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Spine Wave Inc., a developer of spinal disorder devices in Shelton, Conn., has landed marketing approval from the U.S. Food and Drug Administration for its StaXx XDL Expandable Device.
The device is a PEEK spacer, intended for spinal fusion through lateral surgery. The StaXx XDL uses the company's proprietary expandable technology.
Spine Wave develops surgical technology for use in vertebral compression fraction repair, nucleus replacement and augmentation and spinal fusion, the company notes on its website.
In February, the company raised $17.5 million in a funding round led by return backer New Enterprise Associates, with additional support from Morgenthaler Ventures, Compass Global Fund, New Leaf Venture Partners, Canaan Partners, Foundation Medical Partners and Memphis Implant Partners. At the time, Spine Wave planned to use the funding to assist in bringing its NuCore Injectable Nucleus to clinical trials.
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