Xtant Medical wins CE Marks for Aranax, Irix-A spine devices

Xtant Medical said today it won CE Mark approval in the European Union for its Aranax cervical plating system and and Irix-A stand alone anterior lumbar fusion device.

The company’s Aranax cervical plating system is distributed as a pre-stereilized, ready-to-use implant. The Irix-A stand alone anterior lumbar fusion device consists of an integrated titanium ring in a PEEK shell.

“We are very pleased to have received these additional clearances for our best in class medical devices. They will allow us to expand our distribution presence and better serve the surgical needs of our customers internationally,” chief scientific officer Dr. David Kirschman said in a press release.

In July, Bacterin (OTC:BONE) said it agreed to acquire spinal implant maker  X-Spine Systems in a cash-and-stock deal worth about $86 million, including the assumption of debt, and rebrand as Xtant Medical Holdings.

Belgrade, Mont.-based Bacterin, which makes allograft products using its in-house tissue bank, said the deal includes $60 million in cash, about 4.24 million Bacterin shares and the assumption of roughly $13 million in debt.

X-Spine, based in Miamisburg, Ohio, became the hardware subsidiary for Xtant, Bacterin said.

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