Ortho Kinematics said today it won CE Mark approval in the European Union for its Vertebral Motion Analysis system designed to assess spinal motion and radiographic instability.
The VMA system from Austin, Texas-based Ortho Kinematics uses fluoroscopy to capture images of the spine in motion, is designed to displace traditional X-ray imaging as the primary method for identifying spinal dysfunction, the Austin, Texas-based company said.
The company said the system has been shown to increase sensitivity in detecting radiographic instability without a decrease in specificity in peer-reviewed studies.
“The VMA technology has a multi-billion-dollar annual worldwide revenue potential, and with CE mark approval, we can now expand our efforts toward realizing that potential. Europe is very attractive in that it represents the largest market for the VMA technology outside of the US,” CEO Paul Gunnoe said in a press release.
Ortho Kinematics said it intends to begin commercializing the device in the U.K. with plans to expand from there through local distributors in each country.
The company said that prior to winning CE Mark approval, the device had won clearance from the FDA.
In January, Ortho Kinematics said it raised $4 million in a debt financing round to support the general biz and expand the commercialization of its flagship Vertebral Motion Analysis radiographic assessment device.
The round was led by early stage tech venture focused TEXO Ventures and joined by other previous investors, the company said.