New regulatory approval enables commercialization in Europe
AUSTIN, Texas – April 19, 2016 — Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused
on spine imaging informatics, announced today it has received CE mark approval for its lead product, Vertebral Motion
Analysis “VMA”. CE mark approval is required for the commercialization of the VMA in European markets. Prior to
securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to
commercialize in the United States. With this additional approval, OKI can begin selling the VMA technology in
European Countries.
OKI CEO Paul Gunnoe said, “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.” Mr. Gunnoe continued, “Europe
is very attractive in that it represents the largest market for the VMA technology outside of the US.”
VMA, or Vertebral Motion Analysis, is a diagnostic test for the assessment of spinal motion and radiographic
instability. Today’s current test for assessing spinal radiographic instability is ordered over 5 million times per year in the
US, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered
for potential spine surgery. The VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting
radiographic instability with no decrease in specificity relative to today’s current standard test. It has also been shown
to be more accurate, repeatable, and result in a lower dose of radiation.
OKI intends to begin commercialization efforts later this year in the United Kingdom, then expand from there. To
support commercial efforts, OKI will be working closely with local distribution partners in each country.
________________________________________________________________________
About Ortho Kinematics Ortho Kinematics is a privately held diagnostic technology company, focused on spine imaging
informatics and committed to the idea that spine motion matters. The company is working with a group of leading
clinicians, researchers, and developers who are passionate about leveraging spine biomechanical data to improve the
diagnosis and treatment of back pain. Ortho Kinematics is located in Austin, Texas and at www.orthokinematics.com.
Published at orthoKINEMATICS Press
No comments:
Post a Comment