New regulatory approval enables commercialization in Canada
AUSTIN, Texas – May 25, 2016 — Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it has received Health Canada authorization for its lead product, Vertebral Motion Analysis “VMA”. The VMA is now licensed for sale in Canada, expanding the VMA’s current list of markets, which include the United States and Europe.
OKI CEO Paul Gunnoe stated, “Expanding into Canada is a big step forward in positioning the VMA as a global standard of care for assessing spinal motion and instability.” Mr. Gunnoe continued, “We believe Canadian patients and their providers stand to benefit significantly.”
The VMA 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 United States, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered for potential spine surgery. Relative to today’s current standard test, the VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity. Furthermore, the VMA has shown to be more accurate, repeatable and result in a lower dose of radiation.
OKI plans to begin offering the VMA in Canada later this year, limiting initial distribution to a select group of spine care institutions.
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