Aurora Spine wins CE Mark for TiNano spine implant

Aurora Spine (TSX:ASG.V) said Tuesday it won CE Mark approval in the European Union for its TiNano spinal fusion implants.

TiNano implants are sterile-packed titanium coated spinal implants made of PEEK thermoplastic material, the Carlsbad, Calif.-based company said.

“This CE Mark issuance is a major accomplishment for Aurora Spine. TiNano intervertebral implants are developed to support the entire spine from cervical to lumbar regions and to accommodate the company’s Zip minimally invasive interspinous fusion system portfolio as part of Aurora’s screwless procedure,” CEO Trent Northcutt said in a press release.

Carlsbad, Calif.-based Aurora Spine is an early stage medical device company focused on screwless, minimally invasive regenerative spine implant technologies.

“We are very excited that after a successful product launch in the United States now we can offer our sterile packed, TiNano-coated fusion cage portfolio to all European markets,” director of regulatory affairs and quality assurance Michael Thompson said in prepared remarks.

“The CE Mark approval includes several interbody fusion devices, including configurations for anterior cervical, anterior lumbar, posterior lumbar, transforaminal lumbar and the fastest growing segment, lateral lumbar interbody spacers,” CTO Laszlo Garamszegi said in a prepared statement.

In March, Aurora Spine raised about $3 million ($3.7 million Canadian) in a private placement broken down in 2 tranches. The California-based spinal device maker plans to use the cash infusion for “working capital purposes.”

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