that the recent marketing authorization approvals in Australia and New Zealand are a significant milestone for the company as they effectively expand the availability of its Endoskeleton interbody fusion devices to four broad global markets, including the US and the EU.
"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," Gemas added.
"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."
Titan Spine’s full line of Endoskeleton devices incorporates the company’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels.
According to the company, the combination of surface levels creates an enhanced environment for bone growth at the cellular level, encouraging natural production of bone morphogenetic proteins, and creating the potential for a faster and more robust fusion.
The company’s line of Endoskeleton interbody fusion devices is available in Europe and the US in addition to Australia and New Zealand.